Abstract:
A pre-fabricated pneumatic tourniquet apparatus and related methods are provided. The tourniquet is easy to apply, ensures consistent and even circumferential pressure, is light weight, provides standard life saving operation, and can be utilized in any setting or situation. The pneumatic tourniquet apparatus is comprised of a bladder, a reservoir chassis, a retaining cover, a receiver and a slider. The bladder is elongated in shaped—long enough to wrap around most human limbs.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. provisional patent application Ser. No. 61/883,797, filed Sep. 27, 2013, the entire disclosure of which is incorporated herein by reference. 
     
    
     GOVERNMENT RIGHTS 
       [0002]    This invention was made with government support under W81XWH-12-P-0497 awarded by USA MED RESEARCH ACQ ACTIVITY. The government has certain rights in the invention. 
     
    
     FIELD 
       [0003]    Embodiments of the present invention are directed to a pneumatic tourniquet and novel blood flow restriction device. In more detail, embodiments of the present invention are directed to an emergency use, pre-fabricated tourniquet used for restricting flow of blood during extreme hemorrhage or exsanguination. 
       BACKGROUND 
       [0004]    Exsanguination or major blood loss has been shown to be the major leading cause of death on the battlefield and directly correlates to major trauma in the civilian sector. Throughout history, tourniquets have been shown to save lives. Several large studies have confirmed the lifesaving benefit and low incidence of complications from pre-hospital use of tourniquets in combat casualties. Furthermore, the civilian Emergency Medical Services have adopted this opinion as well. Tourniquets are frequently used early in the care of trauma casualties because of the immediate lifesaving intervention capability and the speed with which they can be applied. Moreover, tourniquets are the standard of care for the temporary control of life-threatening extremity hemorrhage during the Care Under Fire (CUF) phase of the Tactical Combat Casualty Care (TCCC) in accordance with the Committee for Tactical Combat Casualty Care (CoTCCC) guidelines. These guidelines are becoming the standard of care for treatment of massive hemorrhage across the spectrum of pre-hospital care worldwide. 
         [0005]    Due to the nature of traumatic amputation and dismemberment, there is a requirement for application of an emergency tourniquet to be operated by one hand. For a device to be truly operable by only one hand, it must be capable of being placed on an extremity, upper or lower, without having to perform fine motor skill functions. In general, tourniquet operation should not require the use of fine motor skills, regardless of the one-handed operability requirement, because tourniquets are generally only used during periods of extreme duress (i.e., when it is difficult or impossible to expect the use of fine motor skills). 
         [0006]    Traditionally, tourniquets were nothing more than a general section of cloth material, usually a cravat, and a stick or dowel used as a windless. The general concept was to tighten the cloth material, reducing the circumference (diameter) of the cloth material against the extremity soft tissue, creating circumferential pressure sufficient enough to occlude blood flow. These make-shift tourniquets were often applied with too much pressure and caused neurovascular damage in limbs. Although the patient&#39;s life and limb were saved, the affected limb was permanently damaged. Therefore, a pre-fabricated tourniquet designed for consistent, even circumferential pressure is ideal for emergency use. 
         [0007]    Additionally, current tourniquet designs are prone to failure and are generally ineffective for use on lower extremities. Pneumatic tourniquet designs can be more desirable than a windless, mechanical design because pneumatic tourniquets can be more effective at restricting blood flow and can be more comfortable during use. However, because of design and cost constraints, current pneumatic tourniquets are generally only used in Hospital environments and are not effective or mechanically operable for field use. 
         [0008]    Furthermore, there are many situations in which a tourniquet can save a life other than in military applications. Some recreational activities can be inherently dangerous and can cause severe injury requiring the use of such an emergency device, especially in a remote setting. Primary examples of this are camping, rock climbing, hiking, boating, etc. Footprint size and weight are always a consideration in such settings since the individual user is required to carry the device in a backpack. Therefore, a ruggedized pre-fabricated tourniquet made of the strong and light material would be best-suited for the end-user. Such a tourniquet would provide for efficient transportation and effective, life-saving utilization. 
         [0009]    Thus, there is a need for a pre-fabricated tourniquet that is easy to apply, that ensures consistent and even circumferential pressure, that is light weight, that provides standard life saving operation, and that can be utilized in any setting or situation. 
