Abstract:
A wire protector to cover an exposed portion of a device inserted into an organism comprises a removable backing layer removably joined to an attachment layer, and a transparent covering layer. The wire protector has a first end and a protector strip, the first end including a site wall and a connector wall, the site wall defining an insertion site therein, the site wall further comprising one or more prongs, the prongs facing the insertion site, the protector strip comprising one or more strip walls, such that when the backing layer is removed from the attachment layer, first end is positioned over the device insertion site, the protector strip is positioned over the exposed portion of the device, the protector device covers the exposed device portion. The wire protector stabilizes and protects needle localization wires used in breast biopsies, and can be used for other implanted devices. Also disclosed is a method for covering such exposed portion of such inserted device.

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
     This application claims the benefit of United States Provisional Application For Patent Ser. No. 60/928,574, filed 9 May 2007, the contents of which are incorporated by reference herein in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The field of this invention is a device and method for the protection of a needle localization wire, and more specifically, such a wire that is used in the diagnosis and treatment of breast cancer. Generally, a wire is inserted into a patient&#39;s breast to mark the location of a suspicious growth, and a length of the wire is left outside the breast where it remains for a time period between insertion and removal. During this time period, the exposed wire needs to be covered, to maintain the inserted wire in a proper position, and to protect the insertion site from potential infection. Embodiments of the present invention cover the insertion site and the exposed wire, allowing medical personnel to see the insertion site and the wire. 
     BACKGROUND OF THE INVENTION 
     Mammography is a procedure commonly used for the detection of breast cancer. Should a suspicious growth be detected, a step in diagnosis and treatment involves either a biopsy of the growth, and/or its removal. Depending upon the type and size of the growth, and whether or not it has spread elsewhere in the body, other treatments, ranging from additional surgery, chemotherapy and radiation may be involved. However, in order to perform either a biopsy, or removal of the growth, it is important to know where the growth is within the affected tissue. 
     Current techniques involve the insertion of one or more needle localization wires into the breast, to direct a surgeon to the affected area. The wires are inserted using a needle, and generally with the aid of X-rays. After the wire has been inserted, the needle is removed and a wire is left in place, with a portion of the wire remaining outside of the breast. 
     This needle localization wire is placed in the breast during mammography and should be protected during the time period between insertion and surgery. The wire should be stabilized, such that it will not move, during this time period. It is also important to secure the implanted wire to the patient such that it will not advance further into the breast, or pull out, complicating the situation and potentially causing harm to the patient. During this time period, the exposed wire needs to be covered, to maintain the inserted wire in a proper position, and to protect the insertion site from potential infection. Embodiments of the present invention cover and protect the wire. 
     In the prior art, there are no devices that perform this protective function. Prior art protection include the following options: (1) using gauze and medical tape to secure the wire in a number of ways, (2) taping the wire to the patient&#39;s skin, (3) using gauze taped to the patient&#39;s breast, (4) using a material such as Tegaderm to cover the wires, and (5) using a paper or plastic cup to cover the wires, and taping the cup to the breast. 
     Embodiments of the present invention are made from a transparent material, such that medical personnel can see the wire&#39;s location through the wire protector. Visibility of the wire aids a surgeon or other medical personnel in removing this device without dislodging the wire from its location. 
     Embodiments of the present invention further comprise channels to allow secretions to flow away from the wire, again improving visibility of the wire. 
     The length of the wire protector device is long enough to cover the longest needle localization wire in use (currently, approximately 20 cm). To accommodate shorter wires, the device may be cut with a scissors, and a tab placed at the cut end to facilitate removal of the device. 
     BRIEF SUMMARY OF THE INVENTION 
     An object of the present invention is to provide a device that can effect localization wire security in a safe and professional manner. 
     Another object of the present invention is to provide a clear and unobstructed view of wire during imaging procedures, such as using X-rays. 
     In one example of current practice, two images are taken of a breast after the wire has been inserted to its proper position. The wire needs to be secured both to maintain it in place, yet be out of the way so that the images can be more accurately reviewed by medical personnel. 
     Yet another object of the present invention is to provide a wire protector device that will prevent obscuring of excess wire over the area of interest on the patient&#39;s body. 
     Another object of the present invention is to provide a wire protector device that is narrow enough to permit for multiple placement of wires, within a close vicinity of each other, without overlapping. 
     The device eliminates messy make-shift dressing combinations (e.g., gauze, tape, Tegaderm®)). 
     Another object of the present invention is to provide a cost effective, easy to use device that can be used to protect localization wires, catheters and the like, after their insertion into an organism. 
