Abstract:
The device protects the proximal extension of an indwelling catheter and its percutaneous puncture site from moisture, fluids and risk of infection and maintains a clean environment and a fluid-impermeable and bacteria growth-inhibiting seal against the patient&#39;s skin when bathing, showering or swimming, and also protects others from being exposed to the patient&#39;s blood and catheter at that time. A faceplate is adhered to the skin about the catheter exit site with medical adhesive, the proximal end of the catheter is secured to the faceplate to prevent it from moving from within the patient&#39;s body, and a water-impermeable housing is sealed to the faceplate, with the proximal end of the catheter extending into a cavity of the housing. An antimicrobial material may be disposed on the backside of the faceplate. The device allows a patient to shower, bathe and swim while preventing the catheter from being dislodged from the patient.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The invention relates to an indwelling percutaneous catheter. It specifically relates to protective guards and sleeves that maintain a clean and dry environment at the site where the percutaneous catheter exits the skin, while preventing movement of the catheter relative to the exit site. 
         [0002]    Percutaneous catheters are flexible tubes used on a daily basis in medical practice for parenteral feeding or drainage, and many are long term, chronic catheters that are left in place within a patient for long periods of time. A catheter may be left in place, for example, to permit periodic blood transfusions, to perform renal dialysis, or to permit the periodic administration of antibiotics, chemotherapy treatment or parenteral nutrition. Such a catheter typically has its distal end positioned within the venous system of the patient or in other body locations including, but not limited to, the biliary, urinary system or peritoneal cavity. The proximal end of the catheter is located outside the patient&#39;s body and is periodically connected to medical equipment for, e.g., transfer of fluids or nutrition, transfusion, dialysis, etc. In the case of a biliary or urinary catheter, the catheter may be continuously or intermittently connected to a drainage bag. 
         [0003]    Because indwelling, percutaneous catheters have the disadvantage of extending through an ostomy in the patient&#39;s skin, the exit site can serve as a portal for infectious agents, such as bacteria, fungi and viruses to enter into the system, and is thus prone to infection. Patients that use this type of catheter must, therefore, take extraordinary precautions to keep the proximal end of the catheter and the region surrounding puncture site in a clean and dry condition. Accordingly, such patients must avoid showering and swimming while indwelling catheters are in place. Naturally, this leads to a considerable discomfort on the part of the patient. In addition, exposure of the external portion of a catheter may be hazardous to others in a public facility such as a swimming pool, for example from blood or purulent infected material. 
         [0004]    In addition, such indwelling, percutaneous catheters that extend through an ostomy in the patient&#39;s skin are typically not mounted or anchored to the outside of the patient in any way. As a result, even through normal daily movement, and certainly from more active movement, these catheters can be pulled from or pushed into the patient, thus dislodging the distal end of the catheter from its desired place within the patient&#39;s body. Such an occurrence can have disastrous consequences, in particular if not quickly detected by the patient or a physician. 
         [0005]    Initially, patients or doctors protected these catheters from moisture by taping over them well with water-impermeable bandages prior to showering by the patient. However, this is a time consuming, uncomfortable and messy process that was not always successful and moreover did not allow for the patient to swim or bathe in a tub or shower. It also does not protect against exposure to sweat, which often leads to infection. 
         [0006]    Alternatively, the catheters could be protected by a shield or drape that extends over a portion of the patient&#39;s body and covers the catheter and its entry site. For example, as shown in U.S. Pat. No. 6,571,395 (Korkor), catheters could be protected by a protective guard in the form of a water impermeable collar and shield that drapes around the patient&#39;s neck and over his shoulders, back and chest to brace the catheter against the user and to protect the catheter and its incision site while bathing. However, this excessively bulky shield is a one time use device and lends itself only to internal jugular vein and subclavian vein catheters. In addition, this shield does not allow for swimming or tub bathing, does not allow the patient&#39;s entire body to be cleaned and does not include any form of microbial growth prevention. 
         [0007]    A commercial device distributed by SDA Product Inc., of North Miami Beach, Fla., known as the CD-1000 Adult Composite Dressing, is a dressing that is draped over the user&#39;s shoulder and the wound area to encompass the external catheter. The dressing has an aperture through its backing and adheres to skin using medical grade adhesive on the backing around the aperture, and has a transparent front for easy viewing of the wound and catheter. Similarly, U.S. Pat. No. 5,415,642 (Shepard) describes a smaller, fluid-impermeable protective shield that is adhered to the skin surrounding an ostomy using medical grade adhesive and provides a pouch-like cover extending from the adhered portion to protect the ostomy and the proximal end of an indwelling, percutaneous catheter from contact with water during showering, bathing or swimming. However, these catheter covers require some degree of expertise in applying the adhesive and must be repeated prior to every bathing event, which could be time consuming and frustrating for the patient. Additionally the daily or frequent application of the adhesive to the patient&#39;s skin could be irritating to the skin. 
