Abstract: A catheter is described herein, having a catheter shaft including a proximal end and a distal end, a tip attached to the distal end, including first and second legs spaced apart to form a slot therebetween, the slot in fluid communication with a lumen of the catheter shaft, and a bladder inflatable element positioned over an outer surface of at least one of the first and second legs.

Abstract: Methods, systems and devices for performing gynecological procedures. According to one embodiment, there is provided a device for accessing the peritoneal cavity of a patient by inserting the device through the vaginal cavity, the cervix, and the uterus and past the fimbria.

Abstract: A method delivers an implantable device through the urethra and into the bladder. A deployment instrument is inserted into the urethra, the implantable device is inserted into the deployment instrument, and a stream of fluid is injected into the deployment instrument. The stream of fluid drives the implantable device from the deployment instrument into the bladder. The deployment instrument is removed from the urethra, leaving the implantable device wholly implanted in the bladder.

Abstract: Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1 N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.

Abstract: A closed specimen collection system includes a port tube that is rotatably attached to tubing of a urinary drainage system attached to an indwelling urinary catheter. The port tube has a one-way valve located adjacent one end formed to fit sealably with a shaped nozzle. A collection has a proximal end and a distal end with a shaped nozzle at the proximal end adapted to fit sealably into the port tube adjacent the one-way valve. A specimen container has a hollow body, a back end and a front end with a sealable aperture sized and shaped to attach to the distal end of the collection tube. A piston fits closely within the hollow body and is attached to an actuating rod. When the actuating rod is moved away from the front end of the container, urine will flow into the specimen container through the collection tube in a sterile condition.

Abstract: Described are needleless injection systems and methods that involve features including one or more of a tissue tensioner and a fitting that includes or attaches to a shaft, exemplary embodiments including: an elastic sleeve sized to fit under tension about the distal end of a flexible scope, such as an endoscope; a non-metal, polymeric tube-like device being optionally attached to the elastic sleeve for delivering a therapeutic fluid to a treatment site within a patient wherein the elastic sleeve may include an integral balloon (tissue tensioner) feature that can be used to position the injection orifice of the tube-like device proximate a treatment area.

Abstract: The present invention is directed to the treatment of various ailments associated with the prostate gland, including benign prostate hypertrophy (BPH), cancer and chronic inflammatory diseases. The present invention describes, inter alia, devices, methods and therapeutic agents for the treatment of prostatic ailments.

Abstract: Device for treating urinary infections comprising a catheter and a container, wherein the container comprises a cholesterol-binding agent. Patients who are using a urinary catheter to empty the bladder of urine are very prone to get an infection and the risk of getting a catheter associated Urinary Tract Infections (UTI) is high. The introduction of a cholesterol-binding agent facilitates a more effective curing of the infection.

Abstract: An apparatus and method used in a urological procedure. The apparatus includes a sheath capable of insertion into a passageway within a patient. A filter is provided that includes a mesh that retains any particulate matter that is entrained with the liquid and allows the liquid to pass therethrough. The filter may be removeably attached to receive flow from an outlet of the sheath.

Abstract: Implant devices for intravesical administration and local drug delivery. The device has a body which includes a hollow tube formed of a biocompatible material; at least one reservoir in the tube which contains a drug; and one or more apertures through which the drug can be released. The device is configured for minimally invasive insertion into a body cavity, such as the bladder. The hollow tube may be elastomeric to permit the device to be elastically deformed from its initial shape into an elongated shape for passage through a catheter, where following such passage the device can return to or toward its initial shape to facilitate retention of the device in the body cavity. The body may have a narrow, elongated shape effective to permit insertion of the drug delivery device through a catheter without necessarily deforming the body, yet include flexible projections which effect retention within the body cavity.

Abstract: A method and device for shunting fluid from high pressure volumes to low pressure volumes to treat various medical problems caused by an imbalance or malfunction of the regulation of flow between these volumes. Typical problems where the method and device are employed include the treatment of incontinence, treatment of hydrocephalus, treatment of elevated intra-cranial pressure, treatment of elevated intra-ocular pressure and the like. The controlled release of fluid from the high pressure volume is accomplished by inserting a sponge using an insertion device such as an endoscope. The sponge retains and releases fluid in response to a pressure differential between the high and lower pressure volumes. The sponge material may be natural or synthetic and sponges with different porosity and fluid retention are provided to achieve desired flow characteristics.

