Apparatus and methods for treating female urinary incontinence
First Claim
1. Apparatus for remodeling a treatment site within the urinary tract of a female patient, the urinary tract including a urethra having a urethral lumen and a bladder having a bladder outlet, the apparatus comprising:
- an elongated shaft having a proximal end, a distal end and a distal region disposed adjacent to the distal end;
a handle coupled to the proximal end;
an expandable member affixed to the distal region in the vicinity of the distal end, the expandable member adapted to be deployed in the bladder and anchored against the bladder outlet;
means for selectively forming a localized inward protrusion of the urethral wall; and
a needle disposed to penetrate the urethral wall in the vicinity of the localized inward protrusion to inject a bulking agent at the interface of the mucosal and submucosal layers.
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Accused Products
Abstract
Apparatus and methods are provided for treating female urinary incontinence by injecting a bulking agent at the interface between the mucosal and submucosal layers of the urethral wall. The remodeling device comprises an elongated shaft preferably having means for forming a localized inward protrusion of the urethral wall, and a needle, movable between retracted and deployed positions, for delivering a bulking agent into the urethral wall in the vicinity of the localized inward protrusion to thereby reduce or eliminate symptoms associated with urinary incontinence.
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Citations
16 Claims
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1. Apparatus for remodeling a treatment site within the urinary tract of a female patient, the urinary tract including a urethra having a urethral lumen and a bladder having a bladder outlet, the apparatus comprising:
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an elongated shaft having a proximal end, a distal end and a distal region disposed adjacent to the distal end;
a handle coupled to the proximal end;an expandable member affixed to the distal region in the vicinity of the distal end, the expandable member adapted to be deployed in the bladder and anchored against the bladder outlet; means for selectively forming a localized inward protrusion of the urethral wall; and a needle disposed to penetrate the urethral wall in the vicinity of the localized inward protrusion to inject a bulking agent at the interface of the mucosal and submucosal layers. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method for remodeling a treatment site within the urinary tract of a female patient, the urinary tract including a urethra having a urethral lumen and a bladder having a bladder outlet, the method comprising:
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providing apparatus comprising a handle and an elongated shaft coupled to the handle, the elongated shaft having a distal region and a needle, the distal region comprising an expandable member; inserting the elongated shaft into the urethra until the expandable member is positioned within the bladder; locating the needle at a position within the urethra; deploying the expandable member within the bladder; retracting the handle proximally to seat the expandable member against the bladder outlet; moving the needle to penetrate the urethral wall; injecting a bulking agent at an interface between the mucosal and submucosal layers of the urethral wall to cause localized narrowing of the urethral lumen; and forming a localized inward protrusion of the urethral wall prior to injecting the bulking agent. - View Dependent Claims (13, 14, 15, 16)
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Specification