Patent Publication Number: US-2020281776-A1

Title: Wound Drain

Description:
This application claims the benefit of U.S. Provisional Application No. 61/880,049 filed Sep. 19, 2013, the disclosure of which is hereby incorporated by reference. 
    
    
     This invention relates a surgical “wound” drain for wound therapy and in particular a drain having an integrated body for stabilizing the drain line within the wound cavity. 
     BACKGROUND AND SUMMARY OF THE INVENTION 
     Surgical wound drains, such as the “Jackson-Pratt” or “JP” drain, are commonly used as a post-operative drain for collecting bodily fluids from surgical sites. Wound drains generally consist of a drain line, which is a perforated sterile tube that is placed directly within the wound cavity. The drain line is often connected to a fluid collection apparatus and/or vacuum source, such as wall suction or a simple suction bulb via a fluid line, which is simply a length of flexible tubing. 
     The drain line is typically cut to length to rest within the wound with a fluid line extending out from the wound. An occlusive dressing is applied over the wound cavity and drain line to create a hermetic seal. Traditionally, occlusive dressings are difficult to work with and manipulate, but are critical for providing the hermetic seal around a wound for negative pressure wound therapy. Often patient movement can dislodge or displace the drain line under the occlusive dressing causing a vacuum leak. Creating a sufficient seal is also complicated by the contours, creases and folds in the patient&#39;s skin around the wound. Heretofore, gaskets and sealants have been used around drain lines and occlusive dressings to maintain the hermetic seals around wound cavities. 
     The present invention seeks to provide a surgical wound drain apparatus that simplifies and improves patient care by freeing the care giver from having to hold a drain line in place within a wound as an occlusive dressing is applied over the wound. The wound drains of this invention in various embodiments are intended for use in combination with a conventional occlusive dressing and certain embodiments can be used simultaneously with both negative and positive pressure wound therapy protocols. In each embodiment, the wound drain has an integral pliable base member with an adhesive backing that affixes the drain to the patient&#39;s skin and holds it in place so that the drain line can be fitted into the wound cavity. The base member is shaped and configured to affix to the skin adjacent the wound cavity and has a domed top, tapered sides or “wings” and a substantially flat bottom surface. The pliable base member stretches and contorts so that it lies flat against the patient&#39;s skin and conforms around and into body creases and folds. The bottom of the base member is coated with an adhesive, which is covered by a removable non-stick backing. When the backing is removed, the base member can be affixed directly to the skin adjacent a wound for conveniently positioning and securing the drain line within the wound, while an occlusive dressing is applied over the wound and drain. 
     The wound drains of this invention simplify and improve patient care by freeing the care giver from having to hold a drain line in place within a wound as an occlusive dressing is applied over the wound. The adhesive coating on the base member allows the drain apparatus to be affixed directly to the patient&#39;s skin adjacent the wound cavity to position and hold the drain line in place within the wound cavity as the occlusive dressing and drain cover are applied. With the drain line held in place within the wound cavity, the care provider does not have to manually hold the drain in place and is free to use both hands to apply the occlusive dressings and drain cover. The shape and contour of the base member provide a large smooth surface area that the occlusive dressings adhere to for creating a hermetic seal around the drain part, as well as the wound cavity. The pliable body of the base member allows it to conform to the contours and creases of the skin around a wound cavity, while still maintaining a hermetic seal with the skin and prevents the drain line from moving or unseating as the patient moves, which may create a leak in the hermetic seal. The use of adhesives on the bottom surface of the base member eliminates the need for gaskets and sealants to be applied around fluid and drain lines in order to maintain a hermetic seal around the drain and the wound cavity. 
