Patent Description:
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.

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'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's view of the surgical area. The drape is placed over the patient to isolate a sterile field near the patient's abdomen. The anesthesia screen is propped up on vertical standards at each side of the operating table near the patient's head or on a crossbar proximal the head.

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'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.

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. Documents <CIT> and <CIT> disclose surgical drapes with coverable transparent window and an opaque cover to alternatively obscure and expose the window. Documents <CIT> and <CIT> disclose surgical drapes with an opaque lower part and a transparent upper part. Documents <CIT>, <CIT> and <CIT> disclose further prior art surgical drapes.

A new surgical drape has now been devised. The invention is as defined in independent claim <NUM>, with further embodiments defined by the dependent claims. 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'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.

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'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's view of the surgical site so that, if desired, the surgeon can continue with the procedure with the surgical area again being occluded.

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.

Referring to <FIG>, the surgical drape <NUM> includes a main sheet <NUM> having a center portion <NUM>, first side portion <NUM>, second side portion <NUM>, and transverse portion <NUM>. The center portion <NUM> has a bottom edge <NUM>, a top edge <NUM>, and first and second side edges <NUM> and <NUM> joining the bottom edge <NUM> and the top edge <NUM>. The transverse portion <NUM> is attached to the center portion <NUM> near the top edge <NUM> of the center portion <NUM>. The first side portion <NUM> is attached along the first side edge <NUM> of the center portion <NUM>. The first side portion <NUM> is also attached along a lower edge <NUM> of the transverse portion <NUM>. Similarly, the second side portion <NUM> is attached along the second side edge <NUM> of the center portion <NUM>. The second side portion <NUM> is attached along the lower edge <NUM> of transverse portion <NUM>.

The main sheet <NUM> and the transverse portion <NUM> 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 <NUM> and <NUM> are made of a flexible fluid impervious and non-absorbent material, such as polyethylene film.

Referring to <FIG> and <FIG>, the surgical drape <NUM> also includes a substantially transparent sheet <NUM>. A bottom edge <NUM> of the substantially transparent sheet <NUM> is attached along a top edge <NUM> of the transverse portion <NUM>. The length of transverse portion <NUM> extends the width of the surgical drape <NUM>. The substantially transparent sheet <NUM> may be made of any suitable material, such as polyethylene film.

The main sheet <NUM> includes a fenestration <NUM> through which a surgery accessing a patient's body may be performed. The fenestration <NUM> is an opening formed in the material of main sheet <NUM> sized according to the particular procedure for which the surgical drape <NUM> is to be used. In one embodiment, fenestration <NUM> is sized to allow sufficient access to a patient's abdominal region to perform a C-section procedure. Fenestration <NUM> is covered with a flexible adhesive film <NUM> 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 <NUM> is laid over a patient, the flexible adhesive film <NUM> is first covered with a removable backing <NUM>. Before the procedure is performed and after the surgical drape <NUM> is laid over the patient, the removable backing is removed from the flexible adhesive film <NUM>, exposing the adhesive bottom surface of the flexible adhesive film <NUM>. The flexible adhesive film <NUM> adheres to the skin of the patient. When the procedure is performed, incisions may be made directly through the flexible adhesive film <NUM>.

As illustrated, flexible adhesive film <NUM> is a full panel film that covers the entirety of fenestration <NUM>. 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's skin is exposed to permit incisions to be made directly though the exposed skin.

With further reference to <FIG>, the fenestration <NUM> may be substantially surrounded by a fluid collection pouch <NUM>. The fluid collection pouch <NUM> is made of a plastic material impervious to fluid. The fluid collection pouch <NUM> surrounds the fenestration <NUM> 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 <NUM>. This prevents fluids from running off the main sheet <NUM> and onto the floor or other areas where fluids are not desired. The fluid collection pouch <NUM> may include one or more suction ports <NUM> for connection to suction equipment for aspirating the fluids from the fluid collection pouch.

