Abstract:
A fluid containment pouch is provided that includes a first layer of material having a first thermal characteristic and a second layer of material having a second thermal characteristic. The first layer of material is thermally compatible with a patient covering upon which it is to be thermally bonded. Thermal bonds between the fluid containment pouch and the patient covering form fluid containment channels that retain expelled body fluids during a patient&#39;s operation to help maintain a sterile operating environment.

Description:
BACKGROUND 
     Operating rooms are maintained as a sterile environment to prevent contamination and the spreading of infections. One method of preventing the spread of contaminates is by covering patients during surgical procedures with patient drapes and patient incises and the like. Moreover, in maintaining a sterile environment, it is important to contain body fluids expelled from a patient during surgery. 
     For the reasons stated above and for other reasons stated below which will become apparent to those skilled in the art upon reading and understanding the present specification, there is a need in the art for an effective and efficient method of containing a patient&#39;s body fluids during an operation. 
     SUMMARY OF INVENTION 
     The above-mentioned problems of current systems are addressed by embodiments of the present invention and will be understood by reading and studying the following specification. The following summary is made by way of example and not by way of limitation. It is merely provided to aid the reader in understanding some of the aspects of the invention. 
     In one embodiment, a fluid containment pouch is provided. The fluid containment pouch includes first layer of material having a first thermal characteristic and a second layer of material having a second thermal characteristic. The first layer of material is thermally compatible with a patient covering. Thermal bonds between the fluid containment pouch and the patient covering form fluid containment channels that retain expelled body fluids during a patient&#39;s operation to help maintain a sterile operating environment. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention can be more easily understood and further advantages and uses thereof will be more readily apparent, when considered in view of the detailed description and the following figures in which: 
         FIG. 1  is a top view of a fluid containment assembly of one embodiment of the present invention; 
         FIG. 2  is a cross-sectional side view of the fluid containment assembly across line AA of  FIG. 1 ; 
         FIG. 3  is a top view of a fluid containment pouch of an embodiment of the present invention; 
         FIG. 4A  is a side view of a portion of a fluid containment pouch coupled to a patient cover; and 
         FIG. 4B  is a side view of a portion of a fluid containment pouch of another embodiment coupled to a patient cover. 
     
    
    