     Still another object of the present invention is to provide a kit for protecting localization wires, catheters and the like, that have been inserted into an organism. 
     This device comprises a special tab at the end of the wire protector which permits the surgeon to remove the device while working towards the entrance site, thereby enabling the surgeon to secure the wire as surgery progresses. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         FIG. 1  is a schematic top view of a first embodiment of the present invention. 
         FIG. 2  is a schematic side view of the embodiment shown in  FIG. 1 . 
         FIG. 3  is a schematic view of the embodiment shown in  FIG. 1  while in use. 
         FIG. 4  is a schematic top view of a second embodiment of the present invention. 
         FIG. 5  is an exploded view of the embodiment shown in  FIG. 4 . 
         FIG. 6  is a schematic top view of a third embodiment of the present invention. 
         FIG. 7  is a schematic top view of a fourth embodiment of the present invention. 
         FIG. 8  is an exploded view of the embodiment shown in  FIG. 7 . 
         FIG. 9  is a schematic view of the embodiment shown in  FIG. 7 , in an exploded view of the packaging. 
         FIG. 10A-G  illustrate usage of an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Embodiments of the present invention are devices for the protection of a needle localization wire. This device protects the needle localization wire that is placed in the breast as a locator for the surgeon when a suspicious finding has been detected and is to biopsied and/or be removed. 
     A first embodiment  10  is shown in  FIG. 1 . Wire protector  10  comprises a first end  12  connected to tail section or protector strip  14 , which is shown in a rolled-up configuration ( FIGS. 1-2 ). The terms tail section and protector strip will be used interchangeably to describe this part of the wire protector device, in all of the embodiments. Both the first end  12  and the protector strip  14  each have a top surface  16  and  18 , respectively, that will be exposed to the environment during use, and a bottom surface,  20  and  22 , respectively, that will be in contact with the skin of the patient.  FIG. 1  is shown with the top surfaces  16  and  18  facing the reader. 
     In this embodiment, the first end  12  has a D-shaped configuration, and comprises a wire site region  24  which is bordered by site wall  26 . A plurality of channels  28  within site wall  26  provide a means for secretions, such as blood, bodily fluids or the like, that have exited the wire localization site on the patient, to escape, and be retained within reservoir  30 , allowing for the clear visualization of the wire. The wire site region  24  is of sufficient size to enable a piece of gauze sponge  62  (optional, see  FIG. 10C ) to be positioned atop the wire localization site, if desired. 
     The reservoir  30  is bordered on several sides by a reservoir wall  32 , which along with site wall  26 , joins connector walls  34  to form the first end  12 . 
     Although the first end  12  in this and the other embodiments is described as being D-shaped, it is to be understood that variations in this configuration, ranging from being rounded, oval, square, or other geometric shapes are expressly contemplated as being within the scope of this invention. The D-shape may aid in handling of the device, but the device&#39;s function is to cover the wire insertion site and provide a visible means of monitoring the position of the inserted wire. 
     In use, the layer of backing material  36  is peeled away from the protector device  10 , exposing a layer of adhesive attached to the bottom surface  20 ,  22  of the first end  12  and protector strip  14 , respectively. The first end  12  is placed over the wire localization site  52  on the breast  50 , and adhered to the skin by pressure. The wire protector  14  is unrolled, and the backing  36  removed, while guiding the wire  60  in the desired direction, working away from the wire localization site  52  ( FIG. 3 ). The distal end of the unrolled wire protector  14  is a second end  38 , which terminates as a tab  40 . The length of wire  60  exposed will vary, depending upon factors such as, but not limited to, the length of wire that is inserted to the target growth, the external length needed to stabilize the wire between insertion and removal, and preferences of attending medical personnel. Before the surgical procedure, the wire protector  10  is removed, starting with tab  40  and working back to the wire insertion site  52 . 
     For the purposes of this specification, the terms “distal” and “proximal” will refer to the location of the component in relation to where the localization wire in inserted into the patient. Thus, a proximal element of the device is close to where the wire is inserted; a distal element of the device is further away from where the wire is inserted. 
     A second embodiment  100 , in a flat configuration, is shown in  FIGS. 4 and 5 . Wire protector  100  is manufactured from several layers, a liner layer  110 , a tape layer  120  and a film layer  130 , which are attached to the tape layer  120 . The tape layer comprises a strip of double-sided foam tape  120 , shaped as shown in  FIGS. 4-5 . The film layer  130  comprises a layer of clear urethane film, providing a transparent surface so that the location of the wire  60  underneath the wire protector  100  can be seen. 