         [0008]    Other devices, such as those described in U.S. Pat. No. 4,213,458 (Nolan et al.), U.S. Pat. No. 4,419,100 (Alexander) and U.S. Pat. No. 4,889,534 (Mohiuddin et al.), provide another type of sealing attachment for an ostomy cover or a medical drainage pouch that could be used to enclose a percutaneous catheter. In these devices, an adhesive faceplate with an opening therethrough is adhered to the patient&#39;s skin about the ostomy, and a medical drainage pouch may be coupled to the ostomy faceplate using a coupling ring assembly. The coupling ring assembly may comprise collars on the faceplate and the drainage pouch that mate, either directly to each other or indirectly via a separate sealing ring that detachably connects the pouch and faceplate together. While these devices eliminate the necessity of daily or frequent application of the adhesive to the patient&#39;s skin, the adhesive that attaches that ostomy cover or faceplate to the patient&#39;s skin will necessarily become soaked with water or bodily fluid during showering or bathing. The wet adhesive surrounding the ostomy can easily promote bacterial growth and, as a result, infection, which is an especially undesirable occurrence close to an open wound. 
         [0009]    Furthermore, in all of these devices, the proximal end of the indwelling, percutaneous catheter is left loosely hanging from the patient&#39;s body in an unsecure state. Such an unsecured indwelling, percutaneous catheter can easily be pulled outward or pushed inward, thereby dislodging its distal end from the desired location within the patient&#39;s body or causing the proximal end of the catheter to slide into the patient&#39;s body. This would be especially problematic if one of the Nolan et al., Alexander and Mohiuddin et al. devices are used, because the drainage pouches allow the catheter greater freedom of movement, thereby creating a greater risk of the catheter being dislodged from its desired place within the patient. None of the prior art devices provides any way for securing the percutaneous catheter to the outside of the patient, while also providing an infection resistant moisture barrier to enable the patient to swim and/or bathe without fear of infection at that site. 
       SUMMARY OF THE INVENTION 
       [0010]    It is an object of the present invention to provide a device that provides a fluid-impermeable seal against the patient&#39;s skin to allow the catheter exit site to be protected from moisture and fluids. 
         [0011]    It is also an object of the present invention to provide such a device that prevents bacterial or other microbial growth and infection of the patient&#39;s skin at the site of the fluid-impermeable seal about the catheter exit site. 
         [0012]    It is a further object of the present invention to provide such a device that also prevents the catheter from being moved in or out of the patient or from being moved laterally at the exit site. 
         [0013]    The objects and advantages of the invention are accomplished by providing an ostomy and percutaneous catheter protective and affixation device in the form of a protective shield around the proximal extension of an indwelling catheter and its percutaneous puncture site for maintaining a clean environment and a fluid-impermeable and bacteria growth-inhibiting seal against the patient&#39;s skin to allow the catheter exit site to be protected from moisture, fluids and risk of infection. This device also affixes the proximal end of the percutaneous catheter to the patient&#39;s skin or to the protective shield in order to secure the proximal end of the indwelling percutaneous catheter. 
         [0014]    In accordance with a preferred embodiment of the invention, the protective shield comprises a fluid-impermeable housing that has an open end and a closed end, with a mouth at its open end and a sealing ring surrounding the mouth. The housing is preferably composed of a flexible material that is substantially impervious to infectious agents and has a sufficient interior volume to receive the proximal extension of the indwelling catheter. 
         [0015]    The protective shield also comprises a base or faceplate, preferably composed of a flexible material that is substantially impervious to infectious agents, that is affixed to the skin of the patient around the catheter exit site. The base comprises an opening through which the proximal end of the percutaneous catheter exits, and which opening either is wide enough to accommodate a bulky catheter end or has radial slits about the edge of the opening to allow a bulky catheter end to fit through the opening when the device is being changed. The opening is surrounded by a sealing ring that mates with the sealing ring surrounding the mouth of the protective shield to form a watertight seal. A fluid impermeable medical grade adhesive is disposed on the back surface of the base, allowing the protective shield to be attached to the skin that surrounds the catheter exit site. It is preferable that an antibacterial and antimicrobial material also be disposed upon the back surface of the base about the opening in order, such as a silver nitrate impregnated material, in order to impede and prevent bacterial growth. 
