Abstract:
The invention comprises a surgical drape formed of a sheet material having a periphery and with a particular type of aperture spaced from periphery. The invention further comprises a method of using the drape. The aperture has a dominant portion and at least one subordinate portion. At least one subordinate portion of the aperture radially extends from the dominant portion. An adhesive layer may underlie an area surrounding the aperture.

Description:
TECHNICAL FIELD 
   The present invention relates generally to surgical drapes and methods of applying same, and more particularly to apertured surgical drapes, especially those utilized in ophthalmic procedures or the like, and methods of applying such drapes. 
   BACKGROUND OF INVENTION 
   Maintenance of a sterile field is critical in surgical applications. Conforming a surgical drape to the patient is of considerable importance, as evidence by the number of issued patents directed to drape configuration and arrangement, let alone the number of commercially available drapes. 
   In ophthalmic procedures, it is advantageous to apply a surgical drape which permits isolation of the eye lashes and eyelids from the surgical site in furtherance of exposure of the eye, and provides a sterile drape surface to minimize infection at the site. Such is the case in refractive surgery wherein draping may be primarily performed to retract the eyelids and lashes from the surface of the eye, thereby keeping those structures clear of surgical instruments such as microkeratomes. As practitioners have come to learn, manipulation of eye structures in furtherance of ophthalmic surgery, while maintaining a sterile field, is not without its inherent and practical difficulties. 
   As the eye is a delicate structure, with the eyelids being very flexible and of unique configuration and dimension from one patient to the next, practitioners find it inconvenient and challenging to conform the margins of the aperture to the edges of a particular patient&#39;s eyelids. This however does not mean a one size fits all approach is taken, instead, one know technique is to cut the drape, at least partly and especially to extend outward from the aperture, prior to applying same to the patient. By doing this, tension is relieved in stressed or stretched areas (i.e., resulting from substantially conforming the aperture margins to the eye structures), and bunching of the adhesive field/layer avoided. Furthermore, cutting the drape prior to application facilitates application of the drape first, for instance, to the upper eyelid, without adhering the lower portions of the adhesive layer to the lower eyelid until ready to do so. In addition to the general inconvenience of requiring the presence of a sterile scissor or the like, making an appropriate cut while attempting to preserve drape sterility is not necessarily achievable. 
   In lieu of practitioners cutting the drape as they had been inclined to do, drape designers next provided drapes having tear lines extending from the aperture so as satisfy objectives of conforming the drape to the surgical site (i.e., matching the margins of the aperture to the edges of the eyelids), and facilitating sequenced placement (i.e., positioning on a first eyelid, followed by positioning on a second eyelid). Such approach is discussed in U.S. Pat. No. 6,286,511 (Levitt et al.). Furthermore, drapes have been supplied in sections (i.e., halves), with each part of the whole separately and accurately applied to the patient. Although such styles or approaches have been perceived as an improvement, both require an attention to detail than makes application of the drape more time consuming that one might imagine, especially the two-piece style, with drapes having a tear line nonetheless requiring manipulation by a practitioner (i.e., tearing). Thus there remains a need to provide an apertured surgical drape which is quickly and readily applied so as to establish and reliably maintain a sterile field about the work site. 
   SUMMARY OF THE INVENTION 
   A surgical drape including a sheet material having a periphery and an aperture spaced apart from said periphery is provided, along with an attendant methodology. The aperture has a dominant portion and at least one subordinate portion, the at least one subordinate portion radially extends from the dominant portion. More specific features and advantages will become apparent with reference to the DETAILED DESCRIPTION OF THE INVENTION, appended claims, and the accompanying drawing figures. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a plan view of a surgical drape of the subject invention; 
       FIG. 2  is a partial cross-section view of the drape of  FIG. 1  taken about line  2 — 2 ; and, 
       FIG. 3  illustrates the drape of the subject invention in an applied condition, more particularly the primary portion, the aperture therein having a deformed margin in furtherance of sterile field establishment. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   The surgical drape of the subject invention is particularly well suited for ophthalmic procedures, but is not so limited. For instance, extremity surgeries, ear, nose or throat procedures, breast surgery, etc., are likewise contemplated. The subject invention is subsequently described in detail in the context of ophthalmic surgery. 
   Referring to  FIGS. 1 &amp; 2 , there is generally shown the surgical drape  10  of the subject invention. The drape includes a sheet material  12  having a periphery  14  and an aperture  16  spaced apart therefrom. The aperture  16 , which is generally of an elongate character, has a dominant portion  18 , and at least a single subordinate portion  20  radially extending from the dominant portion  18 . As shown in the figures, the aperture  16  preferably, but not necessarily, includes opposingly paired subordinate aperture portions. 