The fluid collection pouch <NUM> includes an opening <NUM> through which the surgeon may access fenestration <NUM>. The edges of the opening <NUM> may be bound by a formable material <NUM>, such as a malleable wire encased in plastic. The formable material <NUM> allows the surgeon to shape the opening of fluid collection pouch <NUM> to allow for easier access to fenestration <NUM> or to reconfigure the shape of fluid collection pouch <NUM> in a manner that is most effective for the particular procedure.

The main sheet <NUM> includes one or more line anchors <NUM> for securing wires or lines to the surgical drape <NUM>. The line anchors <NUM> 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.

The main sheet <NUM> also includes an absorbent pad <NUM>, which, as shown, is configured as a separate pad disposed on the main sheet <NUM>. Absorbent pad <NUM> is located near fenestration <NUM> and is made up of a material suitable for absorbing fluids generated during the surgical procedure. The absorbent pad <NUM> provides another measure of fluid retention in the instance where fluids are not collected by the fluid collection pouch <NUM>.

As supplied, the surgical drape <NUM> 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 <NUM> to protect the surgical drape <NUM> and maintain its sterile state. The surgical drape <NUM> wrapped in the sterile fabric wrapper is enclosed in a plastic pouch. The plastic pouch further protects the surgical drape <NUM> and maintains its sterile condition.

Referring to <FIG> and <FIG>, a bottom edge <NUM> of a substantially opaque screen <NUM> is attached to the patient-facing side of the transverse portion <NUM> 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 <NUM> of the substantially transparent sheet <NUM> is attached to the top edge <NUM> of the transverse portion <NUM>. The substantially opaque screen <NUM> may be made of any suitable material, such as SMS nonwoven fabric. A top edge <NUM> of the substantially opaque screen <NUM> is attached proximate its outer edges to the patient-facing side of substantially opaque screen <NUM> proximal a top edge <NUM> of the substantially transparent sheet <NUM>. The attachment is made via first and second adhesive tape strips <NUM> and <NUM> discussed in more detail below.

Referring to <FIG>, the top edge <NUM> of the substantially opaque screen <NUM> is attached to the patent-facing side of the transparent sheet <NUM> via the first and second adhesive tape strips <NUM> and <NUM>. First and second adhesive tape strips <NUM> and <NUM> include first regions, <NUM>, <NUM>' respectively, attached to the patient-facing side of the substantially transparent sheet <NUM>. The strips include a second region <NUM>, <NUM>' respectively attached along the top edge <NUM> of the substantially opaque screen <NUM>. 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 <NUM>, <NUM>' that partially scores the first and second adhesive tape strips <NUM> and <NUM>. The strip scorelines <NUM>, <NUM>' is generally formed by severing the first and second adhesive tape strips <NUM> and <NUM> 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 <NUM>, <NUM>' are generally centrally positioned along the width of the first and second adhesive tape strips <NUM> and <NUM>.

Thus, based at least in part on the relatively small thickness of the bridging area, the first region <NUM>, <NUM>' can be separated from the second region <NUM>, <NUM>' via manual tearing. Referring to <FIG>, to detach the substantially transparent sheet <NUM> from the substantially opaque screen <NUM> a user may manually separate the first and second regions <NUM> and <NUM> of first and second adhesive tape strips <NUM> and <NUM>. When the first and second regions <NUM> and <NUM> are severed along scoreline <NUM>, the first region <NUM> remains attached to the patient-facing side of substantially transparent sheet <NUM>. The second region <NUM> remains attached to the patient-facing side of substantially opaque screen <NUM>. In this manner, the top edge <NUM> of the substantially opaque screen <NUM> is separated from the substantially transparent sheet <NUM>. In this manner, the substantially opaque screen <NUM> may be detached and lowered to permit the patient to view the surgical area, as illustrated in <FIG>.

