Patent Abstract:
A retracting eye drape assembly is disclosed for use around a patient&#39;s eye to seclude and seal off the operative field during eye surgery. The drape assembly includes a retraction member connected to the drape and configured to engage the patient&#39;s eyelid, an extension member connected to the retraction member or to the drape and configured to substantially enclose the patient&#39;s eyelid, and a retraction flap configured to secure the patient&#39;s eyelid in a substantially retracted position. A method of applying an eye drape assembly is disclosed. After application of the drape to the patient&#39;s face, and while the patient&#39;s eyelid is closed, the patient&#39;s eyelid is engaged by a retraction member connected to the drape and retracted. While retracted, the patient&#39;s eyelid is substantially enclosed to seclude the eyelid and eyelashes from the operational area. The secluded eyelid and eyelashes are then secured in a retracted position.

Full Description:
PRIORITY CLAIM 
     This application is a Continuation of Ser. No. 11/467,090 filed on Aug. 24, 2006, which is a Divisional of U.S. application Ser. No. 10/999,240, filed Nov. 30, 2004, which application claims priority to U.S. Provisional Application Nos. 60/526,443, filed Dec. 2, 2003, and 60/620,248, filed Oct. 19, 2004. 
    
    
     FIELD OF THE INVENTION 
     This invention relates generally to surgical eye drapes and, more specifically, to a system and method for a retracting eye drape. 
     BACKGROUND OF THE INVENTION 
     As part of virtually every eye surgery, the facial area around the eye must be sealed off to expose the eye to the surgeon. Various techniques have been used to accomplish this goal. Most of the techniques incorporate the use of a sterilized surgical drape, typically made of plastic, having adhesive on one surface, together with an eyelid retraction device, typically a speculum. 
     The typical prior art technique for draping an eye  10  having an upper eyelid  12  with upper eyelashes  14  and a lower eyelid  16  having lower eyelashes  18  for surgery is described with reference to  FIGS. 1-3 . As shown in  FIG. 1 , the patient&#39;s upper eyelid  12  is held open, preferably with a sterile finger or tool (e.g., cotton tipped applicator stick) and the patient is asked to look down. A drape  20  having an adhesive surface  22  and a non-adhesive surface  24  is applied to the facial area  28  around the eye  10 . After application of the drape with the eye open underneath the drape, a slit  26  is carefully cut extending at least the width of the eye. After the slit is cut in the drape, the drape  20  is positioned over the eye such that the slit  26  extends transversely over the eye and the drape extends to cover both the upper eyelid  12  (in its partially retracted position) and the lower eyelid  16 . 
     As shown in  FIGS. 2 and 3 , once the drape is securely in place on the facial surface around the eye, a retractable eyelid speculum  30  having an upper arm  32  and a lower arm  34  is used to fully retract both eyelids. With reference to  FIG. 2 , a portion of the drape extending over the eye  10 , lower eyelid  16  and lower eyelashes  18  is folded under the lower eyelid and lower eyelashes and held in place, in a retracted position, by the lower arm  34  of the speculum  30 . With reference to  FIG. 3 , a portion of the drape extending over the eye  10 , upper eyelid  12  and upper eyelashes  14  is folded under the upper eyelid and upper eyelashes and held in place, in a retracted position, by the upper arm  32  of the speculum  30 . The drape  20  is maintained in place with relation to the eye by the adhesive surface  22  and the eye is fully exposed, in an open position, by virtue of the speculum  30  retracting both upper and lower eyelids and eyelashes. 
     As illustrated in the above description of the prior art technique, the available drapes require the eyelids to be held open while the drape is applied. This is awkward and cumbersome, and uncomfortable to the patient. Additionally, these techniques frequent result in a mild abrasive effect on the corneal surface during application of the drape. This in turn can make visualization of the eye difficult during surgery. In addition, as described above, the surgeon often has to cut an opening in the drape. This is frightening to the patient, and increases the likely hood of cutting skin, or cutting an eyelash, or abrading the cornea. Frequently, the patient manages to squeeze their eyelids closed under the drape, eliminating the overlap of the drape to the lid margin, thus making it impossible for the drape to wrap around the lid margin. 
     Accordingly, there is a need for a system and method for a retracting eye drape that is easily applied without requiring the eyelids to be held open, that facilitates the incorporation of the eyelashes and lid margin and that reduces the possibility of corneal surface abrasion. 
     SUMMARY OF THE INVENTION 
     The present invention provides a retracting eye drape assembly for use around a patient&#39;s eye to seclude and seal off the operative field during eye surgery. The drape includes a non-adherent side and an adherent side, the adherent side amendable to adherence to the patient&#39;s facial area around the patient&#39;s eye. The drape assembly further includes a retraction member configured to engage the patient&#39;s eyelid, an extension member configured to substantially enclose the patient&#39;s eyelid, and a retraction flap configured to secure the patient&#39;s eyelid in a substantially retracted position. 
     The present invention further provides a method for applying a drape assembly for use around a patient&#39;s eye to seclude and seal off the operative field during eye surgery. The adherent side of a drape having a non-adherent side and an adherent side is applied to the patient&#39;s facial area around the patient&#39;s eye. While the patient&#39;s eyelid is closed, the patient&#39;s eyelid is engaged by a retraction member connected to the drape. The patient&#39;s eyelid is retracted using the retraction member. While retracted, the patient&#39;s eyelid is substantially enclosed to seclude the eyelid and eyelashes from the operational area. The secluded eyelid and eyelashes are then secured in a retracted position. 
