Abstract:
The invention is a simple surgical drape system for female urology procedures that provides sealed isolation of top versus bottom sides of the drape and only exposes the female urethral meatus area for the procedure. It is achieved by a combination of a drape with a fenestration, a labia spreader where the drape fenestration is attached to provide a seal, and local illumination of the meatus area integrated in the drape system for safer and easier instrument insertion. The labia spreader also frees up one of the operator&#39;s hands and provides protection for false catherization. The labia spreader can have a vaginal inserted portion for precise position fixation of the drape fenestration to the female. The drape system also provides improved liquid management made possible by the unique combination of drape and labia spreader acting as seal between the two sides of the drape.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims benefit of U.S. Provisional Application 61/473,150, filed Apr. 8, 2011. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    This invention is in the technical field of medical equipment, in particular for surgical drape systems utilized in urology procedures on female patients. Such drapes have up to now typically been of unisex design, introducing mis-fit and non sterile conditions due to the special female anatomy. Such procedures are relatively common but still have demonstrated less than desired outcome in many cases. Problems may arise with infections and patient discomfort that require prolonged patient care and procedure rework in best cases, but can in worse cases introduce serious long term consequences both for patients and care givers. This occurs currently despite more stringent medical guidelines being in place. There is a very active demand today by the entire society to reduce health care cost, and medical procedure infections and other procedure complications is one important factor. 
         [0003]    A particular problem in urology procedures on female patients is the difficulty to properly insert catheters, endoscopes or other instruments in the urethral meatus. Typically, one hand of the operator must be dedicated to provide access by spreading the labia during most of the procedure. This impairs the operator to perform other important tasks with the patient or with instruments. It also increases infection risk by touching contaminated or loose particulate areas and spreading this to the urethral meatus or to instruments. 
         [0004]    As another problem, the female anatomy also makes the urethral meatus area difficult to clearly observe with normal overhead illumination, due to the meatus recessed location or shadows from operator hands, instruments or drapes. This is compounded by the operator having only one hand free, while the other must spread the labia. Therefore, quite often mis-insertion will occur, with the instrument entering or touching the labia or vaginal vault instead of entering the urethra. This causes a risk for the instrument being contaminated by vaginal bacteria flora. It will in best case result in the operator discarding the instrument and picking a new sterile unit for a re-try. But due to time press and need for medical cost containment, or just difficulty to clearly view the female urethral meatus area, the same contaminated instrument may enter the urethra in a re-try. This could cause urinary tract infections or other procedure complications. 
         [0005]    Additionally, as part of preparation for urology procedures like catheterization, the patient is prepared with antibacterial agents in the pubic area and nearby body parts. This process has the complication that this particular area is typically partially covered with body hair and has several skin folds, resulting in risk for incomplete bacteria elimination. Furthermore, loose hair and skin particles from this area may easily become dislodged during the urology procedure and can contaminate the operator&#39;s gloves, urology instruments, or the urethral meatus and nearby areas. This may call for using extra potent antibacterial agents. However, increasing the amount, or potency, of antibacterial agents can lead to the long term drawback of breeding more resistant bacteria strains. 
         [0006]    In a female urology procedure, the patient is typically cleaned and prepared, and then covered partially with one or more sterile surgical drapes. The drape may use separate sections or have one or more fenestrations included to provide access to the female organ. It is common that sizeable amounts of liquids emerge from the urethra or instruments during the procedure. This can cause patient wetness, discomfort, infectious matter spreading, or inconvenience for the operator. Drape fenestrations or operator shields have in prior art been attempted to control liquid flow. Such liquids may still flow down behind fenestration apertures and reach other parts of the patient body and the operating table, causing inconvenience, sterile area contamination and a generally less clean environment. Medical spent liquids disposal needs special procedures and equipment to avoid spills or undesired contact. 
         [0007]    The female genital anatomy makes it difficult to hold surgical drapes tightly in place in near contact with the body. Methods and devices are known for holding drapes tightly to the body in medical procedures for other body areas include straps, medical tape, temporary adhesives, and alike. However, these are difficult to implement effectively on the female genitals, due to the concave nature of the anatomy, the sensitive tissue, and presence of body hair. 