       SUMMARY 
       [0010]    One object of the general inventive concept is to provide a pneumatically constricting tourniquet apparatus. The pneumatic tourniquet apparatus is made up of a bladder, a reservoir chassis, a retaining cover, a receiver and a slider. The bladder is elongated in shaped—long enough to wrap around most human limbs. In some embodiments, the bladder is formed from a single sheet of plastic, folded over along one edge and sealed along the other three edges so that the bladder holds and maintains air pressure while being inflated. 
         [0011]    The reservoir chassis holds and protects the bladder. The reservoir chassis includes a main section that envelops the bladder and a reservoir chassis extension section that extends from the main section but does not envelop the bladder. A retaining cover attached to the reservoir chassis where the main section and the chassis extension section connect. The retaining cover covers and protects the reservoir chassis. 
         [0012]    A receiver is connected to either the reservoir chassis or the retaining cover, at a location very near to where the retaining cover is attached to the reservoir chassis. A slider is connected to the retaining cover such that the slider can be slid to any point along the retaining cover. The receiver and slider are sized and shaped such that the slider is temporarily locked in position on the retaining cover as a friction buckle when engaged with the receiver. 
         [0013]    Another object of the general inventive concept is to provide a pneumatically constricting tourniquet apparatus. The pneumatic tourniquet apparatus is made up of a bladder placed into a reservoir chassis, a retaining cover attached to the reservoir chassis, a receiver attached to the retaining cover or the reservoir chassis, and a slider attached to the retaining cover. The reservoir chassis includes a main section that holds the bladder and an extension section connected to the main section. The retaining cover is attached to the reservoir chassis at a position adjacent to where the main section of the reservoir chassis connects to the extension section. The receiver is attached to either the retaining cover or the reservoir chassis adjacent to the position where the retaining cover is attached to the reservoir chassis. The slider is attached to the retaining cover such that the slider can slide to numerous positions along the retaining cover. The slider is sized and shaped to engage with the receiver. 
         [0014]    Another object of the general inventive concept is to provide a method of making a pneumatically constricting tourniquet apparatus. The method includes sealing a bladder, inserting the bladder into a reservoir chassis, attaching a retaining cover to the reservoir chassis, connecting a receiver to either the reservoir chassis or the retaining cover, and connecting a slider to the retaining cover. In some embodiments, the bladder is formed from a single sheet of plastic, folded over along one edge and sealed along the other three edges so that the bladder holds and maintains air pressure while being inflated. The bladder is inserted into the reservoir chassis to hold and to protect the bladder. The reservoir chassis includes a main section that envelops the bladder and a reservoir chassis extension section that extends from the main section but does not envelop the bladder. The retaining cover is attached to the reservoir chassis where the main section and the chassis extension section connect. The retaining cover covers and protects the reservoir chassis. 
         [0015]    A receiver is connected to either the reservoir chassis or the retaining cover at a location near where the retaining cover is attached to the reservoir chassis. The slider is connected to the retaining cover such that the slider can be slid to any point along the retaining cover. The receiver and slider are sized and shaped such that the slider is temporarily locked in position on the retaining cover as a friction buckle when engaged with the receiver. 
         [0016]    Another object of the general inventive concept is to provide a method of making a pneumatically constricting tourniquet apparatus. The method includes placing a bladder into a reservoir chassis, attaching a retaining cover to the reservoir chassis, attaching a receiver to the retaining cover or the reservoir chassis, and attaching a slider to the retaining cover. The reservoir chassis includes a main section that holds the bladder and an extension section connected to the main section. The retaining cover is attached to the reservoir chassis at a position adjacent to where the main section of the reservoir chassis connects to the extension section. The receiver is attached to either the retaining cover or the reservoir chassis adjacent to the position where the retaining cover is attached to the reservoir chassis. The slider is attached to the retaining cover such that it can be slid along the retaining cover. The slider is sized and shaped to engage with the receiver. 
         [0017]    The foregoing and other objects are intended to be illustrative of the invention and are not meant in a limiting sense. Many possible embodiments of the invention may be made and will be readily evident upon a study of the following specification and accompanying drawings comprising a part thereof. For example, dimensional values included herein are provided for exemplary purposes, and embodiments of the present invention contemplate tourniquets or tourniquet components having a various dimensional values. Furthermore, various features and subcombinations of invention may be employed without reference to other features and subcombinations. Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein is set forth by way of illustration and example, an embodiment of this invention. 
