Continence augmentor and methods for urinary control

Abstract

A female continence augmentor stops involuntary urine loss due to transient increases in bladder pressure but allows urine flow when automatically opened by transmitted bladder pressure during voluntary voiding. The augmentor improves coaptation and increases midurethral resistance to opening with a resilient mount releasably adhered adhesively to the body in position to prevent inadvertent urine loss. An intralumenal part on the mount has a resilient portion extending into the urethra for urging the dorsal midurethral wall in a dorsal direction for stretching and/or reshaping the midurethral lumen to an arc. The portion has a member located to engage the midurethral wall. A coaptation improver on the member engages with the adjacent midurethra. The improver carries biocompatible hydrophilic material adapted to coact with mucus and mucosa within the urethra. A coated biocompatible hydrophilic membrane can be the member with opposed generally rectangular major surfaces and is circumscribed by an edge. The hydrophilic membrane is bowed along the edge transverse between sides thereof for bearing against the inside of the midurethral walls. The membrane has a mesh of flexible polymer and an arc shape between the sides so the opposed major surfaces are concave and convex. Two struts can extend from the sides to the portion. A method of making the augmentor has the steps of forming the mount of resilient material. The resilient material adheres to the body to support the augmentor in position to prevent inadvertent urine loss through the midurethral lumen. The part on the mount extends into the urethra. Connecting the part to the mount and locating the member on the portion for placement relative to the mount intralumenally is a step. The method step of forming includes molding the mount of a polymer. The step of locating the member uses at least one or two struts. The method has the step of adding an adhesive to the mount and increasing coaptation of the portion with a material. A method of using the augmentor has the steps of inserting the part into the urethra so that the member is within the midurethral lumen and placing the mount adjacent to the urethral exit to retain the member therein. Applying resistance inside the urethra with the member by the portion is a step of using. Urging the dorsal midurethral wall in a dorsal direction and engaging the urethral wall, especially the midurethral wall to remove laxity therein are steps of using.