Abstract: Described are devices useful to deliver fluid to tissue of the bladder, bladder neck, prostate, urethra, ureter, kidney, and related methods, the devices including one or a combination of features such as a steerable shaft, an optical mechanism, multiple fluid delivery orifices that may be moveable or extendable laterally, longitudinally, or distally; the methods allowing for delivery of one or multiple types of fluid to tissue such as the bladder (including the bladder neck), urethra, prostate, kidney, ureter, etc.

Abstract: A non-metal, polymeric tubular device for delivering a therapeutic fluid to a treatment site within a patient. The non-metal, polymeric tubular device can be fabricated using suitable high strength polymers and in some versions can be reinforced through the inclusion of reinforcement materials or braiding. The non-metal, polymeric tubular device can be fabricated so as to have a burst strength exceeding at least about 2,000 psi. The non-metal, polymeric tubular device can be fabricated so as to have distention properties, wherein an orifice or jet port located at a distal end of the polymeric tubular device retains its shape and/or size without suffering swelling that can have a detrimental impact on a fluid jet used to deliver the therapeutic fluid at the treatment site.

Abstract: A catheter and method for draining a bladder and injecting a two part biologic adhesive is provided. The catheter has a tubular body extending between proximal and distal ends. A balloon is located adjacent the distal end with a first port extending between the proximal end and the balloon providing for inflation an deflation of the balloon. A second port extends substantially between the proximal end and the distal end for drainage. A pair of ports separate from one another and from the first and second ports extend between the proximal end and the balloon. The pair of ports are each arranged in fluid communication with separate openings located between the balloon and the proximal end to provide separate fluid flow paths for the separate components of the two part biologic adhesive between the proximal end and the openings.

Abstract: Disclosed is a system that prevents the development of infection and biofilm establishment in medical devices in general, and in particular Urinary Tract Infections (UTI), including Catheter-Associated Urinary Tract Infections (CAUTI). The system comprises of a medical device (such as a catheter) and an antimicrobial composition containing an antimicrobial compound. A medical device delivers the composition both to the inside and/or outside portions of the device, as well as to the inside of the bladder itself and to the urethra. Reduction or elimination of the infection may be accomplished by irrigating the medical device, bathing the bladder, or irrigating the bladder with the composition.

Abstract: Devices and methods for self catheterization and for instilling fluid into the bladder are disclosed. A catheter device is provided for inserting into the urethra of an individual by the subject him or herself for the purpose of instilling a therapeutic compound into the bladder. The catheter assembly includes a catheter that has an opening near the tip, a valve mechanism, and a reservoir at the opposite end from the tip. The catheter may be provided with separate channels for draining the bladder and instilling a therapeutic compound into the bladder. Methods for self catheterization and self-administration of a therapeutic compound into the bladder by a patient are disclosed.

Abstract: An implantable medical device is provided for controlled drug delivery within the bladder, or other body vesicle. The device may include at least one drug reservoir component comprising a drug; and a vesicle retention frame which comprises an elastic wire having a first end, an opposing second end, and an intermediate region therebetween, wherein the drug reservoir component is attached to the intermediate region of the vesicle retention frame. The retention frame prevents accidental voiding of the device from the bladder, and it preferably has a spring constant selected for the device to effectively stay in the bladder during urination while minimizing the irritation of the bladder.

Abstract: Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

Abstract: A urethral catheter comprises an elongate tubular shaft having an open proximal end, a sealed distal end a single lumen therein that extends between the proximal and distal ends. A proximal portion of the shaft has a first outer diameter and a distal portion of the shaft has a second outer diameter smaller than the first outer diameter. A plurality of openings are provided in the distal shaft portion. The plurality of openings communicate between an outer surface of the shaft and the single lumen and extend longitudinally from a point near the distal end toward the proximal end. The plurality of openings are located along one side of the shaft and are oriented in a common plane that bisects a longitudinal axis of the shaft. The openings most distant from the distal end of the shaft have a diameter that is smaller than that of the openings closest to the distal end of the shaft.

