Patent Abstract:
Devices and methods are disclosed for achieving hemostasis in traumatized patients. Such haemostatic packing devices and methods are especially useful in the emergency, trauma surgery or military setting. In such cases, the patient may have received trauma to abdominal viscera, the thoracic cavity or the periphery. The devices utilize fluid impermeable outer surfaces and distributed pressure to achieve tamponade and hemostasis, primarily by exertion of pressure. The devices come in a variety of configurations including sheet, rolled sheet, folded sheet and polygonal solids including extruded shapes. The devices are capable of serving as carriers for thrombogenic or antipathogenic agents. The devices are flexible, bendable, and conformable in their wet or dry state so that they exert distributed pressure on the wound. Peripheral haemostatic packing devices include optional adhesive hemostatic barriers to cover the entire wound area over the hemostatic pack. The hemostatic packing devices may be placed and removed by open surgery or laparoscopic access without generating excessive re-bleeding, and may further comprise antimicrobial or thrombogenic regions.

Full Description:
RELATED APPLICATIONS 
       [0001]    The present application is a Continuation of U.S. patent application Ser. No. 12/012,084, filed Jan. 31, 2008, now U.S. Pat. No. 7,943,810, which is a Continuation-in-Part of U.S. patent application Ser. No. 11/087,224, which is a Continuation-in-Part of U.S. patent application Ser. No. 10/358,881 filed Feb. 4, 2003, the entirety of all of which are hereby incorporated herein by reference, and claims priority benefit under 35 USC §119(e) from U.S. Provisional Application No. 60/555,537 filed Mar. 23, 2004, entitled “METHOD AND APPARATUS FOR PERIPHERAL HEMOSTASIS”, the entirety of which is hereby incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The field of this invention is wound care during trauma surgery, general surgery, combat medicine, and emergency medical services. The invention is applicable to animals, especially including mammals, and is directed primarily at use on humans. 
       BACKGROUND OF THE INVENTION 
       [0003]    As recently as the early 1990s, surgical operations for trauma were directed at the anatomic repair of all injuries at time of the initial operation. It was observed during these exercises that many patients became hypothermic, acidotic, and coagulopathic. Patients showing these three signs often died. Death often occurred in the operating room due to exsanguinations, or postoperatively, due to the complications of prolonged shock and massive transfusion to replace blood lost as a result of the trauma. 
         [0004]    One of the most notable developments in the recent evolution of surgery has been the introduction of the concept of staged laparotomy to overcome the deficiencies of the repair all-at-once approach. This new strategy of staged laparotomy, employing new tactics that have been termed damage control, is now used in 10% to 20% of all trauma laparotomies. 
         [0005]    This damage control strategy opens the way for a variety of new devices and methods for a) control of hemorrhage from solid organs or viscera, b) control of hemorrhage from peripheral wounds and peripheral vascular lacerations, and c) control of contents spillage from hollow viscera. Although there are procedures for controlling these injuries, none of these procedures utilize optimal devices or tactics in their execution. Each area offers technological opportunities to improve the devices and procedures for applying those devices. 
         [0006]    Ever since the advent of abdominal surgery, surgeons have relied on the same thinly woven cotton gauze packing pads that are currently in favor. These gauze pads are called laparotomy pads or Mickulitz pads. These pads were designed for use as sponges but not for use as hemostatic tampons. Nonetheless, since World War I, surgeons faced with severe bleeding have relied on packing patients with these sterilizable gauze sponges in an effort to control bleeding. Since World War II, it has been known that abdominal packing using these pads has been associated with abdominal sepsis and re-bleeding after pad removal. Despite these limitations, even today, they are the mainstay of damage control hemostasis. 
         [0007]    The specific issues with the gauze pads are that they are porous and allow the free passage of blood through the mesh. Other unfavorable characteristics include the lack of intrinsic coagulation inducing properties. The pads are easily saturated and they do not stick to one another. The pads are capable of promoting infection because they serve as a nidus for bacteria in a contaminated field. They have no intrinsic antiseptic or antimicrobial action. These pads are unsuitable for packing solid viscera because they stick to the visceral wound tissue and cause re-bleeding upon removal. Although generally recognized as sub-optimal, the gauze pads have the advantages of being cheap, familiar and ubiquitous. For these later reasons, they continue to remain the mainstay of damage control hemostasis. Among the opportunities for new technologies and instruments to support the process of damage control, the first requirement is an improvement in the surgical pack and for control of peripheral hemorrhage through an open wound through the skin. 
         [0008]    Other current pads for hemostasis include gel-foam, Surgical, and fibrin sponges. These devices are all liquid permeable and require blood coagulation to occur before impermeability and hemostasis are achieved. In addition, the fibrin sponges are very rigid and will not conform to a wound while in the dry state. Typical examples of the prior art in hemostatic packing systems include U.S. Pat. No. 5,643,596 to Pruss et al., U.S. Pat. No. 5,763,411 to Edwardson et al., U.S. Pat. No. 5,800,372 to Bell et al., U.S. Pat. No. 6,054,122 to MacPhee et al., and U.S. Pat. No. 6,056,970 to Greenawalt et al. These patents, all of which are included herein by reference, disclose permeable hemostatic packing and dressings with topical hemostatic coatings. These devices all serve the purpose of stopping bleeding in underlying vessels with an occlusive backing but the backing is still permeable to blood leakage. The lack of impermeability in these prior art patents is not recognized as an issue. 
         [0009]    While hemostatic packing devices are well known in the art, the utility of said packing devices is limited by their propensity to harbor pathogens and their propensity to create re-bleeding by adherence to healing surfaces. One device uses a powdered hemostatic agent that is poured into a wound. The hemostatic agent reacts with the blood, withdrawing water from the blood and causing rapid thrombosis to occur. This agent, however, aggravates the spread of infection and is difficult to remove when definitive repair takes place. The reaction with the blood is exothermic and causes undesirable, localized tissue heating. Further, there is no inherent mechanism to hold the hemostatic agent in place in the wound other than application of a separate covering bandage. In addition, current devices adhere to a wound or surrounding tissue by adhesive methodologies. In an acute or emergency setting there may be profuse bleeding, water, oil, mud, or other contaminants that defeat an adhesive and prevent sticking. Current bandages can control bleeding that weeps from a wound because of pressure restrictions but do not control major vessel hemorrhage because they cannot stop the flow of blood at unrestricted systemic arterial pressure. 
         [0010]    New devices, procedures and methods are needed to support the strategy of damage control in patients who have experienced massive bodily injury. Such devices and procedures are particularly important in the emergency, military, and trauma care setting. These new devices rely on the principles of impermeability to blood passage, limited nidus formation for bacteria, the ability to carry prothrombogenic material, and the lack of intrinsic thrombogenicity except by providing a physical barrier or pressure source. 
       SUMMARY OF THE INVENTION 
       [0011]    This invention relates to an improved hemostatic packing device for use in trauma care. The present invention is an impermeable barrier pack or wrap for a body appendage. Other features of the pack include foldability and moldability to the anatomical surface. The exterior surface of the pack is not intrinsically thrombogenic but is capable of serving as a carrier for thrombogenic substances. Said thrombogenic substances can be liquids or solids but are, preferably gels with internal cohesion and spreadability. Certain regions of the exterior surface of the pack may optionally comprise thrombogenic properties. The pack may be made with a plurality of surfaces, each with distinct characteristics. An exemplary version of the pack has a thin layer of polyethylene or polypropylene, which is impermeable to liquids, covering its entire outer surface. A key advantage of the present invention, in its wet or dry state, is moldability, flexibility and shapeability to the anatomical contacting surface, including the ability to pack wounds in solid viscera. The pack is able to distribute pressure within the wound to generate pressure tamponade. The pack is capable of generating pressure tamponade without regions of sharp or high stress such as would be generated by a rigid packing system. This improvement over certain very hard packing devices allows for better fit to the anatomy and the immediate formation of an impermeable barrier without the need to wait for blood coagulation to occur to form the hemostatic barrier. The hemostatic pack of the present invention is placed via open surgery or through laparoscopic instrumentation. The laparoscopic embodiment includes the capability of reversibly or irreversibly achieving a size and mass change in the device once it is placed within the patient. 
         [0012]    The present invention distinguishes over the cited prior art because it requires no thrombogenic coatings, although it is capable of trapping and carrying such pro-thrombogenic coatings on its surface. The outer surface of the haemostatic packing sponge serves as a carrier by incorporating indents or villi to physically hold the pharmacological, thrombogenic or antibacterial coatings. Since the surface is impermeable to liquids, the arrest of hemorrhage is immediate and does not require thrombosis to occur. When the packing device of the present invention is removed from the patient, re-bleeding does not occur because there is not penetration of the wound tissues or clot into the interstices of the pack. An additional advantage of the impermeable pack is a resistance to bacteria and other pathogenic penetration. In another embodiment, the hemostatic pack comprises two or more layers of material having different compressibility and resilience. The different material properties can be achieved by different manufacturing processes to achieve, for example, different pore sizes and wall thicknesses in a foam structure, or by pre-compressing the foam to different degrees, or both. 
         [0013]    In another embodiment of the invention, the pack, or wrap, comprises raised ridges or dams on its surface. These ridges or dams are comprised of soft, conformable, or elastomeric, materials that form an edge seal to prevent the escape of blood from a wound. The pack, or wrap, optionally comprises additional regions or borders of enhanced blood clotting or thrombogenesis to assist with the hemostatic properties of the device. 