         [0016]    The upper surface of the adhering region of the faceplate contains a fastening structure to secure the proximal end of the percutaneous catheter to the base of the protective shield. The fastening device can include suitable clamps or clips, such as the StatLock or any other similar device, wherein the catheter is secured with preferably a low profile. 
         [0017]    In operation, the faceplate is first placed onto the patient by threading the proximal end of the percutaneous catheter through the opening of the faceplate, and a fluid impermeable medical grade adhesive is used to affix the faceplate to the patient about the catheter exit site. Next, the proximal end of the catheter is secured to the faceplate using the fastening device. The loose-hanging proximal end of the catheter can be inserted through the housing mouth and the protective housing can then be slipped over the proximal end of the catheter, and the housing is sealed against the faceplate by mating the sealing ring of the protective housing mating with the sealing ring of the faceplate opening. 
         [0018]    The faceplate can then remain in place and be changed as infrequently as every few weeks or as often needed, by a home health nurse or dialysis nurse. The protective cover will be supplied in varying sizes depending on the length of the peripheral portion of the patient&#39;s catheter. A new sterile, water impermeable cover will be applied by the patient himself, a family member, a home health nurse or a dialysis nurse, or any other qualified individual, prior to the patient showering, bathing or swimming. Following the bathing activity, the bag will be discarded, and a “breathable”, sterile cover can be applied until the next swimming/bathing event or until the next dialysis session. 
         [0019]    A significant feature of the current invention is the fact that the faceplate may be used multiple times before the need for a new device. It is also unique in that it provides for a fluid impermeable and infection resistant environment while at the same time allowing for the catheter to be secured while the patient is bathing. The covers will be interchangeable between a water-proof cover while swimming, showering and bathing, and a “breathable” gauze (or substitute) cover at other times. 
         [0020]    A significant feature of the present invention is that the protective shield constructed in accordance with the invention provides a fluid-impermeable and infection resistant seal when applied to a patient, while at the same time ensuring that the catheter is not dislodged from its position within the patient. 
         [0021]    Also provided in accordance with the present invention is a method for inhibiting contamination of an indwelling catheter entry site on a patient while preventing dislodging of the indwelling catheter. The method involves the steps of identifying the entry site of the catheter, advancing the proximal end of the catheter through the opening in the faceplate, adhering the faceplate to the skin of the patient around the catheter exit site, securing the catheter to the faceplate, inserting the proximal end of the catheter into the cavity of the housing, and sealing the mouth of the housing to the faceplate. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    The above and other objects and advantages of the invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which the reference characters refer to like parts throughout and in which: 
           [0023]      FIG. 1  is a perspective view of a preferred embodiment of the ostomy and percutaneous catheter protective and affixation device showing the faceplate to be adhered to the skin of a patient and the housing to be attached to the faceplate; 
           [0024]      FIG. 2  is a side cross-sectional view of the device prior to attachment of the housing to the faceplate; 
           [0025]      FIG. 3  is a partial side cross-sectional view of an alternate embodiment of the faceplate; 
           [0026]      FIG. 4  is side cross-sectional view of the device showing the faceplate adhered to the skin of a patient about the catheter and the housing attached to the faceplate. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0027]      FIG. 1  illustrates a two-part ostomy and percutaneous catheter protective and affixation device  10  consisting of a housing assembly  11  and a faceplate assembly  12 . The housing assembly  11  for enclosing the proximal end of the catheter is preferably in the form of a pouch or bag, having a flexible peripheral wall  13 . Because housing  11  will be exposed to the open ostomy, wall  13  should be preferably composed of a fluid-impermeable material that is substantially impervious to bacterium, fungi, viruses and other infectious agents. Various materials such as latex and silicone rubber are available for this purpose, as will be appreciated by one skilled in the art. The housing may also be formed of two panels  13   a  and  13   b  joined together by a peripheral zone of heat sealing  14 . The housing wall  13  defines an internal cavity  19  that has a sufficient interior volume to receive the proximal extension of the indwelling catheter. 
