Abstract:
The present invention is a fenestration drape and a method for providing skin-to-skin contact of a newborn with the mother immediately after birth during a Cesarean delivery. The novel fenestration drape comprises a portal which may be opened and reclosed without compromise to the sterile barrier. The novel method facilitates the critical contact without interruption and with continuity of sterile field throughout the procedure.

Description:
[0001]    This is a U.S. Non-Provisional patent application. 
       FIELD OF THE INVENTION 
       [0002]    This invention relates to surgical fenestration drapes, and more particularly to surgical drapes used in Cesarean-Section procedures. 
       BACKGROUND OF THE INVENTION 
       [0003]    Transition from the intra-uterine environment to extra-uterine life is a dynamic, yet stressful, event for the fetus. Similarly, the critical physiological, neuro-behavioral and regulatory changes which must occur immediately after birth also result in significant neonatal stress. The multiple changes during this sensitive period necessitate significant neonatal adaptations during a very short time-period. Evidence documented in recent scientific reports and research studies, however, suggests that the neonate, or newborn, needs “only the mother” to make an optimal transition during this highly stressful and sensitive period. In fact, skin-to-skin-contact (SSC) between the mother and infant during the immediate post-delivery period mitigates stress associated with the birthing process, facilitates neonatal autonomic, regulatory, motor, and interactive adaptation, and eases overall fetal transition to extra-uterine life. Moreover, evidence suggests that both short-term and long-term benefits result from adoption of this “natural” practice. 
         [0004]    Multiple benefits of adopting SSC during the immediate post-delivery period have been documented in the literature:
       1. SSC mediates the neonatal stress response and promotes physiological regulation and stabilization:
           a. Facilitates neonatal thermo-regulation;   b. Facilitates neonatal cardio-pulmonary stability;   c. Increases neonatal sleep organization;   d. Promotes earlier glucose regulation;   e. Facilitates greater relaxation and reduces crying; and   f. Promotes analgesia during invasive procedures.   
           2. SSC is associated with early initiation and longer duration of breastfeeding:
           Breast milk is the optimal source of nutrition and source of natural immunity for the infant. Currently-accepted evidence-based recommendations regarding breastfeeding indicate that this practice should be initiated within 30-60 minutes after delivery (American Association of Pediatrics, 2012; BFHI, 2009). Immediate mother-infant SSC after delivery has been associated with the following benefits:   a. Increased ability of the neonate to recognize the mother&#39;s milk;   b. A higher rate of successful initiation of breastfeeding;   c. A longer duration of breastfeeding; and   d. Higher prevalence of timely neonatal metabolic/glucose regulation;   
           3. SSC is associated with positive infant developmental and social benefits:
           a. Increased maternal-infant interaction; maternal affection, facilitates bonding;   b. Greater tactile and verbal stimulation of the infant by the mother;   c. Vocal parental-infant interaction after birth; and   d. Greater prevalence of future mother-infant attachment.   
           4. Multiple maternal benefits have also been documented:
           a. Release of oxytocin which facilitates control of bleeding in immediate post-partum period;   b. Increased reported maternal satisfaction and positive feelings;   c. Increased reported maternal feelings of relaxation and well-being;   d. Decreased reported maternal anxiety and stress;   e. Higher reported breastfeeding self-efficacy and overall confidence with breastfeeding;   f. Increased reported maternal sensitivity to the infant; increased maternal affection and attachment; and   g. Fewer reported post-partum depressive symptoms.   
               