     As will be readily appreciated from the foregoing summary, the invention provides system and method for a retracting eye drape that is easily applied without requiring the eyelids to be held open, that facilitates the incorporation of the eyelashes and lid margin that eliminates the need to cut the drape open and that reduces the possibility of corneal surface abrasion. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Preferred and alternative embodiments of the present invention are described in detail below with reference to the following drawings. 
         FIG. 1  is an illustration of a prior art drape being applied around a patient&#39;s eye; 
         FIG. 2  is an illustration of a speculum used with a prior art drape to retract a patient&#39;s lower eyelid; 
         FIG. 3  is an illustration of a speculum used with a prior art drape to retract a patient&#39;s upper eyelid; 
         FIG. 4  is an illustration of a drape system in accordance with the invention; 
         FIG. 5  is an illustration of the underside of a retraction member of the drape system shown in  FIG. 4 ; 
         FIG. 6  is an illustration of the drape system shown in  FIG. 4 , further including protective sheets; 
         FIG. 7  is an illustration of preferred dimensions for aspects of a drape system in accordance with the invention; 
         FIG. 8  is an illustration of preferred dimensions for aspects of the underside of a retraction member of a drape system in accordance with the invention; 
         FIG. 9  is an illustration of preferred dimensions for aspects of the underside of a drape system in accordance with the invention; 
         FIG. 10  is an illustration of a folded drape system in accordance with the invention; 
         FIG. 11  is an illustration of a drape system in accordance with the invention wherein the drape is folded and applied to a patient&#39;s face from a horizontal configuration. 
         FIG. 12  is an illustration of a drape system in accordance with the invention wherein the drape is folded and applied to a patient&#39;s face from a vertical configuration. 
         FIG. 13  is an illustration of a drape system in accordance with the invention being applied around a patient&#39;s eye; 
         FIG. 14  is an illustration of a speculum used with a drape system in accordance with the invention, the speculum being applied to retract a patient&#39;s upper eyelid; 
         FIG. 15  is an illustration of a drape in accordance with the invention wherein a non-adhesive extension includes a small wire or other rigid but malleable material; 
         FIG. 16  is an illustration of a drape system in accordance with the invention wherein a non-adhesive extension is formed of a firm plastic or other substantially rigid material; 
         FIG. 17  is an illustration of a drape system in accordance with the invention wherein a non-adhesive extension is formed of a plastic or other substantially rigid material in the shape of a hook; 
         FIG. 18  is an illustration of a drape system in accordance with the invention wherein hooks as a speculum action members; 
         FIG. 19  is an illustration of the drape system shown in  FIG. 18 , further including bridging elements; 
         FIG. 20  is an illustration of a drape system in accordance with the invention that incorporates the use of a self-adherent retraction member underneath the retraction member; 
         FIG. 21  is an illustration of a drape system in accordance with the invention that incorporates the use of a self-adherent area located underneath the a retraction member; 
         FIG. 22  is an illustration of a drape system in accordance with the invention that incorporates the use of a self-adherent area that lies underneath a retraction member as well as the use of malleable shafts affixed to the retraction member; 
         FIG. 23  is an illustration of a drape system in accordance with the invention that incorporates rotatable “J” shaped rods used to form hooks used to retract a patient&#39;s eyelid, wherein the rods are in a retracted configuration; 
         FIG. 24  is an illustration of the rod assembly of the drape system shown in  FIG. 23 , wherein the rods are in an extended, hook configuration; 
         FIG. 25  is an illustration of a drape system in accordance with the invention that incorporates an additional hook extension along with the hooks as a continuation of a non-adherent extension of a retraction member; 
         FIG. 26  is an illustration of a drape system in accordance with the invention that incorporates the use of a self-adherent area that lies underneath a retraction member as well as several non-continuous cuts between the self-adherent area and the retraction flap; 
         FIG. 27  is an illustration of the drape system shown in  FIG. 26 , further including bridging elements; 
         FIG. 28  is an illustration of a drape in accordance with the invention that incorporated the use of multiple self-adherent areas; 
         FIG. 29  is an illustration of a drape system in accordance with the invention that incorporates the use of a self-adherent area underneath a retraction member along with reinforcing strips that connect hooks to a strip extension having an adherent portion; 
         FIG. 30  is an illustration of the drape system shown in  FIG. 29 , further including bridging elements; 
         FIG. 31  is an illustration of a drape system in accordance with the invention that incorporates elastic strips or rubber bands; 
         FIG. 32  is an illustration of a drape system in accordance with the invention that incorporates a single continuous drape folded into segments; 
         FIG. 33  is an illustration of the underside of the drape system shown in  FIG. 32 ; and 
         FIG. 34  is an illustration of a drape system in accordance with the invention that incorporates an integrated weight. 
         FIG. 35  is an illustration of a drape system in accordance with the invention that incorporates the use of a non-adherent extension located on a second layer rather than attached to a retracting member; and 
         FIGS. 36-38  are illustrations of a drape system in accordance with the invention that incorporates the use of a non-adherent extension located on a second layer rather than attached to a retracting member, further including the use of hooks. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     The present invention provides a new type of draping system, and method of applying the drape, prior to eye surgery. The drape is applied with the patient&#39;s eye closed, reducing the discomfort to the patient and risk of corneal surface abrasion. The drape and method of application also make it easier and less cumbersome for the surgeon to apply. 
