Surgery – Specula – Retractor
Reexamination Certificate
2001-02-27
2003-07-22
O'Connor, Cary E. (Department: 3732)
Surgery
Specula
Retractor
C600S220000
Reexamination Certificate
active
06595917
ABSTRACT:
FIELD OF THE INVENTION.
The disposable speculum with included light and complementary mechanisms for gynecological examination and surgery, is a medical instrument that gives positive advantage compared with others which are used now in this health branch.
The vaginal speculum is a medical device, which is introduced through the introito to the vagina separating its walls, to be examined and making the medical or surgical proceedings easier at the vaginas neck level by sight or guided by colposcopya and of the uterus by the endoscopya.
The speculum upper sheet external face is convex, with flat surface and rounded edges to avoid pinches, that happen frequently using disposable speculas with sharp sides.
The internal face of the same sheet is concave and it has three semicircular cuts with certain distance between them, and they are connected amongst themselves for a pair of internal and lateral channels, that end in the upper right part of the proximal end which will serve to evacuate with a special vacuum (available at the market), the smoke and gases generated when any sort of gynecological surgery is practiced for vaginal tract, when cauterius are used with mono or bipolar electrodes, radio frequency or laser, this protects the medical doctor and close staff of possible contamination, making the procedure easier and shorter, because there is a better visibility.
The vertical branch or upper sheet handle has some prongs, that insert in the vertical branch or lower sheet's handle, that has some foremasts where the saw prongs will rest when the speculum is open to make the visual and the examination area bigger. In order to make the speculum opening smaller, it is necessary to press on a button that makes the prongs come out and move away from the foremast, sliding the upper sheet's vertical branch on the lower sheet's vertical branch, and to close the specula and remove it without pain, pressure has to be made on the other button to unblock the upper sheet.
The lower sheet's external face is convex with flat surface and rounded edges, too. The internal face of the same sheet is concave, and it has three semi-circulars cuts with certain distance between them, connected amongst themselves for an internal oval flat channel, which ends in the lower extreme of the sheet's descendant branch, where it turns into a round channel where the blood, that is originated from the surgical area through a vacuum designed for this proceedings, is evacuated, making them more comfortable easier and faster, avoiding the dryness and the clearing of thief sloped place where the blood is accumulated. If this end is not connected to a vacuum, it can also be connected to make the blood flow through gravity. Joined to the previously described, and to optimize the visibility of surgical and examination area, in the upper sheet's internal face, in the center, and on the space between the two first cuts, there is a light bulb, which given its nearness to the surgical area, will offer clarity and because of its localization will not interfere with the surgical proceedings. The light bulb is protected to avoid damage by the instrumental, and it has a thermal isolation to avoid heat up of the speculum upper sheet, which would cause injuries on the vaginal mucous. The internal face of the anterior portion close to the light bulb has an aluminum reflexive cover (a metal covering vacuum technique with aluminum) which will offer an excellent lighting. The speculum has to be made of dark non-reflective material when used in laser proceedings.
INVENTION BACKGROUND
Convinced by my personal experience as a gynecologist, that many patients don't attend appointments of this specialty and don't take a cytology, because they are afraid to be hurt when the speculum is used; in some cases problems are created due to the designs of some disposable speculum and reusable metal specula that make their use difficult, not practical for the medical doctor and uncomfortable for the patient, in many cases producing small injuries that cause discomfort for the patients which give a bad reputation to these devices.
The vaginal speculum is a device which is introduced through the introito to the vagina separating its walls to be examined and making the medical or surgical proceedings easier at the vaginas' neck level by sight or guided by colposcopya and of the uterus by the endoscopy.
Some speculums have ungentle edges and their surface is rough causing sometimes pinches of the vaginal mucous and on the smaller and bigger lips. Others have their sheets separated which makes them unstable when they are introduced in the vagina, causing discomfort to the patients and not allowing the specula to open on their distal end if it is required, to expand the surgery field and examination area. Some of them have the handle's lower end of the lower sheet with a forward curvature, being this the support point to handle and open the speculum, which allows the contamination of the gloves due to their closeness to the anal and perianal area, besides to cause discomfort to the patients. The same happens with the other ones that have a mechanism to open the sheet's that consist in a curve piece with prongs on the upper sheet's handle, which introduces itself in a cut of the lower sheet handle, producing similar effect as the previous one. In both previous cases if the medical doctor doesn't take precautions to change his gloves and proceed to practice a vaginal tact like a complement of the examination, he would be contaminating the patient with possible anal pathology to the vaginal area, and with possibilities of propagation to the pelvic area, with their consequences sometimes irreversible from the medical point of view, like for example, pelvic inflammatory chronic illness, infertility caused by tubary obstruction among others and they seem expensive from the economic point of view.
The speculum proposed by me, has rounded edges and fat surface and has an opening mechanism comfortable and fast for the upper sheet, the same works to enlarge the distance, between the both sheets, giving wideness to the surgery or examination area. The lower sheet's handle has in its distal end an elbow shaped handle to avoid discomfort to the patients in the anal and perianal area, and therefore with out contamination.
In regards to the portable lighting which come from the light bulbs, which are located on the speculum upper sheet and which after each examination are removed and used again with other patients, open the possibility for contamination even with precautions. The same would happen in other prototypes of reusable lighting, where the light is attached to the upper sheet's internal face with adhesives used for these cases.
The lighting proposed by me, would be included in the disposable speculum upper sheet internal face through a small light bulb localized between the two first cuts, and it will be feed through a plug located on the back end and upper right of the speculum upper sheet. The light bulb has a thermal isolation to avoid injuries of the vaginal mucous membrane, and also because of its proximity to the surgical area, it will give an excellent lighting that will help to make the procedures easier. The internal face in the front part at the light bulb has an aluminum reflexive cover (aluminum metal vacuum technique) which will have effect on an very good lighting. When the speculum is used in proceedings with laser, it has to be made with a dark and no reflexive material.
There is a pipe system for the smoke and gases suction which are generated in specific gynecological methods through vaginal via, but its surface is not too big.
Thinking about the high incidence of bacterial, micotical and viral illness in the gynecological area, and that some of these are involved in the feminine cancer etiology, and that in many cases the practice of methods using cauterius, radio frequency or laser, is necessary, generating smoke and gases that can be sources of contamination, the
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