Patent Publication Number: US-2013237898-A1

Title: Wound treatment system and method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     Not Applicable. 
     BACKGROUND 
     Background and Relevant Art 
     When a person suffers a traumatic wound, such as a wound from a gunshot, knife, or shrapnel, the primary source of bleeding, (i.e. vein/artery) is often located deep inside the wound. To stop the bleeding, it is necessary to apply pressure to the wound, at the source of the bleeding. The deeper the wound, the more difficult it can be to apply pressure directly to the source of the bleeding, to effectively stop the bleeding and to treat the wound. For example, when a gunshot wound punctures an artery, it can be difficult to apply pressure directly to the artery, deep within the wound, in order to stop the bleeding. For this reason, deep wounds can result in continuous internal bleeding and can even be lethal. 
     Various products have been developed and used to treat such wounds. For example, gauze can sometimes be used to pack such wounds by manually injecting the gauze into the wound with one or two fingers, bit-by-bit. By forcing gauze into the wound, it is sometimes possible to apply enough internal pressure to the source of the bleeding in order to stop the bleeding. However, there are several problems that exist with the traditional packing of a wound with gauze. 
     Initially, it is noted that gauze is often supplied in a bulky roll that makes it inconvenient to be carried by a soldier for use during battle. It can also be difficult to unroll and pack the gauze, during a chaotic battle scene, in an aseptic manner. For example, as the gauze is inserted into the wound, the remaining strand of gauze is often unwound and becomes contaminated by dragging the unwound roll of gauze on the ground or across dirty clothing. Additionally, the person who inserts the gauze must do so manually (e.g. by inserting a finger into the wound to push the gauze into the wound). Accordingly, any contaminants on the person&#39;s hands will likely be transferred to the gauze and/or the wound as it is being packed into the wound. 
     Furthermore, it can be very difficult for the person who is inserting the gauze to properly direct the gauze through the wound, to the deepest sources of the bleeding. For example, as the person is packing the gauze into the wound with his finger(s), the gauze can become bunched inside the wound before it reaches the deepest part of the wound. This is particularly problematic when packing shrapnel wounds, punctures and gunshot wounds that present irregular passageways and caverns. It can be difficult to fully and adequately pack a wound that spread across an irregular wound area that is deep and narrow, as opposed to an open laceration or clean puncture or gunshot wound. In many instances, the gauze is only packed into a portion of the wound, resulting in internal bleeding that can cause further injury or sometimes death. Contaminants that are introduced during the packing can also cause additional injury. 
     The difficulty in maintaining asepsis during the gauze packing procedure is even further exacerbated when the packing is performed by the injured party. This is because the wounded person must use one hand to insert the gauze into the wound and the other hand to hold and unravel the roll or folds of gauze. Notably, it can be difficult to unravel a roll of gauze with one hand, particularly when injured, such that it is even more likely that the gauze will fall onto or come into contact with an unclean material or surface (including a bloody and dirty hand of the injured party). 
     Finally, it is also noted that packing a wound with gauze can also take an undesired amount of time, resulting in excessive blood loss when attempting to perform the procedure in asepsis. 
     Although applicator delivery systems that are used with granular haemostatic agents can mitigate some of the risk of contaminating wounds during treatment, they also suffer from various other shortcomings. For example, the haemostatic agent, when coagulated, is structurally insufficient to apply the necessary pressure within the wound to stop the bleeding. While external surface pressure can be applied, after inserting the haemostatic agent, the surface pressure is often insufficient to stop the bleeding at the source, deep within the wound. 
     Gauze can also be packed into the wound after inserting the granules, to provide substance for applying the necessary internal pressure. However, this reintroduces many of the problems discussed above, during the packing. Furthermore, it has been discovered that granular haemostatic agents, such as Celox, can enter the blood stream and form blood clots in the body, away from the wound, such as is the brain, heart, or other organs. 
     Additionally anything introduced into a wound will have to be removed prior to surgical closure of the wound at the hospital. Granule products have been noted to be very difficult to debride wounds and tend to adhere to tissue inside the wound itself. 
     BRIEF SUMMARY 
     The present invention extends to a wound treatment system and a method of using the wound treatment system to treat a wound. The wound treatment system comprises an applicator that contains an absorbent material, and a plunger. The applicator is formed with an elongate sleeve extending between a plunger end and a deployment end. The absorbent material which is packed, stacked, compressed or otherwise disposed within the elongate sleeve has a mass that is continuously and integrally connected, so as to facilitate its removal from the wound. In some embodiments, the absorbent material has a length (when in an uncompressed state) that is at least three times greater than the length of the sleeve, to facilitate the packing of a wound. 
