Abstract:
Disclosed is a surgical drape configured to selectively allow or block a patient&#39;s view of the surgical field, as is desired in Caesarean section operations. Generally, the drape includes a main sheet, a substantially transparent sheet attached to the main sheet proximal the patient&#39;s head, and a substantially opaque screen attached to the patient-facing side of the substantially transparent sheet. This substantially opaque screen occludes the patient&#39;s visual access through the substantially transparent sheet but may be at least partially removed to permit the patient viewing access through the substantially transparent sheet towards the area of the surgery, without compromising the sterility of the surgical field. Desirably, the drape is provided with an adhesive strip disposed on the sheet or screen to permit reconnection to thereby again occlude the patient&#39;s view through the sheet.

Description:
TECHNICAL FIELD 
       [0001]    This patent relates to a drape for covering a patient during a surgical procedure. 
       BACKGROUND 
       [0002]    Currently, a traditional Cesarean section procedure, also known as “C-section,” is most commonly performed with the patient covered by a solid surgical drape. The drape is typically constructed of a multi-layer combination of spunbond and meltblown materials, commonly referred to as SMS nonwoven fabric. 
         [0003]    Because the mother is typically awake and alert during the C-section, it is desirable to provide a barrier or screen to occlude the mother&#39;s view of the surgical area during the procedure. Many traditional drapes are in a “T” shape, with the top portion of the “T” acting as the anesthesia screen that obscures the patient&#39;s view of the surgical area. The drape is placed over the patient to isolate a sterile field near the patient&#39;s abdomen. The anesthesia screen is propped up on vertical standards at each side of the operating table near the patient&#39;s head or on a crossbar proximal the head. 
         [0004]    In this arrangement, the mother does not have an opportunity to see her newborn immediately after delivery. It is desirable in the first moments after birth for the mother and child to establish an immediate connection. Because traditional surgical drapes obscure the mother&#39;s view of the newborn in the first moments after delivery, the mother and child do not have an opportunity to establish this immediate connection. 
         [0005]    To address this concern, it is known to provide surgical drapes that incorporates a coverable window and an opaque flap that can be attached and detached to alternately obscure and expose the window. It has now been realized that many such known drapes are undesirable in that they are configured in ways that might allow for contamination of the surgical field once the flap is removed, particularly if the flap is folded into the surgical field. 
         [0006]    A new surgical drape has now been devised. Generally, the drape includes a main sheet having a first patient-facing side and a second surgeon-facing side. The main sheet includes a fenestration through which a surgical procedure may be performed. The main sheet has a head region that is located near the head of the patient during the surgical procedure, and a substantially transparent sheet attached to the main sheet proximal the head region. The substantially transparent sheet allows the patient visual access to the surgeon-facing side from behind the substantially transparent sheet. The drape also includes also a substantially opaque screen attached to the patient-facing side of the substantially transparent sheet. This substantially opaque screen occludes the patient&#39;s visual access through the substantially transparent sheet when the substantially opaque screen is attached to the substantially transparent sheet. The substantially opaque screen is at least partially removable from the substantially transparent sheet to permit the patient viewing access through the substantially transparent sheet towards the area of the surgery. In this manner, the patient may view the birth of the infant or may view the infant immediately after birth. 
         [0007]    The drape is configured such that the substantially opaque screen may be reattached to the patient side of the substantially transparent sheet to again occlude the patient&#39;s view of the surgical site. In this manner, the surgeon, after having permitted the patient to view the surgical site through the substantially transparent sheet, may occlude the patient&#39;s view of the surgical site so that, if desired, the surgeon can continue with the procedure with the surgical area again being occluded. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is a perspective view of a surgical drape in accordance with one embodiment of the invention, shown in use positioned over a patient in a surgical bed. 
           [0009]      FIG. 2  is a top plan view of the surgical drape shown in  FIG. 1 . 
           [0010]      FIG. 3  is a front perspective view of the surgical drape shown in  FIG. 1 . 
           [0011]      FIG. 4  is a rear perspective view, partially cut away, of the surgical drape and bed shown in  FIG. 1 , depicting the substantially opaque screen attached to the substantially transparent sheet. 
           [0012]      FIG. 5  is a view similar to  FIG. 4  but depicting top edge of the substantially opaque screen having been separated from the substantially transparent sheet. 
           [0013]      FIG. 6  is a rear perspective view of an upper portion of the surgical drape as shown in  FIGS. 1 and 4 , enlarged with respect to  FIGS. 1 and 4 , and depicting a strip of material that connects the substantially opaque screen and the substantially transparent sheet. 