         [0028]    In a preferred embodiment, wall  13  of housing assembly  11  has an open upper end  17  and a closed lower end  18 . The open end  17  allows a catheter to be received into a closed chamber formed by the inner surface of the wall  13 . In certain embodiments, it may be desirable for housing  11  to terminate in an opening at the lower end  18  of wall  13 . Where such an opening is provided, a suitable clamp, such as the clamp disclosed in U.S. Pat. No. 3,523,534 (Nolan), can be used to maintain the opening at the lower end  18  in a closed condition. 
         [0029]    A mouth  20  is disposed through the upper end  17  of wall  13  of housing  11 , which aperture  20  is bordered by a first sealing ring  16 , which is secured to wall  13  (or one wall panel  13   a ) of housing  11  by heat sealing or by any other suitable means. Sealing ring  16  preferably has a generally circular configuration, defining a central opening that communicates with the interior  19  of housing  11  through mouth  20  in the upper portion of wall  13 . A pair of apertured tongues  27  may project laterally from opposite sides of the sealing ring  16  for the attachment of a suitable support belt, if the use of such a belt is desired by the wearer. An integral tab  28  may also project radially outwardly from the periphery of sealing ring  16  to serve as a handle for pulling sealing ring  16  away from the faceplate assembly  12  during an uncoupling operation. 
         [0030]    In a preferred embodiment, faceplate  12  assembly includes a base  30  that should be highly flexible, so that it will conform readily to body contours and body movements, and be relatively strong and durable. In a preferred embodiment, base  30  is formed of a gas-penetrable but water resistant microporous material, for relatively long-term adhesion to the skin. For example, a reinforced non-woven cellulosic material of the type sold under the Kaycel trademark by Kimberly-Clark Corporation, Neenah, Wis., which is not only air-pervious but is surface-coated with an ethyl vinyl acetate latex emulsion so that it is also heat-sealable, may be used. A porous, expanded, high-density polyethylene or polypropylene film of the type marketed under the designation Delnet by Hercules Incorporated, Wilmington, Del. may be included for strength and soil resistance, and other porous thermoplastic films or membranes such as Gore-tex, a microporous polytetrafluoroethylene membrane marketed by W. L. Gore &amp; Associates, Newark, Del., may also be employed. Similarly, it is possible to use copolymer films of ethylene and vinyl acetate laminated to non-woven polyester or non-woven rayon layers. Alternatively, base  30  may comprise one or more additional support layers to produce a laminate or sandwich configuration for imparting increased structural integrity. 
         [0031]    The base  30  may have any outline shape, such as circular, oval, square, or generally rectangular as shown in  FIG. 1 , and is provided with a small central opening  34 , as shown most clearly in  FIG. 1 , through which the percutaneous catheter is threaded. Opening  34  can be made wide enough to accommodate even the most bulky catheter end. Alternatively, in order to maintain a tight fit around the shaft of the catheter proximal end, opening  34  is preferably provided with radial slits  35  radiating outward from the edge of the opening to allow a bulky catheter end to fit through the opening when the faceplate assembly  12  is being changed (after the catheter is in place). As a result of slits  35 , opening  34  expands to allow the bulky catheter end to pass through, after which opening  34  returns to its smaller size for attachment of the faceplate  12  to the patient&#39;s skin. 
         [0032]    A second sealing ring  37  is mounted upon base  30  about opening  34  and is secured to base  30  of faceplate  12  by heat sealing or by any other suitable means. Second sealing ring  37  is adapted to mate with first sealing ring  16  to produce a highly effective watertight sealing interlock between the parts, and for this the sealing rings  16  and  37  may have any one of many suitable configurations that are well known in the art. It is to be understood that many different types or structures of sealing or coupling ring assemblies may be used, such as any of those taught in U.S. Pat. Nos. 4,419,100, 4,786,285 and 4,889,534 assigned to Hollister Incorporated of Libertyville, Ill., and U.S. Pat. No. 5,257,981, all of which are incorporated herein by reference, as well as others. 
         [0033]    As shown in  FIG. 2 , the back or rear surface of base  30  is provided with an adhesive  31  suitable for application to the skin, such as by being coated with a medical-grade pressure-sensitive adhesive  31 . The adhesive  31  is preferably fluid impermeable and is preferably applied around the entire back surface of the base  30  without discontinuity so that a fluid impermeable seal can be formed when the base  30  is applied to the patient&#39;s skin. The adhesive coating  31  may be applied to the back surface of base  30  in accordance with any of a variety of conventional techniques. 