     The liner layer  110  includes a section  112  that is removed during the manufacturing process, in order to form part of the fluid reservoir  152  in the wire protector  100 . The liner layer  110  is a standard silicone coated paper that will be removed from the wire protector device  100  during use. The material used for the liner layer  110  is known to those skilled in the art, and will not be described further; this is the same material used as the liner in all of the embodiments of the present invention. 
     Liner layer  110  also includes a perforated section  114  that can be used as an additional tab. When the wire protector  100  is too long, and the tail section  160  is trimmed, tab  182  is removed. By removing perforated section  114  from the liner along perforations  116 , perforated section  114  is attached to the distal end of the remaining tail section  160 , where it then functions as a replacement tab. Liner layer  110  includes a perforated region  118  that extends across the width of the liner layer  110  at a region below where the protector strip  160  connects to the first end  140 . 
     The tape layer  120  comprises a strip of a double sided foam tape, formed to the desired configuration. In certain embodiments, the tape layer  120  ranges in thickness from about 5 mil to about 50 mil; in other embodiments it ranges in thickness from about 10 mil to about 40 mil, and in other embodiments ranges in thickness from about 15 mil to about 30 mil. 
     The film layer  130  comprises a strip of a clear urethane film, formed to a configuration where it covers and overlaps the tape layer  120 . In certain embodiments, the film layer  130  ranges in thickness from about 1 mil to about 10 mil; in other embodiments it ranges in thickness from about 1 mil to about 5 mil, and in other embodiments it ranges in thickness from about 1 mil to about 3 mil. 
     Although not discussed in relation to the first embodiment  10  ( FIGS. 1-2 ), first embodiment  10 , and the other embodiments shown herein, are manufactured from the same layers and materials as described for the second embodiment, although the configuration and thickness of these layers may differ from that of the second embodiment  100  ( FIGS. 4-5 ). 
     Wire protector  100  comprises a first end  140  connected to protector strip or tail section  160 , which terminates in a tab  182 . This tab  182 , at the end of tail section  160 , is removable. The terms tail section and protector strip will be used interchangeably to describe this part of the wire protector device, in all of the embodiments. Both the first end  140  and the protector strip  160  each have a top surface  142  and  162 , respectively, that will be exposed to the environment during use, and a bottom surface,  144  and  164 , respectively, that will be in contact with the skin of the patient.  FIG. 4  is shown with the top surfaces  142  and  162  facing the reader. 
     First end  140  has a D-shaped configuration, and comprises a wire site  146  which is bordered by site wall  148 . A channel  150  within site wall  148  provides a means for secretions, such as blood, bodily fluids or the like, that have exited the wire localization site  52  on the patient, to escape, and be retained within reservoir  152 , which is bounded by reservoir wall  154 . The wire site  146  is of sufficient size to enable optional gauze sponge  62  (see  FIG. 10C ) to be positioned atop the wire localization site  52 , if desired. A tab  180  is attached along the first end  140  and aids in handling of the wire protector during use. 
     The reservoir  152  is bordered on several sides by reservoir wall  154 , which along with site wall  148 , joins connector walls  156  to form the first end  140 . 
     A third embodiment  200  is shown in  FIGS. 6 and 7 . Wire protector  200  is manufactured from several layers, and has essentially the same structure and configuration as the second embodiment ( FIGS. 4-5 ), except that the wire site region is larger than in the second embodiment; no channel for secretions is present. 
     The liner layer includes a perforated section  214  that can be used as an additional tab. When the wire protector  200  is too long, and the tail section  260  is trimmed, tab  282  is removed. By removing perforated section  214  from the liner along perforations  216 , perforated section  214  can be attached to the distal end of the remaining tail section  260 , where it becomes a replacement tab. 
     Wire protector  200  comprises a first end  240  connected to protector strip or tail section  260 , which terminates in a tab  282 . The terms tail section and protector strip will be used interchangeably to describe this part of the wire protector device, in all of the embodiments. Both the first end  240  and the protector strip  260  each have a top surface  242  and  262 , respectively, that will be exposed to the environment during use, and a bottom surface,  244  and  264 , respectively, that will be in contact with the skin of the patient.  FIG. 6  shows the top surfaces  242  and  262  facing the reader. 
     First end  240  has a D-shaped configuration, and comprises a wire site  246  which is bordered by site wall  248 . The wire site  246  is of sufficient size to enable a gauze sponge  62  (optional, see  FIG. 10C ) to be positioned atop the wire localization site  52 , if desired. A tab  280  is attached along the first end  240  and aids in handling of the wire protector during use. 
