Surgical light handle cover

Illumination – Supports – Handle or bail

Reexamination Certificate

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Details

C362S399000, C362S804000, C016S421000, C016S422000, C016S436000

Reexamination Certificate

active

06447149

ABSTRACT:

FIELD OF THE INVENTION
This invention relates in general to surgical equipment, and more specifically, to disposable covers for surgical light handles.
BACKGROUND OF THE INVENTION
In an operating room, the patient is typically placed on an operating table under an operating room light which illuminates the surgical area for the surgeon. Special lights are used because of the dual requirements for high-powered lighting and maintenance of a sterile environment. These lights typically comprise a bulb or bulbs located within a housing, which is suspended above the operating area. The light projects and focuses the beams upon the surgical area. During the operation, the angle of incidence may need to be adjusted or the light may need to be moved closer to the area which is being operated upon. Because they know best where the light is needed, many surgeons prefer to adjust the operating room lamp themselves rather than instructing someone else to do so. Therefore, it is likely that the light handle of a surgical lamp will come into contact with the hand of the surgeon.
Because a sterile environment must be maintained, the handle of the light's housing must be sterile, even though it may be subject to contact with the hands of the surgeon or other surgical personnel who adjust it.
Because the cost of medical care is constantly escalating, hospital administrators have been forced to search for ways of reducing their facilities' operating costs. Various devices and methods have been proposed in an effort to reduce these ever-increasing costs.
One area in which cost reductions have been sought is in the sterilization of medical equipment. Sterilization is usually accomplished in an autoclave, which is a steam-pressure device for sterilizing devices and instruments. With the ever-increasing number and design of medical instruments, the problems associated with sterilizing a large number of instruments of various sizes and shapes can present a costly burden to the medical facility. In the operating room, all surfaces that may come in contact with the surgeon must be sterile prior to the operation. The sterilization of all surfaces with which the surgeon may come in contact, including surgical light handles, can become extremely burdensome for a medical facility.
One solution to this problem may be to simply dispose of the contaminated item(s). Unfortunately, it is neither practical nor economical to dispose of large operating room fixtures, such as light fixtures after each operation. Because any item touched by any person within the sterile field of an operating room must be sterilized, there must be some way of maintaining the sterility of such large fixtures or steps must be taken to prevent surgical personnel from contacting non-sterile portions of such fixtures.
As another solution, removable handles for operating room lights, can be provided in the operating room. Those handles may be removed and sterilized before each operation. Although it can eliminate the high cost of disposing of fixtures, this solution requires highly paid personnel to remove, clean and sterilize the equipment, expensive materials to wrap the sterilized handles, and the sterilization process itself can be costly.
As a third solution, sterile disposable handles, which can be discarded at the completion of each operation, may be provided. U.S. Pat. No. 4,844,252 to Barron et al. and U.S. Pat. No. 4,974,288 to Reasner disclose examples of such disposable handles. However, use of replaceable operating room lamp handles will not stop the cost escalation because in addition to their cost, disposable handles are bulky, require storage space which is limited at hospitals, and create more hazardous waste. Disposal of the contaminated handles may also expose some hospital personnel to pathogens and disease.
As a result of the above-listed drawbacks, medical facility administrators tend to favor disposable sterile covers for the various surfaces of the operating room subject to contact by operating room personnel. Disposable sterile covers are generally cost effective, because they may be mass-produced and mass-sterilized by a medical manufacturer. Disposable, pre-sterilized covers have the further advantage of being readily available for emergency operations.
Sterile disposable covers are available in the art for covering a non-sterile operating room light handle. U.S. Pat. No. 4,605,124 to Sandel et al. and U.S. Pat. No. 4,976,299 to Bickelman provide examples of such sterile disposable covers. However, each of these disposable covers has some disadvantages.
The invention of Sandel is a disposable cover having a cylindrical grip and integral flange. The cylindrical grip narrows where it attaches to the integral flange to fit the light handle. The flange may either be flat-shaped or bell-shaped, depending on the shape of the handle. The cover has internal reinforcing ribs in the grip portion. At col. 3, lines 41-45, Sandel states that adhesive can be applied to the interior portions of the flange to firmly attach the cover to the handle. It appears that the adhesive is applied to the invention of Sandel to prevent it from inadvertently sliding off the light handle during surgery.
The disposable cover of Sandel also suffers from several other drawbacks. Because the flange is flexible and is adapted to the shape of the handle, the disposable cover does not have a protective guard to prevent the nurse's or surgeon's hand from sliding past the flange and contacting non-sterile portions of the surgical room light fixture. Further, due to the flexibility of the flange, the scrub nurse's or surgeon's glove may become contaminated while applying the cover to the non-sterile light handle. Finally, because the cover of Sandel is intended to be folded prior to shipment, the cover itself may become contaminated from prior folds as it is being applied over the light handle, if the cover edge contacts the non-sterile light handle and/or flange.
The invention of Bickelman is a sterile disposable cover having a cylindrical hollow member and a guard. The guard is intended to prevent the surgeon's hand from contacting non-sterile portions of a light fixture. The cover also includes a retention member that partially closes the opening of the opened end of the cylindrical hollow member. The retention member may be a circular plastic disk with teeth-like projections that is adhered within an annular recessed portion in the guard. However, the disposable cover of Bickelman suffers from the drawbacks that the guard does not appear to be sufficiently rigid nor is it adapted to the shape of the handle and/or light fixture. Thus, it is possible that the surgeon's hand may slide past the guard and contact non-sterile portions of the light fixture. In addition, the retention disk makes application and removal of the cover difficult. The retention disk can also prevent the application of a second cover over the first one, if necessary because of accidental contamination during the surgical procedure.
Therefore, a need exists in the art for a surgical light handle cover that will provide the benefits of disposability, sterilizability, security of attachment to the handle without the need for adhesive and which will help prevent the surgeon's or nurse's hand from accidentally contaminating the handle.
SUMMARY OF THE INVENTION
The present invention provides such a surgical light handle cover with two circular ridges and a guard, which help to minimize the chances of accidental contamination. The surgical light handle cover of the present invention is disposable, sterilizable and will attach to the surgical light handle in a manner which will obviate the need for adhesives.
The present invention also provides a disposable cover for a surgical light handle, comprising a cylindrical portion closed at a first end and tapering outward from a second end to form a generally conical portion, the generally conical portion having a first circular ridge and a second circular ridge thereon, and a guard portion e

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