 
         [0031]    The rate of Cesarean delivery has risen markedly in the near past. In fact, according to the most recent statistics from the U.S. Center for Disease Control and Prevention (CDC, 2014), the current Cesarean delivery rate in the U.S. has risen to 32.8% of all deliveries. Furthermore, in spite of the compelling evidence in support of initiating SSC between the mother and infant immediately after birth, the adoption of this practice is limited to the period after Cesarean delivery, not during delivery. Thus, a significant number of mother-infant dyads are denied the opportunity for a widely-accepted standard of care that facilitates both short-term and long-term physiological, psychological, social and developmental adaptation of the baby and mother. 
         [0032]    Because of the different routines required in the operating room due the highly controlled environment for the surgical procedure, the lower room temperature in the operating suite, the close surveillance of the mother required by the anesthesiologist during the operative procedure, and the sterile operative field environment, many misperceptions, fears and lack of understanding among healthcare providers commonly exist regarding the standard of care for SSC. These misperceptions and fears create many challenges to the adoption of SSC. Thus, it is common practice in the operating suite for the neonate to be placed under a radiant warmer and swaddled or transported directly to the nursery. All of these options result in the delay of immediate bonding between mother and her neonate. 
         [0033]    One significant barrier to SSC immediately after birth in the operating suite is the physical barrier between the mother and her newly delivered baby created by the sterile field. The sterile field must be maintained throughout the Cesarean procedure, which includes, in addition to the delivery, the post-delivery wound closing and dressing. The present state of art in the field of fenestration drapes lacks an effective means to bridge the sterile field to access the mother&#39;s skin immediately upon delivery without, at the same time, compromising the sterile barrier. 
       SUMMARY OF THE INVENTION 
       [0034]    The present invention is a novel surgical drape devised to overcome this barrier. This innovative drape allows the obstetrician to reach through a pre-designed portal in the main drape to place the infant on the mother&#39;s chest immediately after delivery without compromising sterility. 
         [0035]    It is an object of the present invention, therefore, to provide skin-to-skin contact between a mother and her newborn as close to immediately upon delivery as possible during a Cesarean procedure. It is a further object to provide a portal through a surgical drape to be used in a Cesarean procedure, apart from the necessary surgical opening, for directly accessing the mother&#39;s bared breast. It is a further object to maintain the integrity of the sterile surgical field throughout the procedure. It is a further object to open the portal and reclose the portal without lapse in sterile technique. 
         [0036]    These objects, and others to become hereinafter apparent, are embodied in a surgical fenestration drape for the Cesarean delivery of a newborn from his/her mother comprising a drape sheet having a surgical opening and a portal. The sheet has a sterile-field side and a non-sterile-field side. The drape further comprises a first means for closing the portal, which is configured to be selectively manipulated from the non-sterile field side. The drape also comprises a second means for closing the portal, this second means configured to be selectively manipulated from the sterile-field side. The portal remains closed by the first means for closing until birth when the first means is then withdrawn from the portal to provide a window for the newborn to be placed into skin-to-skin contact with the mother&#39;s chest. Thereafter, the portal is reclosed by the second means for closing to protect the integrity of the sterile-field throughout the remaining procedure. 
         [0037]    In the preferred embodiment, the first means for closing comprises a first flap having a sterile-field side. The sterile-field side of the first flap is releasably fastened by hook-and-loop material to the non-sterile-field side of the drape sheet. Further, the second means for closing comprises a second flap fastened to the sterile-field side of the drape sheet by double-sided adhesive after extending it from a fan-folded storage configuration. 
         [0038]    In an alternate embodiment, a method of achieving immediate skin-to-skin contact of a newborn with his/her mother during Cesarean delivery comprises the steps of providing the surgical fenestration drape sheet discussed above; covering the mother with the drape sheet so that the portal is located proximate to the mother&#39;s chest; manipulating the first flap from the non-sterile side to open the portal immediately upon birth of the newborn; handing the newborn through the portal from the sterile-field side to rest in skin-to-skin contact with the mother&#39;s chest; and manipulating the second flap to reclose the portal from the sterile-field side while maintaining sterile-field integrity. The surgical procedure may then continue without interruption pursuant to this method. 
         [0039]    As this is not intended to be an exhaustive recitation, other embodiments may be learned from practicing the invention or may otherwise become apparent to those skilled in the art. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0040]    Various other objects, features and attendant advantages of the present invention will become fully appreciated as the same becomes better understood through the accompanying drawings and the following detailed description, in which like reference characters designate the same or similar parts throughout the several views, and wherein: 
           [0041]      FIG. 1  is a sketch showing a delivery scene using the fenestration drape of the present invention; 
           [0042]      FIG. 2  is a perspective view with the newborn after delivery showing the opened first flap in partial hidden line and the mother in phantom line; 