           [0014]      FIG. 7  is a view similar to  FIG. 6  but depicting the substantially opaque screen being removed from the substantially transparent sheet. 
           [0015]      FIG. 8  is a view similar to  FIG. 5  but with the substantially opaque screen reattached to the substantially transparent sheet. 
       
    
    
       [0016]    Reference herein to “top” and bottom” are intended to relate the various views to one another and such reference is not intended to limit the orientation of the drape when in use. 
       DETAILED DESCRIPTION 
       [0017]    Referring to  FIG. 1 , the surgical drape  10  includes a main sheet  11  having a center portion  12 , first side portion  14 , second side portion  15 , and transverse portion  16 . The center portion  12  has a bottom edge  17 , a top edge  18 , and first and second side edges  20  and  21  joining the bottom edge  17  and the top edge  18 . The transverse portion  16  is attached to the center portion  12  near the top edge  18  of the center portion  12 . The first side portion  14  is attached along the first side edge  20  of the center portion  12 . The first side portion  14  is also attached along a lower edge  22  of the transverse portion  16 . Similarly, the second side portion  15  is attached along the second side edge  21  of the center portion  12 . The second side portion  15  is attached along the lower edge  22  of transverse portion  16 . 
         [0018]    The main sheet  11  and the transverse portion  16  may be constructed of any suitable material, and as shown are constructed of a multi-layer combination of spunbond and meltblown materials, commonly referred to as SMS nonwoven fabric. This combination provides a durable and absorbent flexible fluid barrier between the patient and the sterile field that are soft to the touch. The first and second side portions  14  and  15  are made of a flexible fluid impervious and non-absorbent material, such as polyethylene film. 
         [0019]    Referring to  FIGS. 2 and 3 , the surgical drape  10  also includes a substantially transparent sheet  24 . A bottom edge  25  of the substantially transparent sheet  24  is attached along a top edge  26  of the transverse portion  16 . The length of transverse portion  16  extends the width of the surgical drape  10 . The substantially transparent sheet  24  may be made of any suitable material, such as polyethylene film. 
         [0020]    The main sheet  11  includes a fenestration  42  through which a surgery accessing a patient&#39;s body may be performed. The fenestration  42  is an opening formed in the material of main sheet  11  sized according to the particular procedure for which the surgical drape  10  is to be used. In one embodiment, fenestration  42  is sized to allow sufficient access to a patient&#39;s abdominal region to perform a C-section procedure. Fenestration  42  is covered with a flexible adhesive film  44  known in the industry as “incise film,” which may be formed from polyurethane or another suitable material to form a “full incise” fenestration. When the surgical drape  10  is laid over a patient, the flexible adhesive film  44  is first covered with a removable backing  49 . Before the procedure is performed and after the surgical drape  10  is laid over the patient, the removable backing is removed from the flexible adhesive film  44 , exposing the adhesive bottom surface of the flexible adhesive film  44 . The flexible adhesive film  44  adheres to the skin of the patient. When the procedure is performed, incisions may be made directly through the flexible adhesive film  44 . 
         [0021]    As illustrated, flexible adhesive film  44  is a full panel film that covers the entirety of fenestration  42 . It is contemplated that a “fenestrated incise” structure (not shown) alternatively may be employed, wherein there is adhesive disposed around the perimeter of the fenestration. This leaves an opening in a center portion of the flexible adhesive film through which the patient&#39;s skin is exposed to permit incisions to be made directly though the exposed skin. 
         [0022]    With further reference to  FIG. 2 , the fenestration  42  may be substantially surrounded by a fluid collection pouch  45 . The fluid collection pouch  45  is made of a plastic material impervious to fluid. The fluid collection pouch  45  surrounds the fenestration  42  in a sealing fashion such that any fluids released from the surgical site during the procedure will run off the sheet into fluid collection pouch  45 . This prevents fluids from running off the main sheet  11  and onto the floor or other areas where fluids are not desired. The fluid collection pouch  45  may include one or more suction ports  46  for connection to suction equipment for aspirating the fluids from the fluid collection pouch. 
         [0023]    The fluid collection pouch  45  includes an opening  47  through which the surgeon may access fenestration  42 . The edges of the opening  48  may be bound by a formable material  50 , such as a malleable wire encased in plastic. The formable material  50  allows the surgeon to shape the opening of fluid collection pouch  45  to allow for easier access to fenestration  42  or to reconfigure the shape of fluid collection pouch  45  in a manner that is most effective for the particular procedure. 