         [0014]    In yet another embodiment of the present invention, the hemostatic pack comprises adhesives, fasteners, or the like to allow the packs to adhere to each other, thus forming a syncytium, or contiguous barrier comprised of more than one component, to prevent blood from escaping from a wound. 
         [0015]    In another embodiment of the invention, the hemostatic pack is a bandage or peripheral hemostasis system (PHS) that is worn over a vascular wound that communicates with the exterior environment of the patient through a break in the skin. Such wounds, particularly in the extremities of the patient such as the head, neck, arms, legs, hands, and feet, may include severe vascular damage that could result in bleeding to death, or near-exsanguination with its concomitant complications. In an embodiment, a bandage or PHS is described that comprises one or more external dams that are held against the skin surrounding the wound by force sufficiently capable of sealing the wound from blood leakage. The region inside the dams is bounded by the dams at the perimeter, a liquid impermeable barrier on the exterior, and the skin and wound on the inside. Blood cannot escape from this region as long as the seal between the dam and the skin is intact. This device is most efficacious on patient extremities since the vasculature is typically surrounded by intramuscularly tissue, which cannot be tunneled by blood hemorrhage under systemic arterial pressure to cause blood pooling. In the thorax, abdomen, or pelvic region, internal body cavities can fill with pressurized blood so the hemostatic pack or wrap is less efficacious in these regions. 
         [0016]    In yet another embodiment of the invention, the bandage or PHS comprises a strap to hold the dam and fluid or liquid impermeable region over the wound. The strap, in a preferred embodiment comprises some elasticity and further comprises a fastener that is adjustable. The strap, in another embodiment, further comprises a standoff, which is a rigid or semi-rigid member that prevents the strap from circumferentially constricting the appendage around which the strap is wrapped, yet which allows the strap to pull the dam and fluid impermeable region against the tissue surrounding the wound. The dams and liquid impermeable region therebetween are held against the skin by force in substantially one direction only, not a circumferential or radial force. In yet another embodiment, the bandage comprises a central packing device to exert pressure on the wound to facilitate tamponade. This central packing device may be a folded fabric pad, a sac or a bladder filled with liquid, gas, gel, foam, powder, or the like. The central packing device may also simply comprise an externally communicating port that allows gas or liquid to be infused into the region between the dams, the liquid impermeable layer and the skin. The gas or liquid may be pressurized to exceed systemic arterial pressure and thus tamponade the wound. In yet another embodiment of the invention, the bandage comprises an inner dam and an outer dam. A vacuum drawn on the region between the inner dam and the outer dam, through a port that communicates through the fluid impermeable layer between the two dam regions, holds the bandage against the skin and prevents blood escape under systemic arterial pressure. In another embodiment, the region between the dams comprises hemostatic, bioadhesive, or thrombogenic agents to assist with sealing the bandage to the skin surrounding the wound and preventing blood loss past the dams. In an embodiment, the hemostatic or bioadhesive agents are pre-applied to the bandage in a dry state or are dried after application, wherein the hemostatic or bioadhesive agents are inactive until wetted by the presence of blood or other liquids containing water. 
         [0017]    For purposes of summarizing the invention, certain aspects, advantages and novel features of the invention are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    A general architecture that implements the various features of the invention will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate embodiments of the invention and not to limit the scope of the invention. Throughout the drawings, reference numbers are re-used to indicate correspondence between referenced elements. 
           [0019]      FIG. 1A  illustrates a two-sided hemostatic pack comprising a sheet of material that is impermeable to liquid on one side and the other side is a permeable fabric affixed to the impermeable barrier, according to aspects of the invention; 
           [0020]      FIG. 1B  illustrates a cross-sectional view of the two-sided haemostatic pack, according to aspects of the invention; 
           [0021]      FIG. 1C  illustrates the two-sided hemostatic packing device folded with the impermeable surface facing outward toward the wound surface, according to aspects of the invention. In this embodiment the impermeable surface is on both sides of the device; 
           [0022]      FIG. 1D  illustrates the two-sided hemostatic pack rolled with the impermeable side out, according to aspects of the invention; 
           [0023]      FIG. 2  illustrates a hemostatic packing device comprising a closed-cell foam that is impermeable on both sides, according to aspects of the invention; 
           [0024]      FIG. 3  illustrates a hemostatic packing device comprising an outer surface that is impermeable on both sides where the upper surface further comprises indentations capable of carrying exogenous thrombogenic substances, according to aspects of the invention; 
           [0025]      FIG. 4  illustrates a hemostatic packing device comprising a polygonal deformable solid with an impermeable outer surface, according to aspects of the invention; 
           [0026]      FIG. 5A  illustrates an inflatable hemostatic packing device that comprises an impermeable outer surface, and an internal bladder that is capable of containing material, where said material when reversibly introduced into the bladder through a sealing port, is in the form of solid particles, a fluid, or a combination thereof, according to aspects of the invention; 
           [0027]      FIG. 5B  illustrates one embodiment of the inflatable hemostatic packing device in its deflated or partially deflated state, according to aspects of the invention; 
           [0028]      FIG. 6  illustrates a hemostatic packing device being introduced into a patient through a laparoscopic instrument, according to aspects of the invention; 
           [0029]      FIG. 7  illustrates a hemostatic packing device comprising an adhesive on at least a portion of the outer impermeable surface of said hemostatic packing device, according to aspects of the invention; 
           [0030]      FIG. 8  illustrates a hemostatic packing device comprising a packing material with an impermeable outer surface affixed to an adhesive impermeable drape, according to aspects of the invention; 
           [0031]      FIG. 9A  illustrates a wound of the liver, according to aspects of the invention; 
           [0032]      FIG. 9B  illustrates the wound of the liver being treated by application of internal tamponade of hemorrhage with the impermeable hemostatic packing device used in a peri-hepatic location, according to aspects of the invention; 
           [0033]      FIG. 10A  illustrates a wound of an exemplary extremity, the thigh, with femoral artery transection, according to aspects of the invention; 
           [0034]      FIG. 10B  illustrates the wound to the thigh being treated by application of an impermeable hemostatic packing device with the adhesive impermeable drape, according to aspects of the invention; 
           [0035]      FIG. 11  illustrates a wound dressing, PHS, or bandage for treating a wound to the arm or the leg comprising a blood dam, according to aspects of the invention; 
           [0036]      FIG. 12  illustrates a wound dressing, PHS, or bandage for treating a wound to the arm or the leg comprising a series of blood dams, according to aspects of the invention; 
           [0037]      FIG. 13  illustrates a wound dressing, PHS, or bandage for treating a wound to the arm or the leg comprising a blood dam with a communicating valve, according to aspects of the invention; 
           [0038]      FIG. 14A  illustrates a lateral sectional view of two internal hemostatic packs for solid organs, viscera, and the like, comprising an adherent region for joining the two packs, wherein the adherent region comprises a porous adhesive element but further comprises a plurality of non-porous barrier regions or dams, according to aspects of the invention; 
           [0039]      FIG. 14B  illustrates a lateral sectional view of two internal hemostatic packs that have been joined together to form a syncytium wherein the barrier regions or dams render the adherent region impermeable to fluids such as blood, according to aspects of the invention; 
           [0040]      FIG. 15  illustrates an oblique view of a preferred wound dressing, PHS, or bandage for treating a wound to a body part comprising a strap, a blood dam, and a pillow pack, according to aspects of the invention; 
           [0041]      FIG. 16  illustrates an oblique view of a wound dressing, PHS, or bandage for treating a wound to a body part comprising a strap, a plurality of concentric blood dams, lateral stiffeners and a liquid impermeable central region, according to aspects of the invention; 
           [0042]      FIG. 17A  illustrates a side cross-sectional view of a wound with a bandage or PHS comprising a liquid impermeable region surrounded by a dam or gasket wherein the dam or gasket edge is rounded and is pressed into the skin surrounding the wound, according to aspects of the invention; 
           [0043]      FIG. 17B  illustrates a side cross-sectional view of a wound with a bandage or PHS comprising a fluid access port and valve and a liquid impermeable region surrounded by a dam or gasket wherein the gasket has a rounded triangular cross-section, according to aspects of the invention; 
           [0044]      FIG. 18  illustrates an oblique view of a wound dressing, PHS, or bandage for treating a wound to a body part comprising an optional strap, a plurality of nested blood dams, a stiffening scrim, a central liquid impermeable region, a vacuum port, and vacuum manifold, according to aspects of the invention; 
           [0045]      FIG. 19  illustrates a cross-sectional view of an appendage with a wound and a bandage, or PHW, attached thereto. The bandage includes a standoff to prevent a tourniquet effect to the limb, according to aspects of the invention; 
           [0046]      FIG. 20  illustrates a cross-sectional view of an appendage with a wound and a peripheral hemostasis system attached thereto. The peripheral hemostasis system includes a rigid or semi-rigid cuirass to apply a fluid-tight barrier over the wound without creating a tourniquet effect, according to aspects of the invention; 
           [0047]      FIG. 21A  illustrates a side breakaway view of a hemostatic pack comprising an inner, high spring-force layer surrounded by a softer conformable layer, the entire pack surrounded by an outer, fluid impermeable layer, according to aspects of the invention; and 
           [0048]      FIG. 21B  illustrates a lateral view along cross-section A-A of the hemostatic pack of  FIG. 21A , according to aspects of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0049]    The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope. 
         [0050]      FIG. 1A  illustrates a diagram of a two-sided hemostatic packing device  10  of the present invention. The two-sided packing device  10  comprises a substrate  12  and a fluid impermeable surface  14 . The fluid impermeable surface  14  further comprises an optional adhesive layer  16 , and a plurality of optional indentations  18 . The fluid impermeable surface  14  or the substrate  12  may optionally comprise a plurality of radiopaque markers  20 . 
