Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 61/746,874 filed on Dec. 28, 2012, the contents of which are incorporated herein by reference. 
    
    
     FIELD OF INVENTION 
     This disclosure relates to the field of dressing protection for patients fitted with a central venous access device (CVAD). More particularly this disclosure relates to a removable, adjustable, protective device which allows viewing and access to the dressing and shields and compartmentalizes CVAD peripherals without removal from the patient. 
     BACKGROUND OF THE INVENTION 
     Disclosed is a device which simultaneously provides the advantages of comfort and flexibility while also providing a highly secure position for tubing and lumens extending from a percutaneous site. In one embodiment, the device is provided for use with patients fitted with central venous access devices (CVAD), gastronomy tubes, or chest tubes. CVADs allow frequent access to the veins without deep needle sticks. Examples of CVADs include central venous catheters (CVC) or central lines, surgically implanted ports, and peripherally inserted central catheters (PICC). 
     A central venous catheter (CVC) is surgically implanted into a large vein in the neck, chest or groin. A peripherally inserted central catheter (PICC) is inserted into one of the peripheral veins in the upper amt. In addition to the tube inserted into the vein, CVCs and PICCs include lumens. The tube extending from the percutaneous site is often supplied with a central hub or manifold for connection to one or multiple lumens. The lumens, which may or may not be connected to an infusion pump, are used to administer medication or fluids, obtain blood tests, and directly obtain cardiovascular measurements such as the central venous pressure. Venous access devices typically remain in place for extended periods of time. The percutaneous site is dressed and requires routine observation and attention by medical personnel. Typically, while the lumens are not in use they are secured by adhesive tape to the patient to prevent any accidental contact, unwanted movement, and inadvertent removal. The repeated removal of the tape often causes irritation. 
     When CVADs are used with babies and small children, there is an increased risk that the intravenous tubes and the lumens can be dislodged and contaminated, thus increasing the possibility of bloodstream infections. The disclosed device provides a comfortable fit, is adjustable, allows access to the dressing, redirects and protects the intravenous tubes, and secures the lumens from inadvertent tampering without the use of tape or irritating adhesives. 
     U.S. Pat. No. 4,470,410 to Elliott discloses a protective retaining device for application to the site of an intravenous or catheter intervention system to protect the site and to retain the tubing in a position proximate the body. The device is comprised of an elongated flexible sleeve. An opening is provided over the intervention site. The sleeve has releasable hook type fasteners, such as Velcro®, and includes a fastenable flap covering the opening. Tubing is secured by the flexible material of the sleeve against the body of the patient. 
     U.S. Pat. No. 5,897,519 to Shesol, et al. discloses a device for holding tubing in place in a variety of locations. The device comprises a sleeve having a window. The device is fastened by releasable Velcro®. Strips are provided on opposite sides of the window for securing the tubing. 
     U.S. Pat. No. 6,267,115 to Marshel discloses a flexible sleeve that surrounds an extremity where an intravenous catheter enters a vein. The sleeve is secured with Velcro® and an adhesive layer which adheres to the patient&#39;s skin. An opening in the sleeve provides a passage for the tubing. A flexible tab secures the tubing to the sleeve by an adhesive. The device does not include a transparent window. 
     U.S. Patent Application Publication No. 2005/0020977 to Eldridge, et al. discloses a guard for covering an infusion site while allowing visual inspection. The device is secured with Velcro®. The device provides an opening positioned over the infusion site. A resilient flap having a flexible window is secured to the device over the opening. The flap is also used to secure the tubing. The device does not include a way to redirect tubing or secure lumens. 
     U.S. Patent Application Publication No. 2013/0012883 to Fitzgerald, et al. discloses a sleeve for protecting and securing catheter dressings and tubes. Velcro® is provided to secure the device to the patient. A slit in the body of the device provides a passage for tubing. A strap secures the tubing against the exterior surface of the device. The device also may include a transparent window positioned over the dressing site. 
     Therefore, there is a need for a tamper resistant, intravenous protective device that is easily and adjustably secured to a patient. There is also a need for a flexible sleeve which provides comfort to the patient and provides for flexibility to promote physical activity. There is also a need for a device that secures percutaneous tubes and lumens from inadvertent tampering and dislodgment while allowing ease of access for frequent medication. 