     With reference to  FIG. 4 , a drape  100  is described having an adhesive surface  102 , a non-adhesive surface  104 , and a retraction area  106 . Prior to application of the drape  100 , the adhesive surface  102  is protected by a protective sheet (not shown) that can be pulled away to expose the adhesive surface  102 . The retraction area  106  includes an open area  108  in the non-adhesive surface  104  and two retracting elements, an upper retraction member  110  and a lower retraction member  112 , preferably attached to the non-adhesive surface  104  at upper member base  114  and lower member base  116 , respectively. 
     Each retraction member  110 , 112  includes a non-adhesive extension  118 , 120 , respectively. The non-adhesive extensions  118 , 120  are preferably rectangular in shape, but may be of varied shape, for example, tapered, trapezoidal, semicircular, etc. The non-adhesive extensions  118 , 120 , when extended, are preferably of sufficient length to wrap around the lid margin of eyelid  12 , 16 . When folded, as shown in  FIG. 4 , the non-adhesive extensions  118 , 120  create a retraction gap  124  between edges  126 , 128  of the non-adhesive extensions  118 , 120 . Each retracting member  110 , 112  preferably includes a retraction flap  130 , 132 . 
     The corresponding upper and lower elements of the drape system of the present invention preferably exhibit similar functionality and structural characteristics. Accordingly, throughout this application the description of an upper element, for example, an upper retraction member  110 , an upper non-adhesive extension  118 , or an upper retraction flap  130 , shall be understood to describe the characteristics of the corresponding lower element. 
     As shown with reference to  FIG. 5 , the underside of the retraction member  110  includes an adhesive portion  134 . In addition, the underside of the retraction flap  130  includes an adhesive portion  136 . Prior to application of the adhesive portions  134 , 136 , the adhesive portions are protected by material that can be pulled away to expose the adhesive area. The adhesive portion  136  in these and other embodiments may consist of glue, Velcro (with a corresponding material loop for securing the Velcro connection), button, snap or sliding snap or connection mechanism or other attachment means. 
     More specifically, with reference to  FIG. 6 , a protective sheet  138  is present along the underside of the retraction member  110  to prevent premature adhesion by the adhesive portion  134 . The protective sheet  138  is preferably made out of a relatively stiff material that is larger than the open area  108  in order to stabilize the retraction member  110  with respect to the open area  108  until application of the adhesive portion  134  of the extension. Alternatively, the protective sheet  138  may be continuous with the larger protective sheet (not shown) which protects the adhesive surface  102  of drape  100 , and other means may be used to stabilize the extension during application, for example, removable attachments between the retraction member  110  and the drape  100 . A protective sheet  140  is present along the underside of the retraction flap  130  to prevent premature adhesion by the adhesive portion  136 . Again, the protective sheet  140  is preferably made out of a relatively stiff material that is larger than the retraction flap  130  in order to stabilize the retraction flap with respect to the retraction member  110  until application of the adhesive portion  136  of the retraction flap. 
       FIGS. 7-9  show one embodiment of the drape system of the present invention setting forth preferred dimensions for above-described features of the retraction area  106 . These specific dimensions are exemplary only and may be varied to meet design, manufacturing or patient criteria without departing from the scope of the present invention. Assuming a 100 mm square section of drape, the retraction area  106  is defined as a rectangle approximately 38 mm long by 40 mm wide. The retraction members  110 , 112  extend towards each other approximately 16 mm from the upper member base  114  and lower member base  116 , respectively. The retraction members  110 , 112  are folded along edges  126 , 128  to define the non-adhesive extensions  118 , 120 , respectively, creating a retraction gap  124  of approximately 6 mm between the retraction members  110 , 112 . The non-adhesive extensions  118 , 120  are approximately 8 mm in length and may vary in width depending on the shape of the non-adhesive extension. As shown with respect to  FIG. 7 , which illustrates a tapered shape for the non-adhesive extensions  118 , 120 , the width of the non-adhesive extensions is 20 mm. 
     As better described with reference to  FIG. 8 , the adhesive portion  134  of the retraction member  110  is preferably centered along the edge  126 , approximately 20 mm in width, and extending away from the edge  126  approximately 4 mm. 
     As better described with reference to  FIG. 9 , the retraction flap  130  is preferably formed approximately 7 mm from the edge  126  of the non-adhesive extension  118 . The length of the retraction flap  130  is approximately 16 mm. The width of the retraction flap  130  at their tapered-most edge is approximately 20 mm. The width of the retraction flap  130  at their tapered-most edge preferably corresponds to the width of the adhesive portion  134  to facilitate even pull along the eyelid during application of the drape system. In a preferred embodiment, the adhesive portion  136  of the retraction flap  130  is removed from the tapered edge of the retraction flaps to allow the surgeon to manipulate the retraction flaps without prematurely engaging the adhesion. 