         [0008]    These drawbacks have been attempted to be solved to varying degree of success by prior art, but there is to our knowledge not any solutions disclosed that solves the combination of all these issues with one surgical drape system, yet minimum drawbacks for the urology procedure, and coupled with design and user simplicity, and procedure economy. 
       SUMMARY OF THE INVENTION 
       [0009]    The present invention is a drape system for reduced risk and simplified urological procedures for female patients. The drape system includes a subset, or all, of the following main components:
       1) A drape with a fenestration providing urethral meatus access,   2) A labia spreader that also holds the drape in place and sealed onto the patient,   3) Integrated local illumination to visualize the female urethral meatus   4) A liquid absorbing pad and a liquid control flap.       
 
         [0014]    The novel drape system provides the following benefits—simultaneously or separately:
       1) Isolation of urethral meatus access from other body parts, for reduced infection risk   2) An integrated labia spreading device, freeing up one hand for the operator   3) Easier and safer catheterization or other instrument entry due to integrated illumination   4) Drape can be attached to labia spreader for sealing and stability of drape   5) A vaginal insertable portion of the labia spreader for keeping drape and urethral access fenestration tightly in place at a controlled position   6) A barrier reducing the probability of mis-catherization into the vaginal tract   7) A quick-assembly method of the drape system by adhesive surface   8) Urology liquid discharges stay on the outside of the drape, making liquid management easier, less risk for contamination, and patient more comfortable   9) Urology liquid management for protection and ease of medical waste disposal   10) With catheters or similar urology instruments still in the patient, the entire drape system is still easily removed       
 
         [0025]    The drape system separates a non-sterile environment on the patient side of the drape and a sterile environment on the operator side of the drape, with a sealed fenestration between these areas. This prevents contamination from other body parts to reach the operator side, and reducing risk of urology fluids on the operator side to reach the patient side. The exposed patient area on the top sterile side is limited to only the urethral meatus with near surroundings, and provides a seal from the non sterile areas of the patient. This improves outcome of antibacterial preparation of the patient ahead of the urological procedure, and reduces infection risk by isolating the urology procedure location from the pubic area. 
         [0026]    Because this drape design creates a sealed area on the operator side of the patient except the meatus area, control and collection of urology liquids is simplified. For instance, a disposable and safe to handle absorbing or liquid gelling pad may be placed on portions of drape operator side and a drape flap may control flows. 
         [0027]    Removal of the drape after the urology procedure with instruments like catheters still in place can be achieved by a splittable line in the drape all the way in from an external drape edge and in to the fenestration. The other components in the drape system are designed in such a way that an inserted catheter cannot capture any device of the system. 
         [0028]    As a summary, this female patient urology drape system offers major advantages in safety, functionality, simplicity, predictable procedures and total cost versus prior art. 
         [0029]    Thus, in accordance with the present invention, there is provided a medical system for female urological procedures, the system including a labia spreading device allowing access to the urethral meatus, a flat, flexible, sterile drape for overlaying the spreading device and having an aperture to be located over the access opening of the spreading device, and preferably also one or more illumination means for illuminating the urethral meatus, the illumination means being carried by the spreading device or the drape when the system is in use. 
         [0030]    In one embodiment of the invention, the illumination means comprises a light emitting diode powered by a battery. 
         [0031]    In another embodiment of the invention, the illumination means is integrated into the spreading device or into the drape. 
         [0032]    In certain embodiments of the invention, the light source is carried on the exterior of the spreading device or the drape, while in other inventive embodiments, the light source is carried in the interior of the spreading device or the drape. 
         [0033]    In other embodiments of the invention, the spreading device and the drape are adhesively attached to each other during use. 
         [0034]    In other embodiments of the invention, new labia spreading devices are disclosed, some of which carry one or more light sources 
         [0035]    In still another embodiment of the invention, there is provided a medical method for providing a sterile environment during a female urological procedure, which method comprises the use of a medical system of the present invention, one aspect of which can include the external use of a liquid absorbing pad in combination with a liquid control foldable flap attached to the exterior of the drape. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0036]      FIG. 1  shows a representation of antibacterial cleaning in prior art. 
