Expandable dome-shaped urinary incontinence device and a method of making the same

摘要

An expandable dome-shaped urinary incontinence device is disclosed along with a method of making the device. The device includes a resilient member and a non-absorbent which at least partially encloses the resilient member. The non-absorbent and the resilient member are formed into an elongated softwind having a first end, a second end, a first portion located adjacent to the first end, a second portion located adjacent to the second end and a third portion located between the first and second portions. The softwind is folded upon itself, such that the first and second ends are aligned adjacent to one another and a closed loop is formed. The first and second portions are then brought together to minimize the closed loop and the third portion is transformed into a dome shape. The softwind is then compressed into an elongated pledget having an insertion end and a trailing end with the resilient member located at least in the insertion end. The resilient member is capable of expanding at least a portion of the third portion to provide support for a woman's urethra when properly inserted into a woman's vagina. The method includes the steps of enclosing the resilient member by the non-absorbent, folding the two materials to form a softwind, folding the softwind such that a closed loop is formed and transforming the closed loop into a dome shape, and then compressing the softwind into an elongated pledget.