     For purposes of storage, packaging, display and transportation, and prior to application, the draping system of the present invention may be folded either horizontally or vertically. In one embodiment, as shown with reference to  FIGS. 4 and 10 , the drape  100  is folded along the midway point  122  of the retraction area  106  such that the retraction gap  124  between edges  126 , 128  of the non-adhesive extensions  118 , 120  is preserved. Alternatively, the drape  100  may be folded lengthwise along the midpoint (not shown) of the retraction area  106 . 
     The method of application of the embodiment of the drape system described above is as follows. Prior to application of the drape  100 , the drape system is removed from its storage location or packaging. Depending on the manner in which it is stored or packaged, the drape system will initially be folded in either a horizontal or vertical configuration. Initially, the protective sheet (not shown) covering the adhesive surface  102  of the drape  100  is removed. In a preferred embodiment, the protective sheet would consist of two halves to facilitate the ease of application. The application of the drape begins with the patient&#39;s eye  10  closed. The adhesive surface  102  is applied to the facial area  28  around the eye  10 . As shown with respect to  FIGS. 11 and 12 , a surgeon will typically apply the drape either from the top or the side of the patient&#39;s head.  FIG. 11  shows one example of how a drape folded in a horizontal configuration may be positioned and applied.  FIG. 12  shows one example of how a drape folded in a vertical configuration may be positioned and applied. In either case, the surgeon uses the retraction gap  124  in the retraction area  106  to align the patient&#39;s eye. In the single-fold embodiment shown, one half of the folded drape is aligned and applied, after which the second half of the drape is aligned and applied. Alternative embodiments may include drapes folded more than once, in which case multiple folded drape sections may be aligned and applied. 
     More specifically, with reference to  FIG. 13 , the drape  100  is positioned around the eye such that the upper eyelid  12  with upper eyelashes  14  and a lower eyelid  16  having lower eyelashes  18  of the eye  10  is exposed through the retraction gap  124  between edges  126 , 128  of the non-adhesive extensions  118 , 120 . 
     The protective sheet  138  corresponding to the retraction member  110  is removed, exposing the adhesive portion  134  along the underside of the retraction member  110 . The adhesive portion  134  of the retraction member  110  is applied to the facial surface along the upper eyelid  12 . This step is repeated for the protective sheet  138  corresponding to the retraction member  112 . The protective sheet  138  is removed, exposing the adhesive portion  134  along the underside of the retraction member  112 . The adhesive portion  134  of the retraction member  112  is applied to the facial surface along the lower eyelid  16 . 
     The protective sheet  140  corresponding to the retraction flap  130  is removed and the retraction flap is pulled in a direction away from the eye  10  to pull open the upper eyelid  12 . The adhesive portion  136  along the underside of the retraction flap  130  is applied to the drape  100  to secure the upper eyelid in its retracted position. This step is repeated for the protective sheet  140  corresponding to the retraction flap  132 . The protective sheet  140  corresponding to the retraction flap  132  is removed and the retraction flap is pulled in a direction away from the eye  10  to pull open the lower eyelid  16 . The adhesive portion  136  along the underside of the retraction flap  132  is applied to the drape  100  to secure the lower eyelid in its retracted position. 
     In the preferred embodiment, the adhesive portion  134  of both retraction members  110 , 112  is applied before the upper and lower eyelids are retracted. The adhesive portion  134  of the retraction member  110  may be applied and the corresponding upper eyelid  12  retracted and secured using the retraction flap  130  prior to application of the adhesive portion  134  of the retraction member  112  and retraction of the corresponding lower eyelid  16 . Alternatively, the adhesive portion  134  of the retraction member  112  may be applied and the corresponding lower eyelid  16  retracted and secured using the retraction flap  132  prior to application of the adhesive portion  134  of the retraction member  110  and retraction of the corresponding lower eyelid  12 . 
     The non-adhesive extensions  118 , 120  of the retraction members  110 , 112  are tucked underneath the retracted upper eyelid  12  and lower eyelid  16 , respectively. This may occur in any order. A retractable eyelid speculum  30  having an upper arm  32  and a lower arm  34  is used to hold the eyelids open and to maintain the non-adhesive extensions  118 , 120  tucked underneath the retracted upper and lower eyelids. In one embodiment, shown with reference to  FIG. 14 , the non-adhesive extension  118  is folded around and tucked underneath the retracted upper eyelid  12  and held in place, in the retracted position, by the upper arm  32  of the speculum  30 . The process is repeated with respect to the lower eyelid  16 , wherein the non-adhesive extension  120  is folded around and tucked underneath the retracted lower eyelid  16  and held in place, in the retracted position, by the lower arm  34  of the speculum  30 . Maintaining the non-adhesive extensions  118 , 120  around the upper and lower eyelids  12 , 16  and corresponding upper and lower eyelashes  14 , 18  reduces potential interference with the surgery by the lids and eyelashes and keeps the surgical area clear of potential debris and bacteria from the lid margin and eyelashes. 
     The drape  100  is maintained in place with relation to the eye  10  by the adhesive surface  102 . The adhesive portions  134 , 136  together maintain the eyelids in a retracted state. In this embodiment, in addition to maintaining the non-adhesive extensions  118 , 120  folded around the lids and eyelashes, the speculum  30  further serves to maintain the lids in a retracted state. 
     Alternative configurations of the non-adhesive extensions  118 , 120  are contemplated and described below. Modifying the non-adhesive extensions to more securely hold the eyelid in a retracted position to reduce or eliminate the necessity of an eyelid speculum. While only embodiments describing one of the non-adhesive extensions  118 , 120  are described, these alternative systems are equally applicable to both non-adhesive extensions. 