Referring again to <FIG> and <FIG>, a first refastening strip <NUM> and a second refastening strip <NUM> are connected along the top edge <NUM> of the substantially opaque screen <NUM> on a side of the substantially opaque screen <NUM> proximal the first and second adhesive tape strips <NUM> and <NUM>. First and second refastening strips <NUM> and <NUM> have two sides, both of which are covered by an adhesive. One side of each of the first and second refastening strips <NUM> and <NUM> is adhered to the substantially opaque screen <NUM>. The other side of each of the refastening strips <NUM> and <NUM> is covered by a removable backing <NUM>. The removable backing <NUM> may be removed to expose the adhesive material. Once the removable backing <NUM> is removed and the adhesive is exposed, the first and second refastening strips <NUM> and <NUM> may be used to re-adhere the substantially opaque screen <NUM> to the substantially transparent sheet <NUM> by pressing the exposed adhesive on refastening strips <NUM> and <NUM> to the patient-facing side of the substantially transparent sheet <NUM>. Via these strips, after the patient views the surgical area, the substantially opaque screen <NUM> may be reattached to the substantially transparent sheet <NUM>, as shown in <FIG>.

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.

In using the surgical drape <NUM>, the patient is first laid on a surgical table. Once the patient is in position on the surgical table, the surgical drape <NUM> is removed from the plastic pouch. At this point, the surgical drape <NUM> is enclosed within the sterile wrapper. A member of the surgical team may remove the wrapped surgical drape <NUM> from the container, and, by using methods known in the field, may unwrap the surgical drape <NUM> and present it to a member of the surgical team that has performed personal decontamination, such that the sterile state of the surgical drape <NUM> may be maintained during setup of the surgical procedure. After the surgical drape <NUM> 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 <NUM> is positioned over the surgical site of the patient, the removable adhesive backing is removed from the incise film <NUM>, and the incise film <NUM> is adhered to the patient's skin and the site of the surgical area. The outer portions of substantially transparent sheet <NUM> are attached using spring clamps or other attaching means to IV poles, or other standards used in operating rooms for positioning surgical drapes. The substantially transparent sheet <NUM> attached to the poles separates the patient's head from the sterile field. At this point in the procedure, the substantially opaque screen <NUM> remains attached to substantially transparent sheet <NUM> to occlude the view of the patient through the substantially transparent sheet <NUM>, as seen in <FIG>.

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 <NUM> may be partially detached from substantially transparent sheet <NUM> to allow the patient to view the surgical area, as illustrated in <FIG>. 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 <NUM> to the substantially transparent sheet <NUM> using the first and second refastening strips <NUM> and <NUM>. The remainder of the surgical procedure may then be performed with the patient's vision in direction towards the surgical scene occluded.

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 <NUM> remains outside of the sterile field, the risk of contamination is reduced even where the screen is removed and re-attached. The surgical drape <NUM> is particularly suitable for C-section procedures, but it is contemplated that the surgical drape <NUM> will find other surgical uses.

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, as long as they fall within the scope of the appended claims. 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, the scope of the invention being defined by the appended claims. Any statement herein as to the nature or benefits of the invention or of the preferred embodiments is not intended to be limiting. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein, otherwise clearly contradicted by context or not falling within the scope of the appended claims. 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.

Claim 1:
A surgical drape (<NUM>) comprising:
a mainsheet (<NUM>), the mainsheet (<NUM>) having a transverse width, the mainsheet (<NUM>) having a fenestration (<NUM>) therein permitting access to a surgical region for performance of a surgical procedure when the drape (<NUM>) covers a patient during the surgical procedure, the mainsheet (<NUM>) having a head region for placement proximal a head of a patient during the surgical procedure and having a surgeon-facing side and a patient facing side;
a substantially transparent sheet (<NUM>) having a surgeon-facing side and a patient-facing side, the substantially transparent sheet (<NUM>) extending across the entire width of the surgical drape (<NUM>) and joined to the mainsheet (<NUM>) at said head region for providing the patient with visual access therethrough; and
a substantially opaque screen (<NUM>) attached to the patient-facing side of the substantially transparent sheet (<NUM>) and effective to occlude the patient's visual access through the substantially transparent sheet (<NUM>), said substantially opaque screen (<NUM>) being at least partially removable from said substantially transparent sheet (<NUM>) to thereby permit the patient's visual access through the substantially transparent sheet (<NUM>), said opaque screen (<NUM>) partially covering the transparent sheet (<NUM>).