     In accordance with common practice, the various described features are not drawn to scale but are drawn to emphasize specific features relevant to the present invention. Reference characters denote like elements throughout Figures and text. 
     DETAILED DESCRIPTION 
     In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the inventions may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that changes may be made without departing from the spirit and scope of the present invention. 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 claims and equivalents thereof. 
     Embodiments of the present invention provide a fluid containment system designed to contain bodily fluids of a patient during an operation. In embodiments, a heat seal is used between a fluid containment pouch and a patient cover (substrate) to create a seal without seal channeling defects that can result in bodily fluids contaminating a sterile operative site. Examples, of fluid containment pouches include, but are not limited to, neuro pouches, C-section pouches, ophthalmic pouches, shoulder pouches, knee arthroscopy pouches and the like. Examples of patient covers, include but are not limited to, patient drapes, incises and the like. Referring to  FIG. 1 , a top view of a fluid containment assembly  150  of one embodiment is illustrated. The fluid containment assembly  150  includes a patient drape  102 , a fluid pouch  100  and an incise  106  in this example embodiment. Attached to the patient drape  102  in this example are holding patches  117  and  119  used to hold and organize cords used during an operation. Also referring to the cross-sectional side view along line AA of  FIG. 2 , the fluid containment assembly  150  is further described. The incise  106  includes an adhesive layer  107  that is selectively applied to a patient prior to the start of an operation. The use of an incise  106  which typically is a clear polyurethane or polyethylene is common in C-section procedures. The incise  106  in this example embodiment has a central incise opening  104  where an incision can be made into a patient during a surgical procedure. 
     The fluid pouch  100  embodiment of  FIGS. 1 and 2  has two layers  100   a  and  100   b . The two layers  100   a  and  100   b  are made from different materials that have different melting characteristics. Examples of materials that make up the two layers  100   a  and  100   b  include, but are not limited to, polyurethane, polyethylene, polypropylene and polyester. For example, the first layer  100   a  could be made of polyurethane and the second layer  100   b  could be made of polyethylene. Another example is where the first layer  100   a  is made of polyethylene and the second layer  100   b  is made from polyurethane. It is preferred that the materials that make up the first and second layers  100   a  and  100   b  are transparent to allow for viewing fluid contained in fluid containment channels  109  formed by the pouch  100 . In one embodiment, an example thickness range of the first and second layers  100   a  and  100   b  is approximately between 0.0006 and 0.0024 inches. Other thicknesses for the first and second layers  100   a  and  100   b  are contemplated in other embodiments. In one embodiment, the first and second layers  100   a  and  100   b  are formed with blow techniques known in the art of forming layered poly blend materials. 
     In one embodiment, the pouch  100  is formed by folding a first section of pouch material  125   a  over on a second section of pouch material  125   b  and then heat sealing  121  all non-connected edges. Since compatible material  100   b  (same melting point) are positioned next to each other on the edge seals  121 , the edge seals  121  are formed free from seal channeling defects. The pouch  100  further has centrally aligned pouch openings  105  and  103  that are further aligned with incise opening  104 . The pouch  100  is coupled to the incise  106  via heat seal  108 . The heat seal  108  is accomplished by heating thermally compatible material layer  100   a  of the pouch with thermally compatible material of the incise  106  such as, but not limited to poly blend materials such as, polyethylene, polyurethane, polypropylene and the like. In this embodiment, the pouch  100  is further thermally coupled (heat sealed) to the patient drape  102  via thermal seals  114 . Here again, thermally compatible material in layer  100   a  is heat sealed with thermally compatible material in the patient drape  102 . For example, in one embodiment, layer  100   a  includes polypropylene and the drape  102  includes polypropylene. This seal  114  like the prior seals  121  and  108  discussed above, provide seals without seal channeling defects. 
     The pouch  100  of the fluid containment assembly  150  forms fluid containment channels  109  as briefly discussed above and as is shown in  FIG. 2 . Also included in the fluid containment assembly  150  are elongated manipulation members  112  that are coupled to the containment pouch  100  proximate opening  105 . The elongated manipulation members  112  are generally bendable and in one embodiment contain at least one wire. The elongated manipulation members  112  help to position the sections  125   a  and  125   b  of the containment pouch  100  away from each other to allow fluid to pass into the formed fluid containment channels  109 . Other methods of allowing fluid to pass into the containment channels  109  besides elongated manipulation members  112  are contemplated, such as but not limited to, the use of foam between the first section  125   a  and the second section  125   b , other types of stiffeners and inflatable channels and the like.  FIG. 1  further illustrates a port  116  that provides a passage into the fluid containment channels  109  to allow any fluid in the fluid containment channels  109  to be selectively drained via tube or the like into a container (not shown). During an operation, bodily fluids escaping from an incision will flow into the fluid containment channels  109  in the containment pouch  100 . The fluid in the containment channels  109  can then be removed via port  116 . 
       FIG. 3  illustrates a top view of the fluid containment pouch  100 . As discussed above, in one embodiment, a section of material  125   a  is folded over on another section of material  125   b  in making the pouch  100 . The folded edge  120   a  is illustrated in  FIG. 3 . The other edges  120   b ,  120   c  and  120   d  are heat sealed as discussed above. Also illustrated are aligned central pouch openings  103  and  105  and the respective inner edges  111  of the first section  125   a  of the material and inner edges  110  of the second section  125   b  of material that define the central openings  103  and  105 .  FIG. 4A  illustrates a thermal bond  132  (heat seal) between two materials such as the two layers  100   a  and  100   b  of pouch  100  discussed above and a cover (substrate)  130  such as, but not limited to, an incise or patient drape. As discussed above, layer  100   a  will be thermally compatible with the substrate  130  to prevent seal channeling defects. In one example embodiment, the patient covering  130  is a polyester non-woven patient drape and the first layer  100   a  of the pouch  100  is a polyester layer. The second layer  100   b  may be in this example embodiment, a polyethylene layer. However, any type of thermally compatible layers as discussed above can be used. In  FIG. 4B  another embodiment is illustrated, in this embodiment although a first layer  140  (such as a layer of pouch material) is not thermally compatible with a second layer  144  (such as a patient covering) that it is to be coupled to, a layer of adhesive  142  is used so that when a thermal bond  146  is created, a seal is formed without seal channeling defects. Hence, in this embodiment an adhesive, such as but not limited to, transfer adhesive or double sided tape can be used when the materials to be bonded are generally not thermally compatible. Heat seals made by this method prevent seal channeling defects from forming later due to relief of interfacial stress even in generally non-thermally compatible bonded materials. 
     Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement, which is calculated to achieve the same purpose, may be substituted for the specific embodiment shown. This application is intended to cover any adaptations or variations of the present invention. Therefore, it is manifestly intended that this invention be limited only by the claims and the equivalents thereof.