         [0051]    Referring to  FIG. 1A , the hemostatic packing device  10  is a flat sheet configuration that is flexible and deformable. The substrate  12  is a flat sheet configuration and is integral to or affixed to the fluid impermeable surface  14 . The adhesive  16  is used to affix the substrate to the fluid impermeable surface. The fluid impermeable surface  14  optionally comprises a plurality of indentations  18 . The radiopaque markers  20  may be wire form, dots or patches of barium-impregnated fabrics. 
         [0052]    Referring to  FIG. 1A , the substrate  12  is fabricated from cotton gauze, open or closed cell foam, sponge, fluids, particulates and the like. The substrate  12  is soft in its wet or dry state and may be bent, molded or deformed to maximize surface contact and force distribution on the injured tissue. The foam configuration of the substrate  12  is fabricated from materials such as polypropylene, polyvinyl chloride, polyurethane, polyethylene, silicone rubber, poly methyl methacrylate, polyvinyl alcohol and the like. The foam configuration of the substrate  12  may be pre-compressed, or partially pre-compressed, to achieve the correct amount of hardness, or it can be fabricated in a plurality of layers. For example, the foam substrate  12  can have an inner layer of hard foam and an outer layer of softer foam. The outer layer of softer foam helps to fill space and conform to irregular geometries while the inner layer of harder foam helps to provide the packing force necessary to overcome systemic arterial pressure. The particulates of the inflatable embodiment of substrate  12  may be beads of collagen, PTFE, silica and the like. The fluid impermeable surface  14  is fabricated from materials such as polypropylene, polyvinyl chloride, polyurethane, polyethylene, silicone rubber, poly methyl methacrylate, polyvinyl alcohol, Tyvek and the like. The fluid impermeable surface  14 , in another embodiment, is fabricated from materials such as paper or cloth that is then coated or sprayed with impermeable materials such as polyethylene, polypropylene and the like. The use of rip-stop fabrics will help prevent tearing of the fluid impermeable surface  14 . 
         [0053]    The hemostatic packing device  10  is fabricated in a variety of sizes and thicknesses. The thickness varies from 0.1 mm to 50 mm. The length and width each may vary from 5 mm to 500 mm. The geometry is generally rectangular but may have triangular, circular, or polygonal configurations. The corners may be square or rounded. 
         [0054]    The radiopaque markers  20  are fabricated from a group of materials including but not limited to barium impregnated fabrics or polymers, metal wires, and metal solids. Typical metals used for radiopacity include tantalum, platinum, gold, and the like. 
         [0055]    The hemostatic packing device  10  is packaged in a sealed, sterile barrier package and is sterilized using standard techniques such as steam, cobalt radiation, ethylene oxide, electron beam and the like. 
         [0056]    Referring to  FIG. 1B , the hemostatic packing device  10  is shown from the side. The substrate  12 , the fluid impermeable surface  14 , and the adhesive layer  16  are clearly visible in this view. 
         [0057]      FIG. 1C  illustrates one embodiment of the hemostatic packing device  10  that is folded with the fluid impermeable surface  14  facing outward in preparation for use. 
         [0058]      FIG. 1D  illustrates another embodiment of the hemostatic packing device  10  that is rolled with the fluid impermeable surface  14  facing outward in preparation for use. 
         [0059]      FIG. 2  illustrates another embodiment of the haemostatic packing device  10  where the substrate  12  and the impermeable outer surface  14  are fabricated from the same material. In this embodiment, the hemostatic packing device  10  is fabricated from closed-cell foam. The foam material allows for a resilient, deformable substrate while maintaining the outer surface  14  that is impermeable to fluid penetration since it is a closed cell structure. 
         [0060]      FIG. 3  illustrates the hemostatic packing device  10  where the upper side of the fluid impermeable surface  14  comprises indentations  18 , that may be in the form of dimpling or waffling of varying depth that are useful to hold, or carry, and, subsequently deliver thrombogenic, pharmaceutical or antibacterial agents. The indentations  18  are formed using molds wherein the outer surface  14  of the closed-cell substrate  12  is formed against the mold. In another embodiment, the indents  18  are formed by impressing the fluid impermeable outer sheet with a mold or other forming device. In yet another embodiment, the outer surface  14  comprises projections, or villi, that serve to trap and carry the pharmaceutical, antibacterial or thrombogenic agents. The projections or indents may be macroscopic or microscopic. 
         [0061]      FIG. 4  illustrates another embodiment of the haemostatic packing device  10  wherein the substrate  12  forms a polygonal solid. The polygonal solids include shapes such as brick or rectangular solid, waffle, pyramid, sheet, and oval. The polygonal solids also include extruded shapes such as cylinders, or extended lengths of cross-sections such as rectangular, oval, circular, trapezoidal, triangular, etc. The lengths of these devices range from 5 mm to 1000 mm. The width dimensions of these devices range from 1 mm to 200 mm. At least part of the outer surface  14  of the hemostatic packing device  10  comprises a fluid impermeable barrier. This fluid impermeable barrier  14  may be smooth, indented, or covered by villi, or projections. The substrate  12  is fabricated from materials that allow for deformation in the dry or wet state. These materials include cotton batting, polymeric foams of varying densities, sand, polymer beads, oils including silicone oils, water, and the like. 
         [0062]    Referring to  FIGS. 1A ,  1 B,  1 C,  1 D,  2 ,  3 , and  4 , the hemostatic packing device  10 , in another embodiment, comprises a fluid impermeable layer  14  that is fabricated from resorbable materials. The substrate  12  may be removed and the impermeable layer  14  left behind to complete healing. The resorbable layer  14  is fabricated from resorbable materials such as polyglycolic acid (PGA), polylactic acid (PLA) and the like. The fluid impermeable layer  14  has a complex surface that comprises indentations or villi  18 . 
         [0063]      FIG. 5  illustrates yet another embodiment of the hemostatic packing device  10  wherein the device may have fluid reversibly or irreversibly introduced to provide for size adjustment. The outer surface  14  of said device  10  comprises an access port  22  for introduction of materials to fill the substrate  12 . In this embodiment, the substrate  12  is a fluid impermeable membrane that is filled with material to achieve the desired volume. The substrate  12  membrane is fabricated either from elastic materials such as silastic or polyurethane, or it is an inelastic bag with folds that allow for size increase. The outer surface of the substrate  12  preferably is not adhered in all places to the outer surface  14  of said device  10  and optionally a lubricating layer  24  is placed between the two structures. The outer surface  14  of said device  10  is fabricated from either elastic materials such as polyurethane or silicone rubber, or it is an inelastic material such as polyethylene terephthalate, polyimide, polypropylene or polyethylene or a copolymer including one of these materials. The outer surface  14  of the hemostatic packing device  10  may be smooth, indented or include villi. The villi or indents may be macroscopic and have size ranges from 0.1 mm to 10 mm. The villi or indents may also be microscopic and difficult to see with the unaided eye. Such sizes are less than 0.1 mm. 
         [0064]    Referring to  FIG. 5 , in another embodiment, the hemostatic packing device  10  comprises a hydrogel material that is placed into a wound and expands upon absorption of fluids from the patient to compress the wound. In this embodiment, the substrate  12  is fabricated from hydrophilic hydrogels such as those described by Park et al. and are incorporated herein by reference. Hydrogels are made from materials such as, but not limited to, carboxymethyl cellulose, cross-linked sodium starch glycolate, and cross-linked polyvinylpyrrolidone and the like. The substrate  12  can also be fabricated from a water-absorbable sponge that expands once it becomes wet. The water-absorbable sponge may be fabricated from materials such as, but not limited to polyvinyl alcohol, polymethyl cellulose, and the like. In this embodiment, the fluid impermeable outer surface  14  comprises an opening to allow for fluid penetration into the substrate  12  to allow the expansion to occur. This opening may be the nipple  22  and the fluid to expand the hydrogel or sponge may be injected through the nipple  22 . Alternatively, in the case of the hydrogel, the substrate  12  and the surface  14  may be of the same hydrogel material. Hydrogels generally absorb water but do not adhere to biological surfaces. The hemostatic packing device  10  fabricated from hydrogel would be small enough in its dry state to be introduced through an optional laparoscopic access port and expand due to water absorption once placed within the body. 
         [0065]      FIG. 6  illustrates the hemostatic packing device  10  being introduced into a wound  42  in a liver  40  through a laparoscopic instrument  30 . The laparoscopic instrument  30  is an axially elongate hollow device that provides porthole access to the internal organs of a patient. 
         [0066]      FIG. 7  illustrates the hemostatic packing device  10  comprising an adhesive strip  28  on one side. The adhesive strip  28  is used to permit attachment of the hemostatic packing device  10  to other similar devices so as to create an impermeable syncytium or impermeable contiguous mass. The adhesive strip may also comprise an optional peel away cover that protects the adhesive strip  28  prior to use. The peel away cover is fabricated, preferably, from the same materials use to fabricate the fluid impermeable outer surface  14  of the hemostatic packing device  10 . The adhesive strip is optionally fabricated from materials such as Velcro or even self-adhesive materials such as Coban, marketed by 3M. Velcro is a trademark of Dupont and is a hook and loop fastener that is well known in the art. 
