The present invention relates generally to the field of surgery including ophthalmic surgery, and more particularly, to a disposable surgical drape for use during surgery of the human eye, in particular bilateral surgery, as well for use during other surgical procedures. The surgical drape comprises a base sheet, defining first and second surgical apertures, for attachment to a patient, and at least one protective patch which can be applied over one of the surgical apertures after the drape has been positioned on the patient.
When the eye becomes aged, diseased, or injured it may be necessary to remove the natural lens of the eye. Such removal is common for cataract surgery, in which a lens that has become clouded is removed. The removal of the natural lens of the eye may result in the loss or alteration of focused vision of a patient. Eyeglasses, contact lenses, or the implantation of an artificial lens may be necessary to restore the vision of the patient.
During the removal of the natural lens of the eye, a physician will typically make one or more small incisions in the eye and insert a vibratory needle into the incision. The needle may be vibrated at ultrasonic speeds in torsional, longitudinal, elliptical, or blended modes in order to dismember the lens in a process known as phacoemulsification. The needle typically contains one or more aspiration passages for removing the broken lens particles from the eye. Lasers may also be used to dismember the lens.
This surgical process is typically performed with an ophthalmic drape being placed over the eye of the patient. The ophthalmic drape has one aperture for being placed over the eye upon which surgery will occur, The drape has an aperture for insertion of the surgical equipment and may have an adhesive to secure the drape to the patient's skin. A topical or local anesthetic is applied to the eye. However, general anesthesia may be required for some patients who cannot remain still for the surgical procedure or for some patients who may suffer from claustrophobia. The obstructed vision of the eye which is not being operated upon may further exacerbate such claustrophobia. General anesthetic can add substantial expense to the surgical operation and may further present risks to the health of the patient, when compared to local anesthetic.
The present invention is directed to a disposable surgical drape with a wide range of potential applications. The inventor of the present invention has discovered the present drape can made particularly suitable for ophthalmic surgical procedures, in particular a bilateral procedure, and can be configured for minimizing the claustrophobia of a patient undergoing ophthalmic surgery. Notably, the drape includes a base sheet having a pair of surgical apertures and having an adhesive, preferably a pressure-sensitive adhesive, to facilitate securement of the base sheet to the patient. The drape includes one or more protective patches, also provided with an adhesive, preferably a pressure-sensitive adhesive, for sequentially covering each one of the surgical apertures during the procedure. Each protective patch defines a slit through which the surgical procedure can be performed, while the other surgical aperture remains open and unobstructed to minimize or prevent patient claustrophobia. After the procedure is performed on one eye of the patient, the protective patch can be removed, and a fresh protective patch may be applied to the other surgical aperture to permit the surgical procedure to be performed on the other eye of the patient.
In accordance with the present invention, a disposable surgical drape is provided, which is particularly useful for ophthalmic surgery, including a bilateral procedure. The drape has a base sheet of thin, flexible material, The base sheet has an upper surface, a lower surface for contacting a patient, and at least one edge.
To facilitate surgical use, the base sheet of the present surgical drape includes first and second surgical apertures formed through the base sheet, with the surgical apertures each having a length, and with surgical apertures for being located proximal to first and second eyes of the patient. An attachment zone formed on the base sheet lower surface, comprising pressure-sensitive adhesive, is located proximal to the first and second surgical apertures, preferably at least partially surrounding the surgical apertures. The attachment zone thus facilitates attachment of the base sheet lower surface to the patient to secure the base sheet to the patient in the desired position for performing the surgical procedure. In the preferred embodiment, the attachment zone extends completely about the first and second surgical apertures on the lower surface of the base sheet.
In accordance with the present invention, the present surgical drape further includes at least one protective patch for positioning at and substantially covering one of the surgical apertures to protect the eye of the patient. Each protective patch has the form of a polymeric sheet having pressure-sensitive adhesive applied to one surface thereof, and defines an elongated slit through which the surgical procedure is performed. The pressure sensitive adhesive on each of the protective patches is preferably provided on the periphery thereto, to thereby define an adhesive-free region surrounding the slit defined by the protective patch.
Thus, after positioning of the base sheet on the patient, with the first and second apertures respectively aligned with the eyes of the patient, one of the protective patches can be applied over one of surgical apertures, and removably secured to the base sheet with the pressure-sensitive adhesive provided on the protective patch. After the surgical procedure is performed through the protective patch, the patch can be removed and discarded, and a fresh protective patch applied to the other surgical aperture. The surgical procedure can them be performed on the other eye of the patient.