     In one such embodiment, shown in  FIG. 15  with reference to the non-adhesive extension  118 , the non-adhesive extension includes a small wire or other rigid but malleable material  140  nonabrasively embedded along the non-adhesive extension edges  142  and partially along the adjoining edge of the retraction member  110 . When the non-adhesive extension  118  is folded around and tucked underneath the retracted upper eyelid  12 , the wires are folded as well, and in holding their newly folded shape maintain the non-adhesive extension  118  folded around the eyelids and eyelashes. 
     In yet another embodiment, shown in  FIG. 16  with reference to the non-adhesive extension  118 , the non-adhesive extension is formed of a firm plastic or other substantially rigid material. The action of folding the rigid non-adhesive extension  118  around and tucking it underneath the retracted upper eyelid  12  lodges the rigid non-adhesive extension under the eyelid where it is unable to independently dislodge from under the eyelid, thereby securely maintaining the eyelids and eyelashes in the retracted position. 
     In an alternative embodiment, the shape of the non-adhesive extension is altered to mirror the functionality of an eyelid speculum. In one example, shown in  FIG. 17  with reference to the non-adhesive extension  118 , the non-adhesive extension is formed of a plastic or other substantially rigid material in the shape of a hook  146 . In this embodiment, as the retraction flap  130  pulls the lower eyelid  12  and lower eyelashes  14  away from the eye  10 , the hook  146  of the non-adhesive extension  118  engages and captures the lower eyelid and eyelashes, retracting them away from the eye and maintaining them in a retracted position by virtue of the strength of the rigid hook  146 . 
     Further alternative embodiments of the present invention exist that eliminate the need for an external eyelid speculum to hold the eyelids open and to maintain the non-adhesive extensions  118 , 120  folded around the eyelids and eyelashes. Such embodiments involve initial retraction of the eyelid in order to apply a speculum action member, after which the speculum action member is used to independently retract and secure the eyelid and eyelashes. In these embodiments there is preferably relative movement between the device used to initially retract the eyelid and the speculum action member. This relative movement facilitates both the application of the speculum action member and the subsequent movement of the speculum action member. Many such alternative embodiments also provide additional benefits, such as the reduction of surgeon manipulation required to apply the drape or an increase in sterilization protection. 
       FIG. 18  illustrates an alternative embodiment using hooks as speculum action members. In this embodiment, a plurality of hooks  150  are attached to the retraction member  110  and non-adherent extension  118 . In a preferred application, a surgeon inserts one sterilized finger or tool (not shown) under the retraction flap  130  and directly retracts the eyelid  12 . Once the eyelid and eyelashes have cleared the hooks  150 , the surgeon uses a sterilized hand or other tool (not shown) to engage the hooks  150  and non-adherent extension  118  around the eyelid  12 . The retraction flap  130  is then pulled away from the eye  10 , which causes the hooks  150  and non-adherent extension  118  and, correspondingly, the eyelid  12  and eyelashes  14  secluded therein, to retract. The adherent portion  136  on the underside of the retraction flap  130  is applied to the non-adhesive surface  104  of the drape  100  to secure the retraction flap  118 , the hooks  150  and non-adherent extension  118 , and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system. 
       FIG. 19  illustrates an alternative embodiment of the drape system described above with reference to  FIG. 18 . This embodiment incorporates the use of bridging elements to maintain the retraction members  110 , 112  in position within the retraction area  106  until retraction of the eyelids occurs. The bridging elements are preferably made of the drape material and formed during creation of the drape system. The bridging elements are preferably formed of a thin, strip material that is easily broken upon application of a degree of force. Alternatively, the bridging elements may be made of any type of connectable material independent of the creation of the other aspects of the drape system. In an alternative embodiment (not shown), the bridging elements maintain the retraction members  110 , 112  in position within the retraction area  106  via other connections, for example, connections between the extension flaps  118 , 120  rather than between the retraction members  110 , 112  and the drape  100 . The bridging elements may be incorporated into many of the alternative drape systems described herein. 
     As shown in  FIG. 19 , bridging elements  152  preferably extend between the edge  126  of the retraction member  110  and the drape. As the surgeon inserts one sterilized finger or tool (not shown) under the retraction flap  130  and directly retracts the eyelid  12 , the bridging elements  152  maintain the retraction member  110  in place with respect to the eye  10 . As the retraction flap  130  is pulled away from the eye  10 , causing the hooks  150  and non-adherent extension  118  and, correspondingly, the eyelid  12  and eyelashes  14  secluded therein, to retract, the bridging elements  152  are broken, allowing the retraction flap  130  to be retracted. This process may be repeated for the corresponding lower elements of the drape system. 
