Apparatus and methods for treating female urinary incontinence
First Claim
1. Apparatus for remodeling at least one treatment site within the lower urinary tract of a female patient, the lower urinary tract including a urethra having a urethral lumen and a bladder having a bladder outlet, the apparatus comprising:
- an elongated shaft having proximal and distal ends and a distal region disposed adjacent to the distal end;
markings on the shaft configured to indicate depth of insertion;
a handle coupled to the proximal end;
a plurality of needle electrodes extendable from around the shaft in a plane and configured to emit energy to treat a submucosal layer of the urethra or bladder outlet to cause a reduction in the compliance of the submucosal layer; and
an expandable member deployable at a predetermined distance distal of the plurality of needle electrodes, the expandable member adapted to be deployed in the bladder.
2 Assignments
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Accused Products
Abstract
Apparatus and methods are provided for treating female urinary incontinence by applying a form of energy to tissue in the vicinity of the urethra and/or bladder outlet to change tissue compliance without substantially narrowing the urethral and/or bladder outlet lumen. The apparatus comprises an elongated shaft having a means for treating urethral tissue and an expandable member deployable distal of the means for treating. The expandable member is configured to be anchored against the bladder outlet to dispose the means for treating at a desired treatment site in the urethra using only tactile feedback. The means for treating may include a needleless RF electrode, an ultrasound transducer, or a cryogenic probe configured to be advanced through a hollow needle, each of which are designed to reduce or eliminate symptoms associated with urinary incontinence.
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Citations
13 Claims
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1. Apparatus for remodeling at least one treatment site within the lower urinary tract of a female patient, the lower 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 proximal and distal ends and a distal region disposed adjacent to the distal end; markings on the shaft configured to indicate depth of insertion; a handle coupled to the proximal end; a plurality of needle electrodes extendable from around the shaft in a plane and configured to emit energy to treat a submucosal layer of the urethra or bladder outlet to cause a reduction in the compliance of the submucosal layer; and an expandable member deployable at a predetermined distance distal of the plurality of needle electrodes, the expandable member adapted to be deployed in the bladder. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for remodeling at least one treatment site within the lower urinary tract of a female patient, the lower urinary tract including a urethra having a urethral lumen and a bladder having a bladder outlet, the method comprising:
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inserting a distal end of a device though the urethra thought the bladder neck outlet and into the urethra, the device having an elongate shaft with proximal and distal ends and markings on the shaft to indicate depth of insertion, a handle coupled to the proximal end, an expandable member disposed near the distal end, and a plurality of needle electrodes disposed a predetermined distance proximally of the expandable member; reading a first depth measurement from the markings on the shaft; extending the plurality of needle electrodes from a retracted position within the shaft to an extended position to advance the needle electrodes into tissue surrounding the urethra at a treatment site to form a first plane relative to the treatment site; supplying radio frequency energy to the plurality of needle electrodes for a predetermined time to remodel tissue surrounding the urethra at the treatment site; retracting the plurality of needles into the shaft; rotating the shaft within the urethra; positioning the shaft at the same first depth measurement; and extending the plurality of needle electrodes from the retracted position within the shaft to the extended position to advance the needle electrodes into tissue surrounding the urethra at a treatment site in the same plane as the first plane. - View Dependent Claims (9, 10, 11, 12, 13)
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Specification