This disclosure relates to a device for assisting a surgeon in making a surgical incision.
Currently, a traditional cesarean section procedure, also known as a “C-section,” is most commonly performed with the patient lying recumbent on an operating table. Generally, surgical patients are covered with a sterile surgical drape to isolate the area of the patient on which the surgery will be performed from the rest of the patient so that a sterile field can be created and maintained. In the case of a C-section, the area isolated by the drape is the patient's abdomen. A surgeon makes an incision in the abdomen in this isolated region.
C-section procedures necessarily leave the patient with a sizeable scar that may later be visible when the patient wears certain attire. For cosmetic purposes, it is desirable that the scar should be neat, bilaterally symmetric with respect to the centerline of the patient, and oriented generally perpendicular with regard to this centerline. With many conventional drapes, it can be difficult to achieve this result.
The portion of the surgical drape that overlays the patient's abdomen typically includes a fenestration that provides surgical access to the patient's abdomen. C-section procedures generate substantial amounts of bodily fluids, and it is necessary to mitigate the flow of these fluids to undesirable areas. To address this concern, it is known to fill the fenestration of the drape with an adhesive film known in the field as “incise film” and to provide a fluid collection pouch proximal the fenestration. The incise film covers the fenestration in the surgical drape, and is constructed of a material through which an incision in the patient's skin may be made. Via adhesive attachment to the patient, the incise film inhibits fluids generated during the surgical procedure from escaping beneath the drape. Fluids instead flow over the drape into the collection pouch.
The incise film is typically a flat film and it can be difficult to adhere the film to the patient's anatomy, which is very rounded. Also, the adhesive connection of the incise film to the underlying skin will often cause the underlying skin to bunch up or distort. This can result in an incision that is irregular in shape, despite the best efforts of the surgeon, and consequently may lead to a jagged scar. Also, fragments of the incise film may detach while the surgeon is making the incision and those small fragments may migrate into the incision, increasing the chances of an infection or otherwise inhibiting proper healing. Some surgeons do not prefer the tactile feel of cutting through incise film when making an incision.
In addition, with some known drapes, once the drape is placed over the patient and the area in which the surgery is to be performed is isolated, the surrounding anatomy of the patient is occluded by the opaque drape material. This can make it difficult for a surgeon to precisely locate and orient the incision. This configuration can lead the surgeon to make an incision that is not bilaterally symmetric or that is skewed relative to the patient's centerline.
A new device, namely, a surgical bib has now been devised, and a kit that includes the bib and a corresponding surgical drape are likewise disclosed herein. The flexible bib sheet is made of a flexible sheet of material having a patient-facing side and a surgeon-facing side opposite the patient-facing side. Generally, the surgical drape kit includes a fenestrated surgical drape and this flexible bib sheet. A bib fenestration is formed in the flexible bib sheet thereby permitting surgical access to a patient through the bib fenestration. The flexible bib sheet includes at least one surgical guide marking that is visible on the surgeon-facing side of the flexible bib sheet. The flexible bib sheet is sized such that it at least partially covers the fenestration in the surgical drape, and preferably substantially or completely covers the fenestration in the surgical drape when properly positioned in intended use.
At least a portion of the patient-facing side of the flexible bib sheet is covered with an adhesive field, either upon manufacture or by contemporaneous application of adhesive by the surgeon, or in some instances via application of supplemental adhesive to a bib that already includes a coating of adhesive. The adhesive field comprises an adhesive suitable for adhering a portion of the patient-facing side of the flexible bib to the patient's skin in an area surrounding the surgical site. The adhesive field of the surgical bib sheet may be covered with a removable film that may be removed to expose the adhesive at a time when the surgical bib is to be applied to the patient.
Although it is contemplated that the bib could be used with a full incise film drape, or with a drape having no incise film, more preferably the surgical drape is provided with a drape window that is only partially covered by incise film. This incise film includes an open fenestration intended to be placed proximal the portion of the patient's body where the incision is to be made, this open fenestration in the incise film defining the drape fenestration. The bib is used to assist the surgeon in more precisely locating and orienting the situs of the incision. When the surgical drape is placed over a patient, the flexible bib sheet is placed over the patient and positioned over the patient's body by aligning at least one surgical guide marking on the flexible bib sheet with at least one anatomic feature of the patient and by locating the surgical bib fenestration over the area of the patient in which an incision will be made. The bib may include a rule or scale to assist the surgeon in making a bilaterally symmetric incision.