           [0043]      FIG. 3  is a perspective view with the newborn in skin-to-skin contact under the closed second flap showing the portal and the newborn in hidden line and the mother in phantom line; 
           [0044]      FIG. 4  is a perspective view of the top of the drape with the second flap shown in fan-folded configuration, and in extended configuration by phantom line, with the first flap shown in hidden line; 
           [0045]      FIG. 5  is a plan view of the top of the drape showing the fan-folded second flap and the double-sided adhesive with the first flap shown in hidden line; 
           [0046]      FIG. 6  is a perspective view of the bottom of the drape showing the first flap closed, and opened in phantom line, with the portal shown in hidden line; 
           [0047]      FIG. 7  is a plan view of the bottom of the drape showing the first flap closed with the portal and the hook-and-loop fasteners in hidden line; and 
           [0048]      FIG. 8  is a schematic of the method of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0049]    As best shown in  FIGS. 1-3 , a surgical fenestration drape  1  for a Cesarean procedure delivering a newborn  3  from his/her mother  4  comprises a drape sheet  2 , a portal  6 , a first means for closing  10  the portal  6  and a second means for closing  20  the portal  6 . The first means  10  and the second means  20  are used with sterile techniques to maintain a sterile-field barrier defined by a sterile-field side  7  ( FIGS. 4 and 5 ) of the drape sheet  2  opposed by a non-sterile field side  8  ( FIGS. 6 and 7 ). The portal  6  is an opening through the drape sheet  2 , generally positioned to the chest-side of a surgical opening  5  located over the abdomen. The purpose of the portal  6  is to give immediate access for skin-to-skin contact (SSC) between the newborn  3  and the mother  4  to receive the benefits enumerated above. 
         [0050]    In the preferred embodiment, the first means for closing  10  comprises a first flap  11 , as shown in  FIGS. 6 and 7 . The first flap  11  also has a sterile-field side  13 . The sterile-field side  13  of the first flap  11  is attached at the non-sterile field side  8  of the drape sheet  2  along one edge proximate the abdomen to hingingly flap down on a bared chest  9  of the mother  4  ( FIG. 2 ). In a particularity, the first flap  11  is releasably held in place by hook-and-loop material  12 , or otherwise by any known releasable attachment means, to cover the portal  6  until birth. Immediately following birth, the first flap  11  is released using sterile technique to lay it upon the bared chest  9  in the non-sterile field side  8  and provide thereby a sterile-field extension for placement thereon of the newborn  3 . 
         [0051]    Additionally, the second means for closing  20  comprises a second flap  21 , as shown in  FIGS. 4 and 5 . The second flap  21  remains in a fan-folded conformation  22  until released therefrom after the newborn  3  is handed through the portal  6  from the sterile-field side  7  to be placed on the laid-open first flap  11 . In a particularity, the second flap  21  is secured in place over the portal  6  ( FIG. 3 ), thereby closing it to maintain sterile barrier, by double-sided adhesive  23 , or otherwise by any known bonding means. 
         [0052]    The drape sheet  2 , the first flap  11  and the second flap  21  may be comprised of one or more laminations of a non-woven material with poly film. In one particularity, the lamination may comprise a combination of spun-bonded and melt-bonded layers, otherwise known as SMS. In another particularity, the composition may comprise a moisture-impervious tri-laminate of SMS/Poly/SMS. The first and second flaps may be hingeably attached to the drape sheet by any known bonding means. 
         [0053]    In an alternate embodiment shown in  FIG. 8 , a method of achieving immediate SSC  30  of a newborn  3  with his/her mother  4  during Cesarean delivery comprises:
       Step  31 : Providing a drape sheet  2  having a surgical opening  5  and a portal  6 , said sheet having a sterile-field side  7  and a non-sterile field side  8 , said portal closed by a first flap  11  before birth and by a second flap  21  after birth;   Step  32 : Covering the mother  4  with the drape sheet  2  so that the portal  6  is located proximate to the mother&#39;s bared chest  9 ;   Step  33 : Manipulating the first flap  11  from the non-sterile field side  8  to open the portal  6  immediately upon birth of the newborn  3  ( FIG. 6 );   Step  34 : Handing the newborn  3  through the portal  6  from the sterile-field side  7  to rest in SSC with the mother&#39;s chest  9  ( FIG. 2 ); and   Step  35 : Manipulating the second flap  21  to reclose the portal  6  from the sterile-field side  7 , thereby and there through maintaining sterile-field integrity and allowing continuation of post-delivery procedure without interruption ( FIG. 4 ).
 
In one particularity, the step  33  further comprises:
   Step  36 : Unfastening and lowering the first flap  11  onto the mother&#39;s bared chest  9 , whereby the sterile field is extended through the portal  6 , by a first assisting person  38  (not shown) positioned on the non-sterile side  8 .
 
In another particularity, the step  34  further comprises:
   Step  37 : Assisting the mother  4  and the newborn  3  with skin-to-skin contact after an obstetrician  43  ( FIG. 1 ) passes the newborn through the portal  6  onto the first flap  11  and the mother&#39;s bared chest  9 .
 
In another particularity, the step  35  further comprises:
   Step  38 : Raising and securing a fan-folded second flap  22  to and onto the portal  6 , whereby integrity of the sterile field is maintained throughout subsequent procedure, by a second assisting person  42  (not shown) positioned on the sterile side  7 .       
 
         [0062]    It is to be understood that the invention is not limited in its application to the details of construction, to the arrangements of the components and to the method of using set forth in the preceding description or illustrated in the drawings. For example, the first flap  11  may be transparent so that the mother may see the birth happening. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of the description and should not be regarded as limiting.