Surgery – Female reproductory tract shields – supports – or birth...
Reexamination Certificate
2000-11-14
2002-07-16
Brown, Michael A. (Department: 3764)
Surgery
Female reproductory tract shields, supports, or birth...
C128S834000, C128S885000
Reexamination Certificate
active
06418930
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an incontinence pessary having a shape more closely resembling the anatomic conformation of the vaginal vault. More specifically, the invention provides a design that confers stabilization in all three of the vaginal axes, the longitudinal axis, the antero-posterior axis, and the lateral axis, as well as, stabilization against rotation around these axes. In addition, the invention more specifically provides for an expanding flexible segment and/or electrode surface for engaging the periurethral tissue of the antero-superior vaginal vault.
BACKGROUND OF THE INVENTION
Pelvic floor relaxation in women, as a natural result of childbirth, age and anatomic predisposition, often results in prolapse of one or more of the various organs within the pelvis, such as the uterus, urinary bladder, rectum and intestines. In particular, relaxation of the support to the urinary bladder and the urethra often results in urinary incontinence. Typically, this urinary incontinence is a form known as stress incontinence that results in leakage of urine at times of physical stress that suddenly increase the intraabdominal pressure, such as coughing, laughing, sneezing, or physical exercise.
Stress incontinence is not only a medical problem for the woman, but also creates social difficulty, as well. Inappropriate urine leakage may result in perineal skin maceration and skin breakdown, which can be further complicated by bacterial and fungal infection. In addition, the woman's clothing becomes soiled and emanates characteristic urine malodor unless steps are taken to absorb the urine in devices such as pads or incontinence diapers.
A common solution to the problem of pelvic relaxation is the use of a pessary inserted within the vaginal vault. A number of different types of pessaries are available, ranging from cubes, doughnuts, rings, and discs, to blocks of material, each completely, or at least partially inserted within the vaginal vault. Pessaries having inflatable portions are also contemplated. In all cases, the pessary acts as a vaginal space-occupying device intended to support the organs and tissues of the pelvis when the woman's own anatomic suspension has failed. Consequently, a pessary is subjected to prolong use and must maintain its positioning and support continuously while not interfering with normal activities of daily living. Additionally, there have been several pessaries designed for the treatment of urinary stress incontinence. These have not achieved their desired effect because they are not stable in all axes of vaginal orientation. Lack of stability in all axes allows for off axis forces to be applied to these pessaries, which causes misdirection of the force to the periurethral tissue and urethra relied on for continence by these devices.
However, the type and extent of pelvic relaxation and subsequent prolapse of any one or more organs and the degree of urinary incontinence encountered is highly variable from one woman to the next. Unfortunately, current pessary styles may provide relief for a particular aspect of the problem, but do not provide for adequate problem solving for all the difficulties encountered. As an example, a pessary may be well adapted for support of a prolapsing rectum, but is inefficient at providing simultaneous urethral support for control of stress incontinence. The rectum, uterus, and urinary bladder are midline anatomic structures that generally prolapse in the midline, or sagittal plane. The prolapsing organ places antero-posterior, longitudinal, lateral and/or rotational displacement forces on any pessary placed within the vaginal vault. When not stabilized against all of these forces, a pessary becomes displaced. This displacement of the pessary defeats the pessary's function in controlling urinary incontinence by failing to support the urethra.
What is needed is an incontinence pessary that is anatomic in its orientation to various pelvic structures, providing continuous support of these organs. Such a pessary will also provide continuous control of urinary incontinence, provide for proper release of vaginal secretions, and not interfere with normal daily activities.
SUMMARY OF THE PRESENT INVENTION
The present invention contemplates an incontinence pessary device for use within a vaginal vault of a woman that comprises a resilient main support body, at least two resilient lateral support bodies, and a suburethral support body. The main support body is generally a disc or torus shape of resilient material, the disc having a primary plane of orientation. The disc or torus shape provides for a differential response to compressive forces, particularly to forces applied to the disc or torus along the primary plane of the disc or torus.
As contemplated by the present invention, the main support body, when inserted in the vagina will be oriented with the plane of the disc or torus oriented to the sagittal plane of the woman's pelvis. Thus, the main support body is in a position to counter the effects of any prolapsing organ, such as the urinary bladder, uterus or rectum into the vaginal vault. The prolapse movement of any of these organs will exert a compressive force on the main support body that is in the primary plane of the main support body. The orientation of such compressive forces may be any of the sagittal plane axes of orientation: antero-posterior, cephalo-caudal, and longitudinal, i.e., along the long axis of the vaginal vault. These forces are readily countered by the resiliency of the material used in the main support body.
A tendency for some pessaries, after placement in the vaginal vault, is to shift laterally or rotate out of position when encountering the forces applied to it along the sagittal plane. The present invention uses at least two resilient lateral support bodies to effectively counter this effort. The present invention contemplates that the lateral support bodies will be provided as opposing pairs, but the number of pairs used is not limited. The Description and Figures provided herein disclose the use of two lateral support bodies, although, any number of pairs may be used depending upon the degree of stabilization sought.
The lateral support bodies project at an angle from a position on the main support body toward generally opposite sides of the main support body. Each lateral support body generally sweeps backward and outward from the primary plane of the main support body. Each pair of lateral support bodies forms a secondary plane generally perpendicular to the primary plane. Thus, when the pessary of the present invention is placed within the vaginal vault, the lateral support bodies project posteriorly within the vaginal vault, and laterally from the sagittal plane of the pelvis. The ends of the lateral support bodies will abut the posterio-lateral vaginal wall with the rectum between the lateral supports.
The lateral support bodies also demonstrate a differential response to the compressive forces, the lateral support bodies being stiffer along their length than across their width. Forces that would tend to push the pessary laterally will be generally exerted along the secondary plane of each pair of lateral support bodies used. The lateral support bodies stabilize the pessary of the present invention by countering any tendency for the pessary to want to move laterally out of the way of a any prolapsing organ.
Additionally, the lateral support bodies stabilize the pessary in the anterop osterior axis keeping the suburethral support body intimately adjacent the mucosa of the periurethral tissues. The lateral support bodies are stiffer along the secondary plane in this antero-posterior axis and contribute directly to the pressure applied by the suburethral support body to the woman's urethra to control incontinence. Note that either lateral forces or antero-posterior forces exerted on the lateral support bodies are designed to meet the lateral support bodies at oblique angles, limiting the mechanical advantage that might be encountered if met e
Brown Michael A.
Cotterell Gregory F.
Mayo Foundation for Medical Education and Research
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