Incontinence insert applicators and methods for their use

Details Incontinence insert applicators and methods for their use Incontinence insert applicators and methods for their use

2000-09-28

2003-11-11

Lacyk, John P. (Department: 3736)

Surgery

Body inserted urinary or colonic incontinent device or...

C128S885000

Reexamination Certificate

active

06645136

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to devices for reducing the occurrence and/or severity of female urinary incontinence, and to methods for their use. In particular, the present invention relates to incontinence insert applicators for positioning and orientating an insert member within a vagina.
BACKGROUND
Some women, especially women who have given birth to one or more children, and older women, can experience incidences of involuntary urine loss due to stress urinary incontinence or combined stress and urge incontinence. A sneeze or cough can increase the intra-abdominal pressure impinging on a person's bladder and cause the involuntary release of urine. The frequency and severity of such urine loss can increase as the muscles and tissues near the urethro-vaginal myofascial area grow weaker. It has also been recognized that the urinary sphincter muscle, which is located at the upper end of the urethra adjacent to the bladder, works well at sealing off the passing of urine from the bladder to the urethra when it has a round or circular cross-sectional configuration. However, when this passageway becomes distorted into a cross-sectional configuration having more of an elliptical or oval appearance, the sphincter muscle can not close properly, therefore, the tendency for involuntary urine loss increases.
As the world's female population ages, there is an ever increasing need for a non-surgical procedure and/or device to reduce the involuntary urine loss commonly associated with “stress urinary incontinence.” One way to alleviate the problem of incontinence is to place an insert within the vagina to press against and/or compress the urethra and provide support for the urethro-vaginal myofascial area in order to prevent the involuntary loss of urine. Inserts developed for such purposes are disclosed in U.S. Pat. Nos. 6,090,038 and 6,090,098; and in commonly assigned, co-pending U.S. application Ser. No. 09/217,395 entitled “A Urinary Incontinence Device and a Method of Making the Same,” filed Dec. 21, 1998; U.S. application Ser. No. 09/675,459 entitled “A Urinary Incontinence Device and a Method of Making the Same,” filed Sep. 28, 2000; and in U.S. application Ser. No. 09/675,460 entitled “Resilient Incontinence Insert and a Method of Making the Same,” filed Sep. 28, 2000.
One challenge associated with the use of the inserts of the above mentioned patents and applications is that they should be properly oriented within the vagina in order to be most effective. Furthermore, because the inserts are relatively large compared to other vaginally inserted devices, such as catemenial tampons, there is a challenge making a device that can properly place the inserts within the vagina without causing discomfort. Accordingly, there continues to be a need for improvements in devices and methods for alleviating the problem of female urinary incontinence.
SUMMARY
In one aspect of the present invention, an insert member applicator includes an outer member adapted to house an insert member, and an inner member moveable within the outer member and operable to discharge the insert member from the outer member. At least the leading, vaginal insertion end portion of the outer member has a non-circular cross-section in a direction substantially perpendicular to the longitudinal axis of the outer member.
In another aspect of the invention, a device is provided for reducing the occurrence and/or severity of female urinary incontinence. The device includes an insert member and an applicator. The applicator includes an outer member adapted to house the insert, and an inner member moveable within the outer member and operable to discharge the insert member out of an exit portion of the outer member. The outer member is substantially cone-shaped and has its wider cross-section at the insert member exit portion, and the insert member is positioned within the outer member such that a portion of the insert member extends out of an exit portion of the outer member.
In another aspect of the invention, another device is provided for reducing the occurrence and/or severity of female urinary incontinence. The device includes an insert member and an applicator. The applicator includes an outer member adapted to house the insert member and an inner member moveable within said outer member and operable to discharge the insert member from an exit portion of the outer member. The outer member has a substantially elliptical cross-section in a direction substantially perpendicular to the longitudinal axis of the outer member.
Other aspects of the invention will be apparent to those of skill in the art in view of the appended claims.


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