Patent Publication Number: US-2009234296-A1

Title: Protective device for an intravenous catheter or other peripheral body penetrating object

Description:
RELATED APPLICATION DATA-CLAIM TO PRIORITY 
     This application claims the priority benefits of U.S. Provisional Patent Application Ser. No. 60/936,209, filed Jun. 20, 2007, titled “Protective Device For Intravenous Catheter”. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to devices for protecting and stabilizing the external portion of a medical device extending through a penetration in a body part of a patient, and in its preferred embodiments more specifically relates to a device for protecting and cushioning the external portion of a peripherally inserted central catheter placed through penetration in a limb of an ambulatory human patient. 
     BACKGROUND 
     In the course of long term drug treatment, including but not limited to chemotherapy for cancer patients, it is a relatively common practice to fit the patient with a central catheter for the administration of the drug therapy. A central catheter may remain in place in the patient&#39;s body for an extended period of time without damage, allowing the patient to remain ambulatory between treatments and to leave the hospital or other treatment center with the catheter in place. Historically, central catheters were inserted through the chest wall, but it has become increasingly common for a central catheter to be inserted peripherally, typically in a patient&#39;s upper arm, and routed through a vein to the chest, so that the drug is administered into a central vein. Whether centrally inserted or peripherally inserted, a portion of the catheter remains disposed outside the patient&#39;s body, and the external portion of the catheter should be shielded and protected for the patient&#39;s health and safety, and for the patient&#39;s comfort. 
     A common approach to protecting the external portion of the catheter, which, for convenience, is referred to in this application as the catheter, is to wrap an elastic bandage around the patient&#39;s arm or other insertion location in the body to secure the catheter between the patient&#39;s body and the wrapped bandage. Although a wrapped flexible elastic bandage can be effective in protecting the catheter and shielding it from contact, the elastic bandage approach has a number of disadvantages. An elongate elastic bandage can be difficult for the patient to wrap and secure, especially around an arm. The bandage can also be difficult to adjust during use. Wearing an elastic bandage for an extended period of time can also become very uncomfortable for the patient. Further, especially for a heavy patient, an elastic bandage has a tendency to roll and bunch as the patient moves, making the bandage even more uncomfortable. 
     Devices for stabilizing a peripheral intravenous catheter, which is left in place only while the patient is in the treatment facility, during administration of drugs or other fluids are known in the prior art, but such devices are neither designed for nor suitable for long term use with an ambulatory patient. There remains a need for an effective, comfortable, easily positioned and removed, and inexpensive device for protecting especially a peripherally inserted central catheter between treatments, and over an extended period of time. 
     SUMMARY OF THE INVENTION 
     The present invention provides a protective wrap device for securing, protecting, and cushioning a catheter disposed in a patient&#39;s body. The device is formed as an elongate, generally flat body with a preferably soft, breathable fabric cover. In the preferred embodiment of the device, one or more strips of semi-flexible material are disposed within the cover, to provide a degree of rigidity or stiffness to the device so as to prevent it from rolling up or down on the patient during use. The inside face of the cover of the device may be provided with a flexible pocket into which the catheter is inserted as the device is positioned and wrapped, to retain and secure the catheter itself and assure that all parts of the catheter remain covered by the device. The device is secured around the arm or other body part of a patient by, preferably, hook and loop fasteners, commonly identified by the trademark “Velcro”; so that a comfortable but secure, and adjustable fit can be readily achieved, and to facilitate placement of the device by the patient without assistance. 
     The structure and features of the device of the invention will be described in detail with reference to the accompanying drawing figures. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a top plan view of the preferred embodiment of the device of the invention, showing the inner face of the device. 
         FIG. 2  is a bottom plan view of the preferred embodiment of the device of the invention, showing the outer face of the device. 
         FIG. 3  is an edge view of the preferred embodiment of the device of the invention, along line  3 - 3  of  FIG. 1 . 
         FIG. 4  is a sectioned end view of the preferred embodiment of the device of the invention, along line  4 - 4  of  FIG. 1 . 
         FIG. 5  is a top plan view of the inner face of a variation of the device of the invention without a catheter pocket. 
         FIG. 6  is a top plan view of the inner face of an alternative embodiment of the device of the invention. 
         FIG. 7  is a partially cut-away top plan view of the inner face of another alternative embodiment of the device of the invention. 
         FIG. 8  is an illustration of the device of the preferred embodiment of the invention in place upon the arm of a patient, showing one manner of use of the device. 
     
    
    
     DESCRIPTION OF THE INVENTION 
     In the preferred embodiment, the device of the invention, generally identified by reference number  10 , comprises an elongate semi-flexible generally planar body with an outer face  11 , an inner face  12 , a first end  13 , a second end  14 , a first edge  15 , and a second edge  16 . It is preferred that the device be formed with a generally rectangular configuration, with generally square corners at the intersections of the ends and edges, but it is to be understood that the device could be formed in other configurations, such as but not limited to an elongate oval, within the scope of the invention. 