         [0034]    It is preferable that, prior to use, the adhesive  31  on the back surface of base  30  be covered by a release layer  32 , such as backing sheets. Upon removal of the release layer  32 , the faceplate  12  may be adhesively secured to the patient&#39;s skin in the peristomal region. Release layer  32  can be adapted so as to be easily removable after the proximal end of a catheter has been inserted through opening  34 , so that the catheter may be inserted through opening  34  without sticking to the adhesive  31 . Other release layer configurations can also readily be devised by one of skill in the art. 
         [0035]    In a preferred embodiment, faceplate  12  contains, in addition to its fluid impervious composition, some infection resistant, antibacterial and/or antimicrobial treatment in order to ensure that the peristomal region remains free of potential infectious agents and contamination. In one embodiment, the region about opening  34  on the back side of the faceplate  12  can contain, bear or be impregnated with such a material  36 . One preferred material is a silver nitrate plated polymeric substrate, such as described in U.S. Pat. Nos. 6,087,549 and 7,005,556, both assigned to Argentum Medical LLC of Willowbrook, Ill., which are incorporated herein by reference. Preferred materials are Silverlon® by Argentum Medical LLC and Acticoat® by Smith &amp; Nephew plc of London, England, which provide a controlled release of silver ions to protect the wound and dressing from bacterial contamination. Adhesive  31  may be applied to the back surface of the antimicrobial material  36  as well to adhere it to the patient&#39;s skin. Alternatively, adhesive  31  may be applied around the antimicrobial material  36  on the back surface of base  30  so as to allow the antimicrobial material  36  to have greater contact with the patient&#39;s skin. 
         [0036]    In addition, it is apparent that the use of protective covers to enclose percutaneous catheters having relatively long proximal extensions protruding from the skin can, upon normal movement of the patient, cause the catheter to move relative to the patient and cause the distal end of the catheter to be dislodged from its position within the patient. In order to minimize this, one or more structures are preferably provided to immobilize the proximal end of the catheter. 
         [0037]    Accordingly, faceplate assembly  12  also includes a fastening structure  25  to secure the proximal end of the percutaneous catheter so that it does not move relative to the patient. In a preferred embodiment, such a fastening structure is incorporated on base  30 , within the bounds of the sealing ring  37 . In certain embodiments, the fastening structure  25  may be bonded directly to or mounted directly onto base  30 , while in other embodiments the fastening structure  25  is mounted onto a base or pad  21  that is in turn bonded to or mounted onto base  30 . Such a fastening device can be clamps, clips, brackets  22  or any one or combination of those known to the art that are generally used to secure devices, particularly catheters and their associated tubing to the patient. It is also preferred that such a fastening structure  25  have a low profile and most preferably not protrude outward beyond the height of sealing ring  37  in order that it not interfere with the mating of the sealing rings  16 , 37  or tend to cause tears in wall  13  of housing  11  due to its protrusion. 
         [0038]    Many types of catheter fastening structures may be used, such as those shown in U.S. Pat. Nos. 5,722,959, 5,855,591, 6,117,163 and 7,014,627 to Bierman, all of which are incorporated herein by reference, as well as others assigned to Venetec International, Inc. of San Diego, Calif. Preferred fastening devices are made by Venetec International under the name StatLock®, and one example of a preferred embodiment of this brand is known as the PICC Plus/PICC model (used for peripherally inserted central catheters). In a typical fastening structure  25 , the brackets  22  are closed around the proximal end of the catheter as it exits through opening  34  in base  30  to thereby against the catheter against base  30 . In certain embodiments, the spacing of the brackets  22  is adjustable to accommodate catheters of different widths, for example via movable posts  24  upon which the brackets  22  are mounted. To use this embodiment of the fastening structure  25 , the brackets  22  are opened, the moveable posts  24  are adjusted to fit the particular catheter being used, the catheter is placed between the brackets  22 , and the brackets  22  are closed around the proximal end of the catheter to secure the catheter against base  30  of faceplate assembly  12  and to prevent it from moving. 
         [0039]    To use the ostomy and percutaneous catheter protective and affixation device  10 , the proximal end of the indwelling catheter is threaded through opening  34  in faceplate assembly  12 , from the back side of base  30  to the front of base  30 , expanding slits  35  in the process, if necessary. Release layer  32  is then removed from the back surface of the base  30  to expose the adhesive  31 . The base  26  is then applied and adhered to the skin of the patient such that the opening  34  is directly above the catheter exit site  12 . Then, the proximal end of the catheter is secured to faceplate  12  using fastening structure  25  so as to be immobilized relative to the catheter exit site and opening  34 . 