         [0067]      FIG. 8  illustrates another embodiment of the hemostatic packing device  10  further comprising a fluid impermeable drape  32  affixed to the packing device  10 . The fluid impermeable drape  32  is, preferably adhered to the hemostatic packing device  10 . The drape  32  comprises an adhesive layer  36  and a backing layer  38 . The backing  38  is, preferably, fabricated from non-elastomeric materials such as, but not limited to, polyethylene, polypropylene, and the like. It is preferable that the drape  32  does not stretch once applied. The adhesive layer  36  is on the same side of the drape  32  to which the hemostatic packing device  10  is affixed. The hemostatic packing device  10  further optionally comprises a series of straps  34  to assist with fixation of the device to the patient. The straps  34  are fastened with standard buckles, Velcro or the like. This embodiment of the device  10  is useful for treatment of wounds to the periphery and especially those wounds that involve vascular injury. Such periphery includes the thigh, knee, lower leg, arm, shoulder, and forearm. 
         [0068]      FIG. 9A  illustrates the wound  42  to the liver  40 . The liver  40  represents an exemplary case of parenchymal tissue that is friable and becomes severely damaged during an abdominal injury. 
         [0069]      FIG. 9B  illustrates the wound  42  to the liver  40  being treated by application of intra-parenchymal packing using one or more hemostatic packing devices  10 . In this embodiment, two hemostatic packing devices  10  are used to provide hemostasis for the wound  42 . The hemostatic packing devices  10  are applied manually via open surgery, in this case. 
         [0070]      FIG. 10A  illustrates a wound  44  to the periphery and more specifically, the thigh  46 . The wound  44  has caused femoral artery  48  to become transected. 
         [0071]      FIG. 10B  illustrates the wound  44  to the thigh  46  being treated by application of the impermeable hemostatic packing device  10  with an adhesive impermeable drape  32  and straps  34 . 
         [0072]    In yet another embodiment, a wound closure device is fabricated from a material that has skin and wound contact surfaces that are impermeable to water, blood and tissue penetration. Preferably, these wound closure devices are fabricated from sheets of materials such as, but not limited to, polyurethane, polypropylene, polyethylene, silicone elastomer, and the like. The skin contact surface is a biocompatible adhesive and is further impregnated with anti-microbial agents such as, but not limited to, iodine, betadine and the like. The bandage, peripheral hemostasis wrap (PHW), or wound closure device is large enough to completely surround the wound and seal in the wound so that blood cannot escape. The bandage, optionally, has additional straps that fully surround the body or appendage and seal with Velcro, buckles, clamps or the like. The straps may be fabric or they may be rubberized or coated, fluid impermeable fabric, or they may be sheets of polymer. The bandage or wound closure device seals the wound against the full systolic blood pressure and, thus tamponade any bleeding that occurs from damaged vessels other than the one repaired with the shunt  10 . The bandage comprises an adhesive region that sticks to the skin, even if the skin is wet or bloody. The bandage, or peripheral hemostasis wrap, is optionally maintained in place using straps that wrap around the body or appendage and secure the bandage in place with adequate pressure to generate pressure tamponade of the wound. Adhesive methodologies will suffice to hold the bandage in place in many cases. However, non-adhesive methodologies such as hook and loop fasteners or buckles will work in almost all applications. The straps  34 , in a preferred embodiment, are fabricated from materials that have longitudinal or axial stretch. Stretching of the straps  34  in the lateral direction is not preferable. Flexibility in both the lateral and longitudinal directions is preferable for the straps  34 . In a preferred embodiment, the straps  34  with latching devices provide the only form of attachment of the wound closure device to the patient. The straps  34 , in one embodiment, are wrapped one or more times over the liquid impermeable region of the bandage to provide for extra tightness and control of pressure. The straps  34  are configured to exert sufficient force on the fluid impermeable bandage to seal the packing device into the wound or any dams or gaskets against the skin in order to prevent or minimize blood loss from the wound. The straps  34  are further configured to distribute pressure on the body so that a tourniquet effect does not occur and so that blood flow is not impeded in any area except the wound itself. The straps  34  distribute pressure by maintaining a wide footprint and not kinking so as to form a small width high-tension area, which could be a problem. For short-term applications, the need for tissue impermeability is less important than the need for liquid (e.g. blood and water) impermeability. A scrim, not shown, is also useful to back up the fluid impermeable region  32  and prevent stretching or distortion of the fluid impermeable drape or region  32 . Further, the straps  34  may be fabricated as a rigid or semi-rigid shell or cuirass to prevent a tourniquet effect from occurring on the limb being treated. A tourniquet effect is that result when a tight band or cord is wrapped around a limb, thus preventing or restricting arterial blood flow, venous return blood flow, or both. 
         [0073]    The preferred wound closure is a large piece of Ioban, a trademark and product of 3M Corporation, the non-adhesive side of which is adhered to a piece of woven gauze or mesh to provide adequate structure to the weak membrane of the Ioban. The Ioban has adhesive and anti-microbial properties preferred for this application. A strap extending from opposing ends of the bandage and terminated with Velcro or 3M Coban, which is self-adherent, assists in maintaining pressure against the wound and proving full tamponade of the hemorrhage. In yet a further embodiment, the central part of the skin contact region comprises a malleable or conformable pad, preferably adhered to the wound closure device, which helps to exert hemostatic force on the wound. The conformable pad evenly distributes the forces throughout the wound so that no areas receive either too high a pressure, or too low a pressure, such as would permit further bleeding. The conformable central pad may be a block of foam covered by the aforementioned impermeable layer, or it may be an impermeable membrane, preferably elastomeric, filled with liquid such as saline or even a particulate material such as, but not limited to, sand, flour, sugar, silicone oil, or the like. In a preferred embodiment, the material used to form the fluid-tight membrane is liquid impermeable but gas permeable. Materials suitable for such permeability requirements include expanded polytetrafluoroethylene (ePTFE) and the like. 
         [0074]      FIG. 11  illustrates another embodiment of the present invention. The hemostatic packing device  10  is in the form of a wound dressing, PHS, or bandage  50 . The wound dressing, PHW, or bandage  50  further comprises an optional gauze or absorbent region  52 . The gauze or absorbent region  52  may have material bulked up or rolled up to aid in the application of pressure to cause pressure tamponade of the wound or perforation to the body. The gauze or absorbent region  52  may alternatively be a fluid pouch, which may be inflated or deflated to apply the required pressure tamponade to the wound area. The gauze or absorbent region  52  is further comprised of a peripheral gasket  54  or a plurality of gaskets  54  running in a honeycomb, rectangular, nested oval, nested rectangle, concentric ring, concentric oval, concentric rectangle, or other appropriate pattern throughout and within the gauze or absorbent region  52  of the bandage  50 . The gauze or absorbent region  52  preferably further comprises a fluid or liquid impermeable barrier that prevents the escape of blood from the wound area, even under systemic systolic arterial pressure. The gasket  54  is sealed to the fluid or liquid impermeable barrier to prevent the escape of blood out the side of the bandage at pressures up to that of systemic systolic arterial pressure. 
         [0075]    The gasket  54  aids in hemodynamic control and is made out of fluid impermeable, elastomeric or compliant materials, such as, but not limited to, silicone, C-flex, hydrogels, silicone oil-filled membrane, polyurethane closed-cell foam, and the like. The typical width of the gasket  54  material will be ⅛ to ¼ inch. However, it should not be limited to these dimensions, as there may be wounds that require greater hemodynamic stabilization using the here claimed damming concept or technique. The gasket  54  is wide enough to distribute pressure over the skin area so as not to cause petcheciae, bruising or tissue damage but enough pressure to seal against systemic arterial pressure, typically 100 to 300 mm Hg. The absence of petcheciae is preferable but is not essential for performance of the gasket  54 . The gasket  54  should press into the skin hard enough to form a complete liquid-impermeable seal. Bruising of the skin is generally considered to be an acceptable alternative to bleeding to death. The dam or gasket  54  generally presses gently into the tissue surrounding the wound to ensure a strong resistance to hemorrhage or leakage of blood beyond the dam. The gasket  54  or dam is configured to indent the skin and seal against the skin so as to prevent the loss of blood at systolic systemic blood pressure levels. The gasket  54  or dam is configured with a skin contact surface that has a cross-section that includes, but is not limited to, triangular, rounded, trapezoidal, rectangular, rounded triangular, and the like. The gasket  54  or dam further is configured without any bumps, defects, or gaps that wound permit liquid loss between the gasket  54  and the skin when pressed together. The gasket  54  to skin contact and seal is generally improved by the presence of water, blood, or other liquids. In one embodiment, a fluid impermeable region exists in the area inside the gasket  54 . 
         [0076]    Affixed or integral to the gauze or absorbent region  52  is a plurality of optionally fluid impermeable straps  58  that will wrap around the extremity or wound area. The straps  58  may contain an adhesive layer  36  or may be of material suitable for stretch wrapping, or they preferably comprise mechanical fasteners. Optionally, the straps  58  may comprise an adhesive layer  36  and a backing layer  38 . The backing  38  is, preferably, fabricated from non-elastomeric materials such as, but not limited to, polyethylene, polypropylene, Tyvek, polytetrafluoroethylene, polyester, and the like. Another option for the straps  58  could be self-adhesive straps  58  made from materials such as, but not limited to, those manufactured by 3M, Inc., under the trade name of Coban. This material would be suitable and desirable for use as the straps  58  due to its chemical composition and inherent antiseptic properties. In addition, the wrapping material may also have buckles or hook and loop fasteners such as Velcro  62  or another means of securing or attaching the bandage in place on the patient. Self-adhesive materials such as, but not limited to, those manufactured by 3M, Inc., under the trade name of Coban are suitable for use as the binding system for the straps  58 . The straps  58  may also be fluid impermeable and optionally possess at least some degree of elastomeric properties, so as to aid in the wound containment. The bandage or wound dressing  50  also has a free end or side  60 . Ideally, the wound dressing or bandage  50  would be packaged with a protective, removable layer over the gauze or absorbent region  52  and quite possibly over the entire surface applied to the patient. 