     The device  10  includes a cover  17 , preferably formed of a flexible, soft, breathable fabric, to facilitate conforming the body of the device to the portion of the body a user in the location of the catheter to be protected, and for the comfort of the user. Cover  17  includes an outer face  18 , generally coextensive with outer face  11  of device  10 , an inner face  19 , generally coextensive with inner face  12  of the device, a first end  20 , a second end  21 , a first edge  22 , and a second edge  23 . The ends and edges of the cover  17  are generally coextensive with the ends and edges of the device. 
     In one embodiment of the device, a catheter pocket  24  is connected to the inner face  19  of cover  17 , to receive and protect the external portion of a catheter during use of the device. In this embodiment, pocket  24  is formed in a generally rectangular configuration, with a first end  25 , a second end  26 , a first edge  27 , and a second edge  28 , and is connected to the inner face  19  of the cover along the first and second ends and the second edge of the pocket, leaving first edge  27  open toward second edge  23  of the cover, for access to the interior  29  of the pocket. It is preferred that pocket  24  be formed of the same fabric material as cover  17 , and is connected to cover  17  by stitching. It is also preferred that pocket  24 , if used, be generally centered between first and second edges  22  and  23  of the cover, and offset slightly toward second end  21  of the cover rather than being centered between the first and second ends of the cover. 
     Pocket  24  is preferably formed from a single sheet of material, generally twice the size of the completed pocket, that is folded over itself into a double layer of material. The free ends and edge of the folded over piece of material are connected to cover  17 , leaving the folded edge without connection to the cover as open edge  27  of the pocket. It is to be understood, however, that neither the material of construction nor the folded construction of pocket  24  is critical, and if used, pocket  24  may be formed of other materials and with, for example, a single layer construction, if desired, within the scope of the invention. 
     Cover  17  is preferably formed from a single sheet of fabric that is folded over itself. The free ends and edge of the folded sheet are connected together, preferably by stitching, to form the cover. In the preferred embodiment, and as shown in the drawing figures, the connected free edges of the sheet form first edge  22  of cover  17 , with the folded edge of the sheet forming second edge  23  of the cover. 
     The device of the invention further includes a stabilizer means for maintaining the position of the device in place on a patient&#39;s limb, without sliding and without rolling up upon itself as a result of the patient&#39;s movements. In the preferred embodiment, the stabilizer means comprises a single stabilizer band  30  disposed and connected within a substantial portion of the interior  31  of cover  17 , between the inner and outer faces of the cover. Stabilizer band  30  is preferably a flat, relatively thin generally planar band formed of a semi-flexible shape retentive material with sufficient flexibility to allow the band to be readily rolled, bent, or folded, but that will return to its original planar configuration when released. A non-woven material commercially available under the brand name “Polartec®” has been found to be a well suited material for the construction of stabilizer band  30 , but it is to be understood that the scope of the invention is not limited to this particular material, or to any other particular material, for the formation of band  30 , and that any material with suitable characteristics may be used. It is preferred that the material of construction of band  30  be permeable to air and moisture, washable, hypo-allergenic, and with sufficient flexibility to closely conform to the shape of an arm or other body part when wrapped around the body part. The material of construction of band  30  should also retain its original configuration and properties, e.g., stiffness, after repeated washing and drying. As non-limiting examples, it is contemplated that materials commonly used as stabilizers or stiffeners in sewing would be suitable for use as band  30 , and that other non-textile materials, such as an open cell or closed cell foam, may also be used. 
     In the preferred embodiment, stabilizer band  30  extends the full length of the device, between the first and second ends  20  and  21  of cover  17 , with first end  32  of band  30  aligned with first end  20  of the cover and with second end  33  of band  30  aligned with second end  23  of the cover. Stabilizer band  30  also extends from the first edge  22  of the cover, with the first edge  34  of band  30  aligned with first edge  22  of the cover through at least a majority of the distance between first edge  22  and second edge  23  of the cover. In one embodiment of the device, second edge  35  of band  30  does not extend fully to the second edge  23  of the cover. In forming the device, stabilizer band  30  is preferably placed and positioned in the interior of cover  17  before the edges of the sheet of material forming the cover are stitched together, and the first and second ends and the first edge of band  30  are preferably caught by the line or lines of stitching  36  used to close the cover, so as to assure that the stabilizer band will remain in the desired disposition within the cover. It is also preferred that a line of stitching  36  be formed between the first and second ends of the cover and stabilizer band along the second edge of the stabilizer band, extending though the cover and the stabilizer band to secure the second edge of the stabilizer band. Although it is preferred that cover  17  and stabilizer band  30  be permanently secured together, it is to be understood that the stabilizer band may be disposed in the interior of the cover without connection to the cover. If at least one end or one edge of the cover is releasably connected, so as to allow the cover to be opened, the stabilizer band would then be removable from the cover, allowing, e.g., each to be replaced without replacing the other. 