       FIG. 20  illustrates an alternative embodiment of the drape system that eliminates the need for a surgeon to directly contact the patient&#39;s skin during application. This embodiment incorporates the use of a self-adherent retraction member  154  that lies underneath the retraction member  110  and extends towards the eye  10  beyond the edge  126  of the non-adherent extension  118 . When the drape is applied, the self-adherent retraction member  154  is adhered to the upper eyelid  12 . Subsequently during the application of the drape system, a surgeon inserts a finger or tool (not shown) under the retraction flap  130  and retracts the eyelid  12 , this time by pulling the self-adherent retraction member  154  and the upper eyelid  12  and eyelashes  14  away from the eye  10 . Once the eyelid and eyelashes have cleared the hooks  150 , the surgeon uses a sterilized hand or other tool (not shown) to engage the hooks  150  and non-adherent extension  118  around the eyelid  12 . The retraction flap  130  is then pulled away from the eye  10 , which causes the hooks  150  and non-adherent extension  118  and, correspondingly, the eyelid  12  and eyelashes  14  secluded therein, to retract. The adherent portion  136  on the underside of the retraction flap  130  is applied to the non-adhesive surface  104  of the drape  100  to secure the retraction flap  118 , the hooks  150 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system. 
       FIG. 21  illustrates an alternative embodiment of the drape system that eliminates the need for a surgeon to directly contact the patient&#39;s skin during application, this time by taking advantage of the inherent elasticity of the drape and the close positioning of the hooks  150  to the eyelid  12 , and the more remote position of the adhesive area  156  in relation to the hooks  150 , to allow for relative movement between the adhesive area  156  and hooks  150 . This embodiment incorporates the use of a self-adherent area  156  that lies underneath the retraction member  110 . During the application of the drape system, a surgeon applies pressure to the self-adherent area  156 , adhering the retraction member  110  to the facial area  28  above the eyelid  12 . While pulling the retraction flap  130  away from the eye  10 , the surgeon pulls the hooks  150  in the opposite direction towards the eyelid  12 , thus causing the drape to stretch sufficiently to allow the hooks  150  and non-adherent extension  118  to wrap around the lid margin. The retraction flap  130  is then pulled away from the eye  10 , which causes the hooks  150  and non-adherent extension  118  and, correspondingly, the eyelid  12  and eyelashes  14  secluded therein, to retract. The adherent portion  136  on the underside of the retraction flap  130  is applied to the non-adhesive surface  104  of the drape  100  to secure the retraction flap  118 , the hooks  150 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system. 
       FIG. 22  illustrates an alternative embodiment of the drape system that eliminates the need for a surgeon to directly contact the patient&#39;s skin during application. This embodiment incorporates the use of a self-adherent area  158  that lies underneath the retraction member  110  as well as the use of malleable shafts  160  affixed to the retraction member  110 . During the application of the drape system, a surgeon applies pressure to the self-adherent area  158 , adhering the retraction member  110  to the facial area  28  on or above the eyelid  12 . Pulling the retraction member  110  away from the eye  10  retracts the eyelid  12  away from the eye, allowing room for the surgeon to bend the shafts  160  into a hook configuration around the eyelid  12  that engages the non-adherent extension  118  around the eyelid  12  and eyelashes  14 . The retraction flap  130  is then pulled away from the eye  10 , which causes the shafts  160  and non-adherent extension  118  and, correspondingly, the eyelid  12  and eyelashes  14  secluded therein, to retract. The natural elasticity of the skin allows for relative movement between the hooks  150  and adhesive area  158  such that the hooks  150  rather than adhesive area  158  bear the load of securing the lids. The adherent portion  136  on the underside of the retraction flap  130  is applied to the non-adhesive surface  104  of the drape  100  (not shown) to secure the retraction flap  118 , the shafts  160 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system. 
       FIGS. 23 and 24  illustrate an alternative embodiment of the drape system described with reference to  FIG. 18 . The retraction member  110  includes a substantially rigid plate  162  to which are preferably attached “J” shaped rods  164 . These rods are attached to the plate  162 , preferably using connectors  166 , in a manner that allows the rods  164  to rotate. The rods  164  are preferably prevented from pulling through the connectors  166  by rod heads  168  located at one end of the rods  164 . As shown with further reference to  FIG. 24 , during application of the drape system, the rods  164  are rotated to lie underneath the non-adhesive extension  118  of the retraction member  110 . This position forms hooks that are in position to engage the eyelid. 
     During the application of this embodiment of the drape system, a surgeon inserts a finger or tool (not shown) under the retraction flap  130  and retracts the eyelid  12 . The surgeon rotates the rods  164  into a more vertical alignment, thereby engaging the non-adherent extension  118  around the eyelid  12  and eyelashes  14 . The retraction flap  130  is then pulled away from the eye  10 , which causes the rods  164  and non-adherent extension  118  and, correspondingly, the eyelid  12  and eyelashes  14  secluded therein, to retract. The adherent portion  136  on the underside of the retraction flap  130  is applied to the non-adhesive surface  104  of the drape  100  (not shown) to secure the retraction flap  118 , the rods  164 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system. 
     The embodiment incorporating the use of rotating rods carries a further advantage in that it allows potentially greater compaction of the drape system. Depending on the embodiment, the incorporation of a speculum action member adds bulk to the drape system. The use of rotating rods as described above allows orientation of the speculum action member in a flat configuration that facilitates folding, packaging and transportation of the drape assembly. Other embodiments might include a variety of pre-formed members which can be moved such that a speculum action member is created. 