     The above described features and advantages, as well as others, will become more readily apparent to those of ordinary skill in the art by reference to the following detailed description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention may take form in various system and method components and arrangement of system and method components. The drawings are only for purposes of illustrating exemplary embodiments and are not to be construed as limiting the invention. The drawings illustrate the present invention, in which: 
         FIG. 1  is a top view of an embodiment of the wound drain with its adhesive cover; 
         FIG. 2  is a perspective view of the wound drain of  FIG. 1   
         FIG. 3  is a perspective view of the adhesive covering of  FIG. 1 ; 
         FIG. 4  is a partial perspective view of the end of the dual lumen connection line, which forms part of the sound drain of  FIG. 1 ; 
         FIG. 5  is a partial perspective view of the end of the dual lumen drain line, which forms part of the wound drain of  FIG. 1 ; 
         FIG. 6  is a perspective view of the wound drain being positioned adjacent a wound cavity with the adhesive cover and the occlusive dressing positioned over a wound site; 
         FIG. 7  is a perspective view of the wound drain secured to the body adjacent a wound cavity with the drain line seated within the wound cavity and covered by the occlusive dressing; 
         FIG. 8  is a perspective view of the adhesive cover positioned over the wound drain and the occlusive dressing to hermetically seal the drain line within the wound cavity; 
         FIG. 9  is a top view of a second embodiment of the wound drain of this invention; 
         FIG. 10  is a partial perspective view of the end of an alternative single lumen connection line used in the wound drain of  FIG. 9 ; 
         FIG. 11  is a partial perspective view of the end of an alternative drain line used in the wound drain of  FIG. 9 ; 
         FIG. 12  is a perspective view of a second embodiment of the wound drain of this invention; 
         FIG. 13  is a top view of the wound drain of  FIG. 12 ; 
         FIG. 14  is a perspective view of the wound drain of  FIG. 11  being positioned over a wound cavity on patient&#39;s leg; 
         FIG. 15  is a perspective view of the wound drain of  FIG. 11  secured to the body adjacent a wound cavity with the drain line seated within the wound cavity; 
         FIG. 16  is a perspective view of the occlusive dressing positioned over the wound drain of  FIG. 11 ; and 
         FIG. 17  is a perspective view of the occlusive dressing covering the wound site and the wound drain of  FIG. 11 . 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific preferred embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is understood that other embodiments may be utilized and that logical, structural, mechanical, electrical, and chemical changes may be made without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the invention, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims. 
     Referring now to the drawings,  FIGS. 1-8  illustrate an embodiment of the wound drain of this invention, which is designated generally as reference numeral  100 . As shown in  FIGS. 6-8 , wound drain  100  is intended for use in combination with a conventional occlusive dressing  10 . Occlusive dressing  10  is an air- and water-tight trauma dressing commonly used in surgical and wound therapies. Occlusive dressing  10  generally consists of a thin polymer film  12 , an adhesive coating  13  and a removable non-stick backing  14  covering the adhesive sides of the film. As shown, wound drain  100  has a two piece design consisting of a pliable drain part  110  and a separate annular adhesive drain cover  150 , which covers the drain part and provides a secure hermetic seal around the drain part and the wound cavity in conjunction with occlusive dressing  10  ( FIG. 8 ). Occlusive dressing  10  is dimensioned and sized to cover the wound cavity and at least a portion of drain part  110 . Drain cover  150  is designed and intended to cover and seal around drain part  110 . Drain cover  150  is a conventional occlusive dressing having a polymer film  152  coated with an adhesive  154  and covered by a removable non-stick backing  156 . Drain cover  150  is cut into an annular shape with an offset opening  151 , which is shaped to receive the domed top  122  of base member  120 , which helps position and align the cover relative to drain part  110 . 
     Drain part  110  is molded or otherwise formed from a silicone rubber or similar material suitable for surgical and medical use. Drain part  110  has a base member  120  and integral connection line  130  and a perforated drain line  140 . The body of base member  120  has a domed top  122  with a substantially flat bottom surface  126  and flat tapered peripheral flanges or side “wings”  124 . Bottom surface  126  and side wings  124  are shaped and contoured to overlie and affix to the patient&#39;s skin adjacent the wound cavity  2 . As shown, side wings  124  of base member  120  taper laterally outward from domed top  122  to provide a large surface area for adhering the base member to the skin adjacent a wound cavity. Base member  120  and particularly side wings  124  are pliable so that the base member can be contorted to conform to the patient&#39;s body so that the base member lies flat against the patient&#39;s skin even over, around and into body creases and folds. The flat bottom surface  126  of base member  120  is coated with an adhesive coating  127 , which is covered by a removable non-stick backing  128 . When backing  128  is removed, base member  120  can be affixed to the skin around a wound cavity and held in place by the adhesive coating  127 . Adhesive coating  127  and removable backing  128  used on base member  120  are of the type readily known in the medical field and therefore not described in detail herein. It should be noted however, that the adhesive is selected to affix the base member to the body adjacent the wound cavity  2  without adversely affecting the skin around the wound cavity or the wound treatment therapy. 
