Abstract:
Devices and methods are disclosed for achieving hemostasis in patients who have received skin-penetrating wounds to the body in regions such as the shoulder, pelvis, neck, or groin, where standard bandages are difficult to apply and where large blood vessels exist which can hemorrhage severely. Such haemostatic packing devices and methods are especially useful in the emergency, trauma surgery, or military setting. The devices utilize packing pillows that are held in place by rigid structures that can cause the packing pillows to be brought into the wounds and be held in place while the packing pillows are inflated to fill the wounds, prevent bleeding, and tamponade hemorrhaging large blood vessels exposed therein.

Description:
RELATED APPLICATIONS 
     The present application is a Continuation-in-Part of U.S. patent application Ser. No. 12/012,084, file 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, filed Mar. 23, 2005 now U.S. Pat. No. 7,329,782 which is a Continuation-in-Part of U.S. patent application Ser. No. 10/358,881 filed Feb. 4, 2003, now U.S. Pat. No. 6,998,510 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 Applications No. 60/555,537 filed Mar. 23, 2004, entitled “METHOD AND APPARATUS FOR PERIPHERAL HEMOSTASIS”, and 61/277,927 filed Oct. 1, 2009, entitled METHOD AND APPARATUS FOR HEMOSTASIS, the entirety of both of which are hereby incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     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 
     As recently as the early 1990&#39;s, 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. 
     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. 
     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. 
     There are situations, especially in the battlefield, where soldiers are placed at risk for penetrating injuries from bombs and projectiles. Soldiers are often equipped with body armor. However, this body armor generally protects the torso but not the arms, legs, and neck in the region where body flexibility is required. Thus, soldiers often incur injuries to the region just adjacent to the body armor, wherein such injuries are difficult to treat, hemorrhage significantly, and represent a real risk of loss of life, exsanguination cardiac arrest, or cerebrovascular dysfunction. 
     There are no devices, available today, which can be used to reliably treat injuries to individuals in the groin, shoulder, neck or other region immediately adjacent to the torso. New devices, procedures and methods are needed to support the strategy of damage control in patients who have experienced massive bodily injury in these regions. Such devices and procedures are particularly important in the emergency, military, and trauma care setting. 
     SUMMARY OF THE INVENTIONS 
     These inventions relate to improved haemostatic packing devices for use in trauma care. The present inventions include an impermeable barrier pack or wrap for a body appendage in a region located close to the torso. In these regions, it is not possible to wrap a bandage completely around the patient and to provide pressure to prevent loss of blood from a wound. 
     In some embodiments, the inventions include a C-shaped, or U-shaped, cuirass or other rigid or semi-rigid structural element that partially surrounds a hip, groin, shoulder, upper arm, upper leg, or neck. One side of the cuirass, near the opening and on the inside of the C, comprises a compression pack that can optionally be made to expand in volume, inward projection, pressure, or the like. The compression pack can be an inflatable bladder, a porous bladder filled with expandable hydrogel, a foam pillow, or the like. On the other side of the cuirass, near the opening and on the inside of the C, an expandable structural element is provided, which is adjustable and can project inward to varying degrees for the purpose of pulling the compression pack into a wound. The expandable structural element can include inflatable pillows or bladders, a jack-screw such as is used in a C-clamp, a scissor jack, a pneumatic or hydraulic piston, or the like. The C-shaped cuirass can be complete or it can be fabricated from segments, which can be stored and transported in a semi-flat configuration and then interconnected to form the C-shape, a structure that has increased volume and does not necessarily make it easy for transportation. An inflation system is also provided to inflate the compression pack, the expandable structural element, or both. Such inflation system can be a mouth operated inflation port with a valve or other closure. The inflation system can also include a piston that is advanced with a lever or, threaded rod and handle, jack-screw, or the like. Inflation can use fluids such as air, nitrogen, carbon dioxide, water, antimicrobial liquids, and the like. 