         [0040]    Once faceplate assembly  12  is applied to the patient&#39;s skin at the catheter exit site, housing assembly  11  must be attached to faceplate  12  so as to retain the proximal end of the catheter and also sealingly engage against faceplate  12 . It is contemplated that the housing  11  as described can be sold in individually wrapped, sterile packages that can be opened immediately prior to use. First, the portion of the proximal end of the catheter that is not bound using fastening structure  25  is inserted into the cavity  19  of housing assembly  11  through mouth  20 . Housing  11  is then attached to faceplate assembly  12  by pressing first sealing ring  16  on wall  13  of housing  11  against second sealing ring  37  on base  30  of faceplate assembly  12  so that their structures mate, as discussed above, to provide a fluid-impermeable seal between them. The catheter cover  10  thereby allows the patient to swim, bathe, etc. without undue risk of infection. The catheter cover  10  also protects public and private swimming and bathing facilities from exposure to blood and other potentially hazardous fluids that may be present on the outside of the catheter.  FIG. 4  shows a cross-sectional view of the device with the faceplate  12  adhered to the skin of a patient about the percutaneous catheter exit site, with the housing  11  attached to the faceplate  12  and the proximal end of the catheter disposed within cavity  19  of housing  11 . 
         [0041]    In order to remove housing assembly  11  from faceplate assembly  12 , sealing ring  16  on wall  13  of housing  11  must be uncoupled from sealing ring  37  on base  30 . This is achieved by gripping tab  28  on sealing ring  16  and pulling it radially outwardly to disengage sealing ring  16  on the housing assembly  11  from sealing ring  37  on faceplate assembly  12 . During such operation, the patient (or other person) immobilizes sealing ring  37  by gripping base  30  in the area adjacent tab  28 . The housing  11  is then moved downward to slide it off the proximal end of the catheter and discarded. It is contemplated that the housing  11  can be sold as a relatively inexpensive, one-time-use disposable product. Then, if desired, fastening structure  25  is opened, releasing the catheter for use or manipulation by a physician. 
         [0042]    In a first embodiment, as shown in  FIG. 2 , base  30  is a flat pad that is adhered directly to the patient&#39;s skin. But, because the pulling action during uncoupling of the sealing rings may transmit some pulling forces to the faceplate assembly  12 , it may also cause some patient discomfort or result in separation (or weakening) of the adhesive seal between the patient and the adhesive  31  on faceplate assembly  12 . Accordingly, in an alternative embodiment, it may be desirable not to form base  30  as a flat pad that is adhered directly to the patient&#39;s skin but rather to incorporate within the structure of the faceplate assembly  12  any one of the flexible webs, accordion flanges or extra faceplate assembly portions that are known in the art to lessen or eliminate such forces. Structures that resist or minimize such pulling forces are shown, for example, in U.S. Pat. Nos. 4,419,100 and 4,889,534 assigned to Hollister Incorporated of Libertyville, Ill., and U.S. Pat. Nos. 4,648,875, 4,664,661, 4,685,990 and 4,846,820 assigned to E. R. Squibb &amp; Sons, Inc. of Princeton, N.J., all of which are incorporated herein by reference, as well as others. For example,  FIG. 3  shows an alternate embodiment of the faceplate  12 , wherein base  30  is connected a flexible annular web  28  that is in turn connected to sealing ring  37  by way of flange  29 , such as described in U.S. Pat. No. 4,419,100. This structure, wherein the inner edge of annular web  28  is connected to the front side of base  30  about aperture  34  and the outer edge of annular web  28  is connected to sealing ring  37  via flange  29 , allows only limited movement of sealing ring  37  in generally axial directions normal to base  30 , thereby providing relief from the pushing or pulling forces that would be applied to faceplate  12  and cause discomfort to the patient during attachment or removal of housing  11 . 
         [0043]    It should be understood that a catheter cover in accordance with the present invention can be used with virtually any type of device that passes through the skin, such as to permit the passage of fluids, electrical currents, and the like. Thus, the terms “catheter”, “percutaneous catheter” and “indwelling catheter” as used herein to describe the present invention are intended to include all devices that meet this description. 
         [0044]    Although this invention has been described in terms of certain preferred embodiments, other embodiments that are apparent to those of ordinary skill in the art are also within the scope of this invention. Accordingly, the scope of the present invention is intended to be defined only by reference to the appended claims.