           [0037]      FIG. 2  shows a urological procedure in prior art 
           [0038]      FIG. 3  shows a simplified planar view of the drape of the invention 
           [0039]      FIG. 4  shows a planar view of the drape of including a different material insert 
           [0040]      FIG. 5  shows an enlarged planar view of the fenestration in the drape 
           [0041]      FIG. 6  shows a cross section of the fenestration 
           [0042]      FIG. 7  shows an example of the labia spreading device, viewed from the drape side 
           [0043]      FIG. 8  shows a vertical cross section of a labia spreading device 
           [0044]      FIG. 9  show a top view of a labia spreading device 
           [0045]      FIG. 10  shows a perspective view of a labia spreading device 
           [0046]      FIG. 11  shows an alternate design of the flange in the labia spreading device 
           [0047]      FIG. 12  shows a flexible labia spreading device deformed for insertion 
           [0048]      FIG. 13  shows an alternate labia spreading device with split flange 
           [0049]      FIG. 14  shows an alternate labia spreading device with U-form. 
           [0050]      FIG. 15   a  and  FIG. 15   b  show the U-form labia spreading device spring action 
           [0051]      FIGS. 16 ,  17  and  18  show different views of a labia spreader with direct illumination 
           [0052]      FIGS. 19 ,  20  and  21  show different views of a labia spreader with light guide illumination 
           [0053]      FIG. 22  shows a U-form labia spreader with illumination 
           [0054]      FIGS. 23   a  and  23   b  show a labia spreader with self adhesive for drape and peel-off cover 
           [0055]      FIG. 24  shows attachment of the drape to a labia spreader 
           [0056]      FIG. 25  shows attachment of the drape to a U-shape labia spreader 
           [0057]      FIG. 26  shows a cross section of the drape attached to a labia spreader 
           [0058]      FIG. 27  shows the operator&#39;s view of the drape system in place on a female patient 
           [0059]      FIG. 28  shows a vertical cross section of the drape system in place on a female patient. 
           [0060]      FIG. 29  shows a variation in embodiment with an illumination device attached to the drape. 
           [0061]      FIG. 30  shows a variation in embodiment with a plug-in illumination device. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0062]    The purpose of the invention is easiest clarified by first a brief comparison to prior art.  FIG. 1  (prior art) shows a female patient being prepared by antibacterial swab before a urological procedure, according to prior art. The whole exposed genital area must be treated. It is noted that exposed body hair and skin folds will create crevices that may harbor particles and bacteria that is difficult to fully reach with the swab. 
         [0063]      FIG. 2  (prior art) shows a female catherization or similar urology procedure performed according to prior art. It is noted that hair or particles in the genital area may become dislodged during the process and reach the urethral meatus, or the operator&#39;s sterile gloves, or insertable urology instruments. It is also noted that labia must be supported by two fingers of one hand during the process, or labia will obscure the meatus access. Furthermore, the need for one hand providing support during most of the process makes it inconvenient for the operator to do other duties during the procedure. It is also noted that due to the open path to the pubic area, liquids emerging from the patient or from treatment can flow down onto the patient and operating table. 
         [0064]    The system of the present invention comprises at least a labia spreader and a drape, and preferably also includes a light source (source of illumination or illumination means) carried by the spreading device or by the drape. 
         [0065]    By the term “system’ as used herein, is meant that the individual components of the system are brought together at least by the time of use of the components in a female urological procedure. Thus, when the system contains two components of a labia spreader and drape, these two components can be jointly packaged or separately packed in separate containers, prior to use. The two components can be adhesively combined prior to use or at the time of use. When the system includes three components (the third component is the light source), two of them or all of them can be packaged as a connected unit in which the three components are in someway attached to one another, or in a bi-connected unit in which two components are attached to one another, or the three units can be separately packaged. Often, the light source is attached to or forms part of the spreading device or of the drape. The three components, in certain inventive embodiments, are attached to each other at the time of use. 
         [0066]    The invention drape is shown in  FIG. 3  and includes a drape  1  with a fenestration  2  and a split line  8 . It may also include an orientation mark with printed instructions  5 . The drape  1  may be made of a transparent material, for instance clear plastics, or by a thin elastic film, for instance latex. The plastics used in making the drape are well known in the prior art and, for example, include vinyl (such as polyvinyl chloride), polyethylene, polypropylene, polycarbonate, polyester, silicone elastomer, acetate and so forth film materials. As an example, the drape may be 1 to 5 mil (0.025-0.125 mm) in thickness. The purpose of the fenestration split line is to enable drape removal with catheters in place. The shape of the drape can be planar and rectangular as shown, but may also be cut to any shape or formed to fit the female anatomy and include additional drape shape features known from prior art. 
