Patent Publication Number: US-2023133259-A1

Title: Injury protection device for intravenous lines

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of priority of U.S. Provisional Patent Application No. 63/274,730, filed Nov. 2, 2021, the entire disclosure of which is hereby incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to devices for use in the operating theater or other vise in connection with medical treatment or care in which the patient requires intravenous (IV) placement for a prolonged period of time or has fragile skin that may deteriorate from being in contact with IV tubing or ports, and more particularly, to a protective device for use to protect the arm, hand and/or other limb/body regions of a patient from skin/tissue and/or nerve injuries caused by contact of medical procedure-related intravenous (IV) lines with the patient&#39;s skin, which creates pressure points during medical treatment that can lead to ulcers and other injuries. 
     DISCUSSION OF RELATED ART 
     Various surgeries, medical treatments, and other aspects of medical and health care (collectively referred to herein as “procedures”) involve the use of intravenous (IV) lines, which generally have an associated needle, tubing, tubing hubs, ports, Luer locks, Y-piece connections and/or other fittings. Often, as part of proper medical procedure and/or convenience, these IV lines are positioned to extend along, rest upon and/or abut the patient&#39;s hand and/or arm regions. 
     While discrete medical procedures may be relatively short in duration, e.g., 3-6 hours, in other health care settings, such as in hospital, hospice, rehabilitation and/or nursing home-type care settings, IVs may be placed due to chronic conditions for much longer periods of time, such as a period of days or more. Such prolonged IV use increases the likelihood that skin/pressure ulcers and/or nerve or other injuries (e.g., contact dermatitis, infection, laceration, itching) will occur from pressure on the skin by the associated IV line components. 
     Skin injuries/wounds/sores are undesirable, and tend to be expensive for the care facility. Skin injuries may be particularly likely to occur in elderly fragile patients or patients with peripheral vascular disease, neuropathy, obesity, diabetes, smoking history or advanced age, where skin perfusion can be compromised. Additionally, nerve injuries are undesirable for many reasons, including neuropathy and/or other impacts upon the patient, the possible need for corrective surgery and/or procedures to aid in recovery from the injury, or extensive and costly rehabilitation treatment, dissatisfaction of the patient, and potential medical malpractice or similar claims, all of which are undesirable. 
     Accordingly, there is a need for a device that is compatible with conventional IV lines and associated care/procedures that protects the patient&#39;s skin and other tissues from sores, nerve compression and/or injury resulting from pressure on the skin by IV lines associated with such procedures. 
     SUMMARY 
     The present invention provides a protective device that defends/protects the patient&#39;s skin and underlying tissue from pressure and injury resulting from pressure on the skin/tissue and/or compression of nerves by IV lines associated with medical procedures, medication administration, for nutritional purposes, and the like. In one embodiment, a protective device in accordance with the present invention comprises a body defining a window dimensioned to receive a portion of an IV line, said body having a lower surface having an area greater than said portion of said IV line. The window may be internal to, or open to, a peripheral edge of the body. Adhesive may be applied to the upper and/or lower surface of the body. A securing tab or catch may be provided to secure the IV line to the body. The body may have a uniform thickness or may have a varying thickness, and be generally wedge-shaped. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       An understanding of the following description will be facilitated by reference to the attached drawings, in which: 
         FIG.  1    is a perspective view of a skin and nerve injury protection device in accordance with an exemplary embodiment of the present invention, shown in use on a human hand; 
         FIG.  2    is a perspective view of the device of  FIG.  1   ; 
         FIG.  3    is a perspective view of another exemplary device in accordance with an alternative embodiment of the present invention; 
         FIG.  4    is a perspective view of yet another exemplary device in accordance with an alternative embodiment of the present invention; 
         FIG.  5    is a perspective view of the device of  FIG.  3    or  FIG.  4   , shown in use on a human hand; 
         FIG.  6    is a top view of yet another exemplary device in accordance with an alternative embodiment of the present invention; and 
         FIG.  7    is a top view of yet another exemplary device in accordance with an alternative embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention provides an IV skin and nerve injury protection device (also referred to herein as a “protective device” or “device”) that is configured to protect the patient&#39;s hands, arms (or other limbs or body parts) from pressure exerted by IV lines on the skin and other tissues and resulting compression of the skin, and possibly, nerves, and from resulting skin sores, nerve compression and/or other injuries resulting from such pressure. 
     Referring now to  FIGS.  1  and  2   , an exemplary embodiment of an IV skin and nerve injury protection device  100  in accordance with the present invention is shown. As shown in  FIGS.  1  and  2   , the injury protection device  100  includes an elongated body  102 . The body  102  may be formed as a unitary body defining a lower surface  106  having an area greater than the area of a hub/connector  14  of a conventional IV line. The lower surface  106  abuts the skin/bodily tissue during use, and the relatively larger area of the lower surface  106  allows pressure that would be exerted on the skin/bodily tissue by the hub/connector  14  to be spread over an area larger than the area of the hub/connector, to thereby reduce the pressure per unit area exerted on the skin/tissue, and thus to reduce the likelihood of resulting skin compression and skin and/or nerve injury, and thereby protect the patient against pressure ulcers/sores/nerve injuries, etc. Preferably, the area of the lower surface  106  is at least 1.5 times to at least 2.0 times greater than the area of the hub/connector  14 . In certain embodiments, the overall device is approximately 9 to approximately 12 square inches in overall size. 
     The body  102  is preferably formed of a relatively flexible and readily compressible material, such as a foam material or gel, so as to readily bend and conform to any contours of a forearm, etc., and to act as a cushioning material. Further, the material, or at least a portion of the material, is preferably relatively thick, meaning at least 0.125 or 0.25 inches in thickness or having a thickness that is in the range of at least about 1 to about 5 times as thick as the thickness of the IV lines/connectors/fittings with which it is intended to be used, to facilitate the function of a portion of the material as cushioning, as described below. In other embodiments, the material may have any thickness suitable for decreasing pressure per square unit area to diminish the risk of the skin, nerve or tissue injury from unintended pressure from an IV line during prolonged procedures, etc. in which the IV line overlies bodily tissue, e.g., when it is compressed against the skin as a result of fixation to the skin or during patient positioning/limb fixation and/or tucking, e.g., for medical procedures. 
     Further, the elongated body may be constructed of a material that is readily cleanable, e.g., disinfectable and/or sterilizable, using cleaning methods of the type typically used for products used in the operating theater, and/or that resists absorption of bodily or other fluids, making it well-suited for use in the operating theater. By way of example, a closed-cell EPDM foam material may be used for this purpose. Alternatively, materials intended to be disposable, and not cleaned and reused, may be used. 
     In accordance with the present invention, the body  102  may define a window  104 . The window defines a space for receiving a portion of the IV line, such as the catheter (or needle) and/or a hub/connector/fitting, as the body  102  is placed in close proximity to the point of entry of the IV line&#39;s needle, etc. into the skin. The body  102  then acts in somewhat of a wedge-like fashion, to be positioned between the IV line and the skin, to separate the IV line from the skin, to support the IV line above the skin, and to distribute pressure that would be exerted on the skin by the IV line (tubing, fittings, connectors or ports) over a relatively larger area. 
     In the exemplary embodiment of  FIGS.  1  and  2   , the window  104  is defined entirely internally to the body  102 , so that material of the body  102  fully surrounds the window  104 . As shown in the example of  FIG.  2   , the entire catheter  12 , hub/connector  14 , and a portion of the tubing  16  of the IV line  10  are positioned within the window  104  of the exemplary protective device  100 . As shown in the example of  FIG.  1   , the entire catheter  12  (including the portion beneath the skin) is positioned within the window  104  of the exemplary protective device  100 , and the hub/connector  14  is partially overlying and supported on an upper surface  108  of the body  102  of IV skin and nerve protective device  100 . Additionally, a sheet of IV tape  30  (e.g., such as that commercially available from 3M under the name Tegaderm) is placed over the entire IV skin and nerve protective device  100  and a portion of the IV line  10 . The placement of tape to fix/secure the IV line to the skin adjacent the penetration site is common practice, but it contributes to the exertion of pressure on the skin/tissue by the IV line and its components parts, such as the hub/connector  14 . Here, undesirable pressure on the skin/tissue is mitigated by the skin and nerve protective device  100 . 
       FIGS.  3  and  4    are perspective views exemplary alternative embodiments of an protective device  100  in accordance with the present invention. In these exemplary embodiments, the window  104  is not defined entirely internally to the body  102  (as in  FIGS.  1  and  2   ), but rather the window  104  is open to a peripheral edge of the body  102 , so that the window is formed somewhat like a notch in the peripheral edge and can be customized by the person placing the IV line, e.g., by using scissors to cut/trim the body  102 . As with the embodiment of  FIGS.  1  and  2   , the window defines a space for receiving a portion of the IV line, such as the needle and/or a hub/connector/fitting, as the body  102  is placed in close proximity to the point of entry of the IV line&#39;s need into the skin. The body  102  then acts in somewhat of a wedge-like fashion, to be positioned between the IV line and the skin, to separate the IV line from the skin, to support the IV line above the skin, and to distribute pressure that would be exerted on the skin by the IV line over a relatively larger area, as will be appreciated from  FIG.  5   . 