     SUMMARY OF INVENTION 
     In a preferred embodiment, the device is comprised of a two-sided, flexible body sized to fit around the torso of a patient. The body has an interior surface and an exterior surface. The interior surface is fitted with a layer made of an absorbent, wicking, anti-bacterial material. The interior surface of the body further includes strips of anti-slip material to fix the device in place on the patient. A flexible window is positioned between two lumen retaining flaps. The lumen retaining flaps are permanently attached to the body along one edge. An opposing edge of each lumen retaining flap is adjustably secured to the body via a Velcro® strip. A pair of indentions is positioned above and below the window to allow for nesting of the tubes around the body of the device. A pair of locking closures is attached to the body on the exterior surface directly adjacent the indentions and each can be readily repositioned to completely cover the indentions and any exposed tubing sections. Velcro® is positioned on each end of the body. The Velcro® provides adjustability of the diameter of the device. A resilient gauze section is integrally formed in the body to provide flexibility and encourage air flow. 
     In use, the device is adjustably fitted to a patient with a percutaneous site from a CVAD, G-tube, or chest tube. The adjustable nature of the device allows for positioning of the window over the site. Because the site is covered by the window, it is kept clean and also prevents patient tampering. Tubes from the percutaneous site are redirected vertically along the medial axis of the patient toward and nested within the indentions. In a preferred embodiment, the tubes are bent around the indentions and releasably secured within them by the locking closures. Velcro® secures the lumen retaining flaps and nucleus hub of the lumens which prevents accidental dislodgment and patient tampering. Each lumen retaining flap, when open, provides access on three sides which allows easy access for an attending caregiver to engage the hub and lumens while the device is in place. The device may be removed from the patient without interfering with the percutaneous site or disconnecting the lumens from the infusion pump. 
     The device is symmetrical about a longitudinal axis, therefore it is reversible. Reversibility reduces wear and increases the useful life of the device. Further, the flexible nature of the device allows for vigorous patient activity without disturbing the lumens secured under the lumen retaining flaps. The device reduces the use of tape thereby reducing skin irritation and allergic reactions. 
     A smaller version is provided in an alternate embodiment which is suitable for patients with a surgically implanted PICC line and is envisioned to be fitted around an appendage of the patient. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       Reference will now be made to the drawings, wherein like parts are designated by like numerals, and wherein: 
         FIG. 1  is a plan view of the exterior surface of a preferred embodiment. 
         FIG. 2  is a plan view of the interior surface of a preferred embodiment. 
         FIG. 3  is an isometric view of a preferred embodiment. 
         FIG. 4  is an isometric view of a preferred embodiment in place on a patient. 
         FIG. 5  is a plan view of the exterior surface of an alternate embodiment. 
         FIG. 6  is a plan view of the interior surface of an alternate embodiment. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     In the descriptions that follow, like parts are marked throughout the specification and drawings with the same numerals, respectively. The drawing figures are not necessarily drawn to scale and certain figures may be shown in exaggerated or generalized form in the interest of clarity and conciseness. 
     Referring to  FIGS. 1 and 2 , device  100  is comprised of a two-sided, layered, flexible body  102  having exterior surface  104  and interior surface  106 . Body  102  is generally rectangular and symmetrical around longitudinal axis  148 . Exterior surface  104  is comprised of primarily durable cotton blend material resistant to abrasion, although cotton and synthetic blends will suffice. Interior surface  106  includes a gusset comprised of a breathable, absorbent material. The interior surface may also comprise an antimicrobial material, agent or surface. In a preferred embodiment, the internal gusset is treated with Silpur Silver Antimicrobial Treatment, available from Thompson Research Associates of Toronto, Ontario, Canada (http://www.ultra-fresh.com/silpure). 
     Approximately centrally located in body  102  is window  118 . In a preferred embodiment, window  118  is a transparent, flexible material such as polyethylene terephthalate (commonly abbreviated PET or PETE). Window  118  is fixed between exterior surface  104  and interior surface  106 . The window is fixed in place by sewing. In more rigorous environments, hermetically sealed closures such as adhesive, inductive welding will be used. On exterior surface  104  and adjacent window  118  on two opposing sides of window  118  are lumen retaining flaps  110  and  112 . Lumen retaining flap  110  is attached to exterior surface  104  along edge  140 . Lumen retaining flap  112  is attached to exterior surface  104  along edge  142 . In the preferred embodiment, the lumen retaining flaps are sewn to the body along one edge. However, other methods of attachment such as inductive welding will suffice. End  155  of lumen retaining flap  112  includes fastener  154  to releasably attach end  155  to exterior surface  104 . End  157  of lumen retaining flap  110  includes fastener  156  to releasably attach end  157  to exterior surface  104 . 
