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Abstract
Urinary incontinence devices generally include a body configured to be inserted into a vagina. The body may have a proximal insertion portion, a plurality of legs coupled to and extending distally from the insertion portion, and a distal retrieval portion. The plurality of legs may each have a length, a width, and a distal end, and the distal ends of the plurality of legs may be coupled together. The body may have a compressed configuration, an expanded configuration, and a lateral cross-sectional diameter, and the lateral cross-sectional diameter of the body may be largest at the widest point of each of the plurality of legs. Methods of treating urinary incontinence may include loading a urinary incontinence device into an applicator, inserting the applicator into the vagina, advancing the incontinence device out of the applicator to position a distal end of the device past the pelvic floor, and removing the incontinence device from the vagina using the distal retrieval portion.
Core Innovation
The invention relates to female stress urinary incontinence devices and methods of treating stress urinary incontinence in a user having a vagina and a pelvic floor. The method uses a urinary incontinence device having a body with a compressed configuration and an expanded configuration along a longitudinal axis. The body includes a solid proximal insertion portion, a central portion formed from a plurality of legs extending distally to a distal surface, and a distal retrieval portion coupled to the distal surface.
In the expanded configuration, a length of the central portion is at least three times a length of the solid proximal insertion portion along the longitudinal axis. The device is self-expanding when advanced out of the applicator to a delivered position in which a distal end of the device is positioned past the pelvic floor. In the delivered position, the incontinence device applies a closure force to the urethra.
The disclosed device includes a vaginally insertable, collapsible/self-expanding body with multiple radially expandable legs forming a hollow central chamber and a distal retrieval portion, where the legs and their geometry support applying closure and/or lifting forces to the urethra and/or bladder neck. Additional disclosed structural and delivery concepts include leg geometry and cross-sections, self-expansion and self-orientation/cradling of the urethra using direct and/or lateral force components, and optional force concentrators and frictional elements.
Claims Coverage
The provided independent claim covers one inventive method for treating stress urinary incontinence. The inventive features are loading a compressed self-expanding urinary incontinence device into an applicator, advancing it past the pelvic floor to apply a closure force to the urethra, and removing it using a distal retrieval portion.
Loading a compressed self-expanding urinary incontinence device in an applicator
loading a urinary incontinence device into an applicator, wherein the urinary incontinence device comprises a body comprising a compressed configuration, an expanded configuration, and a longitudinal axis, the body further comprising a solid proximal insertion portion, a central portion formed from a plurality of legs extending distally from the solid proximal insertion portion to a distal surface, and a distal retrieval portion coupled to the distal surface, wherein in the expanded configuration, a length of the central portion is at least three times a length of the solid proximal insertion portion along the longitudinal axis of the body, and wherein the incontinence device is in the compressed configuration when loaded in the applicator
Advancing past the pelvic floor to apply a closure force to the urethra via self-expansion
advancing the incontinence device out of the applicator to a delivered position in which a distal end of the device is positioned past the pelvic floor and the incontinence device applies a closure force to the urethra, wherein advancing the incontinence device causes it to self-expand
Removing using the distal retrieval portion
removing the incontinence device from the vagina using the distal retrieval portion
The claim coverage centers on delivery of a compressed, self-expanding urinary incontinence device past the pelvic floor to apply a closure force to the urethra, followed by removal using the distal retrieval portion.
Stated Advantages
Documented Applications
No documented applications found
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