     The C-shaped cuirass and its components can be fabricated in different sizes, or it can be adjustable in size, or it can be a one-size-fits-all configuration. The C-shaped cuirass can be fabricated from polymeric materials such as, but not limited to, polyethylene, polypropylene, polycarbonate, polyetheretherketone (PEEK), polysulfone, polyester, acrylonitrile butadiene styrene, or the like. The cuirass can also be fabricated from metals such as, but not limited to, aluminum, stainless steel, nitinol, titanium, or the like. The cuirass is preferably open at one side but the closed side can comprise between about 160 to about 270 degrees of a circle. The opening can comprise between about 200 to about 90 degrees of the circle. The cuirass can be approximately C-shaped but not necessarily symmetrical as various shapes may be advantageous for surrounding the shoulder or certain points of the groin that might include somewhat distorted C-shapes with elongated upper and lower wings or even an open rectangular shape, for example. The C-shaped cuirass is configured with enough strength so as not to open, substantially distort, or fail under pressure significant enough to stop hemorrhage at systemic blood pressures up to about 100 to 300 mm Hg. 
     The compression pack can be fabricated from elastomeric materials such as C-flex, silicone elastomer, Hytrel, Pebax, polyurethane, polyester, polyethylene, polypropylene, polyamide, or other thermoplastic. The compression pack can also comprise a fabric fabricated from similar materials in a woven or knitted structure. The fabric like structure can be placed on the outer surface of the compression pack to enhance clotting because of its high surface area. Alternatively, the exterior surface of the compression pack can be made advantageously smooth to still cause tamponade but prevent adhesions that might interfere with later surgical reconstruction of the wound. The surface of the compression pack can be coated prior to application to the wound with antimicrobial agents such as silver azide, betadine, iodine, or antibiotics and it can also be coated with thrombogenic materials, such as fibrin glue, configured to enhance stoppage of bleeding from the wound. The compression pack can be configured to expand and fill whatever space is required to completely close off the wound to prevent hemorrhage. In other embodiments, the compression pack can be configured to adjust for spacing differences in one-size-fits all cuirass devices. The expansion can be caused by fluid (e.g. air, water, radiopaque dye) pressure injected through an injection port to fill a bladder, it can be caused by swelling of a hydrophilic hydrogel, swelling of a foam, or the like. Expansion can also occur by resilient expansion of compressed foam or other polymeric structure following insertion into the body through a laparoscopic instrument, tube, cannula, or the like. 
     Other aspects of the inventions include the methods of use. The methods of use include folding the pack in a container providing the minimum volume for portability and storage, especially in the field. Other embodiments include providing the pack in an aseptic container, wherein the pack has been sterilized using ethylene oxide, gamma irradiation, electron beam irradiation, steam sterilization, and the like. In some embodiments, the methods include removing the pack from its aseptic container, such as a Tyvek, heat sealed pouch, and assembling the relatively rigid cuirass structure from a plurality of parts, wherein the final assembly comprises an approximately C- or U-shape. The device can also be provided fully assembled in other embodiments. The methods of use include cleaning and preparing the wound by removing dirt, clothing, or other debris or contamination and then applying the sterile pressure pad into the wound and then making sure the cuirass has surrounded a sufficient part of the body that the expandable region on the opposite side may be activated to hold the pressure pack in place. The pressure pack is then inflated to its operational pressure or allowed to generate whatever pressure it is pre-set to generate. The expandable structural element is next activated to pull the pack into the wound to apply tamponade forces within the wound sufficient to generate hemostasis while not causing a tourniquet effect. In other embodiments, the pressure pack can be pulled into the wound first to cause tamponade, followed by expandable element being expanded to secure the pressure pack in place so that it is not easily disturbed or dislodged. In other embodiments, the expandable element is first expanded to pull the unexpanded pressure pack into the wound. The pressure pack is next inflated to generate the necessary hemostasis and tamponade. 
     The patient can now be transported to a medical facility where repair of the injured wound can be accomplished knowing that blood loss from the wound will be substantially reduced or prevented by the device, which is firmly in place and is resistant to jarring or coming loose. 
     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 
       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. 
         FIG. 1  illustrates the torso of a patient wearing body armor, according to aspects of the invention; 
         FIG. 2  illustrates wounds to a shoulder, a groin, and a neck just adjacent to the body armor, according to aspects of the invention; 
         FIG. 3  illustrates a C-shaped wound treatment device with a wound pack and a compression mechanism, according to aspects of the invention; 
         FIG. 4  illustrates the C-shaped wound treatment device applied to the groin wound, the neck wound, and the shoulder wound, according to aspects of the invention; and 
         FIG. 5  illustrates a partial sectional view of the C-shaped wound treatment device, according to aspects of the invention. 
         FIG. 6  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. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     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. 
       FIG. 1  illustrates a front view of a patient  100 , looking posteriorly, wherein the patient  100  is wearing a protective vest  102  over their torso and a helmet  110  on their head. The patient  100  further comprises a shoulder  108 , a groin  104 , and a neck  106 . 
     Referring to  FIG. 1 , the patient  100  is shown with protective gear similar to that used by military personnel. Other garments are not shown for simplicity. The protective vest  102  does not extend significantly over the groin area  104 , the neck  106 , or the shoulders  108  since mobility would be unduly restricted if such coverage existed. 
       FIG. 2  illustrates the patient  100  with their helmet  110  removed. The patient  100  has incurred a groin injury  202 , a shoulder injury  204 , and a neck injury  206 , all of which are skin  214  penetrating. The groin injury  202  has exposed and endangers a femoral artery  208 . The shoulder injury is an open wound and has endangered a large artery  210  running down the arm while the neck injury  206  has exposed and endangers a carotid artery  212 . 
     Referring to  FIG. 2 , these types of injuries, if they result in damage to the blood vessels  208 ,  210 , and  212  can be life threatening and can lead to exsanguination or sufficient loss of blood to cause severe long-term mental disability. The injuries  202 ,  204 , and  206  are all located just adjacent to the body armor  102  in areas that are unprotected but are difficult to treat. 
       FIG. 3  illustrates a severe wound pack system  300  comprising a three-part cuirass fabricated from a top plate  306 , a bottom plate  304 , and a curved connector plate  302 . The plates  302 ,  304 , and  306  are interconnected with a connector  320  that permits interlocking by sliding the plates together along their edges. The wound pack system  300  further comprises a compression pack  310 , an expandable tightening pack  308 , a tightening adjustment line or port  312 , a tightening adjustment line valve  314 , a compression adjustment line or port  316 , and a compression adjustment valve  318 . 
     Referring to  FIG. 3 , the compression pack  310  is affixed to the inside of the bottom plate  304  such that, upon expansion, the compression pack  310  projects inward and, optionally outward to a restricted degree. The expandable tightening pack  308  is affixed to the top plate  306  and is configured to be hollow and expand generally away from the top plate  306  to provide for gap adjustment between the two plates  304  and  306 . The connector plate  302  is configured to permit substantially little or no opening of the distance between the top plate  306  and the bottom plate  304 . The plates  302 ,  304 , and  306  have the properties of rigidity and resistance to opening under pressure forces sufficient to hold the system  300  onto the patient and tamponade a wound with the compression pack  310 . The valves  314  and  318  can be stopcocks or other types of inflation ports. The lumens of the valves  314  and  318  are operably connected to the lumen of the lines  312  and  316 , respectively, which are, in turn, operably connected to the volume within the compression pack  310  and the expandable tightening pack  308 . An optional strap can be affixed to, and used to secure, the open ends of the top plate  306  and the bottom plate  304  and the strap can be secured with a buckle, hook and loop fastener and the like. The connector plate  302  can be curved or straight, thus forming a rectangular structure with an open end. The connector plate  302  can comprise telescoping sections and can further comprise a threaded screw such as is found in a C-clamp to adjust the separation between the top plate  306  and the bottom plate  304 . Manual rotation of a handle affixed to the threaded screw can cause the screw, which passes through either one of the top or bottom plates and is affixed to the other plate such that it can rotate but not move axially relative to that plate, to adjust the distance between the plates  304  and  306 . The connector plate  302 , the top plate  306 , the bottom plate  304 , or any combination thereof can be further reinforced with, for example I-beams, T-beams, or other structural support members either affixed externally or embedded therein to provide appropriate strength and resistance to distortion. The connector plate  302  can comprise a jack-screw and further comprise an alignment rod or element running along the same axis as the jack-screw to maintain the top plate  306  and the bottom plate  304  in correct alignment. The connector plate  302  can, in other embodiments, comprise a cam and lever system for opening and closing the jaws created by the top and bottom plates  306 ,  304 , respectively. 