         [0024]    The main sheet  11  includes one or more line anchors  51  for securing wires or lines to the surgical drape  10 . The line anchors  51  consist of two plies of hook and loop material that may be separated at one end, but which are attached at another end. When the plies of the hook and loop material are separated, a line may be inserted between the two plies and when the plies are joined again, the hook and loop material captures the line between the two plies of material. 
         [0025]    The main sheet  11  also includes an absorbent pad  52 , which, as shown, is configured as a separate pad disposed on the main sheet  11 . Absorbent pad  52  is located near fenestration  42  and is made up of a material suitable for absorbing fluids generated during the surgical procedure. The absorbent pad  52  provides another measure of fluid retention in the instance where fluids are not collected by the fluid collection pouch  45 . 
         [0026]    As supplied, the surgical drape  10  is initially provided in a sterile folded state wrapped in a sterile fabric wrapper (not shown) and an outer package (also not shown), as is conventional. The sterile fabric wrapper surrounds the surgical drape  10  to protect the surgical drape  10  and maintain its sterile state. The surgical drape  10  wrapped in the sterile fabric wrapper is enclosed in a plastic pouch. The plastic pouch further protects the surgical drape  10  and maintains its sterile condition. 
         [0027]    Referring to  FIGS. 3 and 4 , a bottom edge  27  of a substantially opaque screen  28  is attached to the patient-facing side of the transverse portion  16  sufficiently to preclude the patient from viewing the surgical field beneath the screen. Preferably the screen is attached below the point at which the bottom edge  25  of the substantially transparent sheet  24  is attached to the top edge  26  of the transverse portion  16 . The substantially opaque screen  28  may be made of any suitable material, such as SMS non-woven fabric. A top edge  30  of the substantially opaque screen  28  is attached proximate its outer edges to the patient-facing side of substantially opaque screen  28  proximal a top edge  31  of the substantially transparent sheet  28 . The attachment is made via first and second adhesive tape strips  32  and  34  discussed in more detail below. 
         [0028]    Referring to  FIG. 6 , the top edge  30  of the substantially opaque screen  28  is attached to the patent-facing side of the transparent sheet  24  via the first and second adhesive tape strips  32  and  34 . First and second adhesive tape strips  32  and  34  include first regions,  35 ,  35 ′ respectively, attached to the patient-facing side of the substantially transparent sheet  24 . The strips include a second region  36 ,  36 ′ respectively attached along the top edge  30  of the substantially opaque screen  28 . The first and second regions of each adhesive tape strip are connected to one another along a demarcated line of weakness, such as strip scoreline  37 ,  37 ′ that partially scores the first and second adhesive tape strips  32  and  34 . The strip scorelines  37 ,  37 ′ is generally formed by severing the first and second adhesive tape strips  32  and  34  along their lengths partially through their thickness such that a separated area is formed above the bridging area between the first region and the second region of each strip. In this embodiment, the strip scorelines  37 ,  37 ′ are generally centrally positioned along the width of the first and second adhesive tape strips  32  and  34 . 
         [0029]    Thus, based at least in part on the relatively small thickness of the bridging area, the first region  35 ,  35 ′ can be separated from the second region  36 ,  36 ′ via manual tearing. Referring to  FIG. 7 , to detach the substantially transparent sheet  24  from the substantially opaque screen  28  a user may manually separate the first and second regions  35  and  36  of first and second adhesive tape strips  32  and  34 . When the first and second regions  35  and  36  are severed along scoreline  37 , the first region  35  remains attached to the patient-facing side of substantially transparent sheet  24 . The second region  36  remains attached to the patient-facing side of substantially opaque screen  28 . In this manner, the top edge  30  of the substantially opaque screen  28  is separated from the substantially transparent sheet  24 . In this manner, the substantially opaque screen  28  may be detached and lowered to permit the patient to view the surgical area, as illustrated in  FIG. 5 . 
         [0030]    Referring again to  FIGS. 6 and 7 , a first refastening strip  38  and a second refastening strip  40  are connected along the top edge  30  of the substantially opaque screen  28  on a side of the substantially opaque screen  28  proximal the first and second adhesive tape strips  32  and  34 . First and second refastening strips  38  and  40  have two sides, both of which are covered by an adhesive. One side of each of the first and second refastening strips  38  and  40  is adhered to the substantially opaque screen  28 . The other side of each of the refastening strips  38  and  40  is covered by a removable backing  41 . The removable backing  41  may be removed to expose the adhesive material. Once the removable backing  41  is removed and the adhesive is exposed, the first and second refastening strips  38  and  40  may be used to re-adhere the substantially opaque screen  28  to the substantially transparent sheet  24  by pressing the exposed adhesive on refastening strips  38  and  40  to the patient-facing side of the substantially transparent sheet  24 . Via these strips, after the patient views the surgical area, the substantially opaque screen  28  may be reattached to the substantially transparent sheet  24 , as shown in  FIG. 8 . 
