Abstract: An improved method and device for locating a nerve based on a closed-loop automated system is described. The device applies an electro-stimulus to a target tissue area and measures and interprets a change in a response evoked by application of an electro-stimulus to determine the location and responsiveness of a nerve. The improvement of the invention comprises a method for determining if the signal of the response is stable prior to application of electro-stimulation to prevent misinterpretation of a response and to enhance the locating accuracy of the device.

Abstract: A device for managing urinary incontinence comprises a resilient body that engages the external genitalia and sealingly occludes the urethral meatus. In female embodiments, the body fits between the labia minora and the floor of the vulval vestibule, occluding the meatus. An adhesive on the body provides a sealing engagement with the meatus. In a first female embodiment, the body has a base with an adhesive layer that seats against the vestibule floor. A pair of flexible, lateral flaps engage the labia minora. A layer of super-absorbent material may be situated between the base and the adhesive Layer, and/or a layer of scrim material may be so situated. The body may have a longitudinal ridge with a posterior edge having a finger hole to facilitate installation and removal of the device. In a second female embodiment, the body is substantially tubular, with the adhesive on the exterior surface of the body.

Abstract: Methods and devices are described for calibrating the pressure sensors of a tissue examination device to enable the sensors to produce signals that accurately indicate whether an underlying tissue structure is present in tissue being examined. In general, the calibration is performed using a substance configured to apply a selected amount of pressure to the sensors when engaged in a selected way by the tissue examination device. The sensors are calibrated based on levels of the signals produced in response to the selected amount of pressure imposed by the substance. The tissue examination device may be pressed against the substance, or the substance may be pressed against the sensors. Preferably, the substance applies the selected amount of pressure substantially uniformly to the sensors. A wide variety of substances can be used, such as a foam pad, a rubber pad, a gel, a fluid-containing balloon, and pressurized air.

Abstract: Tissue is examined with a device that includes one or more transducer elements, each of which generates a signal in response to force imposed on the transducer element in accordance with varying properties of an underlying tissue structure as the transducer element is pressed against and moved over the tissue. The tissue examination device further includes circuitry for detecting a variation in the signals as an indication of a composition of the underlying tissue structure.

Abstract: An apparatus and method for stimulating and locating a nerve is described. The apparatus is closed-loop in nature in that the device is automated and is independent of the skill of the operator. The apparatus includes a stimulating probe having an array of electrodes, an automatic control means, and a response detecting means. Response feedback is analyzed according to an electrode selecting algorithm (incorporating a response interpreting algorithm) so that ongoing stimulation is restricted to a subset of the array which produces a criterion response with the least magnitude of stimulation. A method of use is also described. The device and method are also intended to permit optimal stimulation of a located nerve for therapeutic purposes.

Abstract: A novel urethral plug having adhesive thereon, wherein the adhesive seals the plug against the tissues surrounding the meatus and/or urethra, thereby arresting movement of the plug while it functions in the urethra to block the flow of urine. The urethral plug comprises a hollow or solid body which is of a sufficient length and diameter to occlude the urethra. In one embodiment, adhesive is disposed on the meatal plate of the plug so as to secure the plug against the tissues surrounding the urethral meatus. In a second embodiment, adhesive is disposed on the body of the plug so as to seal the plug against the urethral wall. In a third embodiment, the adhesive is disposed on a portion of the meatal plate so as to seal the plug against the tissues surrounding the urethral meatus. The adhesive seals the urethral plug in place until the user wishes to void, at which time, the seal may be broken by exerting a pulling force on the plug.

Abstract: A novel urethral plug assembly having adhesive thereon, wherein the adhesive seals the plug assembly against an internal wall thereby arresting movement of the plug assembly while it functions in the urethra to block the flow of urine therefrom. The plug assembly may comprise a solid body which is of a sufficient diameter to occlude the urethra. Alternatively, the plug assembly may comprise a body which has the ability to change its shape from a compressed to an elongated condition so as to conform to the urethral wall and occlude the opening to the urethra. In one embodiment of the invention, the adhesive lies on the meatal plate of the plug assembly so as to secure the plug assembly against the meatus urinarius. In a second embodiment of the invention, the adhesive is on the body of the plug assembly so as to seal the plug assembly against the urethra, bladder neck or bladder wall.

Abstract: A urinary continence device for males, having a body to cover and seal the urethra of the wearer and capable of conformably securing to the penis of the wearer. In the preferred embodiment, the body has a substantially hemispherical configuration and is sized to cover the glans penis. One or more adhesives may be used to adhere the device to the penis and the one or more adhesives may be in a continuous or discontinuous layer. The device may additionally include a locating member to assist in placement and may provide additional sealing properties. In use, the body seals the urethra so as to prevent urine leakage. To void, the wearer simply removes the device, and reapplies the device or a new device when evacuation is complete.