Abstract: An improved catheter design for use in visualizing the prostate. The catheter includes an imaging balloon and a bladder retention balloon. The imaging balloon is disposed along the catheter proximate the location of the prostate. An actuator mechanism is operably connected to the imaging balloon so that the operator can selective inflate/deflate the imaging balloon to correspond with treatment or an ultrasound procedure. The actuator mechanism will allow for various inflation and deflation settings.

Abstract: An endoscope adapter ring for a needleless fluid delivery system for delivering therapeutic fluids to treatment sites within a patient. The needless fluid delivery system can include an automated injector source and a needleless access device. The access device can include a delivery scope and a treatment specific applicator. The adapter ring is operably attached to the endoscope to keep the injector lumen in a known orientation for the use of a side injector.

Abstract: A urethral suppository comprising a non-meltable base member sized to prevent insertion of the base member into the urethra, a non-meltable reinforcement projecting from the base member, and a meltable portion formed around a portion of the reinforcement. The meltable portion tapers along the reinforcement and is shaped for cooperating with the action of the periurethral musculature to retain the suppository within the urethra. A method of delivering one or more therapeutic agents to the female urinary tract, the method involving insertion of the urethral suppository into the urethra. A method for manufacturing a reinforced urethral suppository.

Abstract: An implantable fluid management device, designed to drain excess fluid from a variety of locations in a living host into a second location within the host, such as the bladder of that host. The device may be used to treat ascites, chronic pericardial effusions, normopressure hydrocephalus, hydrocephalus, pulmonary edema, or any fluid collection within the body of a human, or a non-human mammal.

Abstract: A urinary incontinence device for reducing the occurrence and/or severity of female urinary incontinence. The urinary incontinence includes a non-absorbent core structure and a resilient member having a generally trapezoidal shaped profile. The resilient member is adapted to expand the urinary incontinence device within a vagina, while also providing a soft tip for the facilitating the insertion of the device.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, the lumen being obstructed by the effect of a local cell proliferation, the device including a tubular element, in particular of cylindrical shape, intended to be placed in the natural lumen and sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain an artificial channel in the lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect the lumen is obstructed.

Abstract: A tube system (1) for reconstructing a hollow organ, comprising a tube (2) for draining a substance, like e.g. urine, wherein the tube (2) for draining the substance is arranged within an outer tube (5) and that the space (4) between the two tubes (2, 5) is provided for the application of cells, and wherein the outer tube (5) is formed by a membrane (5) permeable for the cells to be applied, in particular a micro-perforated membrane (5).

Abstract: An intraurethral device for use in a female urinary tract is provided. The intraurethral device comprises a urethral element that contains a chemical compound capable of treating or detecting the presence or absence of a disorder or disease. In one embodiment, the intraurethral device also contains outer and inner insertion elements that are in operative communication with the urethral element to facilitate the insertion of the urethral element into the urethra without substantially contaminating the chemical compound prior to insertion.

Abstract: An expandable umbrella-like device for insertion into the urinary bladder of an individual. The umbrella may be used in the treatment of urinary incontinence or in treating urinary bladder dysfunctions.

Abstract: An expandable vaginal insert device for reducing the occurrence of female urinary incontinence. The vaginal insert device includes at least a resilient member capable of expanding to transmit pressure to the urethro-vaginal myofascial area. Optionally, the device may include one or more non-absorbent layers in addition to the resilient member. The resilient member and any additional layers are formed into an elongated member, which may be then be shaped into a M-shaped shaped profile or a dome-shaped profile.

Abstract: A preferred embodiment of the device of the invention, which is adapted to be applied circumferentially about a phallus, having a perimeter, and to facilitate intracavernosal anesthesia, generally comprises: a strip having a length at least slightly greater than the perimeter of the phallus, and a first end and a second end; and a hook and loop closure for releasably fixing at least a portion of the strip proximate the first end to a second portion of the strip

Abstract: A method of treating abnormal biological conditions arising in and/or affecting the vagina involves supplying a flow of water to the vaginal canal while a treatment device having an external surface of stainless steel is disposed therein so as to primarily or preventatively treat an existing or potential abnormal biological condition including fungal, bacterial, viral, inflammatory and neoplastic conditions. The supply of water to the vaginal canal while the stainless steel of the treatment device is disposed therein causes a natural reaction to occur in the vaginal canal which prevents and/or normalizes abnormal biological conditions.