         [0067]    In  FIG. 4  is shown a variation of the design where the drape  1  is attached to a surrounding larger drape sheet  3  that is made of a different material, for instance textile, non-wovens, or opaque plastics. 
         [0068]      FIG. 5  shows an example of fenestration details. The aperture  3  may be surrounded with a marking  4  on the drape  1  in order to enable operator to make a quick location of the fenestration, in particular useful on transparent drape materials to save time. The marking  4  may be printed or a separate part attached to the drape, where it may also act as a gasket material or adhesive for attachment to the labia spreader. 
         [0069]      FIG. 6  is a cross section through the aperture  3 . It may simply be a cut hole in the drape or it may have edge reinforcements if material is very thin. 
         [0070]      FIG. 7  shows a view from the drape side on one of many possible embodiments for the labia spreader  9 . In this design, the labia are spread by the flange  9  that includes a slot  11  and an aperture  12  in order to provide access to urethral meatus. The slot allows removal of the labia spreader with a catheter in place. In this example, the shape of the flange  9  is elliptical, however many other shapes like polygons or circular may be utilized without deviating from the spirit of the invention. 
         [0071]    In  FIG. 8  is shown a vertical cross section of the same embodiment of labia spreader  9 ,  FIG. 9  shows a view from the top side and  FIG. 10  shows a perspective view. The flange  10  is attached to the body or shaft  13 , or preferably both made as one molded part. The body or shaft  13  is inserted in the vagina and includes a closed end to prevent false catherization. It is remarked that the slot  11  in the flange  10  as shown may continue a portion into the body  13 . This is to permit access to the urethral meatus despite personal anatomy variations. The body  13  may furthermore include a locally widening section  14  forming an enlarged or bulbous head to better secure the labia spreader  9  in inserted position. In the shown embodiment this is molded in shape, but it may also be achieved by other means, for instance a balloon that can be inflated from outside of the patient. In one embodiment, shaft  13  has an annular cross-section and the urethral meatus opening is formed between an outer radius of the shaft and the periphery of flange  10 . 
         [0072]      FIG. 11  show a perspective view of a labia spreader  9  with a different cross section shape of flange  10  with the protruding central flange surface  15 . The purpose of this is to enable the flange  10  to be positioned and held between the spread labia, while the protruding surface  15  extends beyond the labia, to easier facilitate attachment to the drape to the labia spreader flange  10 . The illustration shows sharp corners just for ease of drawing, but for patient comfort, all corners on the labia spreader  9  may have generous radii. 
         [0073]    Now going to  FIG. 12 , this shows a variation in the embodiment where the labia spreader  9  is molded in a flexible material to permit easier insertion. In this example, the operator bends the flange  10  by finger force  16  to a smaller footprint and inserts between labia. Upon release, the flange  10  will expand to normal shape and grip the labia in spread position. Making the flange  10  of a flexible rubber-like material will promote single handed insertion. The entire labia spreader  9  may be molded in a flexible material. 
         [0074]      FIG. 13  shows an alternate design for the labia spreader  9  and utilizing flexible materials with spring property. By including two slots  11   a  and  11   b , the flange  10  gets divided into two parts  10   a  and  10   b . When operator applies finger force  16 , the flanges  10   a  and  10   b  can be held closer to ease insertion in the patient and then allowed to expand by spring force for secure grip. The spring force may originate in the flexible material of labia spreader  9 , or it may also include separate springs known from prior art. The labia spreader  9  may also be pre-packaged in a folded-out shape in order to increase the separation force between the flanges  10  a and  10   b.    
         [0075]      FIGS. 14 ,  15   a  and  15   b  show yet another variation on a labia spreader utilizing flexible materials. In  FIG. 14 , it is shown an U-shaped labia spreader  9  which preferably is made of a soft material. The material may have inherent spring properties, or be aided by a built in spring member  17  while the rest of the material may be soft. One of the sides  10  is generally flat and will serve as attachment flange to the drape, as will be shown in later illustrations. The opposing side may be flat or contoured for vaginal entry. In  FIGS. 15   a  and  15   b  is illustrated how the labia spreader is pinched together by finger force  16  before insertion and then expands in place, thus separating the labia. 
