Patent Publication Number: US-2002007135-A1

Title: Device for shielding tissue

Description:
FIELD OF THE INVENTION  
       [0001] The present invention relates to a flexible and disposable shielding device for protecting skin from an external contaminant.  
       BACKGROUND OF THE INVENTION  
       [0002] There is a need for an inexpensive and easy to use device that provides for the protection of skin surfaces from external elements such as water. Skin surface may be subject to a wound, an IV shunt, stitches, staples or other disturbances and injuries. Each type of disturbance or injury requires that the skin surface be protected from external elements on a periodic or continuous basis. For instance, hospital patients are often fitted with an IV shunt. Should the patient desire to shower or otherwise bathe, the patient is left with very few options. In fact, in order to provide the greatest amount of protection, the shunt is typically sealed using tape and a rubber glove or removed and replaced with a new one after the shower. Both options are painful and cause the patient discomfort. The removal of the tape can result in removal of hair and pain. The patient is also subjected to pain upon reinsertion of the IV shunt. Thus, a device that would allow a patient to painlessly protect the skin surface without the use of tape or removal of the IV shunt would be very useful.  
       [0003] Provided herein is such a device, as described below. 
     
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
     [0004]FIG. 1 is a view of a human arm including an embodiment of a tissue shielding device of this invention.  
     [0005]FIG. 2A ls a side view and FIG. 2B is a perspective view of an embodiment of a tissue shielding device of this invention. 
    