     Connection line  130  and perforated drain line  140  are lengths of pliable silicone tubing. Connection line  130  extends integrally from a mid point in domed top  122  of base member  120 . Drain line  140  is designed to be embedded directly into a wound cavity. Drain line  140  integrally extends from the rear of base member  120  diverging downward out of domed top  122  with the bottom of drain line  140  being continuous with the bottom surface  126  of the base member. 
     Wound drain  100  is configured for use in combined negative and positive pressure wound therapy applications. As such, connection line  130  and drain line  140  are configured as dual lumen tubing (two separate flow channels) integrally connected to and in corresponding open fluid communication through the body of base member  120 . Connection line  130  is configured to connect to the pump and fluid collection apparatus (not shown) so that one lumen is in communication with the positive air/fluid pressure port of the pump/fluid collection apparatus and the other lumen is in communication with the negative air/fluid pressure port of the apparatus. In addition, the use of a dual lumen fluid line allows for fluid delivery to the wound cavity, as well as fluid drainage from the wound site. It should be noted that in a negative pressure only wound therapy application, both lumens of the connection line may be connected to the negative pressure port of the pump/fluid collection apparatus. In such case, the use of a dual lumen connection line helps reduce the opportunity for line clogs and fluid flow disruption. Drain line  140  has a plurality of spaced openings  143 ,  145  and  147 , which allow air/fluid communication into and out of drain part  110 . Each lumen of drain line  140  has its own row of spaced slots  147  formed in the bottom of drain line  140  and a row of spaced drain holes  143  and  145  formed in the top and sides of drain line  140 , respectively. 
     In use, the wound site is cleaned and prepared before wound drain  100  and occlusive dressing  10  are applied. Once cleaned and prepared, drain part  110  and drain cover  150  are removed from their packaging (not shown) along with the desired occlusive dressing  10 . Next, base member  120  is affixed to the patient&#39;s skin adjacent wound cavity  4 . Adhesive backing  128  is manually peeled from base member  120  exposing adhesive coating  127 , which adheres the base member to the skin. Base member  120  lies flat against the patient&#39;s skin with wings  124  spread laterally following the curves and contours of the skin adjacent wound cavity  4 . Once base member  120  is affixed to the patient&#39;s skin, drain line  140  may be cut to length and inserted into wound cavity  4 . With base member  120  affixed to the patient&#39;s skin and drain line  140  seated within the wound cavity, occlusive dressing  10  is applied to cover the wound cavity and at least partially cover the base member. The adhesive back  16  is peeled off to expose the adhesive coating  14 , which adheres occlusive dressing  10  to the skin around wound cavity  4  and base member  120 . Occlusive dressing  10  is applied ideally to lay flat over the skin and provide a hermetic seal around wound cavity  4 . Lastly, drain cover  150  is applied over drain member  120 . As shown, fluid line  130  passes through opening  151  so that drain cover  150  overlies base member  120  with fluid line  130  exposed atop the drain cover. Again, adhesive backing  156  is peeled off to expose adhesive coating  154 , which adheres drain cover  150  to base member  120 , a portion of occlusive dressing  10  and the skin around the base member. It should be noted that occlusive dressing  10  is partially sandwiched between base member  120  and drain cover  150 . 