The bib and drape may be provided together as a kit. The kit optionally may also include a container of adhesive, which may be used to provide supplemental adhesive or may be used as the primary source of adhesive if the bib is manufactured without its own coating of adhesive.
Referring to
The surgical drape 21 may be constructed of any suitable material. As shown, the main sheet 22 and the anesthesia screen 26 of the surgical drape 21 are constructed of a multi-layer combination of spunbond and meltblown materials, commonly referred to as SMS non-woven fabric. This combination provides a lightweight, durable, repellent, and flexible fluid barrier between the patient and the sterile filed that is easily drapeable and soft to the touch. The first and second side portions 24 and 25 are made of a flexible fluid impervious and nonabsorbent material, such as polyethylene film, or may be SMS as well.
Referring now to
As shown, the drape window 30 is partially covered by an incise film 31. The incise film 31, which may be formed from a polyurethane or other suitable material, is a substantially transparent film. Notably, in many embodiments the purpose of the incise film will be to provide adhesion and a fluid seal proximal the abdominal incision, Although the term “incise film” will be used, in these embodiments it is not necessarily intended for the surgeon to make an incision through the film. In any case, the incise film 31 has a patient-facing side which includes an adhesive field suitable for adhering the incise film 31 to the skin of the patient in an area where the surgical procedure is to be performed. Before the drape is to be used in a surgical procedure and during packaging and storage, the adhesive field on the patient-facing side of the incise film 31 is covered by a removable backing 34 (shown further in
In the illustrated embodiment, the incise film 31 includes a generally triangular-shaped drape fenestration 32 which defines the fenestration in the drape. The drape fenestration 32 is an open void in the incise film 31 that permits surgical access to a region of a patient on which a surgical incision is to be made. In other embodiments, the drape fenestration 32 may take any suitable shape and size that would facilitate providing surgical access to a region of a patient adequate for the specific surgical procedure that is to be performed. Alternatively, the drape window of the main sheet may not be covered with any incise film, or may be fully covered with incise film (not shown). It is contemplated that in embodiments wherein the drape window does not include incise film, the drape window will itself define the fenestration in the drape.
As shown, the surgical drape 21 includes a fluid collection pouch 35 that substantially surrounds the drape window 30 of the main sheet 22. The fluid collection pouch 35 is made of a plastic material that is impervious to fluid. The fluid collection pouch 35 surrounds the drape window 30 in a sealing fashion such that any fluids released from the surgical site during the procedure and flowing over the drape will run off the main sheet 22 and into the fluid collection pouch 35. This prevents fluids from running off the main sheet 22 and migrating through the drape window 30 and onto the patient or the surgical bed or the floor of the operating room, where fluids are not desired. The fluid collection pouch 35 may include one or more suction ports 40 for connection to suction equipment for aspirating the fluids from the fluid collection pouch 35. Because the region surrounding the drape fenestration 32 is adhesively secured to the patient, fluids are inhibited from escaping beneath the perimeter of the drape fenestration.
With reference to
With reference again to
The main sheet 22 also includes an optional absorbent pad 41, (shown in
Referring now to
Referring to
As shown, the flexible bib sheet 45 includes one or more surgical guide markings 52. The surgical guide markings 52 are printed in an area proximate to the bib fenestration 51. The surgical guide markings 52 are visible from the surgeon-facing side 46 of the flexible bib sheet 45 and to the extent that they are composed of letters or numerals are oriented to be read normally from the surgeon-facing side. The surgical guide markings 52 provide reference points to assist in locating and orienting the incision. With reference to
Referring to
In placing the flexible bib sheet 45 over the patient, the flexible bib sheet 45 is positioned over the drape fenestration 32 such that the bib fenestration 51 of the flexible bib sheet 45 is unobstructed by any portion of the incise film 31 and such that the bib fenestration 51 exposes an area of the patient's abdominal skin 42 at which the surgeon wishes to make an incision 60 (shown as a phantom line in
The surgeon may use the ordinate indicia 53 to align the flexible bib sheet 45 to the patient's anatomy before it is adhered to the patient. As shown, the ordinate indicia 53 include upper and lower arrows. The arrow pointing towards the patient's navel 44 may be aligned with the patient's navel 44. The arrow pointing away from the patient's navel 44 may be aligned with the patient's vagina. In this manner, the surgical bib may be positioned and adhered to the patient in a way that aligns the flexible bib sheet 45 along the centerline of the patient with the ordinate indicia 53 generally corresponding to the patient's centerline and lateral incision guide 54.