         [0076]    Now going to  FIGS. 16 ,  17  and  18 , theses show different views of optional illumination devices included in the labia spreader. The purpose of this illumination is to shine light onto the urethral meatus area, to make catheter insertion clearly visible for the operator and improve success at first try. Note that the typical general clinical room illumination from the ceiling is partially shadowed by the female anatomy and operator&#39;s hand to separate the labia. The illumination light intensity can easily be made ample with small power due to the closeness of illuminator to the meatus target. In this example, light is generated by LEDs (light emitting diodes)  20  that can be one or several, and they may be mounted directly into the labia spreader  9 . For instance, the flange  10  may hold the LEDs  20  as well as batteries  21 . The illumination does not need to be engaged very long time for catheter entry, so relatively small size batteries will suffice for a urology procedure. The LEDs  20 , the batteries  21  and associated wiring and other electrical components may be overmolded in to the labia spreader  9 , or fitted in cavities that are sealed after the illumination components are inserted. Yet another way of fabricating the labia spreader with included illumination is to make the labia spreader  9  as a two-part design wherein the illumination components are mounted in open cavities before joining the labia spreader parts to create a one-piece sealed unit. 
         [0077]    It is pointed out that while  FIGS. 16-18  shows light sources and batteries are internal to the material of labia spreader  9 , variations of embodiments of the invention include light sources or batteries mounted on exterior of labia spreader  9  or on holders that are part of labia spreader  9 , or utilize remote electric power source instead of integrated batteries. 
         [0078]      FIGS. 19 ,  20  and  21  show different views of another variation of an illumination system integrated in the labia spreader  9 . In this implementation, the material in the labia spreader  9  is translucent and has an additional purpose of guiding light from light sources to direct it onto the urethral meatus. For this embodiment, one or more LEDs  20  direct light into the translucent material of labia spreader  9 , and light rays  22  emerge from inwards facing areas of the labia spreader  9  in the direction to the urethral meatus. Batteries  21  may be integrated also in this embodiment of the labia spreader  9 . 
         [0079]    Now going to  FIG. 22 , this shows a U-shaped labia spreader  9  that was described previously in  FIGS. 14-15 , but here equipped with one or more light sources  20  that illuminate the urethral meatus. Batteries  21  may be easily integrated in also this embodiment of the labia spreader  9 . 
         [0080]    In  FIG. 23   a  is shown a self adhesive coating  30  on the flange  10  of the labia spreader  9 . The purpose of this adhesive is to attach the drape to the flange to create a sealed barrier isolating the urethral meatus from other patient areas. In  FIG. 23   b  is shown a removable cover  31  that is used to protect the adhesive on the labia spreader  9  up to the time when the drape will be attached. It is obvious that the location of the adhesive coating may alternatively be on the drape portion of this drape system instead of the flange  10 . It is also within the spirit of this invention to use other means of attachment of the drape, for instance magnetic materials or permanent attachment from the factory. However, the drape system application on a patient may be easier by first inserting only the labia spreader and then attaching the drape. 
         [0081]      FIG. 24  shows how the drape  1  is attached to the labia spreader  9 . The alignment marking  4  and the aperture marking  4  are used to properly mount the drape  1  to the labia spreader  9 . This procedure is preferably done after the labia spreader  9  is inserted into the patient, but a pre-assembled drape system is also possible. 
         [0082]      FIG. 25  shows how the previously mentioned U-shaped version of the labia spreader can be mounted via the self adhesive layer  30  applied on its flat side. The opening in the U-shape will be facing the urethral meatus side of the patient. 
         [0083]      FIG. 26  shows how the drape  1  attaches and seals to flange  10  of labia spreader  9 . This procedure is preferably done after the labia spreader is inserted into the patient. 
         [0084]      FIGS. 27 and 28  show different views of the complete drape system utilized on a schematically drawn female patient that is now ready for a urology procedure. 