     
    
     
       DRAWINGS 
         [0018]    Embodiments of the invention are set forth herein and are shown in the following drawings: 
           [0019]      FIG. 1  shows an exemplary pneumatic tourniquet according to embodiments of the present invention. 
           [0020]      FIG. 2  shows an exemplary bladder that can be positioned within a reservoir chassis of the tourniquet from  FIG. 1 . 
           [0021]      FIG. 3  shows an exemplary receiver of the tourniquet from  FIG. 1 . 
           [0022]      FIG. 4  shows an exemplary slider of the tourniquet from  FIG. 1 . 
           [0023]      FIG. 5A  shows an additional view of a pneumatic tourniquet according to embodiments of the present invention. 
           [0024]      FIG. 5B  is a detail view on an enlarged scale of a portion of the tourniquet from  FIG. 5A . 
           [0025]      FIG. 6  shows an additional view of a pneumatic tourniquet according to embodiments of the present invention. 
           [0026]      FIG. 7  shows an additional view of a pneumatic tourniquet according to embodiments of the present invention. 
           [0027]      FIG. 8  shows another exemplary bladder that can be positioned within a reservoir chassis of the tourniquet from  FIG. 1 . 
       
    
    
     DETAILED DESCRIPTION 
       [0028]    The following detailed description of the invention references the accompanying drawings that illustrate specific embodiments in which the invention can be practiced. The embodiments are intended to describe aspects of the invention in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments can be utilized and changes can be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense. 
         [0029]    In this description, references to “one embodiment,” “an embodiment,” or “embodiments” mean that the feature or features being referred to are included in at least one embodiment of the technology. Separate references to “one embodiment,” “an embodiment,” or “embodiments” in this description do not necessarily refer to the same embodiment and are also not mutually exclusive unless so stated and/or except as will be readily apparent to those skilled in the art from the description. For example, a feature, structure, act, etc. described in one embodiment may also be included in other embodiments, but is not necessarily included. Thus, the present technology can include a variety of combinations and/or integrations of the embodiments described herein. 
         [0030]    With reference to the figures, and in particular  FIG. 1 , embodiments of the present invention are directed to a pneumatic tourniquet for restricting a blood flow in a body part, such as an upper or a lower extremity, with the tourniquet comprising: (a) a bladder  200  (See  FIGS. 2 and 8 ) sealed from 3 edges to hold and maintain air pressure while being inflated with an inflation pump  108 ; (b) a reservoir chassis  102  to hold and to protect the bladder  200 , with the reservoir chassis  102  including a main section that holds the bladder  200  and a reservoir chassis extension section  101  that extends from the main section but does not hold the bladder  200 ; (c) a retaining cover  103  that is attached to the reservoir chassis  102  where the main section and the chassis extension section connect, with the retaining cover  103  operable to cover and protect the reservoir chassis  102  (d) a receiver  106  (See also  FIG. 3 ) connected to either the reservoir chassis  102  or the retaining cover  103  proximate to where the retaining cover  103  is attached to the reservoir chassis  102 , with the receiver  106  being operable to accept a slider  107  (See also  FIG. 4 ) that is positioned on the retaining cover  103  from any position along the retaining cover  103 , and furthermore with the receiver  106  being operable to allow a user to “snap” the slider  107  into place and lift the lip  303  of the receiver  106  to remove the slider  107  upon demand; (e) the slider  107  serves as a friction buckle operable to be placed along any section of the retaining cover  103 , with the slider  107  including one round side bar  401  and one square side bar  402  with grippers  405  allowing for free rotation when attached to the receiver  106 . In operation, the pneumatic tourniquet (See also  FIGS. 5A-7 ) is operable, via the above described components (a-e), to form a continuous loop around an extremity, such as an arm or a leg, so as to create a circumferential pressure that will restrict blood flow. Such a circumferential pressure is created by and 1) joining the slider  107  and the receiver  106  together and manipulating the retaining cover  103  so as to reduce the circumference of the tourniquet, and 2) pumping air into the bladder  200 . 