     The wire site  246  is bordered on several sides by site wall  248 , which joins connector walls  250  to form the first end  240 . 
     A fourth embodiment  300  ( FIGS. 7-9 ) is manufactured from several layers, a liner layer  310 , a tape layer  320  and a film layer  330 , which are attached to the tape layer  320 . The tape layer comprises a strip of double-sided foam tape  320 , cut out as shown in  FIGS. 7-8 . The film layer  330  comprises a layer of clear urethane film, providing a transparent surface so that the location of the wire  50  underneath the wire protector  300  can be seen. 
     The liner layer  310  is a standard silicone coated paper that will be removed from the wire protector device  300  during use. The material used for the liner layer  310  is known to those skilled in the art, and will not be described further; this is the same material used as the liner in all of the embodiments of the present invention. Liner layer  310  includes a perforated region, shown at  312  which extends across the width of the liner layer  310  at a region below where the protector strip  360  connects to the first end  340 . 
     Liner layer  310  also includes a section  314  that can be used as an additional tab. When the wire protector  300  is too long, and the tail section  360  is trimmed, tab  382  is removed. By removing section  314  from the liner along cut region  316 , section  314  can be attached to the distal end of the remaining tail section  360 , where it becomes a replacement tab. Liner layer also includes an attachment region  318  where an adhesive foam strip  319 , which is used to tack down the end of the wire  50 , is attached. 
     The tape layer  320  comprises a strip of a double sided foam tape, formed to the desired configuration. In certain embodiments, the tape layer  320  ranges in thickness from about 5 mil to about 50 mil; in other embodiments it ranges in thickness from about 10 mil to about 40 mil, and in other embodiments ranges in thickness from about 15 mil to about 30 mil. 
     The film layer  330  comprises a strip of a clear urethane film, formed to a configuration where it covers and overlaps the tape layer  320 . In certain embodiments, the film layer  330  ranges in thickness from about 1 mil to about 10 mil; in other embodiments it ranges in thickness from about 1 mil to about 5 mil, and in other embodiments it ranges in thickness from about 1 mil to about 3 mil. An example of a film used for this layer is COTRAN® 9702 (Registered trademark of 3M Company, St. Paul, Minn. for what the manufacturer describes as a controlled caliper ethylene vinyl acetate membrane for use in the fabrication of transdermal, topical and transmucosal drug-delivery systems. This material is also described as being heat sealable and able to be laminated directly to adhesives). Other materials having comparable properties could also be used. 
     Wire protector  300  comprises a first end  340  connected to protector strip or tail section  360 , which terminates in a tab  382 . The terms tail section and protector strip will be used interchangeably to describe this part of the wire protector device, in all of the embodiments. Both the first end  340  and the protector strip  360  each have a top surface  342  and  362 , respectively, that will be exposed to the environment during use, and a bottom surface,  344  and  364 , respectively, that will be in contact with the skin of the patient.  FIG. 7  is shown with the top surfaces  342  and  362  facing the reader. 
     First end  340  has what can best be described as an internal clover-leaf configuration, and comprises a wire site  346  which is bordered by site wall  348 . The wire site  346  is made to a size such that a piece of gauze sponge  62  ( FIG. 10C ) can be positioned atop the wire localization site, if desired, without interfering with adhesion of the device to the patient. A tab  382  is attached along the first end  340  and aids in handling of the wire protector during use. 
     Site wall  348  is configured such that it has a plurality of extensions or prongs  350  that extend from the site wall  348  towards the wire site  346 . The prongs  350  serve to retain a gauze sponge; prongs  350  can be moved away from the film layer  330  and a gauze sponge  62  positioned therebetween. The device can be used without a gauze sponge and form the walls of reservoirs  352  that will allow for the accumulation of secretions from the wire insertion site  52  to accumulate away from the wire  60 . The prongs  350  can be moved away from contact with the film layer  330  and then be used to hold a gauze sponge  62  in place. Site wall  348  becomes connected to strip protector wall  362  by means of connector wall  356 . 
     Embodiments of the present invention may be packaged as individual units, or as part of a kit. Such a kit could comprise one or more wire protector devices, and one or more gauze sponges, or comparable materials. Kits could be supplied either in sterile or non-sterile packaging. 