     The plunger is used to eject the absorbent material from the deployment end of the applicator. In this manner, the absorbent material can be directly injected into a flesh wound, such as a wound from a gunshot, knife, or shrapnel, in an aseptic manner. Further, because the applicator is inserted into the flesh wound prior to injecting the absorbent material, the wound treatment system facilitates the speedy injection of an absorbent material directly at the source of bleeding, even deep within the wound, thus facilitating the application of pressure and foreign bodies to promote clotting in order to stop blood loss. 
     Preferably, the applicator has a tip or deployment end that is tapered to facilitate the injection of the applicator into the wound. The applicator can also be formed from flexible materials that facilitate the navigation of the applicator into irregular wounds. 
     Different absorbent materials can also be used, with different decompression properties and forms, so as to facilitate their use in packing a wound, as described herein. The absorbent materials can also be impregnated or otherwise treated with chemical agents, such as haemostatic agents to assist the body in clotting the blood, or anti-microbial agents to prevent infection. In some embodiments, mechanical materials are also used, such as x-ray detectable materials, within the absorbent materials, so as to facilitate an exam to determine whether the entire absorbent material has been removed prior to cleaning and closing the wound at a later time. 
     The applicator can be covered with a cap (such as at the deployment end) to help keep the absorbent material within the sleeve and to protect the absorbent material from contaminants during periods of non-use. The entire applicator can also be packaged within a protective sleeve for similar purposes. 
     Methods for using the inventive treatment system include deploying the absorbent material from one or more applicators into the wound. In some instances, the wound is further packed with gauze or another packing material, on top of the absorbent material. In other methods, the absorbent material is deployed onto a surface wound and then wrapped with gauze or another wrapping material or compression bandage. 
     This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. 
     Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention. The features and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In order to describe the manner in which the above-recited and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  illustrates a prior art wound treatment system for injecting a granular agent into a puncture wound; 
         FIG. 2  illustrates an applicator of a wound treatment system that can be used in embodiments of the invention; 
         FIG. 3  illustrates some absorbent materials of various form factors that can be included within the wound treatment system of the present invention; 
         FIGS. 4A-4B  illustrate some exemplary configurations of the wound treatment system of the present invention; 
         FIG. 5  illustrates an exemplary wound treatment system after absorbent material having a form of a string or cord has been ejected or deployed from the applicator; 
         FIGS. 6A-6D  illustrate various stages of a deep tissue wound being treated by a wound treatment system of the invention; and 
         FIGS. 7A-7C  illustrate exemplary retaining means for retaining the absorbent material within the applicator of the wound treatment system. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention extends to a wound treatment system and a method of using the wound treatment system to treat a wound. The wound treatment system comprises an applicator that contains an absorbent material, and a plunger. The applicator is formed with an elongate sleeve extending between a plunger end and a deployment end. The absorbent material which is packed, stacked, compressed or otherwise disposed within the elongate sleeve has a mass that is continuously and integrally connected, so as to facilitate its removal from the wound. In some embodiments, the absorbent material has a length (when in an uncompressed state) that is at least three times greater than the length of the sleeve, to facilitate the packing of a wound. 
     The plunger is used to eject the absorbent material from the deployment end of the applicator. In this manner, the absorbent material can be directly injected into a flesh wound, such as a wound from a gunshot, knife, or shrapnel, in an aseptic manner. Further, because the applicator is inserted into the flesh wound prior to injecting the absorbent material, the wound treatment system facilitates the speedy injection of an absorbent material directly at the source of bleeding, even deep within the wound, thus facilitating the application of pressure and foreign material to stop blood loss. 
     Preferably, the applicator has a tip or deployment end that is tapered to facilitate the injection of the applicator into the wound. The applicator can also be formed from flexible materials that facilitate the navigation of the applicator into irregular wounds. 
     Different absorbent materials can also be used, with different decompression properties and forms, so as to facilitate their use in packing a wound, as described herein. The absorbent materials can also be impregnated or otherwise treated with chemical agents, such as hemostatic agents to assist the body in clotting the blood or anti-microbial agents to prevent infection. In some embodiments, mechanical materials are also used, such as x-ray detectable materials, within the absorbent materials, so as to facilitate an exam to determine whether the entire absorbent material has been removed prior to cleaning and closing the wound at a later time. 
     The applicator can be covered with a cap (such as at the deployment end) to help keep the absorbent material within the sleeve and to protect the absorbent material from contaminants during periods of non-use. The entire applicator can also be packaged within a protective sleeve for similar purposes. 
