Surgery – Specula – Retractor
Reexamination Certificate
2000-09-15
2002-07-09
Hirsch, Paul J. (Department: 3747)
Surgery
Specula
Retractor
C600S220000
Reexamination Certificate
active
06416467
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a speculum, a medical device for expanding a cavity within the body of a patient. In particular, the invention related to a vaginal speculum for use during obstetrical/gynecological examination and procedures.
BACKGROUND
Currently available vaginal specula generally include a pair adjustable, longitudinally arranged blades and handles. These bladed are inserted into the vaginal opening and pivotally adjusted to expand the cavity. Specula are typically used by medical practitioners, especially obstetricians, gynecologists, and surgeons, to visually observe the vaginal walls, cervix or uterus, and to create a cavity within the body in which to perform various procedures. Most currently available vaginal specula push the tissue along the vertical axis of the vaginal opening by pivoting at fulcrum located between the blades and the handles.
However, expanding the cavity along a single axis can be an inefficient method for the practitioner. Many patients have extraneous tissue which can intrude around the sides of the speculum blades into the physician's filed of view through the vaginal canal. These patients include those who are multiparous, patients who are currently gaining weight during pregnancy, and those who simply have extraneous tissue or localized flaccid tissue. In some instances, the intruding tissue decreases the size of the cavity created by the speculum. More importantly, the tissue can impede the practitioners view of the vaginal interior, making the examination or procedure more difficult, time consuming and thereby impeding the practitioner's efficiency.
In order to overcome these problems, some practitioners have employed a second instrument to retract the tissue from their field of view, e.g. side-wall retractors. The use of a second instrument may require the practitioner to operate both instruments at once simply to obtain a clear field of view. Alternatively, the practitioners may have to insert and adjust the speculum, setting its width with a clamping means, then insert and adjust the retractors before continuing with the medical procedure.
The use of multiple instruments can have several drawbacks. It is doubly intrusive into the patient's body and may cause more discomfort than the use of a single speculum alone. In many cases, it requires the practitioner to use both hands, which prolongs the procedure and impedes the physician's efficiency. In other cases, it will require the practitioner to set and maintain two instruments within the vaginal cavity. In either scenario, the use of multiple instruments may obstruct the practitioner's field of view of the vaginal interior. Thus, there is a particular need for a vaginal speculum that can be operated with one hand to retract the extraneous tissue which impedes the field of view through the vaginal canal or restricts the size of the vaginal cavity.
SUMMARY OF THE INVENTION
The present invention is directed towards a single instrument which has a handle and two pluralities of blades, is minimally intrusive into the patients body, and expands the vaginal cavity in both the vertical and horizontal axes, as well as towards a method of using the instrument to enlarge the vaginal opening/cavity to perform an examination or other medical procedure. The invention is a single instrument which removes from the field of view the extraneous tissue which pushes around the longitudinal blades. This feature enable the practitioner to efficiently and quickly perform a vaginal examination or procedure without undue manipulation of the speculum and without the use of an additional instrument. The vertical and horizontal axes as the terms are used herein are defined by the instruments orientation along the long axis of its handle.
In one preferred embodiment of the invention, the instrument includes a handle for the practitioner to manipulate and adjust the speculum, a longitudinal assembly including a plurality of adjustable, longitudinally arranged speculum blades which expand the vaginal cavity in a vertical direction, and a latitudinal assembly including a plurality of adjustable latitudinally arranged paddles or blades which expand the vaginal cavity in a horizontal direction, retracting the extraneous tissue from the practitioners field of view. The blades and paddles are contoured for the comfort of the patient and at least partially encompass a cavity forming an aperture along the practitioner's field of view.
In one embodiment of the invention, one of the longitudinal blades includes an inferior haft and an inferior blade, and one of the longitudinal blades includes a lever and superior blade. The lever is depressed or squeezed toward the haft by the practitioner following insertion of the speculum, which adjustably pivots the top and bottom longitudinal blades to expand the vaginal cavity. In one embodiment of the invention, the lever and handle are also linked by an adjuster device which is adjusted by the practitioner to keep the expansion of the top and bottom blades at a set width.
Each of the latitudinal or side wall members is moveably mounted to move in a horizontal direction. In one embodiment shown in
FIGS. 1-4
, these members are located interior to the longitudinal blades. Each of the side wall members include a sidewall paddle or blade which is inserted into the vaginal opening, and an arm for adjusting the side wall paddle. The members extend out of the vaginal opening, pivot upon the handle, and operably connect to an adjuster device. This adjuster device can be operated by the practitioner one-handed. This adjuster device expands and sets the side-wall or latitudinal paddles at the desired width for the practitioner. The latitudinal paddles are also contoured for the patient's comfort. Thus, in one embodiment, the speculum of the invention can be adjusted and manipulated one-handed by the practitioner.
In another aspect of the invention, a method of using the four-bladed seeculum is provided. The method includes the steps of inserting the speculum into the vaginal opening, expanding the longitudinal blades by depressing a lever and adjustably setting the width of these blades, expanding the latitudinal paddles within the vaginal canal to push aside the extraneous tissue which may impede the practitioners field of view, setting or expanding this set of blades one-handed, and proceeding with the medical procedure or examination as the practitioner sees fit. In one embodiment of the invention, adjustably setting the width of the blades may be performed one-handed.
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paten
Baumstark Jennifer
McMillin James
McMillin Matthew
Barnes & Thornburg
Hirsch Paul J.
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