   In the embodiment shown, the sheet material  12  of the drape  10  includes a line of weakness  22  extending substantially parallel to an axis of elongation  24  of the aperture  16  so as to divide the drape  10  into primary  26  and secondary  28  portions. The sheet  12  further includes an adhesive layer  30  on a surface thereof, in the vicinity of the aperture  16 , with such adhesive layer  30  being well know to those of skill in the surgical drape art. The adhesive  30  generally surrounds the aperture  16  in furtherance of initially, and finally, positioning and securing the drape  10  at the surgical site, more particularly, the adhesive  30  is at least adjacent the dominant portion  18  of the aperture  16 , and preferably further adjacent at least a portion of the subordinate portion  20  of the aperture  16 . A release liner  32 , of the form and substance generally known to those of skill in the art, generally overlays the adhesive layer  30 . 
   The aperture  16  is preferably, but not critically, centrally located within the periphery  14  of the sheet material  12 . Similarly, in the context of sheet material configured as a parallelogram, it is advantageous but not essential that the aperture  16  have its axis of elongation  24  normal to a portion of the periphery  14  (i.e., the elongate aperture  16  is substantially parallel to a first set  34  of opposing drape edges, and substantially perpendicular to a second set  36  of opposing drape edges). 
   As previously noted, the aperture  16 , which is preferably but not necessarily die cut from the sheet material  12 , comprises a dominant portion  18  and at least one subordinate portion  20 , a description of the functionality of said portions being reserved for discussion relative to FIG.  3 . The dominant portion  18 , as shown, resembles an oval, however other curved, symmetrical or otherwise, or non-curved (i.e., angular) configurations are contemplated, the critical consideration being structure permitting sterile access to a surgical/incision site, or more broadly, a work site. Although the shape of the dominant portion  18  of the aperture  16  may be, and is likely to be, elongate, the at least one subordinate portion  20  extending radially therefrom will substantially define an elongate aperture  16  for the drape  10 . 
   The at least one subordinate aperture portion  20  is generally elongated (i.e., this portion has a length and width dimension, the length dimension exceeding the width dimension), being preferably slot or finger like in appearance (i.e., being delimited by parallel lines joined at their free ends, as by a uniform curve as shown, or other linkage configuration). The at least one subordinate aperture portion  20  may likewise be delimited by converging lines extending from a periphery or margin  38  of the dominant aperture portion  18  (see FIG.  3 ). 
   The subordinate aperture portion  20  generally has a minimum dimension less than the minimum dimension of the dominant aperture portion  18 . Each of the opposingly paired subordinate aperture portions  20  of  FIG. 1  preferably terminate within the foot print of the underlaying adhesive layer  30 /release liner  32 , however, as indicated by the dashed lines in  FIG. 1 , they need not. In other words, the subordinate aperture portion  20  may have a maximum dimension greater than the maximum dimension of the dominant portion aperture portion  18  (i.e., dashed lines of FIG.  1 ), however, it is preferable that the maximum dimension of the at least one subordinate aperture portion  20  not exceed that of the dominant aperture portion  18 . 
   In the preferred embodiment, the drape  10  is generally dimensioned as a square, about 16″×16″. The line of weakness  22  is positioned about 4″ from an edge of the drape so as to delimit the primary  26 , about 16″×12″, and secondary  28 , about 16″×4″, drape portions. As previously noted, the aperture  16  is centrally positioned relative to the periphery  14  of the drape  10 , and is generally centrally positioned with respect to the adhesive layer  30 /release liner  32 , typically about a 3″×4″ area. The dominant aperture portion  18  is preferably dimensioned as a 1″×1.5″ oval, the subordinate aperture portion  20  having a width of about 0.25″ and a length range dimension of about 0.5″ to 1.5″ 
   Referring now to  FIG. 3 , the drape  10  of the subject invention is illustrated in an applied condition, in anticipation of a surgical procedure, for example a lasik procedure. As shown, the secondary portion  28  of the drape  10  has been removed, an expedient for such procedure, the primary drape portion  26  remaining. The line of weakness  22  offers an adaptability for the drape not otherwise available in ophthalmic drapes. 
   Post removal of the release liner  32 , the aperture  16  of the drape  10  is aligned in a position so as to centrally overlay the work site, more particularly, the dominant aperture portion  18  is to overlay the work site. The dominant aperture portion  18  is the gateway to the work site, the at least one subordinate aperture portion  20  permitting deformation of the margins  38  of the aperture  16 , more particularly the dominant aperture portion  18 , in furtherance of adhering the drape and establishing the sterile field. 
   Application of the drape  10  includes deforming the margin  38  of the dominant aperture portion  18  such that the subordinate aperture portion  20  extending therefrom respondingly deforms so as to provide improved compliance for the dominant aperture portion  18  in and about the surgical site. In this way, and by the structures of the subject drape invention, the drape may be easily adhered to both the upper and lower margins of the eye without requiring the use of separate instruments for cutting and adjusting. No mutilation of the drape as by breaking a tear line is required so as to obtain a conforming application of the drape to the work site, furthermore, a quickly set and reliable sterile field is established with ease. 
   It will be understood that this disclosure, in many respects, is only illustrative. Changes may be made in details, particularly in matters of shape, size, material, and arrangement of parts without exceeding the scope of the invention. Accordingly, the scope of the invention is as defined in the language of the appended claims.