         [0031]    With respect to  FIG. 1  (see also  FIGS. 5A-7 ), the reservoir chassis  102  retains and protects the air bladder  200 . In some embodiments, the total length is 33 inches and the width is between 2 and 4 inches. In some embodiments, the reservoir chassis  102  includes a section of dual hook and loop fasteners on both sides of the reservoir chassis faces. In other words, the dual hook and loop fasteners are on the side facing “in” and the side facing “out.” The tourniquet also includes a retaining cover  103  sized and shaped to overlap the reservoir chassis  102  as a secondary securing mechanism to prevent slippage or pressure reduction. The retaining cover  103  also provides extra protection for the reservoir chassis  102  and bladder  200 . The outer surface of the retaining cover  103  includes dual hook and loop fasteners. The reservoir chassis extension  101  does not contain the bladder  200 . The reservoir chassis extension  101  is sized and shaped to accommodate larger arm or leg circumferences. In some embodiments, the reservoir chassis  102  and/or the retaining cover  103  further include a blank label  109 . The blank label  109  may be used to write the time when the tourniquet is applied or various other relevant notes regarding patient care. 
         [0032]    Extending from the bladder  200  (see also  FIGS. 2 and 8 ) is a nipple  104  that connects the bladder to an air pump. In some embodiments, a half bulb inflation pump  108  is used to pump air into the bladder  200  via the nipple  104 . In some embodiments, the half bulb inflation pump  108  is latex free and ergonomically designed for ease of use. In some embodiments, the inflation mechanism includes a relief valve  105  to manually control the release of pressure inside the bladder  200 . In some embodiments, the inflation includes a metal clamp  201 , such as a small brass ring, attached to the connection between the nipple  104  and the relief valve  105  or inflation pump  108 . 
         [0033]    In more detail, the retaining cover  103  (See FIGS.  1  and  5 A- 7 ) includes dual hook and loop (i.e., Velcro) on its exterior surface and a nylon denier on its interior surface (i.e., the surface that faces the bladder  200 ). Thus, the retaining cover  103  is operable to cover and protect the reservoir chassis  102  and also operable to secure the tourniquet around an extremity. For example, the retaining cover  103  can be positioned in a continuous loop around an extremity by wrapping the retaining cover  103  around the extremity. Next, the slider  107 , which is adjustably secured to the retaining cover  103 , can be secured to the receiver  106 , which is fixably connected to either the reservoir chassis  102  or the retaining cover  103 , as previously described. In such an arrangement, the diameter of the continuous loop can be shortened by pulling the retaining strap further through slider  107 , thus creating an increased circumferential pressure (i.e., a radial compression). Once a preferred diameter has been obtained, such a diameter can be maintained by folding the retaining cover  103  back upon itself and securing such a position via the hook and loop of the retaining cover  103 . 
         [0034]    In some embodiments, the bladder  200  (See  FIGS. 2 and 8 ) of the pneumatic tourniquet is formed from a polyurethane plastic material by sealing  3  edges of the plastic material. Furthermore a nipple  104  is attached to the polyurethane plastic and extends therefrom at an approximately 90 degree angle. From the nipple  104 , a silicon tube  202  extends a distance and connects with the pump  108 , which may, in some embodiments include a semicircle pressure inflation bulb (e.g., an ergonomically designed hemicycle pressure pump). Embodiments in which the pump  108  is a semicircular face may be preferable in instances when the tourniquet is required to be packaged in a small space. In certain embodiments, the bladder  200  is preferred to hold at least 450 mmHg of pressure, so as to be sufficient to stop blood flow and hemorrhage in an extremity. In other embodiments, the bladder  200  will hold more or less than 450 mmHg. In some embodiments, the bladder  200  will be approximately 25 inches in length, so as to be sufficient for use with human extremities (i.e., arms and legs) that have sizes within the 5th to 95th percentile. Regardless, embodiments of the present invention contemplate bladder lengths that are more or less than 25 inches. Furthermore, in some embodiments, the width of the bladder will be approximately 1.5 inches, which proves for a broad pressure base that can be applied to an extremity. However, it is understood that widths more or less than 1.5 inches may be used in some embodiments. The bladder  200  will, in some embodiments, also include a relief valve  105  that provides for a manual or automatic release of air pressure within the bladder  200 . 