Because the flexible bib sheet 45 is substantially transparent, when it is positioned over the patient, the patient's anatomy may be viewable through the flexible bib sheet 45. For example, the patient's navel 44 is viewable through the flexible bib sheet 45. This allows the surgeon to position the flexible bib sheet 45 using surgical guide markings 52 with reference to the patient's anatomy visible through the flexible bib sheet 45.
Referring to
In another embodiment in which the patient-facing side 47 of the flexible bib sheet 45 is provided with adhesive field, adhesive 57 provided with surgical drape kit 20 may be used to supplement the adhesive properties of the adhesive field on the patient-facing side 47 of the flexible bib sheet 45. Alternatively, adhesive 57 may be applied to patient-facing side 47 of the flexible bib sheet 45 to restore its adhesive properties if, for example, the flexible bib sheet 45 must be removed and re-adhered to the patient's skin. Often when adhesive materials are removed from a patient's skin, they do not readily re-adhere to the patient's skin due to degradation of the adhesive or due to contamination of the adhesive field with other materials or fluids. Adhesive 57 may be used to restore or supplement adhesive properties of the flexible bib sheet 45 if it must be removed and repositioned. As shown, the bib and drape are physically separate components, although in some surgical applications it is contemplated that the bib may be pre-fastened to the drape.
In using the surgical drape kit 20 in a C-section procedure, the patient is first positioned on a surgical table and the surgical drape 21 is removed from the package 56. At this point, the surgical drape 21 may be enclosed within a secondary sterile wrapper (not shown). A member of the surgical team may remove the wrapped surgical drape 21 from the container, and, by using methods known in the field, may unwrap the surgical drape 21 and present it to a member of the surgical team that has performed decontamination, such that the sterile state of the surgical drape 21 may be maintained during setup of the surgical procedure. The drape and bib are placed as discussed above, and the surgeon may apply adhesive (or supplemental adhesive) to the bib. The bib may be used to assist in orienting and positioning the drape. In embodiments where the bib is pre-fastened, the bib and drape are placed at the same time. It is contemplated in such embodiments that the bib may be partially movable with respect to the drape to aid in orienting an incision. In any case, as heretofore indicated, the indicia may be used to place the incision and the straight edge 58 of the bib fenestration may be used to assist the surgeon in making a smooth, linear incision. Desirably, there is no incise film between the surgeon and the area of the abdomen immediately beneath the bib fenestration, such that there will be no bunching of the skin as might result in a jagged scar. The scale may assist the surgeon in achieving bilateral symmetry.
Via the adhesive connection of the bib to the patient surrounding the bib fenestration, and also because the drape incise film is adhesively secured to the patient, fluids released during the procedure will be inhibited from escaping beneath the drape. Instead, the fluids will be guided away over the bib and incise film into the fluid-collection pouch. The bib is preferably but not necessarily sized to completely cover the drape fenestration when in use. In such configurations, fluid will flow over the bib in areas above the drape fenestration, providing an additional safeguard against escaping fluids.
It is thus seen that the bib and kit are useful in assisting the surgeon in making a C-section incision are provided. It is contemplated that the procedure will assist the surgeon in leaving a scar that is neat and not jagged as a result of bunched incise film. Additionally, the bib assists in placing and orienting the incision such that the incision and resulting scar are bilaterally symmetric with respect to the centerline of the patient, and oriented generally perpendicular to the centerline rather than being skewed. Additionally, the bib and kit in some embodiments provide the heretofore described advantages of not requiring the incision to be made through incise film. The foregoing has been described with particular regard to C-section procedures, but the bib and kit are contemplated to find utility in other surgical applications.
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.