     Methods for using the inventive treatment system include deploying the absorbent material from one or more applicators into the wound. In some instances, the wound is further packed with gauze or another packing material, on top of the absorbent material. In other methods, the absorbent material is deployed onto a surface wound and then wrapped with gauze or another wrapping material. 
       FIG. 2  illustrates some aspects of an exemplary wound treatment system  200  according to certain embodiments of the invention. Wound treatment system  200 , for example, comprises an applicator  201  and a plunger  202 . Applicator  201  and plunger  202  can be similar to those used in wound treatment system  100  shown in  FIG. 1 . In other words, wound treatment system  200  can be comprised of commonly used applicators and plungers. However, as detailed below, applicator  201  can be designed in various novel ways to further facilitate the injection of absorbent material into a flesh wound. 
     Applicator  201  is shaped as an elongate sleeve that has a body that is round (as shown), oval, rectilinear, or another shape that is not currently shown. Applicator  201  can also be configured in various lengths or diameters/widths and shapes to accommodate and treat wounds of different depths, widths and shapes. 
     In some embodiments, the applicator  201  has a length of between about 2 inches and 10 inches, and more preferably a length in a range of between about 4 inches and 8 inches, and even more preferably a length of about 6 inches or in a range of between about 5 inches and 7 inches. 
     The diameter of the applicator is in a range of between about ¼ inch and 2 inches, and more preferably between about ½ inch and 1 inch. 
     Applicator  201  can be made of various materials including rigid and flexible materials. For example, applicator  201  can be made of a relatively flexible material to facilitate insertion of applicator  201  into irregularly shaped wounds. 
     Applicator  201  includes a deployment end  201   a , a plunger end  201   b , and an opening  201   c . Plunger  202  is inserted into the elongate sleeve at plunger end  201   b  to eject absorbent material contained within the elongate sleeve from the elongate sleeve through opening  201   c  (such as shown and described in more detail below, in reference to  FIGS. 3-5 ). 
     Wound treatment system  200  can be packaged with plunger  202  pre-inserted into applicator  201 . Alternatively, wound treatment system  200  can be packaged with plunger  202  removed from applicator  201 , in which case a cap or other means of sealing plunger end  201   b  of applicator  201  may be included to retain the absorbent material within the sleeve and to ensure that the absorbent material remains aseptic. 
       FIG. 3  illustrates exemplary form factors for absorbent materials that can be contained within applicator  201 . Absorbent material, as described herein, comprises any hydrophilic material that is suitable for treating wounds. A common example of such a material is gauze or another woven material; however, the invention is not limited to using gauze as the absorbent material. 
     According to many embodiments of the invention, the absorbent material is compressed within applicator  201  to maximize the amount of absorbent material that can be injected into a flesh wound. This configuration facilitates packaging and portability of gauze for soldiers. 
       FIG. 3  illustrates that the absorbent material can have different form factors, including different widths and lengths. For example, material  301  represents a woven or sponge like material having a generally large width and/or thickness. Material  301  can comprise gauze, another type of woven material, a sponge or another material. 
     The thickness of the absorbent material can vary, from less than ¼ inch to more than four inches, for example. Notably, material  301  represents absorbent material that has a width greater than the diameter or width of applicator  201  and, in some instances more than twice or three times the width of the diameter of the applicator. 
     Material  302  represents a material having a relatively smaller width. For example, material  302  can also comprise gauze having a common width of ¼ or ½ inches. In some instances, material  302  has a width that is substantially the same as the diameter of the applicator. 
     Material  303  represents a material having a minimal width such as a width of a string or cord, having a generally cylindrical cross-sectional. For example, material  303  can comprise a string, cord, rope or other segment of a woven material (like gauze) or another fibrous and continuously connected or interwoven material. In some embodiments, material  303  has a width or diameter that is less than the diameter of the applicator and, in some instances, less than ½ the diameter of the applicator. 
     Although the above description provides various specific exemplary widths, it will be appreciated that absorbent material of any reasonable width may be used. 
     In some embodiments, the absorbent material contained within applicator  201  also has a length that is at least equal to the length of the applicator and, in most embodiments, greater than the length of the applicator. One reason for this is to provide enough material to be applied inside of a wound to apply pressure at the point of bleeding and to assist in stopping the bleeding. 
     In some embodiments, the length of the absorbent material is at least three times greater than the length of applicator  201 . The length of the absorbent material can also vary to accommodate different needs and preferences, such as, for example, based on the width and type of the absorbent material. For example, for a wider absorbent material, a piece of absorbent material having a length of approximately 3 feet or less may be used. In contrast, for absorbent material comprising a string, the length of the absorbent material may exceed 20, 50 or even 100 feet in length. Generally speaking, the absorbent material will have a length of between about 1 foot and 100 feet. 
