Surgery – Body rests – supports or positioners for therapeutic purpose
Reexamination Certificate
2000-02-02
2001-10-16
Brown, Michael A. (Department: 3764)
Surgery
Body rests, supports or positioners for therapeutic purpose
C128S847000, C128S848000
Reexamination Certificate
active
06302109
ABSTRACT:
FIELD OF INVENTION
The present invention relates in general to the field of surgical drapes for head and neck surgery, and more specifically to an apparatus which supports a surgical drape over a patient's face during ophthalmic surgery.
BACKGROUND OF THE INVENTION
During ophthalmic and Head and Neck surgery, a sterile surgical field is required to prevent infection. In ophthalmic surgery, the patient's entire head and body are covered by the sterile drapes. These drapes are usually composed of a combination of cotton or synthetic fabric combined with plastic. The plastic drape usually covers the patient's entire face (example 3-M Corporation 10-60 drape). Other drapes cover the entire head and face with synthetic fiber cloth with plastic covering only the operated eye. Both types of drapes cover the entire face. The drapes are form-fitting and are applied around the operated eye with adhesive. This causes the drape to come in contact with the patient's face nearly 100% of the time.
More than 95% of ophthalmic surgical procedures are performed under local anesthesia. The patient is given topical or injectable anesthesia around the eye. The patient is rarely put to sleep with general endotracheal intubation. Many patients are given intravenous medications for sedation and comfort. Patients who are awake during their surgery may experience feelings of claustrophobia from lying under the plastic drapes closely adherent to the eye, nose and mouth. In addition, the exhalation under a form fitting plastic drape can make a patient feel warm, sweaty and uncomfortable. As the perspiration and temperature rises, it can make the patient feel anxious, contributing to a further sense of claustrophobia and panic.
Carbon dioxide (CO
2
) is a prominent component of exhaled air. When a patient is under sterile drapes during surgery, exhaled air and supplemental oxygen can be trapped under form-fitting drapes. As a result, it is possible that both CO
2
and oxygen levels may rise as air is trapped under the form-fitted drapes. Patients are usually given supplemental oxygen through a nasal cannula or mask under the drapes. This helps to prevent hypoxia (low oxygen blood levels). It does not, however, prevent the slow build up of carbon dioxide under the drape, which can lead to hypercarbia.
Hypercarbia is a potentially dangerous condition that occurs when carbon dioxide levels rise in the blood stream. It can occur from breathing higher levels of carbon dioxide. A person suffering from early hypercarbia may respond in an agitated or combative manner. This is a major concern during long and delicate procedures. Ophthalmic surgical procedures performed under local anesthesia necessitate the patient to lay still for upwards of two hours or more. A patient can easily become agitated during the surgery if he becomes claustrophobic or uncomfortably warm or sweaty as a result of exhaled air trapped under the drape. If carbon dioxide levels rise, leading to hypercarbia, this can make a borderline situation worse. An agitated patient may require deeper sedation to keep him calm. This additional anesthesia, in some cases, may provide the effect opposite than that intended by increasing and exacerbating hypercarbia. Even if it does not worsen the hypercarbia, the extra sedation can increase the risks to the patient and increase the amount of time that the patient spends recovering from the effects of anesthesia.
Form-fitting surgical drapes used in head, neck and ophthalmic surgery tend to increase a patient's discomfort and increase levels of anxiety and claustrophobia. These surgical drapes also allow exhaled air and supplemental oxygen to be trapped under the drapes. This facilitates an increase in temperature, humidity and perspiration under the drapes and contributes to both rising oxygen and CO
2
levels. A number of prior art devices have attempted to address these problems with varying degrees of success.
DESCRIPTION OF THE PRIOR ART
One solution to the above-described problems encountered with surgical drapes is to provide a support to lift the surgical drape off the patient's face. A number of drape support devices have been patented. These devices do not resolve the problems encountered in head and neck surgery in general and ophthalmic surgery in particular.
U.S. Pat. No. 4,122,848 issued to Carpel describes an apparatus, the base of which is attached to the patient's nose with adhesive tape. The base has a loop structure attached to it to elevate the surgical drape away from the patient's nose and mouth area. This invention has several drawbacks. First, it requires the use of a surgical implement table, positioned above the patient's chest, to help support the drape. Second, the invention provides for only passive escape of accumulated CO
2
from around the edges of the drape and appears unlikely to remove heat and moisture. Third, because this invention must be used in conjunction with a surgical implement table, it is likely to impede the surgeon's access to the area around the patient's face.
U.S. Pat. No. 4,465,066, also issued to Carpel, describes a T-shaped device, made of cardboard, in which one leg of the “T” is attached to a patient's right check and the other to his left check, with the third leg of the “T” being attached to the bridge of the patient's nose. This invention also requires an implement table suspended over the patient's chest to help support the drape. This device allows the surgeon slightly more access to the area around the patient's face, but still only provides for passive removal of accumulated CO
2
by allowing it to escape from around the edges of the drape, and provides for no removal of heat and moisture. Another disadvantage of this invention lies in the fact that because of its cardboard construction, it may weaken and allow the drape to come much closer to the face than originally intended, thereby increasing the likelihood of claustrophobic reactions, heat and moisture build-up, and hypercarbia. Another disadvantage of this invention is that the legs of the T-shaped member are attached to the patient's face by an adhesive disk. Attachment to the patient by adhesive is prone to loosening and/or detaching as a result of the patient's perspiration and/or movements of the patient's facial muscles.
U.S. Pat. No. 4,699,131 issued to Crook et al. describes a mask-like device which is designed to fit over the patient's nose and mouth. The W-shaped member of the mask raises the drape above the patient's mouth, thereby preventing the drape from contacting the face. Front and back legs are attached to the device, thus eliminating the problems encountered in taping a device to a patient's face. Several disadvantages are noted with the use of this device. This device, like the other above-mentioned devices, provides for passive escape of accumulated CO
2
from around the edges of the surgical drape and no removal of heat or moisture. The W-shaped member protruding above the patient's mouth can interfere with placement of surgical equipment, such as a microscope, which may be necessary for eye surgery, over the patient. The bulky nature of this invention may also restrict the surgeon's access to the area around the patient's face. Finally, the W-shaped member may not keep the drape sufficiently far from the patient's face to prevent heat and moisture build-up, claustrophobia and/or hypercarbia.
A surgical drape support which facilitates the delivery of oxygen or anesthetic gas to a patient is described in U.S. Pat. No. 4,739,753 granted to Brehm. A flexible conduit is fitted onto a one leg of bracket that supports the conduit above the patient. The other leg of the L-shaped bracket is placed beneath the patient. The adjustable conduit connects to a nozzle that can support a surgical drape above the patient's face. An air supply tube is threaded through the conduit and attached to the nozzle, thereby providing oxygen or anesthetic gas to the p
Brown Michael A.
Thorp Reed & Armstrong
LandOfFree
Evacuating surgical drape support does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Evacuating surgical drape support, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Evacuating surgical drape support will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2586493