     In one embodiment, an individual wire protector device  300  is packaged in a peel-type package  400 , between a sheet of TYVEK® (Registered trademark of E.I. DuPont de Nemours &amp; Co., Wilmington, Del.)  410  as a package bottom, and a sheet of clear polyester  420  ( FIG. 9 ) with a layer of adhesive therebetween. The TYVEK® layer  410  will generally include indicia  412 , such as product identification information and directions for use, either on the inside ( FIG. 9 ) or the outside of the package. The package can be provided either as a non-sterile or sterile package. 
     Reference numeral  422  refers to a region of the packaging that is used for sealing it; this region generally will be a layer of adhesive material, but could include other means for sealing peel-apart packages, such as, for example, heat-sealing, or other methods known to those skilled in the art. As seen in  FIG. 9 , sealing region  422  surrounds the wire protector device  300  within the package  400 . The TYVEK® sheet and polyester employed for the packaging are materials commonly known to those skilled in the art, and will not be described further. Units supplied in non-sterile packages can be sterilized using methods known to those skilled in the art. 
     Instructions for use of embodiments of the present invention are schematically illustrated in  FIG. 10 . Initially, after the localization wire has been inserted within the patient, the free end of the wire  60  is tacked down, using tab  319 . The remainder of the package is then partially opened, by removing the paper backing away from the square first end  340  to the perforated line  312  on the liner. 
     In this embodiment, which includes a sterile gauze pad, the gauze pad  62  is applied to cover the wire insertion site on the patient. The gauze pad can be applied either directly to the wire insertion site, or held in place by means of extension tabs or prongs  350  at the wire protector&#39;s first end. The square patch section is then placed over the wire insertion site on the patient, and pressure is applied on the section to adhere it to the skin. 
     The remaining paper backing is removed from the wire protector device, and the see-through wire protector strip is positioned to cover and protect the wire, applying the adhesive edges to the skin, so that the wire protector strip stays in place. 
     If the user finds that the wire protector strip portion of the device is too long, the strip can be cut to the desired size using a scissor. The additional tab  314  that is part of the backing is then removed from the paper liner, and the tab  314  is applied to the end to facilitate removal of the wire protector device. 
     When it is time to remove the wire protector strip, the adhesive-free tab at either end can be used to assist with removal of the device. 
     Using any of the various embodiments described herein, medical personnel can see the wire&#39;s location through the wire protector strip. Visibility of the wire aids a surgeon or other medical personnel in removing the wire protector without dislodging the wire from its location. 
     The length of the wire protector embodiments is long enough to cover the longest needle localization wire currently in use (currently, approximately 20 cm). To accommodate shorter wires, the wire protector may be cut with a scissors, and the semi-circular tab placed at the remaining end; this tab is removable when used with a shorter wire. Should longer length or wider width localization wires be used in the future, such longer length and/or wider width wires are expressly considered to be within the scope of this invention, and the size of the wire protector embodiments described herein scaled up accordingly. 
     While embodiments of the present invention have been described with use on human beings, it is to be understood that embodiments of the present invention could also be used to cover wires that are placed in other organisms, such as, but not limited to mammals such as farm animals (such as cows, horses, sheep), zoo animals (for example, lions, monkeys, zebras), domestic pets such as dogs and cats, and a range of other animals, literally from A through Z. Additionally, embodiments of the present invention could be used to cover other medical devices, such as catheters, cannulas, mediports, or the like, or other implanted devices that include an external lead or connection of some type, that may be utilized during various procedures, or to prevent an implanted device from being pulled out by an individual. These can include catheters for the intravenous infusion of medications and the like, for removal of blood or other bodily fluids, which can include procedures such as, but not limited to, cranial, digestive, intestinal, phlebotomy, urinary, veterinary and the like. For certain devices which may require a connection to an external source, such as to bag containing an intravenous solution, the wire protector strip can be cut with a scissors, and used to cover the device, omitting the addition of the spare tab to close off the distal end of the protector strip. 
     Other uses of embodiments of the present invention include providing waterproof coverage and added security to a site when a patient is not present at a medical facility, such as when radiation ports are implanted. Another use of embodiments of the present invention is to provide a waterproof covering at an incision site for other types of medical implants, such as wires, intravenous catheters and the like, as described previously. Regarding such other uses, these embodiments may comprise additional adhesive strips strategically placed to enhance further such waterproof coverage and/or added security; determining such strategic placement is well known in the prior art. 
     Although this invention has been described with a certain degree of particularity, it is to be understood that the present disclosure has been made only by way of illustration, and that numerous changes in the details of the composition, construction, and use may be resorted to without departing from the spirit and scope of the invention.