In the illustrated preferred embodiment of the invention, the surgical drape further includes at least one detachable pouch positioned in proximity to one of the first and second apertures defined by the base sheet. The detachable pouch preferably defines an opening facing toward that one of the surgical apertures to which it is positioned in proximity. In the preferred form, the disposable surgical drape includes a pair of the detachable pouches positioned in respective proximity to the first and second surgical apertures defined by the base sheet.
To facilitate efficient use, the base sheet of the surgical drape is folded at lateral margins thereof so that the first and second surgical apertures remain uncovered by the lateral margins,
In accordance with the present invention, a method of covering a patient for bilateral eye surgery comprises the steps of providing a surgical drape comprising a base sheet of flexible material having an upper surface, and a lower surface for contacting a patient, with first and second surgical apertures formed through the base sheet. The surgical apertures each have a length, with the surgical apertures being positionable proximal to (aligned overtop of) the first and second eyes of the patient. The surgical drape further comprises an attachment zone formed on the base sheet lower surface, with the attachment zone being located proximal to the first and second surgical apertures, preferably at least partially surrounding the surgical apertures for attaching the base sheet lower surface to the patient to fix at least a portion of the base sheet with respect to the patient.
The present method further comprises providing at least one protective patch for positioning at one of the surgical apertures to protect the eye of the patient. Each protective patch comprises a polymeric sheet having pressure-sensitive adhesive applied to one surface thereof, and defines an elongated slit. After positioning of the base sheet on the patient with the first and second apertures respectively aligned with the eyes of the patient, with the attachment zone secured to the patient; the protective patch is applied over one of the surgical apertures, with the protective patch removably secured to the base sheet with the pressure-sensitive adhesive.
In the preferred practice, the present method includes providing at least one detachable pouch on the base sheet, positioned in proximity to one of the first and second surgical apertures. Each pouch is removably secured to the base sheet with the pressure-sensitive adhesive and is designed to catch any overflow of balanced salt solution that may not be aspirated into the surgical devices used in the surgical procedure.
The present method contemplates that after the surgical procedure is performed on the first eye of the patient, the protective patch and the detachable pouch for that eye are then removed from the base sheet. Thereafter, another protective patch and another pouch may applied to the base sheet at the other surgical aperture, and at the other eye of the patient.
Another feature of the present invention is to provide a low-cost, disposable surgical drape for the reduction and/or minimization of claustrophobia in a patient.
In another aspect of the present invention, a folded surgical drape is provided to facilitate positioning of the drape on a patient, and subsequent spreading of the drape over the patient.
Other features and advantages of the present invention will be better understood with reference to the accompanying figures and detailed description.
While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment, with the understanding that the present disclosure is to be considered an exemplification of the invention, and is not intended to limit the invention to the specific embodiment illustrated.
The present disposable surgical drape is particularly suited for use in connection with ophthalmic surgical procedures, in particular a bilateral procedure. However, features of the surgical drape permit it be advantageously used in other procedures, including central venous catheterization (CVC), other catheterization procedures, anesthesia procedures, and other surgical procedures, as will be described.
The base sheet 24 has an upper surface (visible in
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Notably, the provision of first and second surgical apertures 28, 30 facilitates the surgical procedure, and desirably minimizes any claustrophobia that the patient might experience, since one eye can remain uncovered while the surgical procedure is performed on the other eye. The inventor has found that providing a pair of surgical apertures, used in sequence such as during a bilateral procedure, can desirably minimize the anxiety of claustrophobic patients because the vision of the second eye is not obscured by the base sheet 24 during the operation. The provision of such stereoscopic vision to the patient can provide a low-cost alternative to general anesthetic and can reduce the movement of an anxious, claustrophobic patient.
Another important feature of the drape 20 is that the eye position can be better controlled by the fixation light seen by the non-operated eye. In the prior art, the conventional fixing light was incorporated into a microscope to control the operated eye position during the surgery. However, due to the bright illumination of the microscope and poor visual acuity of the operated eye, such a fixing light was not ideal. When the non-operated eye can see through the non-surgical one of the apertures, the non-operated eye can be effective in leading the eye position during surgery.