         [0077]    The straps  58 , in a preferred embodiment, comprise elements, which are elastomeric in the longitudinal direction. The elastomeric members in the straps  58  make it easier to apply the bandage and facilitate wrapping the straps  58  tightly enough that the bandage is able to seal against systemic arterial pressure. It is preferable to size the straps  58  to permit the straps to be wrapped around the limb or body part a plurality of times so as to hold the liquid impermeable region and any dams or gaskets tightly over the wound. The straps  58 , in one embodiment, are non-elastomeric or have non-stretching elements affixed thereto in a region encompassing at least the fluid impermeable region. The non-elastomeric or non-stretchable region is generally non-deformable except in flexion. The straps  58  are sized to fit the body part being treated. The width of the straps  58  ranges from ½ inch or less to over 36 inches. Preferably the width of the straps  58  ranges from ½ inch to 12 inches. The length of the strap  58  is sized to allow for at least one wrap around the body part, and preferably, a plurality of wraps. 
         [0078]      FIG. 12  illustrates another embodiment of the present invention. The hemostatic packing device  10  is in the form of a wound dressing or bandage  50 , as shown in  FIG. 11 . The wound dressing or bandage  50  further comprises a gauze or absorbent region  52 . The gauze or absorbent region  52  is generally a central region in the bandage that covers the wound. This region  52  in another embodiment, may not be absorbent or gauze covered at all, but merely a liquid impermeable central wound covering region. The gauze or absorbent region  52  is further comprised of a plurality of dams or gaskets  54  running or weaving in a honeycomb, rectangular, diamond, or other appropriate pattern throughout and within the gauze or absorbent region  52  of the bandage  50 . The gasket  54  aids in hemodynamic control and is made out of fluid impermeable materials, such as, but not limited to, silicone, C-flex, hydrogels, silicone oil-filled membrane, polyurethane closed-cell foam, and the like. The typical width of the gasket  54  material will be ⅛ to ¼ inch. However, it should not be limited to these dimensions, as there may be wounds that require greater hemodynamic stabilization using the here claimed damming concept or technique. The gasket  54  is wide enough to distribute pressure over the skin area so as not to cause petcheciae, bruising or tissue damage but enough pressure to seal against systemic arterial pressure, typically 100 to 300 mm Hg. The gasket or dam  54 , in one embodiment, does cause bruising or petcheciae of the skin. The presence of petcheciae, while not optimal, does not detract from the performance of the gasket  54  and is generally considered to be an acceptable alternative to bleeding to death. The dam or gasket  54  further comprises a tissue contacting edge that is configured with a rounded, rectangular, triangular, trapezoidal, rounded triangular or other shaped cross-section. The dam or gasket  54  is pressed against the skin with enough force to prevent the escape of blood under systemic arterial pressures, which can range from 80 mm Hg to over 200 mm Hg. The dam or gasket  54  seals to the liquid impermeable covering of the bandage by being integrally formed, by adhesives, by overmolding, by heat welding, by ultrasonic welding, or by another process. The dam or gasket  54  does not seal to the skin by adhesives. The use of adhesives in the dam or gasket  54  would be of little value since the bandage would be placed on a wound in an acute setting, which is often, wet, bloody, oily, dirty, or all of the above. In such environments, there are very few, if any, adhesives that could hold a seal to the skin and prevent the escape of blood under systemic arterial pressure. 
         [0079]      FIG. 13  illustrates another embodiment of the present invention. The hemostatic packing device  10  is in the form of a wound dressing or bandage  50 , as shown in  FIG. 11 . The wound dressing or bandage  50  further comprises a gauze or absorbent region  52  and a valve  56 . The valve  56 , which resides within the gasket  54 , may be used to remove fluids or add agents to assist in the coagulation or wound containment. The valve  56  may be, but is not limited to, a duck bill type of valve, stopcock, or the like. 
         [0080]      FIG. 14A  illustrates a cross-sectional view of another embodiment of two internal packs  100  and  102  comprising an impermeable outer layer  16  and a soft-conformable filler region  14 . The left hand internal pack  100  further comprises a female adhesive region  104  further comprising an adhesive material  106  and a plurality of adhesive material gaps  108 . The right hand internal pack  102  further comprises a male adhesive region  110  further comprising an adhesive material  112  and a plurality of dams  114 . 
         [0081]    Referring to  FIG. 14A , the left hand internal pack  100  and the right hand internal pack  102 , in the preferred embodiment each has at least one male adhesive region  110  and one female adhesive region  104  so that a plurality of packs can be chained together to form a contiguous blood impermeable barrier. In the preferred embodiment, the adhesive material  106  is the hook style of Velcro fastener while the adhesive material  112  is the tufted style of Velcro fastener. Thus when the adhesive regions  106  and  112  are brought into contact, they adhere to each other. The adhesive regions  106  and  112  are reversibly adherent to each other and may be separated by manual force, if desired. In another embodiment, the adhesive regions  106  and  112  may be fabricated from materials such as, but not limited to, 3M Coban and the like, hydrogel adhesives and the like, and typical adhesives such as are used in medical bandages. The adhesive material gaps  108 , in the female adhesive region  104  are spaced and designed so that the dams  114  of the male adhesive region impinge on and seal against an impermeable surface of the female adhesive region  104 . The adhesive material gaps  108  and the dams  114  may be configured in a straight line or they may be curved into a wavy pattern to improve the sealing area. Special guide markers either printed on the packs  100  and  102  or fabricated as raised or detented surfaces on the packs  100  and  102  facilitate alignment of the dams  114  and the adhesive material gaps  108 . 
         [0082]      FIG. 14B  illustrates a cross-sectional view of the internal packs  100  and  102  following joining to form a continuous barrier pack. Referring to  FIGS. 14A and 14B , the dams  114  seal against the impermeable surface  16  through adhesive material gaps  108 . The adhesive regions  106  and  112  are firmly in contact and grip each other to hold the two packs  100  and  102  together without any area of seepage, leakage, or weeping. 
         [0083]    In yet another embodiment of the barrier pack, the mating region between the two packs comprises adhesive regions such as those described for  FIG. 14A , except that the barrier dams are replaced with fluid impermeable flaps that fold in to cover the adhesive regions following joining. One flap preferably covers each side of the adhesive region. In a preferred embodiment, the flaps cover the adhesive regions until they are needed to join with another barrier pack. At that time, the flap is pulled away, the two packs are joined, and the flap is folded in to cover the adhesive region and form a fluid-tight seal between the two barrier packs. 
         [0084]    Referring to  FIG. 1  through  FIGS. 14A and 14B , the hemostatic packing device  10  is used to treat wounds that are typically caused by trauma. In a typical procedure, the surgeon or medic, using aseptic procedure, accesses the wound either by open surgery or laparoscopic surgery. The wound is irrigated and cleaned and excess fluids are removed by suction and blotting with gauze sponges. The surgeon may apply antiseptic agents or thrombogenic agents to the wound. The surgeon places the hemostatic packing device  10  into the wound and the device  10  is secured into place. Using current damage control procedure, it is preferable to stabilize the patient prior to removing the hemostatic packing device  10  and permanently repairing the wound. The hemostatic packing device  10  does not stick or heal into the wound and removal is not traumatic to the patient. The hemostatic packing device further does not introduce contaminants or debris, a problem with prior art, powdered hemostatic agents, which would be difficult to remove to perform definitive repair and which would increase the likelihood and severity of wound infection. Referring to  FIG. 13 , he hemostatic packing device  10  is also well suited for a typical “sucking chest wound” because of its inherent impermeable properties. The one-way valve  56  permits fluid and air to exit the chest cavity but prohibits reflux of air into the chest cavity, a condition which prevents lung function and which is known as pneumothorax. 
         [0085]      FIG. 15  illustrates a preferred embodiment of a wound dressing or bandage  120 . The wound dressing or bandage  120  comprises a backbone  122  with a central region and two ends, a first fastener  126 , a second fastener  128 , a fluid-impermeable barrier  124 , a fluid dam  132 , a pillow pack  134 , and an optional peripheral hemostatic region  130 . 