    
     SUMMARY OF THE INVENTION  
     [0006] The present invention relates to shielding devices for protecting tissue from contaminants. The shielding device comprises a flexible membrane forming a tubular structure and having an internal surface, an external surface, and two ends. The external surface is preferably resistant to external elements such as water, dust, dirt and infectious agents such as bacteria. In certain embodiments, the device is impervious to a virus such as the Human Immunodeficiency Virus (HIV). The device also optionally includes one or more sealing mechanisms that apply pressure near one or both ends of the device, effectively sealing tissue covered by the device from external elements following application to an appendage, such as a forearm.  
     [0007] In one embodiment, this invention is a skin shielding device comprising a flexible membrane forming a cylinder having an internal surface, an external surface, a first end, and a second end wherein the external surface is impermeable to at least one contaminant, said membrane including at least one first seal.  
     [0008] In another embodiment, this invention is a method for applying a skin shielding device to an appendage. The shielding device used comprises a flexible membrane forming a cylinder having an internal surface, an external surface, a first end, and a second end wherein the external surface is impermeable to at least one contaminant, said membrane including at least one first seal. The sealing device is applied to an appendage by the steps comprising placing an end of the appendage into the first end of the skin shielding device; and passing the end of the appendage through the skin shielding device until a portion of the appendage passes out of the second end of the skin shielding device. The sealing device is useful for protecting an appendage is selected from the group consisting of an arm, a leg, a hand, a foot, a finger, and toe, a torso, and a head from contaminants. The method is especially useful for protecting appendages including an IV shunt or a wound from contaminants or from getting wet during bathing.  
     DETAILED DESCRIPTION OF THE INVENTION  
     [0009] Provided herein is a shielding device for protecting a mammalian limb or appendage such as a forearm, hand, or foot from contacting contaminants such as dirt, moisture, chemicals, viruses, bacteria and other, similar contaminants. The shielding device may be used to protect the limb or appendage of a human being or other mammal, such as a dog, horse, or cow. The shielding devices are especially useful for shielding a wound or other skin defect such as a defect that may occur by the insertion of an IV shunt, stitches, or staples, for example, from contaminants.  
     [0010] Referring now to FIGS. 1, 2A and  2 B, a shielding device  10  of this invention is constructed as a flexible membrane in the form of a tubular structure that includes an internal surface  12  and an external surface  14  that define first end  16  and a second end  18 . First end  16  and second end  18  may have the same or different cross-section areas. In addition, first end  16  and second end  18  may have a circular or non-circular cross-section with a circular cross-section being preferred.  
     [0011] External surface  14  of shielding device  10  is resistant to at least one contaminant and is preferably resistant to most or all contaminants such as water, dust, dirt and infectious agents such as bacteria. In certain embodiments, sealing device  10  is impervious to a virus such as the Human Immunodeficiency Virus (HIV). It is preferred that shielding device  10  is air permeable.  
     [0012] In an embodiment of this invention, sealing device  10  is constructed of a sufficiently breathable rubber substance that allows for the exchange of air but not other elements between internal surface  12  and the external surface  14  of sealing device  10 . Thus, in one embodiment, sealing device  10  is manufactured of a membrane material that is sufficiently non-porous so as to prevent the passage and accumulation of contaminants near the skin. In order to be essentially impervious to contaminants and/or flexible, shielding device  10  will typically be manufactured from a flexible membranous material such a rubber, synthetic rubber, latex or any other material that is flexible and compatible with skin or tissue.  
     [0013] Shielding device  10  may include a first seal  20  at one or both ends  16  and  18  of shielding device  10 . One purpose of first seal  20  is to urge an end of sealing device  10  into contact with the skin or body part being protected, effectively closing the end of the shielding device  10  thereby inhibiting the passage of contaminants through the closed end and into contact with the portion of the body covered by shielding device  10 .  
     [0014] First seal  20  may be any type of seal that is capable of urging a flexible cylinder into contact with a concentric inflexible body. In a preferred embodiment, first seal  20  is a flexible band that is reversibly or fixably attached to the external surface  14  or internal surface  12  of flexible device  10 . A first seal  20  may be associated with one or both ends of the device. In another preferred embodiment, two adjacent flexible bands  20  and  20 ′are applied to first end  16  or second end  18  or both to urge each end of flexible device  10  into contact with the skin or body. First seal  20  is “adjacent”to first seal  20 ′where it is positioned less than halfway between the centerline of the device and one end of the device. Preferably, the adjacent first seals  20  and  20 ′ are within one quartile of the length of the device and closer to the end of the device than to the centerline of the device. In a more preferred embodiment, the two adjacent first seals  20  and  20 ″ are within an area equal to one tenth the length of the device and closer to one end of the device than to the centerline of the device.  
     [0015] In another alternate embodiment of this invention, sealing device  10  is reversibly sealed along one axis with a second seal  22  to form a sheet when unsealed and to form a cylinder when sealed. When sealing device  10  includes a second seal  22 , sealing device  10  may be applied to a as a sheet and then fitted to the limb by activating second seal  22 . For instance, second seal  22  can be a reversible seal in the form of a zipper, or second seal  22  can be an irreversible seal such a an adhesive associated with one or both surfaces being sealed. To apply a sealing device  10  with a second seal  22  to a limb, the second seal is unengaged to form a sheet and the sheet is then placed upon and around a limb or appendage, and second seal  22  zipper is closed or sealed. In this alternative embodiment, sealing device  10  does not need to be pulled over a hand, for instance, to apply the device to a forearm. The device may simply purchased open or it is opened using a reversible second seal such as a zipper, placed around a forearm for example, and then the zipper is closed to form sealing device  10 . This embodiment would be useful where, for example, the hand attached to the forearm is broken or otherwise injured and in a cast. It should be understood that second seal  22  may be any suitable mechanism for releasing and resealing the device. Non-limiting examples of such useful seals include zippers, adhesives (i.e., an activatable adhesive or Velcro™), or a plastic-based mechanism such as is used to seal refrigerator bags (i.e., ZipLock™) and so forth.  
     [0016] In another alternate embodiment, the device comprises multiple tubular extensions attached to a central portion, where tubular extensions project from the central portion. This embodiment is similar in structure to a glove or a sock, where the device may be applied to protect a hand, foot, or similar appendage. The fingers or toes of the hand or foot, respectively, may protrude from the tubular extensions of the device, while the palm or sole of the foot is protected by the device.  
     [0017] In still another alternate embodiment, the device may comprise a central portion with one or more holes at the edge through which one or more fingers or toes may protrude. These embodiments of the device may also comprise any of the sealing mechanisms described above.  
     [0018] The invention also provides methods for manufacturing the device comprising molding from a starting material a flexible, tubular structure, and fixably attaching to said tubular structure a first seal to one or both ends of sealing device  10 . First seal  20  may be any of those described herein. Sealing device  10  may be constructed of any suitable material provided the material provides the necessary hardness to effectuate the invention while yielding sufficient elasticity. The material is preferably impervious to contaminants such as water, dirt, dust or infectious agents. In one embodiment, a blow molded polyethylene tube may be manufactured and have fixably attached to it a natural rubber band as the sealing mechanism. Blow molded tubing is available in different diameters and thicknesses and can be melt sealed to capture the rubber band or to completely seal an end. One of skill in the art would recognize the many suitable materials for constructing the device.  
     [0019] It will be understood that the embodiment described herein are merely exemplary and that a person skilled in the art may make many variations and modifications without departing from the spirit and scope of the invention. All such variations and modifications are intended to be included within the scope of the invention as defined in the appended claims.