In accordance with the present invention, and with reference to
Each protective patch 40 comprising a polymeric sheet having pressure-sensitive adhesive 42 (visible in
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The method of use of the present ophthalmic drape 20 for covering a patient, such as for bilateral eye surgery, will now be described. In this regard, it will be noted that the drape 20 is preferably folded in a fashion (
After removal of protective layer 34 from the attachment zone 32 to expose the pressure-sensitive adhesive thereof, the surgical drape 20 is placed on the face of the patient and secured with the adhesive of the attachment zone. The lateral margins of the base sheet 24 can then be unfolded, with the drape 20 now in position with the lower surface of the base sheet 24 attached to the patient, as illustrated in
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As noted, in the preferred form, at least one detachable pouch 52 is provided on the base sheet 24, positioned in proximity to one of the first and second surgical apertures 28, 30. Thus, as illustrated in
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It is contemplated that the above-described embodiment may include a nose clip, or like spacing element, in order to provide height and clearance between the drape and the patient to facilitate convenient and comfortable breathing by the patient.
In the foregoing description, the present surgical drape has been described in connection with ophthalmic surgical procedures, but it is to be appreciated that the present surgical drape, including an attachment zone provided by a minimally-adhesive film, can be advantageously employed for other types of surgical procedures.
By way example, central venous catheterization (CVC) requires maximal sterile barrier precautions to prevent catheter-related bloodstream infection, which is associated with preventable morbidity and mortality. Disposable surgical drapes are recommended as a standard of care; however, those specifically meant for this purpose are neither freely available nor cost-effective. The present disposable drape can be advantageously employed for this purpose.
The present disposable surgical drape can be provided with an average size of 70 cm×70 cm, with surgical apertures 28. 30 appropriately sized, such as approximately 7 cm×9 cm.
The present disposable surgical drape provides an ideal option and ensures an optimum level of sterility. The adhesive area provided by attachment zone 32 acts to keep the drape in stable position, thereby avoiding the requirement of multiple drapes. Most current disposable drapes are made of low-lint and abrasion-resistant fabric and have level 4 liquid barrier performance because of their non-perforated design, and hence have poor absorbent quality as compared to the linen cloth drapes. The polyethylene drapes used in the absence of disposable drapes are completely non-absorbent and do not remain stable in place. The pouches 52 provided adjacent to the surgical apertures are designed to collect the irrigation fluid; during internal jugular vein annulation, the pouches can collect the trickle of blood that occurs after dilatation of the subcutaneous tract, preventing soiling and contamination of the neck and the shoulder area and the trickle over the drape down to the floor on the operator's feet.
The disposable surgical drape is more cost-effective as opposed to the one dedicated for CVC.
The present surgical drape can also be used successfully for subclavian, femoral and peripherally inserted central catheter line catheterizations. It can also be used for isolation during spinal or epidural anesthesia procedures and other regional blocks. During neuraxial blockade, the length of the transparent adhesive area should be placed along the length of the spine so that in case of difficulty one can easily have access to 2-3 interspinous spaces. The pouch 52 should be placed in the caudal direction. The best benefit is seen in an epidural procedure as on removing the Touhy needle after the insertion of the catheter; it is common to encounter a trickle of blood down the back soiling the operating table,
In summary, the present surgical drape provides a variety of desirable benefits. The drape is cost-effective, and can be used very efficiently to cover and protect the patient. Because the protective patches 40, with precut slits 44, are provided separately from the base sheet 24, the protective patches can be easily affixed to cover the eyelids of the patent, while the base sheet remains in position on the patient. The protective patches are not fixed to the large drape body.
Because both eyes of the patient can remain open, the present surgical drape desirably minimizes any claustrophobia the patient may experience. Having both eyes uncovered permits the uncovered eye to lead and fix the position of the eye on which the surgery is being performed.
The inventor has found that providing one or more protective patches 40 separately from the large base sheet 24 of the drape 20 not only reduces the cost to manufacture the drape 20 compared to drapes of the prior art, but is more easily and efficiently applied to the patient compared to drapes of the prior art. In one broad form of the present invention, the patch or patches 40 may be sold or otherwise provided separately from the base sheet 24 of the drape 20.
Use of the present surgical drape is also recommended for routine use for various procedures in anesthesia and the intensive care unit.
The illustrated preferred embodiments are included herein for descriptive purposes only and are not to be interpreted as limiting in any way of the broadest concepts of the present invention.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/023492 | 3/19/2020 | WO | 00 |
Number | Date | Country | |
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62821554 | Mar 2019 | US |