Surgery – Specula – Retractor
Reexamination Certificate
2000-12-22
2002-08-13
Philogene, Pedro (Department: 3732)
Surgery
Specula
Retractor
C600S186000
Reexamination Certificate
active
06432048
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a vaginal speculum and method of use, and particularly to a vaginal speculum that provides lateral wall retraction as the speculum is operated to dilate a patient's vagina.
RELATED ART
A vaginal speculum is a vital medical instrument that allows a healthcare provider to visualize the interior aspects of the vagina, as well as the distal portion of the uterus, the cervix. The speculum comprises two blades assembled together and held by a handle. The blades and the handle form a 90-degree angle. As the user holds the handle, a lever attached to the top blade allows it to open away from the inferior blade.
When the instrument is inserted into the vagina, the blades are separated in order to keep the anterior and posterior walls apart. In that position the cervix and the walls of the vagina can be seen, so long as the patient does not have excess loose vaginal tissue. Since no part of the speculum is in direct contact with the lateral walls of the vagina, the clinician tends to open the blades wider than necessary in order to keep the lateral walls apart and conduct an adequate examination. This excessive distension of the vaginal tissue remains a source of discomfort to the patient. Commonly used speculums are generally made of metal such as stainless steel and are designed to be sterilized between examinations. Disposable speculums are being used more and more frequently, particularly for convenience and decreased risk of transfer of contamination from one patient to another.
Two types of patients tend to have excess vaginal tissue: those who are multiparous and those who are obese. The multiparous patient often will have a relaxation of the levator ani musculature, which results in a tendency for the vaginal walls to collapse toward the midline during speculum examination. These muscles may be overstretched from the cumulative weight of numerous pregnancies as well as the mechanical stress of multiple vaginal deliveries.
Patients who are obese may also present this internal vaginal anatomy as a result of an increase in the amount of loose connective tissue beneath the pelvic peritoneum. When these patients have a vaginal speculum examination, the loose lateral vaginal walls similarly collapse toward the midline as the blades attempt to maintain the anterior and posterior walls apart. This collapse prevents a complete and possibly crucial visualization of the cervix for the purpose of cervical cultures, pap smears, ruptured membranes, visual assessment of a degree of dilation, and biopsy.
This problem has been addressed in the past by the combined use of two instruments, one conventional speculum and a lateral retractor having two blades facing normal those of the speculum. Such usage is suggested, for example, by literature provided by CooperSurgical, Inc. (product catalog, 1997).
This problem also has been addressed by a method known in the art of encasing the blades of a conventional speculum with a condom having its distal end removed.
Waters (U.S. Pat. No. 4,994,070) discloses a vaginal speculum that comprises a sheet member that is rolled into an elongate shape and is expandable to form a hollow tube. When expanded, the tube retains the vaginal walls away from the midline in all directions.
Hayes (U.S. Pat. No. 4,492,220) discloses a vaginal speculum that has disposable covers for the blades to prevent cross-contamination of patients examined with the same instrument.
SUMMARY OF THE INVENTION
It is thus an object of the present invention to provide a vaginal speculum, a disposable sheath for a vaginal speculum, and method of use that permits an improved visualization of the cervix in patients with excess vaginal tissue.
It is another object to provide such a speculum, sheath, and method of use that obviates the need for a second instrument to retain the lateral walls of the vagina away from the field of vision during an examination.
It is a further object to provide such a speculum, sheath, and method of use that alleviates physical discomfort experienced by a patient during a routine pelvic examination.
It is an additional object to provide such a speculum, sheath, and method of use that, while retaining the lateral walls, also permits visualization of the lateral walls.
Another object is to provide such a speculum, sheath, and method of use that, while retaining the lateral walls, also permits access to the lateral walls.
A further object is to provide a disposable sheath for use with a currently available nondisposable or disposable speculum, and a method of use therefor that includes a currently available instrument having a sheath added thereto.
These and other objects of the present invention are achieved by the present invention, a lateral wall retractor vaginal speculum, sheath, and method of use. The speculum comprises a pair of blades that are movable between an open position and a closed position. The blades in the closed position ire adapted for insertion into a vagina; in the open position the blades are adapted for dilating the vagina for providing access to a cervix.
The speculum further comprises a flexible membrane structure that extends between the blades. This membrane structure is adapted to retain the lateral walls of the vagina in spaced relation from a midline of the vagina when the blades are in the open position.
The speculum also comprises means for retaining the membrane structure in a generally collapsed configuration when the blades are in the closed position. This feature permits generally unobstructed insertion and withdrawal and minimizes a risk of pinching excess tissue upon closing the blades within the vagina.
In a particular embodiment, the membrane structure comprises a sheath, which comprises a tubular member having a pair of distal pockets. The pockets are of appropriate dimensions to cover the distal ends of the blades of a speculum. The sheath when placed on a speculum provides for retention of the lateral walls of the vagina in spaced relation from a midline of the vagina when the blades of the speculum are in the open position. The pockets prevent the sheath from being pushed in a proximal direction toward the handle of the speculum during insertion into the vagina.
The features that characterize the invention, both as to organization and method of operation, together with further objects and advantages thereof, will be better understood from the following description used in conjunction with the accompanying drawing. It is to be expressly understood that the drawing is for the purpose of illustration and description and is not intended as a definition of the limits of the invention. These and other objects attained, and advantages offered, by the present invention will become more fully apparent as the description that now follows is read in conjunction with the accompanying drawing.
REFERENCES:
patent: 2545201 (1951-03-01), Gilbert
patent: 2579849 (1951-12-01), Newman
patent: 3841317 (1974-10-01), Awais
patent: 4492220 (1985-01-01), Hayes
patent: 4994070 (1991-02-01), Waters
patent: 5007409 (1991-04-01), Pope
patent: 5460165 (1995-10-01), Mayers
patent: 5545122 (1996-08-01), Spruil
patent: 6036638 (2000-03-01), Nwawka
patent: wo-98/33431 (1998-08-01), None
Hopen Anton J.
Philogene Pedro
Smith & Hopen , P.A.
University of South Florida
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