Abstract: A novel urethral plug comprising a cooperating shaft and balloon, lying in coaxial engagement. The balloon possesses a contracted shape for insertion and removal through the opening of the urethra, and a larger, expanded shape for blocking the flow of urine in the urethra, bladder neck and bladder. After insertion, such an expanded shape is achieved by inflation of the balloon through the use of an external source such as a syringe which introduces fluid through an opening and into the shaft. The fluid acts upon a ball valve, thus pushing the ball past a valve seat, thereby permitting fluid to travel through the shaft and into the balloon. Fluid transmission continues until the balloon is expanded to such an extent as to block the flow of urine. The balloon retains the fluid therein, and the force of the fluid on the ball valve causes the ball to rest firmly against the valve seat. The balloon, when expanded thus functions to seal the plug to the urethra, bladder neck and bladder.

Abstract: There is presented an assembly for prevention of urinary incontinence in humans, the assembly comprising an applicator and an elastomer body. The applicator is adapted to position the elastomer body in the urethra of a female or male and includes a support portion for retaining the elastomer body, and a manipulable portion for positioning the elastomer body in the urethra. There is further presented a method for preventing an unwanted discharge of urine, utilizing the aforesaid assembly.

Abstract: There is presented a urethral measuring device for determining the length of a human urethra, the measuring device comprising a member having an expandable portion at a first end and adapted to receive fluid from an external source at a second end. The member includes graduations arranged such that the graduations are located a pre-specified distance from the expandable portion. In certain embodiments, the graduations also are located at least "x" distance from the meatus of the urethra when the device is inserted and in an operative position. The measuring device further includes a collar slidably disposed and movable on the member and is used as a pointer against the graduations to measure the length of the urethra. There is further presented a method for determining the length of a urethra, utilizing the aforesaid device.

Abstract: A device for the control of urinary incontinence comprising a urethral plug self-movable between a first condition in which the plug is relatively rigid and generally tubular, with a smaller diameter for travel through the orifice of the urethra, and a second condition in which the plug is flexible and expansible to a larger diameter for retaining the plug in a mammalian body and blocking the flow of urine. A larger diameter is achieved by exposure of a tube-like member of the plug to natural bodily conditions, resulting in an automatic expansion of the tube, whereupon the expansion causes the tube-like member to form a seal with the urethra, bladder neck or bladder wall. The plug further has a meatal plate for anchoring the plug in the urethra and preventing migration into the bladder.

Abstract: A novel urethral plug assembly having adhesive thereon, wherein the adhesive seals the plug assembly against an internal wall thereby arresting movement of the plug assembly while it functions in the urethra to block the flow of urine therefrom. The plug assembly may comprise a solid body which is of a sufficient diameter to occlude the urethra. Alternatively, the plug assembly may comprise a body which has the ability to change its shape from a compressed to an elongated condition so as to conform to the urethral wall and occlude the opening to the urethra. In one embodiment of the invention, the adhesive lies on the meatal plate of the plug assembly so as to secure the plug assembly against the meatus urinarius. In a second embodiment of the invention, the adhesive is on the body of the plug assembly so as to seal the plug assembly against the urethra, bladder neck or bladder wall.

Abstract: A urethral plug assembly having a cooperating housing and inner member, the plug assembly possessing a contracted diameter for insertion and removal through the orifice of the urethra, and a larger, expanded diameter for blocking the flow of urine in the urethra, bladder neck and bladder. A larger diameter is achieved by mechanical deployment of the inner member, which results in the expansion of the housing, or in another embodiment, which results in the expansion of the inner member. A balloon is additionally expanded, thus sealing the plug assembly to the urethral, bladder neck and bladder wall. The plug assembly further has a meatal plate for anchoring the plug assembly in the urethra, preventing migration of the plug assembly into the bladder. Removal of the plug assembly for bladder evacuation, is easily accomplished by pulling a cord causing the contraction of the expanded housing or inner member, and grasping a tab associated with said meatal plate.

Abstract: The present invention is a removable drug delivery system used by patients suffering from lower urinary tract infections or urine disorders and disorders of the urethra and bladder. The present invention delivers antibiotics to the infected areas utilizing modified urethral plugs. It is particularly advantageous in that it maintains a therapeutic effect without risking contamination. The device includes of a balloon at the proximal end and a fluid receiving port at the distal end. The balloon is inflated by injecting fluid into the fluid receiving port and deflated by pulling on a deflation string.

Abstract: An easily manipulable device for determining the volume of an area under examination, comprises a probe having an actuator imparting motion to the prostate, a sensor for measuring the displacement of the actuator, and a load cell for measuring the force exerted by the prostate in response to the imparted motion or alternatively, the force exhibited by the probe. Signals obtained by the load cell and signals generated by the sensor are sent to a computer processing unit whereby the mass and the volume of the area are each determined and outputted numerically on a visual display. In another embodiment, the probe has only two sensing elements, a sensor for measuring displacement, and a load cell for measuring the force exerted by the prostate or alternatively, by the probe. In this embodiment, the tapping motion of one's finger against the prostate replaces the actuator. In another embodiment, the probe has only two sensing elements on its distal end, a motor driven actuator and a load cell.

Abstract: The present invention is a device and method of using a device by patients who suffer from urinary incontinence. This device is a flexible urethral plug which has two components: a molded soft inflatable plastic catheter and a transportable fluid. The fluid can be moved from an external bellows, through a check valve to inflate and distend the device within the urethra, the bladder neck or the bladder causing the device to block the flow of urine through the urethra and assist the natural function of the sphincter in closing the urethra.