     Adjacent window  118 , on opposing sides, are indentions  120  and  122 . In a preferred embodiment, the indentions are also generally rectangular having sides angled at about 45°. The depth of the indentions may be larger or smaller to accommodate different diameters of tubing. The longitudinal axes of the indentions are generally parallel with longitudinal axis  148 . Locking closure  114  is attached to exterior surface  104  along edge  144 . Locking closure  116  is attached to exterior surface  104  along edge  146 . End  151  of locking closure  114  includes fastener  150  to releasably attach end  151  to exterior surface  104 . End  153  of locking closure  116  includes fastener  152  to releasably attach end  153  to exterior surface  104 . In the preferred embodiment, locking closures  114  and  116  are made of a nylon rope weave for strength and for a low coefficient of friction. Locking closures  114  and  116 , when closed, bridge and cover indentions  120  and  122 , respectively. The locking closures are positioned to follow the edges of the body and completely cover the indentions. 
     Body  102  is provided with a flexible closure. The closure allows for adjustment of the circumference of the device to fit different sized patients. At end  160  of body  102  and proximate lumen retaining flap  112  is fastener section  124 . Fastener section  124  mates with fastener section  128  on interior surface  106  located at end  162  of body  102 . Fastener section  124  is larger than fastener section  128 . In the preferred embodiment, fastener sections  124  and  128  and fasteners  150 ,  152 ,  154 , and  156  are Velcro® type fastening means, but other fasteners such as snaps, buttons, or releasable adhesives will suffice. Adjacent end  162  of body  102  and proximate lumen retaining flap  110  is resilient gauze section  126 . Gauze section  126  is comprised of a low-density cotton, spandex weave material which provides ventilation and flexibility to permit patient movement. 
     Adjacent window  118  are segments of silicon “gripper tape.” The gripper tape provides a non-slip surface against the skin of the patient to hold device  100  in place. Segment  130  extends from gauze section  126  towards indention  122  and window  118 . Segment  132  extends from gauze section  126  towards indention  120  and window  118 . Segment  134  extends from end  160  towards indention  122  and window  118 . Segment  136  extends from end  160  towards indention  120  and window  118 . Segments  130 ,  132 ,  134 , and  136  are generally parallel with longitudinal axis  148 . Fastener section  128  on end  162  is one half of a typical hook and loop fastener such as Velcro® which mates with fastener section  124  on end  160  from exterior surface  104 . 
     Referring to  FIG. 3 , lumen retaining flaps  110  and  112  and locking closures  114  and  116  are shown unfastened. Fastener  156  is comprised of fastener section  166  affixed to exterior surface  104  and fastener section  168  affixed to lumen retaining flap  110 . Fastener  154  is comprised of fastener section  170  affixed to exterior surface  104  and fastener section  172  affixed to lumen retaining flap  112 . Fastener  150  is comprised of fastener section  174  attached to exterior surface  104  and fastener section  176  attached to locking closure  114 . Fastener  152  is comprised of fastener section  178  attached to exterior surface  104  and fastener section  180  attached to locking closure  116 . 
     Referring to  FIG. 4 , device  100  is shown in use. Preferably, device  100  is affixed around the abdomen or chest, in proximity to a percutaneous site the device can be adapted to uses on appendages, the neck, or head. 
     Device  100  is removably situated so that window  118  is directly above percutaneous site  402 . Body  102  is wrapped around patient  400  such that fastener section  128  engages fastener section  124 . Fastener section  124  allows for size adjustability of different diameters. The resiliency of gauze section  126  provides additional size adjustability and flexibility. 