Abstract: An applicator for applying fluid from a squeeze bottle to various parts of the body that may be difficult to reach includes two rigid arms connected by an adjustable angle joint. One end of the first arm screws onto the bottle. The other end of the second arm ends in a tubular connector such as a grease gun fitting. A flexible tube provides a fluid passage between the bottle and the tubular connector. A variety of terminals for different purposes can sealingly snap onto the tubular connector. The terminals preferably have a grease fitting for easy connection. The terminals may include an enema tip, a douche tip, a bidet tip and a suntan lotion spreader. The arms may retract telescopically for compact transport and storage.

Abstract: A method shaping polymeric structures by coating a support structure with a bond-preventing agent to attain a particular shape and subsequently coating the shaped structure of the bond-preventing agent with a polymeric bonding composition is provided. Such shaped polymeric structures can have one or more cavities which can be fluid-filled or gel-filled. Also provided is a hand-actuating retention female urinary catheter having an inner tube and an outer overcoat layer encircling the tube with an elastomeric collar with a shroud. A cavity containing a fluid is interposed between the tube and the overcoat layer. The cavity includes a balloon portion and a reservoir portion. The shroud encircles the reservoir section to inhibit the ballooning of the reservoir section when the reservoir section is squeezed to force fluid from the reservoir portion to the balloon portion through the sleeve portion of the cavity. The overcoat layer and the collar with a shroud are made of soft resilient material.

Abstract: A system for treating a urinary bladder of an individual. The system comprises a resiliently flexible, solid body for insertion into the urinary bladder. The system also comprises an applicator for inserting the body into the urinary bladder or for removing the body from the urinary bladder. The system is useful in treating the urinary bladder, in monitoring the urinary bladder and in the treatment of urinary incontinence.

Abstract: An intraurethral device for use in a female urinary tract is provided. The intraurethral device comprises a urethral element that contains a chemical compound capable of treating or detecting the presence or absence of a disorder or disease. In one embodiment, the intraurethral device also contains outer and inner insertion elements that are in operative communication with the urethral element to facilitate the insertion of the urethral element into the urethra without substantially contaminating the chemical compound prior to insertion.

Abstract: Devices, systems, and methods for diagnosing and/or treating urinary incontinence can accurately and reliably monitor both a vesicle pressure and a maximum urethral pressure of a patient during an abdominal pressure pulse so as to determine relationships between these pressures. Alignment between the location of maximum urethral pressure and a pressure sensor of a catheter can be maintained using an anchoring structure having a surface which engages a tissue surface along the bladder neck, urethra, or external meatus, which move with the urethra during abdominal pressure pulses. A pressuregram is generated graphically showing an increase in urethral pressure relative to an increase in vesicle pressure, and is often displayed in real time to a system operator adjacent the patient. Quantitative and/or qualitative diagnostic output allow selective remodeling of the patient's support structure so that the incontinence is inhibited.

Abstract: A medical instrument adapted for disposition a relative to an orifice defined in a body wall or for disposition in a passage in a body is provided. The medical instrument includes an elongate tube portion having a handle disposed at one end thereof, and an expandable section disposed near the other end thereof. The expansion member is expandable to form a seal between the expansion member and a surface of the body wall orifice or the body passage around substantially an entire circumference of the expansion member.

Abstract: A method for treating obstructions of tubular anatomical passageways of the urinary tract, including the urethra and fallopian tubes, provides inserting an ultrasonic catheter device into an anatomical passageway, passing ultrasound to the distal end of the catheter and infusing liquid infusate to the distal end of the catheter to expel it through lateral fluid outflow apertures at a rate which will cause fluidic dilation of the anatomical passageway.

Abstract: A surgical device for expanding and viewing tissue is disclosed. The surgical device includes a handle, an insertion probe, and at least one window disposed within the insertion probe. The handle has a proximal end and a distal end, and the handle is sized and shaped to be held by a surgeon. The insertion probe has a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. The proximal end of the insertion probe is removably attached to the distal end of the handle. The window extends along a length of the longitudinal axis, and has an opening that is sufficient in size to allow tissue to prolapse through the window and into the insertion probe.