         [0035]    Embodiments of the present invention provide for the reservoir chassis  102  (See FIGS.  1  and  5 A- 7 ) to protect the bladder  200  (See also  FIGS. 2 and 8 ) from environmental damages that may occur during transportation or use of the tourniquet. In some embodiments, the reservoir chassis  102  will be formed in a coyote brown color to uniquely identify a first application of the tourniquet over the circumference of the damaged extremity. In some embodiments, a length of the reservoir chassis  102  is approximately 33 inches. However, in other embodiments, the chassis  102  may be more or less than 33 inches. With the total length of the reservoir chassis  102  being 33 inches, some embodiments provide for the main section to be about 25 inches length (or at least long enough to hold the bladder  200 ), and the extension section  101  to be about 8 inches in length. In some embodiments, the extension section  101  is included so as to provide for the comfortable placement of the tourniquet onto larger sized extremities. Further, some embodiments provide for two sections of approximately 16 inches of hook and loop to be positioned on an interior and exterior surface of the reservoir chassis. In particular, a first section of hook and loop is positioned on the exterior surface of the reservoir chassis  102  adjacent to an end of the reservoir chassis  102  that is opposite the extension section  101 . In some embodiments, more or less than 16 inches of hook and loop will be added to the reservoir chassis  102 . In certain additional embodiments, the interior surface of the reservoir chassis  102  will have a section of hook and loop thereon, with the section covering the extension section  101  and extending from the extension section  101  along a portion of the main section. In such embodiments, the main section of the reservoir chassis  102  can be wrapped around an extremity and can be secured in place by connecting the dual hook and loop on the outer surface of the main section with the dual hook and loop on the interior surface of the extension section  101 . As such, the tourniquet can be initially positioned over and secured to an extremity until the slider  107  can be connected to the receiver  106  and the retaining cover  103  tightened and secured in a preferred position. Once the retaining cover  103  is tightened and secured in a preferred position, the bladder  200  can be pumped up and filled with air to create the intended circumferential pressure to stop hemorrhaging and blood loss. 
         [0036]    In some embodiments, the pneumatic tourniquet includes the retaining cover  103  (See FIGS.  1  and  5 A- 7 ) which is sewn with nylon coated fabric and dual hook and loop, as previously described. In some embodiments, the retaining cover  103  is approximately 39 inches length. In other embodiments, the retaining cover  103  may be more or less than 39 inches. The retaining cover  103  preferably overlaps the reservoir chassis  102  as a secondary securing mechanism to prevent any slippage and provides extra protection. The retaining cover  103  includes a time label  109  which is comprised of a clothing label and is inserted on an end of the cover to write the time when application of the tourniquet is made. 
         [0037]    Additional embodiments of the present invention include a tourniquet (See FIGS.  1  and  5 A- 7 ) that is operable for restricting a flow of blood in a body part, such an upper or a lower extremity, with such a tourniquet comprising: (a) a bladder  200  (See  FIGS. 2 and 8 ) placed into a reservoir chassis  102 , with the reservoir chassis  102  including a main section that holds the bladder  200  and an extension section  101  connected to said main section; (b) a retaining cover  103  attached to the reservoir chassis  102  at a position adjacent to where the main section of the reservoir chassis  102  connects to the extension section  101 ; (c) a receiver  106  (See also  FIG. 3 ) joined with the retaining cover  103  or the reservoir chassis  102  adjacent to the position where the retaining cover  103  is attached to the reservoir chassis  102 ; and (c) a slider  107  (See also  FIG. 4 ) attached to the retaining cover  103  for quick application to the receiver  106 . In such embodiments, when the tourniquet is placed onto the damaged circumference of the extremity, the slider  107  can be attached to the receiver  106  and then the retaining cover  103  can be adjusted to a preferred position so as to create a circumferential pressure. Furthermore, the retaining cover  103  can be secured in such a position by folding an end of the retaining cover  103  back on itself such that the dual hook and loop of the retaining cover  103  secures the retaining cover  103  in place. 
         [0038]    As illustrated in  FIG. 3 , the receiver  106  includes a hook-shaped catch  301  that the round side bar  401  of the slider  107  (See  FIG. 4 ) can be placed into or removed from by the user on demand through application of the receiver flange  302 . A lip portion  303  of the receiver is the narrower portion of the receiver  106  and facilitates ease of placement for the round side bar  401  of the slider  107 , and the bar locks the hook slider into place. 