         [0086]    Referring to  FIG. 15 , the wound dressing or bandage  120  is configured to wrap around a body part, arm, leg, torso, head, etc. and fasten using the first fastener  126  and the second fastener  128 . The bandage  120  is pre-packaged in a barrier package that prohibits contamination. Following packaging, the bandage  120  and package are sterilized using ethylene oxide, gamma radiation, E-beam radiation, or the like. In a preferred embodiment, the package comprises an inner and an outer pouch which are sealed and which constitute a double-aseptic package. The fasteners  126  and  128  are of the type including, but not limited to, Velcro, buckles, snaps, jam cleats, buttons, and the like. Fastener  128  is, in a preferred embodiment, a loop fastener, while fastener  126  is the hook fastener. In another embodiment, there are a plurality of loop fasteners  128  or a continuous loop fastener along a large region of the bandage  120 . In another embodiment, a plurality of hook fasteners  126  are comprised by the bandage  120 . In a preferred embodiment, the hook fastener  126  is affixed at one end and on one side of the backbone  122 . The fluid impermeable region and gaskets are affixed to the same side of the backbone  122  as the hook fasteners  126 . The side of the backbone  122  opposite that of the hook fasteners  126  comprises loop structures, such as those found in Velcro loops, covering essentially the entire side, that compatibly lock or reversibly engage with the hook fastener  126 . This configuration is preferable because it permits a wide range of adjustability in locking the bandage in place. Other conceivable lock structures are appropriate in this application. An optional cinch mechanism to increase mechanical advantage and allow the caregiver to apply the PHS or bandage  120  with increased compression may be added to the configuration. The backbone  122  is preferably a woven or knitted fabric of material such as, but not limited to cotton, polyester, polypropylene, polyurethane, polyethylene, PTFE, nylon, and the like. The woven backbone is configured to be flexible but have high tensile strength, while porosity is not an important characteristic. The impermeable barrier  124  is preferably applied to the central region of the bandage  120  and is created by a separate polymer layer that is adhered or welded to the backbone  122 . The backbone  122  may also be dipped, sprayed, or coated with materials such as, but not limited to, polyurethane, C-Flex thermoplastic, silicone elastomer, and the like. Since the dressing is intended for short-term application, gas permeability is not considered objectionable but it is desirable. The fluid dam  132  is fabricated from materials including those used to fabricate the fluid impermeable barrier  124 . The fluid dam  132  may also be fabricated from gel-filled membranes, hydrogels, oil-filled membranes, and the like. The membrane of the fluid dam  132  is preferably, inelastic at the pressures used for filling. The fluid dam  132  is configured to provide a pressure seal against the body and form a complete barrier to prevent blood from escaping the wound. In another embodiment, the fluid dam  132  is inflatable following or before application to the patient through a valve such as a stopcock or standard inflation valve on the exterior surface of the bandage  120 . 
         [0087]    Further referring to  FIG. 15 , the pillow pack  134  is adhered to the central region of the bandage  120 , preferably adhered to the fluid impermeable region  124 . The pillow pack  134 , preferably resides within the region described by the fluid dam  132 . The pillow pack  134  outer surface is preferably smooth and resistant to blood adherence but in another embodiment, the pillow pack  134  outer surface may be a fabric mesh or other convoluted surface capable of accelerating thrombosis or of carrying thrombogenic materials or antimicrobial agents. The thrombogenic materials are preferably spreadable gels or liquids. Typical thrombogenic materials include fibrin, substances that remove water from blood and cause coagulation, or other materials derived, for example from crustaceans, and which exhibit thrombogenic properties when exposed to blood. The pillow pack  134  is the primary distributor of force upon the wound to generate pressure tamponade. The pillow pack  134  is capable of extruding into a wound and distributing pressure evenly to generate hemostasis. The pillow pack  134  preferably comprises an elastomeric membrane filled with materials such as, but not limited to, air, water, oil, sand, gel materials, and the like. The pillow pack  134  in the embodiment where gas, air or liquid, is used for inflation, comprises an optional valve such as stopcock on the exterior surface of the bandage  120 . The peripheral hemostasis region  130  preferably resides within the fluid dam  132  and accelerates clotting in the region outside the wound area but within the environs of the bandage  120 . In a preferred embodiment, the peripheral hemostasis region  130  comprises materials, which are elastomeric thus allowing the pillow pack  134  to apply a predetermined or known amount of force to the wound. The peripheral hemostasis region  130  is fabricated from materials such as, but not limited to, cotton gauze, polyester knits and the like. 
         [0088]      FIG. 16  illustrates another embodiment of a wound dressing or bandage  120 . The wound dressing or bandage  120  comprises a backbone  122  with a central region and two ends, a first fastener  126 , a second fastener  128 , a fluid-impermeable barrier  124 , an outer fluid dam  132 , an inner fluid dam  152 , an optional pillow pack  134  (not shown), an optional peripheral hemostatic region  130 , an optional adhesive region  170 , and a plurality of lateral stiffeners  150 . 
         [0089]    Referring to  FIG. 16 , the backbone  122  provides the structure to which other components are affixed. The fluid impermeable barrier  124  is permanently affixed near the central portion of the backbone  122  and is sized to completely cover a wound. The fluid impermeable barrier  124  is affixed to the backbone  122  with adhesives, heat welding, mechanical interlocks, or the like. The lateral stiffeners  150  are affixed to the backbone and prevent lateral collapse or wrinkling of the backbone. The lateral stiffeners  150  possess column strength and they are flexible. The lateral stiffeners  150  may optionally be elastomeric or stretch beyond their unstressed configuration but they cannot be substantially compressed below their unstressed configuration. The lateral stiffeners  150  may be discrete elements, like sail battens, or they may be a sheet of material integral to or attached to the backbone  122 . The backbone material  122  is preferably permeable to gas or even liquids, however the central fluid impermeable barrier  124  is not permeable to liquids such as blood, water, oil, or the like. In one embodiment, the backbone material  122 , in the region of the fluid impermeable barrier  124  is preferably, not elastomeric in either the longitudinal or the lateral direction. 
         [0090]    The inner dam  152  and the outer dam  132  are permanently affixed to the backbone  122  so that only fluid impermeable barrier exists on the interior of the outer dam  132 . The multiplicity of dams  132  and  152  allows greater flexibility in sizing the bandage because only one of the dams needs to provide the seal against systemic arterial pressure. The exact number of dams  132  and  152  is undetermined and could range from one to 50 or more. Practically, the number of dams will be in the range of 1 to 10, and preferably number two to three. The dams  132  and  152  form a concentric or nested pattern of rings that may be ovals, squares, circles, or the like. The dams  132  and  152  have a skin contact surface that is even and smooth with no distortion, gaps, dimples, or roughness. The dams  132  and  152  have structure to resist gross distortion but elastomeric enough to cushion the skin when pressed thereon. In another embodiment, an asymmetrical tightening mechanism is provided which allows for relative tightening of one side of the PHS or bandage  120  relative to the other. The asymmetrical tightening mechanism is advantageous, when placing the bandage  120  on a tapered body member such as a forearm or thigh, to obtain even pressure distribution on the dams  132  or  152  or both. The asymmetrical tightening mechanism can also be useful to cinch the bandage so that observed hemorrhage from beyond the dams  132  and  152  are substantially eliminated. The dams  132  and  152  can range in height from 0.020 inches to 0.5 inches, and preferably range between 0.08 and 0.250 inches in height. The width of the dams  132  and  152  can range between 0.020 and 0.5 inches with a preferred width of 0.08 to 0.250 inches. 
         [0091]    The optional adhesive region  170  is affixed to the same side of the PHS or bandage  120 , as is the dam  132 . The adhesive region  170  is located adjacent to but outside the dam  132 . The adhesive region  170  is preferably affixed to the PHS or bandage  170  at or near an end. The adhesive region  170  serves to allow for initial placement and stabilization of one end of the bandage  120  against the patient&#39;s body so that the PHS or bandage  120  can be wrapped with one hand. The adhesive region  170  also allows for generation of correct tension when wrapping the bandage  120  around the body part or limb. In a preferred embodiment, the outer dam  132  is affixed to the backbone  122  relatively closer to the end of the bandage  120  where the adhesive region  170  is located than to the other end of the bandage  120 . Thus, in this preferred embodiment, the dams  132  and  152  are located closer to one end of the bandage  120  than to the other end. The adhesive region  170  is preferably fabricated from adhesives that work in a wet or bloody environment. Such adhesives, while not extremely strong, offer sufficient adherence to stabilize the bandage for initial wrapping. Hydrophilic hydrogels and other materials known in the art comprise materials suitable for fabrication of a wet-adhesive region. The fastener  128  in a preferred embodiment is the loop of a hook and loop fastener while the fastener  126  is the hook of the hook and loop fastener. In another embodiment, the adhesive region  170  is replaced or augmented by an elastomeric ring or wrap (not shown) through which the limb is placed. The ring or wrap is affixed to the backbone  122  at the same end of the bandage  120  as the adhesive region  170  and temporarily secures the bandage  120  to the limb until the backbone  122  can be wrapped securely around the limb or body part. 
         [0092]    The hemostatic region or zone  130  between the two dams  132  and  152  can be filled with a biological adhesive prior to adhering the bandage  120  to the patient, or the biological adhesive can be applied, in advance, to the hemostatic region  130 . The hemostatic region  130  can be coated with thrombogenic agent or biological adhesive. Biological adhesives can include those fabricated using polyethylene glycol (PEG), 2-arm, 4-arm, or a combination thereof. The biological adhesive can also comprise proteins, or other materials, to interact with the PEG. Suitable proteins can include albumin, either from human, animal, recombinant, etc, or the like. Other materials can include poly (2-hydroxyethyl methacrylate) polyHEMA, or the like. The biological adhesives or thrombogenic substances can be applied to the region  130  between the dams  132  and  152  but should not be applied interior to the inner dam  152  since clotting or adhesive characteristics within the inner dam  152 , within the region of the wound, would cause the wound to reopen upon bandage removal, or damage the wound so that a trauma surgeon or medic could have trouble repairing the wound once the patient reached medical attention. The adhesive material can be coated onto the inner dam  152 , the outer dam  132 , or both, such that the adhesive material assists with the seal between the dams  132  and  152 , and the skin surrounding the wound. Suitable biological adhesives can be found in U.S. Pat. Nos. 6,458,147, 6,371,975, and 6,899,889, the entirety of which are hereby incorporated herein by reference. In another embodiment, the biological adhesive, both PEG and albumin or other protein can be applied to the hemostatic region  130  in their dry state or can be applied wet and then dried after application. In their dry state, these materials exhibit no adhesive properties. However, in the presence of water, these materials can be strongly adhesive to skin or other tissues. The biological adhesives or thrombogenic materials, in their dry state, can sustain a long shelf life if packaged within a fluid-impermeable package such as a foil package or fluid impermeable polymer. The hemostatic regions  130  or the dams  152 ,  132  can be coated with or comprise deformable, gap filling materials, such as, but not limited to, gels, or weak elastomers, fluid filled bags, or the like, with or without adhesive surfaces, the gap filling materials being configured to maintain the seal between the dams  132 ,  152  and the skin or the hemostatic region  130  and the skin. 