       FIG. 25  illustrates an alternative embodiment of the drape system that incorporates an additional hook extension  170  along with the hooks  150  as a continuation of the non-adherent extension  118  of the retraction member  110 . A surgeon applies pressure to the retraction member  110  underneath the hook extension  170  in close proximity to the eyelid  12 , pulling the retraction member  110  away from the eye  10  and retracting the eyelid  12 . The surgeon then engages the hooks  150  and non-adherent extension  118  around the eyelid  12  and eyelashes  14 . The hook extension  170  is then pulled away from the eye  10 , which causes the hooks  150  and non-adherent extension  118  and, correspondingly, the eyelid  12  and eyelashes  14  secluded therein, to retract. An adherent portion  172  on the underside of the hook extension  170  is applied to the non-adhesive surface  104  of the drape  100  to secure the hook extension  170 , the hooks  150 , non-adherent extension  118  and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system. 
       FIGS. 26-31  illustrate alternative embodiments of the drape system that eliminate the need for an external eyelid speculum, in part by taking advantage of the inherent elasticity of the drape and the close positioning of the non-adherent extension  118  to the eyelid  12 . 
     The embodiments shown in  FIGS. 26 and 27  incorporates the use of a self-adherent area  158  that lies underneath the retraction member  110  as well as several preferably non-continuous cuts  174  between the self-adherent area  158  and the retraction flap  130 . The cuts assist in ensuring that there exists differential movement as between the self-adherent area  158  and the hooks  150  when the retraction flap  130  is pulled to retract the eyelid  12  and eyelashes  14 . During the application of the drape system, a surgeon applies pressure to the self-adherent area  158 , adhering the retraction member  110  to the facial area  28  on or above the eyelid  12 . The surgeon then pulls on retraction flap  130  to partially retract the eyelid  12  away from the eye  10 . The non-adherent extension  118  and hooks  150  are unfolded toward the eye and the surgeon wraps them around the partially retracted eyelid  12 . As the surgeon continues to pull on the retraction flap  130 , the non-continuous cuts  174  stretch apart, relaxing the forces on the self-adherent area  158  and allowing the hooks  150 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  to easily retract and be maintained in the retracted position. The adherent portion  136  on the underside of the retraction flap  130  is applied to the non-adhesive surface  104  of the drape  100  (not shown) to secure the retraction flap  118 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system.  FIG. 27  illustrates the same drape system described with reference to  FIG. 26 , further incorporating the use of a bridging element to maintain the retraction member  110  in position within the retraction area  106  until retraction of the eyelids occurs. 
     The embodiment shown in  FIG. 28  incorporates the use of a self-adherent area  158  that lies underneath the retraction member  110 . During the application of the drape system, a surgeon applies pressure to the self-adherent area  158 , adhering the retraction member  110  to the facial area  28  on or above the eyelid  12 . The surgeon then pulls on retraction flap  130  to partially retract the eyelid  12  away from the eye  10 . The non-adherent extension  118  and hooks  150  are then unfolded toward the eye, and are of sufficient length such that the surgeon can then wrap them around the partially retracted eyelid  12 . The surgeon then pulls the retraction flap  130  in a direction more tangential to the plane of the retracting member  110  in order to peel the self-adherent area  158  off of facial area  28 . This relaxes the forces on the self-adherent area  158  and allows the hooks  150 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  to easily retract and be maintained in the retracted position. The adherent portion  136  on the underside of the retraction flap  130  is applied to the non-adhesive surface  104  of the drape  100  (not shown) to secure the retraction flap  130 , hooks  150 , the non-adherent extension  118 , and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system. 
     The embodiments shown in  FIGS. 29 and 30  incorporate the use of a self-adherent area  158  that lies underneath the retraction member  110  along with reinforcing, nonelastic strips  176  that connect the hooks  150  to retracting flap  130  which has inherent elasticity. During the application of the drape system, a surgeon applies pressure to the self-adherent area  158 , adhering the retraction member  110  to the facial area  28  on or above the eyelid  12 . The surgeon then pulls on retraction flap  130  to partially retract the eyelid  12  away from the eye  10 . The non-adherent extension  118  and hooks  150  are then unfolded toward the eye and the surgeon wraps them around the partially retracted eyelid  12 . As the surgeon continues to pull on the retraction flap  130 , the elasticity of retracting flap  130  and the inelasticity of strips  176  allow for relative movement between hooks  150  and the self-adherent area  158 , thus relaxing the forces on the self-adherent area  158  and allowing the hooks  150 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  to easily retract and be maintained in the retracted position. The adherent portion  136  on the underside of the retraction flap  130  is applied to the non-adhesive surface  104  of the drape  100  (not shown) to secure the retraction flap  118 . This process may be repeated for the corresponding lower elements of the drape system. 
       FIG. 30  illustrates the same drape system described with reference to  FIG. 29 , further incorporating the use of a bridging element to maintain the retraction member  110  in position within the retraction area  106  until retraction of the eyelids occurs. 
       FIG. 31  illustrates an alternative embodiment of the drape system that eliminates the need for a self-adhering retraction flap through the use of integrated elastic strips or rubber bands  182 . During the application of the drape system, a surgeon inserts a finger or tool (not shown) under an access flap  184  and retracts the eyelid  12  away from the eye  10 . The rubber bands  182  are stretched in order engage the hooks  150  and non-adherent extension  118  around the eyelid  12 . Once engaged, the hooks  150  are released, and the elasticity of the rubber bands  182  retracts and maintains the hooks  150 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system. 