       FIG. 4  illustrates the patient  100  with wound packs  300  applied to the groin injury  202 , the shoulder injury  204 , and the neck injury  206  (Refer to  FIG. 2 ). The patient  100  is shown still wearing the body armor  102  so these devices can be used without removing certain protective gear. The compression pack  310  is illustrated inflated in the neck wound  206  while the expandable tightening pack  308  is also visible on the opposite side of the neck. The soft, pillow-like configuration of the expandable tightening pack  308 , which can contain a saddle or concave region, provides for comfort and stability to main the tightening pack  308  in place. All packs  300  are shown with their inflation lines  316  and valves  318 . The valves  318  are closed following inflation of the packs  300  to their desired degree of compression. 
     The compression pack  310  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. Embodiments of the compression pack  310  are superior to other packing devices of the prior art in that they can apply pressure, in excess of 70 to 300 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. 
       FIG. 5  illustrates a side view of the wound pack  300  in partial breakaway, or cross-section. The lower plate  304  is shown in breakaway view as is the compression pack  310 , further comprising the interior volume  502 . The upper plate  306  is also shown in breakaway view with the tightening pillow  308  shown in sectional view with its interior volume  506  visible. In the illustrated embodiment, the tightening pillow  308  comprises a slight saddle shape on its inner edge, the edge that faces the patient. The tightening pillow  308  is inflated through the port  508  within the upper plate  306 , which is operably connected to the lumen of the inflation line  312 . The interior  502  of the compression pack  310  is operably connected to the inflation port  504 , which is operably connected to the inflation line  316 . The connectors  320  are visible and are shown as sliding dovetail attachments. The connectors  320  could be fabricated in other embodiments such as plates and screws, or the like. The pressures at which the interior of the compression pack  310  is inflated can approximate that of systemic arterial pressure, which can be vary from patient to patient and can range from 300 mm Hg to below 100 mm Hg in very sick patients. 
     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., as well as the applications shown herein. 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. 
     The inventions described herein and in U.S. patent application Ser. No. 12/012,084, the entirety of which is hereby incorporated herein by reference, describe packing devices to tamponade patient wounds, either open or closed. The devices and methods can be used to treat closed wounds of the abdomen by means of the laparoscopic, thoracoscopic, or general percutaneous delivery of a packing devices as described herein and inflation by means of a fluid pressure port, which can be on the pack or routed out the laparoscopic delivery system to the outside of the patient or by uptake of water or liquid from the patient, or by resilient expansion of the packing device internal structure. The resilient internal structure can be foam such as foam fabricated from polyurethane, polycarbonate urethane, or the like. The foam can be in multiple layers with different amounts of resiliency, pre-compression, or both. The laparoscopic instrument or introducer can be removed or left in place with the pack. Such packs introduced via cannula or instrumentation can be used to pack not only arm and leg wounds, but also abdominal, thoracic, groin, shoulder, or other injuries, for example. The pack can be permanently affixed at or near the distal end of the laparoscopic instrument, detachable, or separate. In some embodiments, the pack can be a bladder fabricated, at least in part, with fluid impermeable membrane chosen from materials such as, but not limited to, polyester, polyimide, polyamide, polyurethane, silicone, or the like. 
     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, a strap means can be used to secure the U or C-shaped rigid cuirass to the patient in certain situations. The cuirass could be assembled to form a complete surround that does not compress the limb completely and thus does not generate a tourniquet effect. The shell could be square and the pillow be tightened with a plate and a jackscrew with a handle or knob. This shell, or cuirass, is able to force a fluid impermeable barrier or 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. 
       FIG. 6  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 . 
     Referring to  FIG. 6 , 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. 
     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. 
     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. 
     Applicant asserts that no new matter has been added.