         [0093]      FIG. 17A  illustrates a wound  160  covered by a hemostatic bandage  120  or PHS further comprising a liquid impermeable region  124 , a strap  166 , and a dam  132 . The wound is surrounded by a layer of skin  162  with a dimpled region  164 . The strap  166  is of sufficient tightness to hold the dam  132  against and pressing into the skin  162  to form a dimple  164  and a barrier against pressurized blood. Blood cannot escape the environs of the PHS or bandage  120 . The strap  166  is configured with elastomeric elements in the longitudinal direction to facilitate generation and control of sufficient tensile forces to cause hemostasis. The elastomeric elements are fabricated from material such as, but not limited to polyurethane, Lycra, silicone elastomer, thermoplastic elastomer, and the like. The fabric of the strap  166  may be porous or may be rubberized or sealed against fluid escape. Elastomeric properties can also be achieved by fabric forming processes such as, but not limited to, weaving, knitting, crocheting, and the like. In another embodiment, mechanical elements are provided to tighten the bandage straps  166  in a controlled fashion. The mechanical tightening elements include winches, pulleys, turnbuckles, levers, inflatable elements such as bladders, and the like. A plurality of such tightening elements, in one embodiment, are distributed so as to permit selective or controlled tightening of one or both edges of the straps  166 . The dam  132  has a skin  162  contact surface that is rounded so as to be minimally traumatic causing temporary dimpling  164 . 
         [0094]      FIG. 17B  illustrates a wound  160  surrounded by a layer of skin  162 , covered by a hemostatic bandage  120  further comprising a liquid impermeable region  124 , a strap  166 , a dam  132 , and a fluid port and valve  168 . The fluid port and valve  168  are affixed to the fluid impermeable region  124  and permit liquids or gasses to be injected or removed from the space between the liquid impermeable region  124 , the dam  132 , the wound  160  and the skin  162 . Injection of liquids such as saline or water or even gasses may be advantageous in causing distributed pressure within the wound  160  to cause hemostasis against restricted or unrestricted systemic arterial pressure. Such fluid injected into the wound region under the liquid impermeable region  124  is preferably pressurized to a level exceeding systemic systolic arterial pressure, typically in the range of 100 mm Hg to 250 mm Hg, depending on the level of hypertension of the individual. The dam  132  has a skin contact surface that is triangular in cross section with a slight rounding to minimize trauma to the skin  162 . The dimple  164  is formed in the skin by the pressure applied to the dam  132 . The liquid impermeable region  124  is held against the skin  162  by the strap or straps  166  and fastened with fasteners that work in a wet, contaminated environment. 
         [0095]      FIG. 18  illustrates yet another embodiment of the bandage  120  wherein it is held against the skin surrounding a wound by a vacuum. In this embodiment, the bandage  120  comprises a liquid impermeable region  124 , an inner dam  152 , an outer dam  132 , a vacuum port  180 , a vacuum valve  182 , a vacuum manifold  184 , a scrim  186 , and an optional strap  166 . The fluid port  180  and valve  182  are used to facilitate pulling a vacuum under the liquid impermeable region  124  of the bandage  120  to hold the bandage  120  in place. A pump to continuously draw a vacuum is preferable to a pump that is deactivated after the vacuum is created, because of leakage of the vacuum at the seals could occur, resulting in hemorrhage from the wound  160 , unless the vacuum loss is corrected. The scrim  186  is affixed to the liquid impermeable region  124  so as to permit flexion but not stretch of the liquid impermeable region  124 . The scrim  186  may further be extended to provide additional reduction in stretch characteristics of the strap  166 , which is generally elastic in nature. 
         [0096]    In an embodiment, the vacuum is created between an inner dam  152  and outer dam  132  so that the wound  160  is not subjected to the vacuum, but rather the surrounding skin  162 . In this embodiment, the outer dam  132  may surround a region 4 inches by 4 inches, for example. The inner dam  152  may surround a region 3 inches by 3 inches for example. At 2.5 psi, the inner dam  152  and liquid impermeable region  124  are pushed away from the skin by a force of 2.5 psi times 9 square inches or 22.5 pounds. A full or partial vacuum drawn in the space between the inner dam  152  and outer dam  132  will be forced inward at between 14.7 psi and something less, such as 10 psi. The area of the region between the two dams  132  and  152  is approximately 16 square inches minus 9 square inches or 7 square inches. Assuming a loss of 2 square inches to dam or gasket material, the space between the inner and outer dam is approximately 5 square inches. With the 10 psi of a partial vacuum exerted on this space, the bandage  120  is held against the skin by a force of 50 pounds, twice the force of that exerted by the blood on the center of the bandage  120 , thus, even an imperfect bandage  120  or vacuum will firmly hold to the skin  162  and provide hemostasis. The area of the region covering the wound  160  is sized, relative to the area of the region between the inner and outer dams so that the vacuum force always overcomes the blood pressure force and keeps the bandage  120  against the skin  162 . The inner dam  132  can be sized to encase a wound of practically any size from 0.25 inches in length to a full limb amputation, which may be 10 or more inches in diameter. The region interior to the inner dam  132  can be pressurized to assist with hemostasis control even though a vacuum is being drawn to keep the bandage  120  in place, as long as the net pressure force does not exceed the net vacuum hold-down force. 
         [0097]    The port  180  communicating between the space between the inner dam  152  and outer dam  132  through the fluid impermeable region  124  or membrane connecting the dams to a region outside the bandage  120  is connected to a vacuum generation device such as a bulb with one or more one-way valves, or another type of vacuum pump. The vacuum port  180  further comprises a vacuum valve  182 , which prevents disabling of the vacuum but may be opened to relieve the vacuum when desired. The strap  166  is optional in this embodiment but can assist in positioning the bandage  120  and keeping a good seal with the skin  162  while the vacuum is being generated. The vacuum therefore generates all or some of the force holding the bandage  120  to the skin  162 . The bandage  120  further preferably comprises a delivery channel for the vacuum or vacuum manifold  184 , which is optional, so that the region between the two dams  132  and  152  does not collapse and prevent full distribution of the vacuum. The vacuum port  180  is in fluid communication with the inner lumen of the vacuum manifold  184 , if the vacuum manifold  184  is used. The vacuum manifold  184  is a structure, such as a perforated tube that is operably connected to the vacuum port  180  and will not collapse under application of the vacuum and will allow the vacuum to be exerted evenly around the region between the two dams  132  and  152 . In the embodiment where the vacuum manifold  184  is not used, the vacuum port  180  is in direct fluid communication with the region between the two dams  132  and  152 . 
         [0098]      FIG. 19  illustrates a cross-sectional view of a limb or appendage  200  with a bandage  202  affixed thereto. The bandage  202  comprises a fluid impermeable region  204 , a dam  206 , a strap  208 , a fastener  210 , a scrim  212 , and a standoff  214 . The body appendage  200  further comprises a wound  216 , a severed blood vessel  218 , and skin  220 . A space  222  exists between the strap  208  and the appendage  200 . 
         [0099]    Referring to  FIG. 19 , the standoff  214  prevents the strap  208  from tightly encircling the limb or body appendage  200  in such a way that a tourniquet effect is created, thus preventing the flow of blood to tissues distal to the bandage  202  or the return of venous blood from the region anatomically distal to the bandage  202 . The strap  208  is pulled tightly enough that the component of the force exerted by the strap  206  on the dam  206  that forces the strap  206  into the skin  220  is sufficient to overcome systemic arterial pressure. Generally one or two straps  206  are required. By creating spaces or gaps  222  along the side of the limb  200  between the limb  200  and the strap  206 , pressure forces created by the strap  206  do not prevent the flow of blood through vasculature within the limb  200 . The fastener  210  is a buckle or hook-and-loop material such as Velcro and may further comprise a lever to create a mechanical advantage to increase tightness of the strap  206  around the limb  200 . The strap  206  is fabricated from woven or knitted materials including but not limited to polyester, nylon, cotton, polyurethane, combinations of the aforementioned, or the like. The strap  206  may further be a bolt or rigid member fabricated from polymer or metal with telescoping or foreshortening and locking apparatus or means. A threaded bolt traversing the standoff  214  and the scrim  212  is tightened by use of a threaded nut exterior to the standoff  214 , the scrim  212  or both. The scrim  212  is a stiffening member that is either fully rigid, partially rigid, or flexible so as to bend outside the plane of the scrim  212 . The scrim  212 , however, is inelastic and will not deform within the plane of the scrim  212 . The standoff  214  is generally rigid or semi-rigid and preferably comprises padding on the surface that comes into contact with the limb  200 . The fluid impermeable region  204  and the dam  206  are generally fabricated from soft, elastomeric materials such as but not limited to, C-Flex, polyurethane, silicone elastomer, hydrogel, or the like. In this embodiment, the force holding the bandage  202  against the skin is substantially non-radially distributed, but is, instead, along only one axis. 