     Generally, a single continuous strand of absorbent material is contained within applicator  201  to facilitate the removal of the absorbent material from the flesh wound after treatment. However, in some embodiments, multiple pieces of absorbent material can also be contained within applicator  201 . 
       FIG. 4A  illustrates a transparent view of applicator  201  to illustrate absorbent material  400  compressed within applicator  201 . Absorbent material  400 , as shown, can be packed and/or compressed into applicator  201  in a random manner. Alternatively, as shown in  FIG. 4B , absorbent material  401  can be packed into applicator  201  using a repeating pattern, such as a folded pattern, to maximize the amount of absorbent material that can be contained/compressed within applicator  201 . Using a folded repeating pattern can be most effective when an absorbent material having a width similar to or smaller than the diameter or width of applicator  201  is used. 
       FIG. 5  illustrates absorbent material  400  after it has been ejected from applicator  201  by pressing the plunger  202  into the applicator  201 . As shown, once deployed, the absorbent material  400  expands from its compressed state to occupy a greater area than it contained within the applicator. In some cases, the amount of area the absorbent material occupies (in an uncompressed state), is at least 25%, 50%, or more than 100% greater than the area it occupied within the applicator. 
     Because absorbent material  400  can be ejected after applicator  201  is inserted into a flesh wound, absorbent material  400  can be positioned directly at the source of the bleeding, even at the base of deep wounds. Also, as opposed to the insertion of gauze by hand, applicator  201  facilitates the aseptic deployment and spreading of the absorbent material  400  throughout the area of the wound to ensure the entire source of bleeding is treated. Specifically, because the absorbent material is injected internally, it more easily spreads throughout the wound to apply internal pressure to the wound. 
       FIG. 6A  illustrates an exemplary flesh wound  601 , in the leg  600  of a victim, which may be treated using the wound treatment system of the present invention. Wound  601  includes a puncture  602  into leg  600 . Puncture  602  can be from a gunshot, a knife, shrapnel, or any other source. As shown, puncture  602  can extend deep into leg  600  and can have an irregular shape, thus making it difficult or impossible to reach the deepest source of bleeding with one&#39;s fingers. A wound or puncture from a gunshot, knife, shrapnel, and the like can pierce an artery or vessel in different locations. For example, as shown in  FIG. 6A , wound  601  has pierced artery  603  in two locations,  603   a  and  603   b . It can be difficult to reach multiple locations when inserting gauze using one&#39;s fingers. 
     Accordingly, to facilitate treatment of wound  601 , the applicator  604  of a treatment system can be inserted into wound  601  via puncture  602  as shown in  FIG. 6B . Applicator  604  can be the same as applicator  201 . Applicator  604  contains absorbent material  605 . Although absorbent material  605  is shown as being similar to material  303  of  FIG. 3 , any suitable absorbent material can be used. Applicator  604  can be inserted into puncture  602  until applicator  604  is in the immediate proximity of the source of bleeding (e.g. pierces  603   a  and  603   b ), deep within the wound  601 . 
     To facilitate different wound depths, different applicators of different lengths can also be utilized, as described above. During treatment, for example, a practitioner can be presented with a kit of different treatment systems/applicators having different shapes and/or sizes and that contain similar or different types of absorbent materials. 
       FIG. 6C  illustrates that absorbent material  605  has been partially ejected from applicator  604  by depressing plunger  606 . Notably, absorbent material  605  has spread into each pierce  603   a  and  603   b  as well as throughout wound  601 . Also, as the remaining portion of absorbent material  605  is ejected from applicator  604 , additional pressure will be applied to wound  601  to stop blood loss. 
       FIG. 6D  illustrates that absorbent material  605  has now been fully ejected into the wound  601  and that applicator  604  has been partially removed from wound  601 . If necessary, an additional one or more wound treatment systems (of the same or different configuration) can be used to treat wound  601 . For example, if wound  601  were large thus requiring additional absorbent material, another applicator could be inserted into wound  601  in a similar manner to inject additional absorbent material. Further, after injecting absorbent material using the wound treatment system of the present invention, additional absorbent material can be used to treat wound  601  using traditional techniques, such as by inserting gauze using a finger to increase internal pressure on wound  601 , at the upper end of the wound, or by wrapping gauze around leg  600  to apply external surface pressure. 