     The portion of cover  17  between the second edge of stabilizer band  30  and the second edge of the cover, through which stabilizer band  30  does not extend, forms skirt  37  that extends loosely from the stabilized portion of the body of the device. Skirt  37  provides some additional cushioning along the second edge of the device for the comfort of the user. However, it is to be understood that skirt  37  may be omitted within the scope of the invention, with stabilizer band  30  extending fully between the first and second edges of the cover. 
     In the preferred sequence of construction, catheter pocket  24 , if used, is connected to cover  17  after the stabilizer band has been positioned within cover  17  and the ends and edge of those components secured together. It is preferred that second edge  28  of pocket  24  be aligned with the second edge  35  of stabilizer band  30 , whether skirt  37  is present or not. It is also preferred that the line(s) of stitching  36  used to connected pocket  24  to cover  17  extend fully through the inner and outer faces of the cover as well as through stabilizer band  30 . It is preferred that cover  17  and stabilizer band  30  be connected along at least the ends and edges of the stabilizer band, and additional lines or points of connection between the cover and the stabilizer band may certainly be used to help prevent shifting of the cover and/or stabilizer band relative to each other. 
     The device of the invention is intended to be used to protect and cover the external portion of an intravenous catheter by placing the external portion of the catheter in pocket  24  of the device, if the pocket is used or otherwise under and fully covered by the second edge of the device, wrapping the device around the part of the body in which the catheter is positioned, and then securing the device around the body part with releasable fastening means to prevent it from unwrapping. In the preferred embodiment the fastening means is a two component hook and loop type fastener, commonly referred to by the brand name “Velcro®”. A strip  38  of the hook component of the fastener is disposed on the inner face  19  of cover  17  at first end  20 , extending between the first edge  22  of the cover and the second edge  35  of stabilizer band  30 , and also extending from first end  20  of the cover a short distance toward the second end of the cover. A plurality of strips  39  of the loop component of the fastener, each preferably of the same dimension as strip  38 , are disposed on the outer face  18  of cover  17 , extending between the second edge  32  of the cover and second edge  35  of the stabilizer band, and from second end  21  of the cover toward the first end of the cover. Strip  38  and strips  39  are preferably connected by stitching  36  extending through the fastener strips, both faces of the cover, and the stabilizer band. Extending the stitching through the entire structure when connecting the components of the device as described services to secure the stabilizer band within the cover at several locations along the length of the device, and prevents the stabilizer band from shifting within the interior of the cover. Although the disposition and connection of strips of the hook and loop components as described are preferred, it is to be understood that variations in the hook and loop fasteners could be made, such as, without limitation, using a single piece of the loop component rather than a plurality of strips of that component. It is preferred that the loop component extend a greater distance from the second end of the body of the device toward the first end than the hook component extends from the first end toward the second end, so that the points of connection between the hook component and the loop component, and thus the fit of the device around a limb can be adjusted. 
     It is also to be understood that though the use of hook and loop fasteners is preferred, that other types of fastening means could be used within the scope of the invention. As one non-limiting example, illustrated in  FIG. 6 , snaps may be used, preferably with a plurality of female snap components  40  arrayed along a portion of the length of the device and connected to the outer face, to provide multiple choices for connection of male snap components  41  disposed near the first end of the device and connected to the inner face. As further examples, straps and buckles could be used, as could elastic bands placed over and around the device when in place on a limb, though with less convenience than the preferred hook and loop fastener means. 
     It is contemplated that the device of the invention will be most often used to protect and cover an intravenous catheter inserted in a patient&#39;s upper arm. As briefly described above, the device is used in that configuration by placing the device on the patient&#39;s arm with the first edge of the body adjacent to the shoulder, and with skirt  37  adjacent to the elbow. In an embodiment with a pocket  24 , the external portion of the catheter is placed into the pocket through the open end of the pocket, and arranged in the pocket so that the catheter is in a reasonably flat and comfortable position. It is contemplated that the use of a pocket may help stabilize the catheter, and will also prevent direct contact between the catheter and the patient&#39;s skin, which often becomes very sensitive during the course of treatment. In an embodiment without a pocket, the device is positioned on the patient&#39;s arm over the catheter and the second end of the device is placed along and partially wrapped around the arm and held in position while the first end of the device is wrapped around the arm and releasably connected to the outer surface of the device using the selected fastening means. For proper fit, the length of the device, between its first and second ends, should be sufficiently greater than the circumference of the arm, or other body part, around which the device is to be wrapped and secured, to provide a sufficient overlap for engagement and adjustment of the fastening means without creating enough bulk to be uncomfortable. Accordingly, it is contemplated that the device of the invention will be provided in a variety of lengths, to accommodate patients of different sizes. It is also contemplated that the device may be provided with differing widths, between the edges of the device, to accommodate arms of different lengths. Because the device is readily sizable and adaptable, it may be effectively used by patients ranging from young children to large adults. 