     Segments  130 ,  132 ,  134 , and  136  are positioned adjacent the skin of the patient and secure the device in position relative to the percutaneous site. Locking closure  114  is detached from exterior surface  104  at end  151 . Lumen retaining flap  112  is detached from exterior surface  104  at end  155 . Tube  404  extends from percutaneous site  402  adjacent interior surface  106  and is directed in a superior direction generally perpendicular to longitudinal axis  148  towards indention  120 . The direction of the tube towards the indention is important. The normal twisting movement of the torso generally causes unwanted damage to the implanted tube if the tube is taped horizontally to the patient. Therefore, directing the tubes to be secured vertically reduces the effect that a twisting movement has on the site. Tube  404  is nested within indention  120  and redirected in an inferior direction towards lumen retaining flap  112 . In a preferred embodiment, the tube is positioned centrally within the indention to achieve a maximum of torso rotatability for the patient. End  151  is attached to body  102  via fastener  150 . The nylon construction of the locking closure provides low friction for the tube, allowing it limited movement within the confines of the indention and the locking closure, thereby further reducing the deleterious effect of a twisting torso. Tube section  406  redirected around indention  120  is completely covered by locking closure  114 , thereby preventing any likelihood of tube section  406  being hooked or grasped. Lumens  410 ,  412 , and  414  attached to the end of tube  404  are placed under lumen retaining flap  112 . End  155  of lumen retaining flap  112  is attached to body  102  via fastener  154 . Lumens  410 ,  412 , and  414  are stored within and protected by lumen retaining flap  112  to prevent tampering, infection, or dislodgement. 
     It is understood that any combination of locking closures  114  and  116 , indentions  120  and  122 , and lumen retaining flaps  110  and  112  could be used alternatively or in conjunction with additional tubes or hubs with equal success. The availability of directly opposing indentions and lumen retaining flaps provides for greater adaptability and ease of use. The open sides of the lumen retaining flaps allow for routing of the tube in the manner most convenient to the caregiver. 
     Transparent window  118  allows visual inspection of the percutaneous site thereby reducing the need to remove a dressing. Lumens are secured in the lumen retaining flaps on either side of the window to prevent accidental breakage and patient tampering. The lumen retaining flaps allow easy access while the device is place. 
     The symmetrical construction of the invention allows it to be reversible about an axis generally perpendicular to the longitudinal axis, and the plane of the window, thereby reducing wear and increasing its useful life. The flexibility and “breathability” of the device promotes patient physical activity while keeping the lumens safely retained to prevent infection and dislodgement. Further, securing the lumens reduces skin irritation and potential allergic reactions of the patient. The device may be removed from the patient without disconnecting the lumens from an infusion pump. 
     Referring to  FIGS. 5 and 6 , an alternate embodiment, device  500  is shown. Device  500  is primarily manufactured of a cotton material or cotton synthetic blend. Device  500  is comprised of a two layered body  501  having an exterior surface  502  and an interior surface  504 . Device  500  is generally applied to smaller, narrower appendages such as arms or legs for use with a PICC line. 
     Exterior surface  502  includes pocket  510  located proximate end  524  of body  501 . Pocket  510  is affixed to exterior surface  502  on three edges. Edge  530  is not affixed to exterior surface  502  and is open. Window  506  is a flexible, transparent layer fixed between exterior surface  502  and interior surface  504 . Window  506  is proximate end  520  of body  501 . Opening  508  is generally centrally positioned on body  501  adjacent window  506  and pocket  510 . Opening  508  passes through body  501  and is visible from both exterior surface  502  and interior surface  504 . Proximate end  522  of body  501  and affixed to interior surface  504  are fastener sections  512  and  516 . Proximate end  526  of body  501  and affixed to exterior surface  502  are fastener sections  514  and  518 . In the preferred alternate embodiment, fastener sections  512 ,  514 ,  516 , and  518  are hook and loop type fasteners, but alternate fasteners such as snaps, buttons, or adhesive are acceptable. 
     In use, device  500  is worn on appendage  540  of the patient where ends  522  and  526  are generally parallel with the longitudinal axis  542  of appendage  540 . Device  500  is wrapped around appendage  540  such that fastener section  512  engages fastener section  514  and fastener section  516  engages fastener section  518 . The intravenous site is covered by window  506  to allow observation of the dressing. A tube exits the intravenous site and passes through opening  508 . When lumens attached to the tube are not in use, they are tucked into pocket  510 . 
     It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept. It is understood, therefore, that this disclosure is not limited to the particular embodiments herein, but it is intended to cover modifications within the spirit and scope of the present disclosure as defined by the appended claims.

Technology Category: 1