         [0100]      FIG. 20  illustrates another embodiment of the peripheral hemostasis system  320  further comprising an upper shell member  314 , a lower shell member  312 , a hinge  306 , a separation line  308 , a latch  300  further comprising a tab  302  and a catch  304 , a dam  206 , an optional pad  310 , and a fluid impermeable barrier  204 . The peripheral hemostasis system  320  is wrapped around a limb  200  further comprising a bone  316 , a blood vessel  218 , a wound  216 , and a skin layer  220 . A gap  222  exists in at least one circumferential region between the limb  200  and the shell halves  312  and  314 . 
         [0101]    Referring to  FIG. 20 , the upper shell member  314  and the lower shell member  312  are rigid or semi-rigid structures that are rotatably affixed to each other by the hinge  306 . The upper shell member  314  abuts the lower shell member  312  at the separation line  308 , which exists on the hinge  306  side and the latch  300  side, when the shell  320  is closed around limb  200 . This type of device  320  is also known as a cuirass. The fluid impermeable barrier  204  and the dams  206  surrounding the barrier  204  are affixed to the inner aspect of the upper shell member  314 . The pad  310  is affixed to the interior aspect of the lower shell member  312 . The latch  300  is preferably formed integrally to the upper shell member  314  and the lower shell member  312  and is a simple snap latch. Other latches  300  include, but are not limited to, snaps, buckles, zippers, buttons, Velcro, pushbutton latches, slide latches, bayonet catches, screw fixation, and the like. 
         [0102]    The upper shell member  314  and the lower shell member  312  are fabricated by injection molding, metal forming, die stamping, blow molding, laminating, or the like, using materials including, but not limited to, thermoplastics, steel, aluminum, polysulfone, polystyrene, polyethylene, polyester, polycarbonate, polyvinyl chloride, and the like. The latch  300  components  302  and  304  are similarly fabricated and are either integral to the upper and lower shell members  314  and  312  or they are separately fabricated and affixed using adhesives, screws, rivets, or the like. Provision for size adjustability can be made with the peripheral hemostasis system  320  using, for example, internal cinches and straps, different thickness padding  310 , variable catch locations on the latch  300 , a multi position hinge  306 , and the like. The peripheral hemostasis system  320  creates a closure and sealing force directed substantially along only one axis. The peripheral hemostasis system  320  does not, in this embodiment, create uniform radially inwardly directed forces that completely circumnavigate the appendage, a situation that could reduce venous return blood flow and cause a tourniquet effect. 
         [0103]    The peripheral hemostasis system  320  is provided opened and in a container which is sealed from contamination. The peripheral hemostasis system  320  is preferably sterilized using ethylene oxide, gamma radiation, electron beam irradiation, or the like prior to use. A single or double aseptic pouch, such as one fabricated from Tyvek, is a preferred container for the peripheral hemostasis system  320 . The peripheral hemostasis system  320  is removed from its aseptic container and placed around the limb  200  so that the dams  206  impinge on the skin  220  surrounding the wound  216 . The upper shell member  314  is brought into apposition with the lower shell member  312  and the latch  300  is engaged making sure a tight seal occurs between the dam  206  and the skin  220 . Thus, blood escaping from the blood vessel  218  cannot escape the environs of the wound  218  and the patient cannot bleed to death. At the minimum, blood loss is greatly slowed minimizing the chance of bleeding to death during transport to a medical facility. The space  222  between the shell parts  314  and  312  and the limb  200  make sure that force is only applied in one direction to the limb. Force in the orthogonal direction is not applied so a complete seal is not created around the limb  200 . Thus, the potential for venous return being compromised is reduced and the tourniquet effect is eliminated or reduced. 
         [0104]      FIG. 21A  illustrates a side breakaway view of a hemostatic pack  2100  comprising a core  2102  of higher spring force material, a surrounding layer  2104  of softer material, and an outer fluid-impermeable layer  2106 . 
         [0105]    Referring to  FIG. 21A , the surrounding layer  2104  can be bonded to the core  2102  or it can be placed around the core  2102  without bonding, welding or other fastening system. The fluid-impermeable layer  2106  can be placed around the concentric core  2102  and surround layer  2104  with or without attachment to the surround layer  2104 . The fluid-impermeable layer  2106  can be welded, bonded, heat-sealed, or encased in liquid form and allowed to solidify around the surround layer  2104 . The core  2102  can be open-cell foam, closed-cell foam, an elastomeric polymer, gel, particulates, or the like. The core  2102  can be fabricated from materials such as, but not limited to, polyurethane foam, polycarbonate foam, thermoplastic elastomer, silicone elastomer, and the like. The core  2102  can be foam that is pre-compressed to increase its spring-back force or effective hardness. The core  2102  can have at least one dimension compressed between 10% and 90%, and preferably 30% to 80%, to achieve the desired amount of hardness or spring rate. In another embodiment, the core  2102  can be compressed in more than one dimension, for example diameter and length, or width and height. 
         [0106]    The surround  2104  can be fabricated from the same materials as the core  2102  or it can be fabricated from gel, liquid, particulates, or other materials that can move and re-shape themselves to distribute forces. The surround  2104  can be pre-compressed to achieve a desired degree of spring-back or resiliency. The surround  2104  can have one or more dimension (e.g. length, diameter, width, etc.) compressed by between 10% and 90% of its unstressed dimension, and preferably between 20% and 70% of said dimension. The fluid impermeable layer  2106  can maintain the core  2102  and the surround layer  2104  in their pre-compressed states. The fluid-impermeable layer  2106  can further comprise flocking, fibers, dimples, protrusions, outer layers of woven, knitted, or braided fabric, or the like. The fluid impermeable layer  2106  can be fabricated from polyethylene blends, HDPE, LDPE, polyurethane, silicone elastomer, thermoplastic elastomer, polyester, and the like. The thickness of the fluid impermeable layer  2106  can range from 0.0001 inches to 0.01 inches and preferably between 0.001 inches and 0.005 inches. 
         [0107]      FIG. 21B  illustrates a lateral cross-section of the tissue-packing device  2100  of  FIG. 21A , taken along the section A-A. The tissue-packing device  2100  comprises the core  2102 , the surround layer  2104 , and the outer fluid-impermeable layer  2106 . The advantage of this embodiment of the packing device  2100  is manufacturability, cost effectiveness, and control over the resiliency of the materials. The device  2100  can be fabricated using biocompatible materials, it can be sterilized, it can further comprise radiopaque markers embedded therein, and it can be provided with a variety of outer surfaces to provide the correct amount of tamponade and thrombogenic properties to the tissues within it is being placed. The packing device  2100  can be configured for short-term, long-term, or permanent implantation. Embodiments of the packing device  2100  are superior to other packing devices of the prior art in that they can apply pressure, in excess of 70 to 250 mm Hg, sufficient to staunch an arterial bleeding situation whereas the devices of the prior art are insufficiently resilient to push against tissue and stop the hemorrhage against systemic arterial pressure. 
         [0108]    The present invention is suitable for wounds to many parts of the body. The external hemostatic pack works on the arms, the legs, the head, a finger, the torso, or various extremities, etc. The present invention also describes a fluid or liquid-impermeable band-aid type device with the further enhancement that a fluid-tight dam is comprised within the device to prevent blood loss out the side of the band-aid. The dam, in a preferred embodiment, does not use adhesives to attach or seal to the body, but rather is attached with mechanical locks and straps since adhesives often fail in a wet or contaminated environment. The dam and liquid impermeable wound covering part of the bandage are preferably conformable to different body curves but still retain the substantial part of their width and length when applied. The dam and liquid impermeable region further are configured to prevent or minimize distortion, wrinkling, kinking, or the like. Such prevention of distortion, wrinkling, or kinking is accomplished, in a preferred embodiment by the use of stiffeners laterally disposed across the bandage to prevent lateral compression. These stiffeners allow for flexibility but provide column strength to prevent lateral collapse of the bandage. In yet another embodiment, the hemostatic packing device is filled through a valved port operably connected to the region inside the dam and underneath the liquid impermeable barrier. The hemostatic packing device can be pressurized with fluids such as air, water, antibiotic material, saline, and the like. Such pressurization to levels at or above systemic arterial pressure assists in even distribution of said pressure and is capable of further assisting with hemostasis. 
         [0109]    The present invention includes apparatus and methods for treating wounds. The present invention, and the means described herein for accomplishing said wound treatment, may be embodied in other specific forms without departing from its spirit or essential characteristics. For example, although the preferred embodiment comprises a sterile bandage or packing device in an aseptic transfer package, a non-sterile device may also be appropriate in certain instances. Further, the strap means, used to hold the fluid impermeable barrier and dams against the skin, may be replaced with a rigid or semi-rigid shell, split to form a hinged or connected pair of clamshells which may be opened and then closed and locked around an appendage. The shell is, in one embodiment, a pair of “C” shaped members forming a bracelet. The shell could be square and the blood seal be tightened with a plate and a jackscrew with a handle or knob. This shell, or cuirass, is able to force the fluid impermeable barrier and dams, pre-mounted to a rigid or semi-rigid backbone, frame, or scrim, against the patient to force the dams into the skin without causing the tourniquet effect of a tightly wrapped strap. Thrombogenic or antimicrobial agents could be applied to any region of the peripheral hemostasis system. Adjustment means, such as a jackscrew or a lever and ratchet is used to control the amount of force with which the dams are impressed into the skin to cause the fluid-tight seal. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Technology Classification (CPC): 0