     In the exemplary embodiment of  FIG.  3   , the body  102  does not have a uniform thickness, but rather is tapered to have a relatively lesser thickness near the window  104  and a relatively greater thickness further from the window  104 . This facilitates use of the body in somewhat of a wedge-like fashion, to support the IV line/needle at an angle relative to the skin and to lift and support the IV line from/above the skin. In the example of  FIG.  4   , a first portion  120  of the body  102  is tapered toward the window  104  according to a first angle A, and a second portion  130  of the body is tapered according to a second angle B that is greater than the first angle A. In the example of  FIG.  5   , a first portion  120  of the body  102  is tapered toward the window  104  according to a first angle A, and a second portion  130  of the body is tapered according to a second angle B that is less than the first angle A. 
     The embodiments of  FIGS.  3  and  4    may be used as shown in  FIG.  5   . In the example of  FIG.  5   , the IV tape  30  is placed over the catheter  12 , a portion of the hub/connector  14 , and a portion of the protection device  100 , to fix the IV line  10  and skin and nerve protective device  100  to the skin. 
     In any of the embodiments shown, the lower surface  106  may be provided/coated with a field of adhesive for adhering/fixing the protective device  100  to the skin. The adhesive may be a pressure sensitive adhesive, and the field of adhesive may be provided with a removable release sheet that initially covers a surface of the adhesive field and is removable to expose the adhesive for forming an adhesive bond with the skin at an appropriate time. In certain embodiments, this may be sufficient to eliminate a need for use of the IV tape  30 , although it may be desirable to retain it to use the tape to prevent against infection at the penetration site. 
     Further, in any of the embodiments shown, the upper surface  108  may be provided/coated with a field of adhesive for adhering/fixing the IV line (or its component parts) to the IV nerve protective device  100 . The adhesive may be a pressure sensitive adhesive, and the field of adhesive may be provided with a removable release sheet that initially covers a surface of the adhesive field and is removable to expose the adhesive for forming an adhesive bond with the skin at an appropriate time. In certain embodiments, this may be sufficient to eliminate a need for use of the IV tape  30 . 
       FIGS.  6  and  7    are top views of other exemplary IV skin and nerve protective devices in accordance with alternative embodiments of the present invention. In the example of  FIG.  6   , the protective device  100  further includes a securing tab  140 , which may be added to any embodiment discussed above. The securing tab  140  may be fixed to the body at one end, and there may be adhesive  142 , on the upper surface  108  and/or on the securing tab  140  (e.g., with a release sheet), such that the securing tab  140  may be folded over to overlie an IV line  10 , and then be secured to the upper surface  108  of the body  102 , to secure the IV line  10  to the protective device  100 . 
     In the example of  FIG.  7   , the protective device  100  further includes a catch  150  which may be added to any embodiment discussed above. The catch  150  may be a discrete body separate from the body  102 , and there may be adhesive, on the upper surface  108  and/or on the catch  150  (e.g., with a release sheet), such that the catch may be placed to overlie an IV line  10 , and then be secured to the upper surface  108  of the body  102 , to secure the IV line  10  to the skin and nerve protective device  100 . 
     Accordingly, in use, the protective device  100  may be positioned with its lower surface  106  abutting and extending along/overlying the patient&#39;s arm (or other body part, as needed) (see e.g.,  FIG.  1   ) adjacent a penetration point (or intended penetration point) of an IV line&#39;s needle  12 . After (or before in the case of the embodiment of  FIGS.  1  and  2   ) the needle has been placed to penetrate the patient&#39;s skin, the protective device  100  may be positioned between the IV line  10  and the patient&#39;s skin, preferably with the hub/connector  14  overlying the top surface  108  of the body  102  of the protective device  100  and with a portion of the IV line passing through the window  104 . This may be performed after removing any release sheet from the lower surface  106  to expose any adhesive for adhering the IV skin and nerve protective device  100  to the skin. 
     IV tape may then be placed to fix the IV line and the protective device  100  to the skin, in certain embodiments. Alternatively, the IV line maybe fixed by pressing the IV line against the top surface  108  of the IV skin and nerve protective device (in embodiments including adhesive on the upper surface  108 ), and/or adhering the securing tab  140  or catch  150  to the upper surface  108  of the IV nerve protective device (in certain embodiments), as appropriate. 
     Accordingly, it will be appreciated that the IV nerve protective device acts to separate the IV line from the patient&#39;s skin/tissue and provide cushioning and/or pressure spreading to protect the patient from nerve compression and injury resulting from pressure exerted by IV lines on the skin. 
     While there have been described herein the principles of the invention, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation to the scope of the invention. Accordingly, it is intended by the appended claims, to cover all modifications of the invention which fall within the true spirit and scope of the invention.