       FIGS. 9-11  illustrate a second embodiment of the wound drain of this invention, which is designated generally as reference numeral  200 . Wound drain  200  is identical in design and function as wound drain  100 , except that connection line  230  and drain line  240  are configured as single lumen tubing. As shown, connection line  230  is a conventional single lumen silicone tubing, but drain line  240  has a generally oval or rectangular cross section with smooth rounded edges defining a single internal drain channel  241 . An integral top support rib  242  extends downward longitudinally into drain channel  241  from the top of the drain line  240 . Two integral bottom support ribs  246  extend upward longitudinally into drain channel  241  from the bottom of drain line  240 . Top and bottom support ribs  242  and  246  provide structural integrity to drain line  240 , which prevents drain channel  241  from collapsing under any negative pressure used to draw fluids from the wound cavity. Again, drain line  240  has a plurality of openings  243 ,  245  and  247  through which fluid enters drain line  240 . 
       FIGS. 12-17  illustrate another third embodiment of the wound drain of this invention, which is designated generally as reference numeral  300 . Wound drain  300  is intended for use in combination with a conventional occlusive dressing  10 , but uses a single piece design consisting of a pliable silicone drain part without the additional adhesive covering of wound drain  100 . 
     As shown, wound drain  300  is configured as a single lumen drain, but may be configured as a dual lumen drain as desired. Wound drain  300  is molded or otherwise formed from a silicone rubber or similar material and has a flat base member  320  and integral connection line  330  and a perforated drain line  340 . As shown, connection line  330  and drain line  340  are formed as single lumen tubing similar in construction and function as connection line  230  and drain line  240  of  FIGS. 10 and 11 . The integral body of base member  320  is generally flat and like drain part  110 , is configured to have pliable peripheral flanges or wings that provide a large surface area that is affixed to the skin adjacent the wound cavity  2 . Base member  320  is pliable so that it can be contorted to conform to the patient&#39;s body so that the base member lies flat against the patient&#39;s skin even over, around and into body creases and folds. As with the above discussed embodiment, the flat bottom surface of base member  320  is coated with an adhesive coating  327 , which is covered by a removable non-stick backing  328 . When backing  328  is removed, base member  320  can be affixed to the skin around a wound cavity and held in place by the adhesive coating  327 . 
     Wound drain  300  is applied and used in substantially the same manner as wound drain  100 . Once the wound site is cleaned and prepared, wound drain  300  is affixed to the patient&#39;s skin adjacent wound cavity  4 . Adhesive backing  328  is manually peeled from base member  320  exposing adhesive coating  327 , which adheres the base member to the skin. Base member  320  lies flat against the patient&#39;s skin following the curves and contours of the skin adjacent wound cavity  4 . Once base member  320  is affixed to the patient&#39;s skin, drain line  340  may be cut to length and inserted into wound cavity  4 . With wound drain  300  in place, occlusive dressing  10  is applied to cover both wound cavity  4  and wound drain  300 , which provides a hermetic seal around wound cavity  4 . 
     One skilled in the art will note several advantages to the wound drain of this invention. The shaped and contour of the base member provide a large smooth surface area that the occlusive dressings adhere to for creating a hermetic seal around the drain part, as well as the wound cavity. The pliable body of the base member allows it to conform to the contours and creases of the skin around a wound cavity, while still maintaining a hermetic seal with the skin and prevents the drain line from moving or unseating as the patient moves, which may create a leak in the hermetic seal. The use of adhesives on the bottom surface of the base member eliminates the need for gaskets and sealants to be applied around fluid and drain lines in order to maintain a hermetic seal around the drain and the wound cavity. 
     The wound drain apparatus of this invention simplifies and improves patient care by freeing the care giver from having to hold a drain line in place within a wound as an occlusive dressing is applied over the wound. The adhesive coating on the base member allows the drain apparatus to be affixed directly to the patient&#39;s skin adjacent the wound cavity to position and hold the drain line in place within the wound cavity as the occlusive dressing and drain cover are applied. With the drain line held in place within the wound cavity, the care provider does not have to manually hold the drain in place and is free to use both hands to apply the occlusive dressings and drain cover. 
     It should be apparent from the foregoing that an invention having significant advantages has been provided. While the invention is shown in only a few of its forms, it is not just limited but is susceptible to various changes and modifications without departing from the spirit thereof. The embodiment of the present invention herein described and illustrated is not intended to be exhaustive or to limit the invention to the precise form disclosed. It is presented to explain the invention so that others skilled in the art might utilize its teachings. The embodiment of the present invention may be modified within the scope of the following claims.