Abstract: The present invention is directed toward a method for accelerating the delivery of a vasodilating agent to the penis. The method of the present invention comprises ingesting a vasodilating agent into the body at a point of ingestion external to the penis, and transmitting ultrasound energy into the penis at a sufficient frequency and intensity to increase hemodynamic activity.

Abstract: Methods and apparatus are disclosed for treating physiological problems, and for providing rapid, efficacious transdermal treatment, for example, of muscle sprains, erectile dysfunction, or baldness, without requiring the use of needles or other invasive interventions. A topical therapeutic agent and ultrasound energy are applied to a tissue surface, e.g., the skin, such that the ultrasound enhances transdermal penetration of the agent. The invention is especially useful in localized delivery of a controlled dosage of a therapeutic agent to the small blood vessels and capillaries beneath the skin's surface.

Abstract: An expandable umbrella-like device for insertion into the urinary bladder of an individual. The umbrella may be used in the treatment of urinary incontinence or in treating urinary bladder dysfunctions.

Abstract: Devices, systems, and methods for diagnosing and/or treating urinary incontinence can accurately and reliably monitor both a vesicle pressure and a maximum urethral pressure of a patient during an abdominal pressure pulse so as to determine relationships between these pressures. Alignment between the location of maximum urethral pressure and a pressure sensor of a catheter can be maintained using an anchoring structure having a surface which engages a tissue surface along the bladder neck, urethra, or external meatus, which move with the urethra during abdominal pressure pulses. A pressuregram is generated graphically showing an increase in urethral pressure relative to an increase in vesicle pressure, and is often displayed in real time to a system operator adjacent the patient. Quantitative and/or qualitative diagnostic output allow selective remodeling of the patient's support structure so that the incontinence is inhibited.

Abstract: A sigmoidoscope comprising at least one disposable part (1), in combination with means (10) for insufflation of a body cavity with a medium via the sigmoidoscope; said medium being susceptible to contamination by a contaminant (as herein defined) during use of the sigmoidoscope, said insufflation means (10) and said sigmoidoscope (eg part 1) being connected, or adapted for connections one to the other; the sigmoidoscope and/or the insufflation means being provided with disposable contamination prevention means (18), or being so formed and arranged, that no non-disposable part of the sigmoidoscope (eg 15) and no non-disposable part of the insufflation means is exposed to any contaminated medium during use of the sigmoidoscope.

Abstract: An improved incontinence device that includes a preferably curved lumen which conforms the urethra to its original anatomical position to control urinary incontinence. The lumen is inserted substantially straight into the urethra via a relatively rigid obturator which causes the lumen to straighten along its entire length. Removal of the obturator causes the lumen to return to its pre formed curved shape allowing the urethra to also conform to the curved shape. The lumen may have a flange integral with its proximal end that acts as a stop and effectively prevents the lumen from migrating into the urethra. Removal of the lumen is accomplished by grasping the flange and pulling the lumen out of the urethra.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Abstract: An indwelling catheter comprising a flexible malecot tube having a plurality of slits elongating toward the longitudinal direction in the vicinity of the tip of the catheter, a flexible core wire movable in the axial direction along the malecot tube with its tip fixed to the tip of the malecot tube, a cylindrical connector fixed to the root side of the malecot tube and permitting the root of the core wire to protrude out of the end portion of the malecot tube, and a stopper provided on the connector to constrain arbitrary movement of the core wire.

Abstract: A method of treatment for impotency is provided. The method involves the administration of nitric oxide by a nitric oxide-releasing agent capable of providing a penile erection-inducing amount of nitric oxide to the corpus cavernosum of the penis of an impotent male animal. Also provided is a nitric oxide delivery means for use in the method.

Abstract: An apparatus and method for placement of a tubular body in the urethra. The tubular body includes a proximal portion adapted for placement toward a bladder end and bladder neck end of the urethra and a distal portion opposite from the proximal portion. A sensor component located on the tubular body is responsive to a feature of the urethra and outputs a first signal indicating proper placement of the proximal portion of the tubular body relative to the bladder and bladder neck. Preferably, an insertion tool is used during positioning of the urethral apparatus. The insertion tool is coupled to the distal end of the urethral apparatus and is used to push the urethral apparatus proximally in the urethra. The first signal can be transmitted from the urethral apparatus through the insertion tool from which it is perceivable by the person positioning the urethral device.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.