     The device is wrapped tightly enough to prevent it from sliding over the elbow and off the arm, but need not be wrapped so tightly as to cause discomfort for the patient. The inclusion of skirt  37 , which is disposed adjacent to the user&#39;s elbow, provides additional cushioning at that edge of the wrapped device and helps prevent constriction of the arm when the elbow is flexed. With the device in place on a user&#39;s arm the stabilizer band  30  performs at least two functions that are significant to the effectiveness of the device. In one function, the stabilizer band prevents the wrapped device from rolling on the patient&#39;s arm, either from the shoulder toward the elbow, or from the elbow toward the shoulder. Preventing the device from rolling not only assures that the catheter is properly protected and secured, but also substantially enhances the patient&#39;s comfort. In addition, because the stabilizer band is relatively stiff, it assists in retaining the device in place on the patient&#39;s arm, and reduces the tendency of any device wrapped around an upper arm to slide downward over the elbow. 
     In an alternative embodiment, illustrated in  FIG. 6 , stabilizing band  30 , which extends fully between the ends of the device in the preferred embodiment and wraps fully around the limb during use of the preferred embodiment can be replaced by a stabilizing pad  42  of shorter length. In this embodiment, the stabilizer pad is disposed within the portion of the hollow interior of cover  17  between its first and second ends that will overlie the catheter penetration site and external portion of the catheter, and is connected to the cover as described above. In a variation of this embodiment, cover  17  may be formed as a single layer (eliminating the hollow interior), and the stabilizer pad, preferably wrapped in its own cover, attached to the single layer cover in the desired location. This embodiment further reduces the bulk of the device on a patient&#39;s arm by eliminating a portion of the bulk of the stabilizer. However, if this alternative device rotates on a patient&#39;s arm during use the stabilizer pad may move from over the catheter and negate much of the advantage the stabilizer provides. Therefore, if this alternative embodiment is used consideration should be given to using a slip-resistant material for cover  17 , and/or making pad  42  with sufficient area to remain over the catheter with limited rotation of the cover on the patient&#39;s arm or other limb. 
     In another alternative embodiment, shown in  FIG. 7 , single stabilizer band  30  is replaced by a plurality of narrow generally planar slats  43  arrayed along the length of the device with each disposed adjacent to each other in parallel relation, and perpendicular to the edges of the device. Each slat  43  is received within an open ended sleeve  44  formed in cover  17 , each of which extends from the first edge of the cover toward the second edge. Sleeves  44  are preferably formed by connecting the two layers of cover  17  together with spaced apart parallel connection lines  45  extending from the first edge of the cover toward the second edge, running from the second end of the cover over the majority of the distance to the first end, with each connection line connecting both layers of the cover. In this embodiment the two layers of the cover at the first edge are open between the connection lines  45 , to form the open ends of the sleeves. The open ends of sleeves  44  may be left open after slats  43  are inserted, allowing removal of the slats, or maybe connected after insertion to close the sleeves with the slats contained therein. 
     This alternative embodiment is used in essentially the same way as the other embodiments, and is positioned around a patient&#39;s arm or other body part as described above. Although slats  43  are separated from each other, they are immediately adjacent to each other and provide what is effectively a continuous stabilizer to protect and cushion the catheter and insertion site. The only significant difference from the single stabilizer band embodiment is that the stabilizer slats extend along a patient&#39;s limb rather than around the limb when the device is in use. 
     The device of the invention, in all embodiments and variations, is more comfortable for a patient and is more easily adjustable during use than, e.g., a wrapped elastic bandage. The device of the invention is wrapped around the arm in a single layer with only a slight overlap of the ends of the device, whereas an elastic bandage is typically wrapped around the arm in multiple layers. Adjusting the fit of an elastic bandage requires removing a substantial part of the bandage and fully re-wrapping it. Adjusting the fit of the device of the invention is easily accomplished by releasing the fastener and then re-fastening it to be slightly tighter or looser, as desired, without unwrapping or removing the device. 
     The foregoing description of the preferred embodiment of the device of the invention, and of certain variations within the scope of the invention is intended to be illustrative and not limiting. The device is susceptible to other alternative embodiments and variations within the scope of the invention, which is intended to be broadly construed.