         [0039]    With respect to  FIG. 3 , in some embodiments, the hook-shaped catch  301  (or slider niche) is sized and shaped to mate with and receive the slider  107  and lock the slider  107  securely in place. The receiver flange  302  guides and provides an easy placement for the slider  107  which locks the retaining cover  103  in place. The flange  302  slopes upward to facility placement. The lip  303  is a narrower part of the receiver  106  to provide an easy placement with the receiver flange  302  for the slider  107 . A bar  304  hangs down from the lip  303 . The bar  304  supports locking of the hook slide and prevents unintentional displacement (dislodging) of the slider  107  from the receiver  106 . The bar  304  allows the slider  107  to “snap” or audibly “click” when the slider  107  and receiver  106  are properly mated. A supporter  306  is a thicker portion of the receiver  106  that structurally supports the receiver slot  305 . The receiver slot  305  is a space for a receiver holder to connect the receiver  106  to the retaining cover  103  or reservoir chassis  102 . 
         [0040]    With reference to  FIG. 4 , the slider  107  functions as a friction buckle that is operable to be placed anywhere on the retaining cover  103 . The square side bar  402  of the slider  107  with protruding grippers  405  facilitates friction when the round side bar  501  is placed into the receiver  106  (See  FIG. 3 ). As such, the slider  107  reduces slippage, yet allows excess slack to be removed from the diameter of the circumferential tourniquet body upon demand from the user with an upward pulling motion of the retaining cover  103 . Furthermore, the retaining cover  103  can be pre-routed through the slider  107 , thus avoiding the necessity to route the retaining cover  103  through the slider  107  during use. 
         [0041]    With respect to  FIG. 4 , in some embodiments, the slider  107  includes a round edge  401  (or round side bar). The round side bar  401  is sized and shaped to interface with the receiver  106 . The round side bar  401  is sized and shaped to allow for articulation when mated with the receiver  106 . The slider  107  further includes a frame  402  (or square side bar). The square side bar  402  gives support, structure and shape to the slider  107 . In some embodiments, the slider  107  will be a distinctive color to easily and quickly visually distinguish the slider&#39;s position relative to the retaining cover  103 . For example, in some embodiments, the slider  107  is coyote brown. In some embodiments, the slider  107  includes a slider friction bar  403 . The slider friction bar  403  provides friction and inhibits the release of tension when the tourniquet is applied. The friction bar  403  is positioned higher than the side bars  401  and  402 . The friction bar  403  is sized and shaped to lock the slider  107  in position when the tourniquet is applied. The slider  107  further includes slider gaps  404 . The retaining cover  103  is routed through the slider gaps  404  with dual hook and loop fasteners on the retaining cover  103  side that faces toward the slider friction bar  403 . The square side bar  402  of the slider  107  also includes grippers  405 . The grippers  405  facilitate friction when the round slider bar  401  is placed into the receiver  106 . This stops slippage, yet allows excess slack to be removed from the retaining cover  103  continuous loop upon demand with an upward pulling motion of the retaining cover  103 . 
         [0042]    Together, the slider  107  (See  FIG. 4 ) and the receiver  106  (See  FIG. 3 ) function as a buckle, so as to create a continuous loop of the tourniquet. Adjustments can be made, via the slider  107 , for shortening or lengthening the continuous loop once applied, and/or the slider  107  can be attached or detached from the receiver  106  to facilitate ease of application by the user. 
         [0043]    In some embodiments, certain portions of the tourniquet, such as the reservoir chassis  102  and the retaining cover  103  may be made from various types of elastic and/or inelastic flexible material, such as woven fabric, vinyl, leather, neoprene, nylon, etc. Additionally, other components of the tourniquet (e.g., receiver  106  and slider  107 ) may be made from rigid or semi-rigid materials, such as various types plastics, metals, or the like. Furthermore, portions of the bladder  200 , including the bladder  200  itself or the nipple  104 , tubing  202 , and pump  108 , may be made from various materials that are flexible but operable to securely hold fluid therein, such as neoprene, polyurethane, other plastic, or other similar material. 
         [0044]    While the present general inventive concept has been shown in the drawings and fully described above with particularity and detail in connection with what is presently deemed to be the most practical and preferred embodiment(s) of the invention, it will be apparent to those of ordinary skill in the art that many modifications thereof may be made without departing from the principles and concepts set forth herein, including, but not limited to, variations in size, materials, shape, form, function and manner of operation, assembly and use. 
         [0045]    It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween. Hence, the proper scope of the present general inventive concept should be determined only by the broadest interpretation of the appended claims so as to encompass all such modifications as well as all relationships equivalent to those illustrated in the drawings and described in the specification. 
         [0046]    Finally, it will be appreciated that the purpose of the annexed Abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. Accordingly, the Abstract is neither intended to define the invention or the application, which only is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way.