     Although the above description describes the use of the wound treatment system to treat a penetrating or puncture wound, the wound treatment system can also be used to treat non-penetrating wounds such as lacerations or avulsions, by deploying the absorbent material directly to the surface area of the wound or into a hand for manual application to the wound. In either event, the wound treatment system provides the benefit of maintaining the absorbent material in asepsis before and often during treatment. The wound treatment systems of the invention also facilitate quick deployment of the absorbent material with accurate placement. 
     Another advantage of the invention in treating wounds of any type is that the wound treatment system facilitates self-treatment. For example, it is generally easier for a person to inject absorbent material into himself rather than packing gauze by hand. Also, the wound treatment system better maintains the absorbent material in asepsis because the absorbent material is not easily exposed to contaminants until it is ejected from the applicator. 
       FIGS. 7A-7C  illustrate various designs for various retaining means that can be used for retaining the absorbent material within the applicator of a wound treatment system of the invention. Retaining means comprise means for retaining compressed absorbent material within the applicator until it is intentionally deployed from the applicator, such as, for example, during treatment (as described above).  FIG. 7A  illustrates that the retaining means can comprise a tapered deployment end  701 . The taper can be sufficient to retain compressed absorbent material within the applicator until a predetermined pressure is applied to the plunger. The taper can also facilitate placing the applicator into and navigating the applicator through a wound. 
       FIG. 7B  illustrates that the retaining means can also comprise a number of flaps at the deployment end.  FIG. 7B  includes a closed configuration  704  and an open configuration  705 . Flaps  702   a  and  702   b  are shown in closed configuration  704  as being interconnected via a seam  703 . Seam  703  is designed to rupture when a predetermined pressure is applied to the plunger as shown in open configuration  705 . Specifically, in open configuration  705  flaps  702   a - 702   d  are shown as separated from each other to increase the size of the opening. In this manner, injection of the absorbent material is facilitated. Although  FIG. 7B  shows the retaining means as comprising four flaps, the retaining means can comprise other numbers of interconnected flaps (e.g. two, three, or more). The flaps can also be sealed shut with an adhesive, molding, welding or other manufacturing process. 
       FIG. 7C  illustrates that the retaining means can comprise a bridge for securing a number of flaps.  FIG. 7C  includes a closed configuration  706  and an open configuration  707 . In closed configuration  706 , a first flap  708   a  is connected to a second flap  708   b  via bridge  709 . Bridge  709  can be made of the same or different material as the remainder of the applicator. Bridge  709  is configured to rupture when a predetermined pressure is applied to the plunger. For example, as shown in open configuration  707 , bridge  709  has ruptured from first flap  708   a  thus enabling first flap  708   a  and second flap  708   b  to separate. Bridge  709  is shown as being permanently connected to second flap  708   b  so that bridge  709  does not remain within a wound after injection of absorbent material. The bridge  709  can also substantially cover (in a sealed or unsealed configuration) the entire opening of the applicator, so as to further protect the aseptic condition of the absorbent material. 
     A seam can also be provided between first flap  708   a  and second flap  708   b  to create a seal. Such a seam could be configured similar to seam  703  of  FIG. 7B  to rupture when the predetermined pressure is applied. However, because of bridge  709 , a seam is not necessary to retain the compressed absorbent material within the applicator. 
     Although  FIG. 7C  shows two flaps, a bridge can be used to secure more than two flaps. For example, a bridge can be permanently connected to a first flap while being temporarily connected to two or more other flaps. Accordingly, when the predetermined pressure is applied to the plunger, the bridge can rupture from the two or more other flaps while remaining connected to the first flap. 
     Regardless of how the applicator is configured (i.e. whether retaining means are used or not), a friction fit cap can also be used to cover the deployment end of the applicator. The cap (not shown) can be beneficial to prevent the unintentional deployment of the absorbent material and/or to prevent contamination of the absorbent material. 
     In some embodiments, the retaining means can comprise the cap. For example, the cap can be pressed over the deployment end of the applicator to retain the absorbent material within the applicator until the applicator is inserted into the wound. 
     In some embodiments, the absorbent material can be impregnated or coated with a haemostatic agent to assist in the clotting of blood. Additionally, in some embodiments, the absorbent material can be impregnated, coated, or interwoven with a material that is detectable via x-ray, radio waves, or some other means to facilitate detection of the absorbent material to ensure complete removal from the wound. 
     The wound treatment system can also comprise a sealed envelope or other package containing the applicator and plunger. The applicator and plunger can be packaged separately inside the sealed package or the plunger can be pre-inserted into the plunger end of the applicator. The sealed package can assist in preventing contamination of the absorbent material within the applicator. 
     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 by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.