       FIGS. 32 and 33  illustrate yet another embodiment of the drape system of the present invention. This embodiment takes advantage of the natural elasticity of the drape material to obviate the need of any a retraction area  106  defined by slits. A single continuous drape  100  is folded into segments along folds  190  and  192 . Hooks  150  and non-adherent extensions  118 , 120  define the retraction gap  124  between edges  126 , 128  of the non-adhesive extensions  118 , 120 . An adherent strip  194  is positioned on the undersurface of fold  190  corresponding to a portion of the drape  100  on the front surface of the fold  190  defined at strip  196 . In an alternative embodiment, adherent strip  194  is made out of Velcro, and strip  196  is a matching strip of Velcro material. With reference to  FIG. 33 , the underside of drape  100  includes a self-adherent area  198 . 
     During application of the drape system, a surgeon applies pressure under the fold  190  along the drape  100  at the self-adherent area  198  and retracts the eyelid  12 . When the eyelid  12  is sufficiently retracted, the surgeon engages the hooks  150  and non-adherent extension  118  around the eyelid  12  and eyelashes  14 . The fold  190  is then pulled away from the eye causing the hooks  150 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  to retract. In a preferred embodiment, Velcro strips  194  and  196  are attached to secure the hooks  150 , the non-adherent extension  118  and the eyelid  12  and eyelashes  14  in a retracted position. This process may be repeated for the corresponding lower elements of the drape system. 
       FIG. 34  illustrates another embodiment of the drape system of the present invention. This embodiment is for use with an eyelid speculum, but allows a surgeon to use one hand to retract the eyelid while freeing the other hand to wrap the drape around the eyelid and insert the speculum. This obviates the need for having to first secure the eyelid in a retracted position. 
     The embodiment shown in  FIG. 34  is similar to the embodiment described with reference to  FIG. 32  except that is does not use hooks or adherent strips  194 , 196 . Instead, this embodiment uses a weight  198  located near the edge  126  of the non-adherent extension  118 . As the surgeon retracts the eyelid  12 , the weight  198  on indents the drape  100  near the edge  126 , allowing the surgeon to easily insert the speculum with one hand while maintaining the eyelid  12  in a retracted state by the continued application of pressure under the fold  190  along the drape  100 . 
       FIG. 35  illustrates another embodiment in which the non-adherent extension  118  is located on a second layer  210  rather than attached to a retracting member. This second layer  210  is attached to the drape  100  at areas  212 . A separate retracting strap  214  is attached to the drape  100  at  216 , and lies underneath the second layer  210 . On the underside and at the opposite end of retracting strap  214  is a Velcro strip  216 , and the matching Velcro strip at  218  on drape  100 . The undersurface of drape  100  adheres to the skin around the eye. The surgeon pulls the retracting strap  214  away from the eye, which retracts the eyelid underneath the non-adherent extension  118  and second layer  210 , where the non-adherent extension is already positioned to drop down around the lid margin, and the Velcro strips  216  and  218  are engaged to maintain the lid in a retracted position so that an external speculum can then be applied. A variation of this embodiment does not include the retraction strap  214 . In this alternative embodiment, the surgeon reaches under the second layer  210  and pulls the drape  100  away from the eye directly to retract the eyelid. 
       FIGS. 36-38  illustrate an embodiment similar to  FIG. 35  further including the use of hooks. A second layer  210  has a non-adherent extension  118 , and is attached to drape  100  at areas  220 . A retracting strap  222  is attached to the second layer  210  and hooks  150  at area  224 . This retracting strap  222  is folded underneath the second layer  210  at  226 . At the opposite end and underneath the retracting strap  222  are a Velcro strip  216  and the corresponding Velcro strip  218  on the drape  100 . There is s self-adherent area  228  underneath the retracting strap  222 , which binds the retracting strap  222  to the surface of drape  100 . The surgeon grasps the end of the retracting strap  222  near the Velcro  216  and pulls it away from the eye, which retracts the self-adherent area  228 , and consequently the drape surface and eyelid, such that the eyelid lies underneath the non-adherent extension  118 , hooks  150 , and second layer  210 , as shown in  FIG. 37 . 
     Referring again to  FIG. 37 , the surgeon continues traction on strap  222 , while the hooks  150  and non-adherent extension  118  are positioned around the lid margin. Then the surgeon pulls the retracting strap  222  in a more tangential direction to the plane of the drape  100  in order to release the self-adherent area  228  from the surface of drape  100 . Once the self-adherent area  228  has released, the surgeon then attaches the Velcro strip  216  to the corresponding Velcro strip  218  to secure the hooks  150 , non-adherent extension  118  and eyelid in a retracted position, as shown in  FIG. 38 . In this embodiment, the fold  226  allows for relative movement to engage the lid margin, and the release of self-adherent area  228  allows for relative movement when further retracting and securing the eyelid. Other embodiments might include a variety of mechanisms to allow for the relative movement of the drape elements and to provide for the release of area  228 , such as a snap or sliding snap mechanism or other latching mechanism. 
     While the preferred embodiment of the invention has been illustrated and described, as noted above, many changes can be made without departing from the spirit and scope of the invention. In many described embodiments the precise order in which the drape, drape elements or speculum is applied may be varied while realizing the advantages of the present invention. Accordingly, the scope of the invention is not limited by the disclosure of the preferred embodiment. Instead, the invention should be determined entirely by reference to the claims that follow.

Technology Classification (CPC): 0