         [0031]    As illustrated, the strips are disposed at the top of the screen, but other configurations are possible. For instance, the strips may be disposed at a different location on the screen, or may be provided on the substantially transparent sheet. Similarly, the sheet and screen are shown as being substantially rectilinear in configuration, but other shapes are possible, as is also possible for the main sheet. As an alternative to the adhesive strip, or in addition thereto, other implementations may be provided for refastening the substantially transparent sheet to the screen, these including, for instance, hook-and-loop material, ties, buttons, or other suitable fasteners. Such fasteners can be positioned in any manner suitable to effectuate refastening. 
         [0032]    In using the surgical drape  10 , the patient is first laid on a surgical table. Once the patient is in position on the surgical table, the surgical drape  10  is removed from the plastic pouch. At this point, the surgical drape  10  is enclosed within the sterile wrapper. A member of the surgical team may remove the wrapped surgical drape  10  from the container, and, by using methods known in the field, may unwrap the surgical drape  10  and present it to a member of the surgical team that has performed personal decontamination, such that the sterile state of the surgical drape  10  may be maintained during setup of the surgical procedure. After the surgical drape  10  is removed from the sterile wrapper, it is unfolded, and as it is unfolded it is lain over the patient. As it is unfolded and lain over the patient, when the portion of fenestration  42  is positioned over the surgical site of the patient, the removable adhesive backing is removed from the incise film  44 , and the incise film  44  is adhered to the patient&#39;s skin and the site of the surgical area. The outer portions of substantially transparent sheet  24  are attached using spring clamps or other attaching means to N poles, or other standards used in operating rooms for positioning surgical drapes. The substantially transparent sheet  24  attached to the poles separates the patient&#39;s head from the sterile field. At this point in the procedure, the substantially opaque screen  28  remains attached to substantially transparent sheet  24  to occlude the view of the patient through the substantially transparent sheet  24 , as seen in  FIG. 4 . 
         [0033]    The surgical procedure may then proceed, and at a time at which the surgeon wishes to allow the patient to view an area around the surgical site, the substantially opaque screen  28  may be partially detached from substantially transparent sheet  24  to allow the patient to view the surgical area, as illustrated in  FIG. 5 . In the case of a C-section, this allows the new mother to view the newborn baby immediately after the baby is removed in the C-section procedure. After the mother has had an opportunity to view the baby, a member of the surgical team may reattach the substantially opaque screen  28  to the substantially transparent sheet  24  using the first and second refastening strips  38  and  40 . The remainder of the surgical procedure may then be performed with the patient&#39;s vision in direction towards the surgical scene occluded. 
         [0034]    It is thus seen that a drape that allows the surgeon to selectively permit the patient to view the area near the surgical field is provided. In a C-section procedure, the patient may or may not be able to view the actual surgical field, so long as she has a view through the substantially transparent sheet towards surgeon-facing side of the drape. Notably, because the substantially opaque screen  28  remains outside of the sterile field, the risk of contamination is reduced even where the screen is removed and re-attached. The surgical drape  10  is particularly suitable for C-section procedures, but it is contemplated that the surgical drape  10  will find other surgical uses. 
         [0035]    Uses of singular terms such as “a,” “an,” are intended to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms. Any description of certain embodiments as “preferred” embodiments, and other recitation of embodiments, features, or ranges as being preferred, or suggestion that such are preferred, is not deemed to be limiting. The invention is deemed to encompass embodiments that are presently deemed to be less preferred and that may be described herein as such. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended to illuminate the invention and does not pose a limitation on the scope of the invention. Any statement herein as to the nature or benefits of the invention or of the preferred embodiments is not intended to be limiting. This invention includes all modifications and equivalents of the subject matter recited herein as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. The description herein of any reference or patent, even if identified as “prior,” is not intended to constitute a concession that such reference or patent is available as prior art against the present invention. No unclaimed language should be deemed to limit the invention in scope. Any statements or suggestions herein that certain features constitute a component of the claimed invention are not intended to be limiting unless reflected in the appended claims. Neither the marking of the patent number on any product nor the identification of the patent number in connection with any service should be deemed a representation that all embodiments described herein are incorporated into such product or service.