         [0085]    In  FIG. 27  is illustrated the operator&#39;s typical view of a female patient with the invention drape system in place. It is remarked that only a very small area of the patient is exposed in the aperture  3  of drape  1  for the procedure compared to prior art, since only the urethral meatus area with nearby tissue areas, while this exposed area is completely surrounded by the sterile side of the drape  1 . The drape  1  is attached and sealed to flange  10  of labia spreader  9 . If this figure is compared with  FIGS. 1 and 2  for prior art, the difference is clearly observed. This greatly reduces the risk for procedure complication by contamination from other patient areas. Furthermore, the drape  1  stays in place close to the patient by the attachment and sealing of drape  1  to labia spreader  9 . This assures that the drape is not in the way for the operator and the aperture  3  is always exposing the urethral meatus. 
         [0086]    Additionally in  FIG. 27 , is schematically illustrated the optional illumination feature of this drape system. Light rays  22  are emitted from light sources in the labia spreader  9  towards the urethral meatus on the patient, thus making this area clearly visible for the operator for safe insertion of urological instruments like catheters or endoscopes. 
         [0087]    Now referring to  FIG. 28 , this shows a schematic vertical cross section of the drape system applied on a female patient. Drape  1  may continuously cover the entire genital area, as well as upper part of the patient&#39;s legs and lower part of her torso. The aperture  3  provides access to the urethral meatus through the openings of labial spreader  9 . The illumination devices in labial spreader  9  emit light rays  22  towards the meatus area. It is noted that in typical female patient positions for urology procedures, normal medical room illumination from the ceiling will not easily reach the meatus area. 
         [0088]    In  FIG. 28  is also visualized an improved urology procedure liquid spill management system that may be incorporated because of the unique features in this drape system. As an effect of the sealed attachment of the drape  1  to the labia spreader  9 , liquids emerging from meatus of the female patient or from urology instruments or irrigation, will stay on the operator side of the drape. Such liquids may be collected by one or more absorber pads  30 , preferably using superabsorbent materials and gelling agents that make the absorber pad  30  non dripping semi solid disposable and eliminates medical waste liquid collection and handling. Optionally, a foldable flap  31  of preferably thin clear material, may be attached to a top area of the drape  1 , close to the torso of the patient, for permitting easy urethral meatus access when folded up, and when folded down it will reduce risk for liquid splashing on the operator or on equipment. 
         [0089]    In  FIG. 29  is shown another embodiment with an illumination module  40  attached to the outside of drape  1  to deliver light to the patient through the aperture  3 . The illumination module  40  contains one or more light sources  20 , for instance LED&#39;s, and a battery  21 . The light source  20  is oriented to illuminate the patient&#39;s urethral meatus by the emitted light  22 . This embodiment can permit illumination of the meatus with or without the use of the labia spreader  9 . However, if the labia spreader  9  is not present, the procedure requires manual labia separation for access, and this would also degrade the antimicrobial and liquid handling integrity. Module  40  is adhesively attached to drape  1  or is attached thereto just prior to use of the inventive system. 
         [0090]    In  FIG. 30  is shown yet another embodiment with a plug-in illumination module  41  that is insertable into the labia spreader  9 . The plug-in illumination module  41  contains one or more light sources  20 , for instance LED&#39;s, and a battery  21 . The light source  20  is oriented to illuminate the patient&#39;s urethral meatus by the emitted light  22 . This embodiment permits a choice of different type of illumination devices for a procedure but it adds one more module to be handled at the surgical procedure, and may slightly obscure urethral meatus access. Module  41  can be adhesively attached to spreading device  9  prior to use or at the time of use after the spreading device has been inserted into the vagina. 
         [0091]    In conclusion, this novel surgical drape system for female patients provides significant advances in the art for safer and more predictable urology procedures It contains a number of features that may be used in a combination for maximum benefit in most cases, but features may also be used individually to provide specific improvements, as required from a case by case basis. 
         [0092]    While the foregoing written description of the invention enables one of ordinary skill to make and use what is considered presently to be the best mode thereof, those of ordinary skill will understand and appreciate the existence of variations, combinations, and equivalents of the specific embodiment, method, and examples herein. The invention should therefore not be limited by the above described embodiment, method, and examples, but by all embodiments and methods within the scope and spirit of the invention as claimed.