Importance

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Abstract

An apparatus for increasing local tissue volume at an injection site including an expandable containment membrane (4) for being hypodermically implanted into a patient. The containment membrane is implanted into the proximal periurethral tissue in an axially uninflated condition. An expansion mechanism (8) is permanently disposed within the containment membrane to add the desired bulk to the proximal periurethral tissues and thereby overcome urinary incontinence by locally controlling the increase of tissue volume. An actuation device (10) inflates the expansion mechanism, expanding the containment membrane in the radial direction. In one embodiment, the expansion mechanism is a plurality of axially elongated elements or spokes (14). Each spoke includes a distal end (16) and a proximal end (18), the ends being movable toward each other, causing the central portion of the spoke to move radially and thereby expand the containment membrane. In alternate embodiments, the containment membrane includes a plurality of nested containment membranes (4, 4',4'), sequentially inflated by injecting biocompatible fluid or suspended particulate matter. In each embodiment, the containment membrane functions as an envelope maintaining the expansion mechanism isolated from the surrounding tissue. The increased bulk of the expanded membrane increases passive occlusive pressure applied to the patient's urethra to control incontinence.

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First Claim