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;
a handle coupled to the proximal end of the elongated shaft and configured to rotate the shaft when the shaft is inserted into the urinary tract;
a plurality of electrodes spaced circumferentially in a single plane around the shaft, the electrodes configured to be deployed from the shaft, retracted back into the shaft, and redeployed after rotation of the shaft to treat a submucosal layer of the urethra or bladder outlet to cause a reduction in the compliance of the submucosal layer;
an expandable member attached to the distal end of the elongated shaft, the expandable member adapted to be deployed in the bladder and be anchored against the bladder outlet; and
a plurality of measurement markers on the shaft, each marker extending around part of a circumference of the shaft, the measurement markers configured to indicate a depth of the shaft within the lower urinary tract.
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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.
325 Citations
20 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; a handle coupled to the proximal end of the elongated shaft and configured to rotate the shaft when the shaft is inserted into the urinary tract; a plurality of electrodes spaced circumferentially in a single plane around the shaft, the electrodes configured to be deployed from the shaft, retracted back into the shaft, and redeployed after rotation of the shaft to treat a submucosal layer of the urethra or bladder outlet to cause a reduction in the compliance of the submucosal layer; an expandable member attached to the distal end of the elongated shaft, the expandable member adapted to be deployed in the bladder and be anchored against the bladder outlet; and a plurality of measurement markers on the shaft, each marker extending around part of a circumference of the shaft, the measurement markers configured to indicate a depth of the shaft within the lower urinary tract. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of treating urinary incontinence, comprising:
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inserting a device into a urinary tract, the device having a shaft, an expandable member, and a plurality of electrodes spaced circumferentially in a single plane around the shaft; determining the depth of insertion of the shaft using a plurality of measurement markers on the shaft; expanding the expandable member in a bladder of the urinary tract; deploying the plurality of electrodes from the shaft into a first set of tissue regions in the urinary tract; withdrawing the electrodes from the tissue; after withdrawing the electrodes, rotating the treatment device without axially moving the device; and redeploying the plurality of electrodes into a second set of tissue regions in the urinary tract, the second set of tissue regions circumferentially spaced from the first set of tissue regions. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification