Abstract: Described herein are devices for placement in surgically created soft tissue spaces, potential spaces, or cavities. The implantable devices generally include a bioabsorbable body having an open framework that facilitates attachment of tissue thereto in a manner that helps avoid post-surgical deformities. Methods for using the implantable devices in oncoplastic surgery are further described.

Abstract: The invention is devices and methods to treat benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms infections (LUTS). The devices are intra-urethral implants placed in a patient in need thereof by minimally invasive procedures, preferably under local anesthesia in an office environment. The devices are sized and designed for atraumatic insertion and expansion within the urethra to engage and retract enlarged prostatic tissue proximate to the urethra that is leading to adverse symptoms associated with BPH. The methods include steps to deploy the implant devices of the invention using a delivery system of the invention and at target prostatic tissue that is visualized during the procedure and yields a reduction in the symptoms of BPH.

Abstract: A nephroureteral catheter is provided that comprises a detachable portion such that when the detachable portion is removed, the catheter converts into an internal stent. The catheter includes a tube with two retention features, a detachable portion, and an inner tube. The inner tube is removably insertable into both the tube and the detachable portion, and a wire extends through at least a portion of a lumen of the inner tube and through the tube, to keep the pieces attached. The wire may be removed to remove the inner tube and then the detachable portion from the tube. When the detachable portion is attached to the tube, the catheter is a nephroureteral catheter. When the detachable portion is removed from the tube, the catheter becomes a stent.

Abstract: Aspects of the present invention relate to a method for locating an expandable implant for treating BPH within the prostatic urethra of a patient. The delivery device comprises an inner tube and an outer sleeve moveable relative to the inner tube between a stored position and a deployed position. The outer sleeve surrounds the inner tube to define an annulus therebetween and the expandable implant is retained within the annulus when the outer sleeve is in the stored position.

Abstract: Drug delivery devices (700) are provided herein and include an elongated, elastic body (706) extending between a first end and a second end, wherein the elastic body comprises a water permeable wall structure (708) having defining an elongated drug reservoir lumen (714) extending between the first and second ends. One or more secondary lumens (718) are structured (e.g., positioned, sized, shaped, and optionally filled) to be effective to retard or prevent in vivo diffusion of (i) water into the drug reservoir lumen and/or (ii) solubilized drug out of the drug reservoir lumen.

Abstract: A stent comprising a tubular member, a lumen extending through the tubular member, a first retention structure and a second retention structure at opposite ends of the tubular member. The first retention structure comprises multiple coils and a removable anti-coiling material over the multiple coils of the first retention structure to present the multiple coils as an elongated extension of the tubular member, whereupon removal of the removable anti-coiling material at least one of the multiple coils of the first retention structure is presented and any excess coils can be trimmed.

Abstract: Embodiments of the invention include drug delivery coatings and devices including the same. In an embodiment, a drug delivery coating is included herein having a base polymeric layer, the base polymeric layer including a hydrophilic polyether block amide copolymer and having a hydrophilic surface. The drug delivery coating can further include a therapeutic agent layer forming an exterior surface the drug delivery coating, the therapeutic agent layer contacting the hydrophilic surface of the base polymeric layer and having a composition different than the base polymeric layer, the therapeutic agent layer including a particulate hydrophobic therapeutic agent and a cationic agent. Other embodiments are also included herein.

Abstract: Drug delivery devices having a drug-permeable component and methods of making and using the same are provided. Drug delivery devices include a housing having a first and second wall structures that are adjacent one another and together form a tube defining a drug reservoir lumen. The second wall structure, or both the first wall structure and the second wall structure, are permeable to water, and the first wall structure is impermeable to the drug while the second wall structure is permeable to the drug, such that the drug is releasable in vivo by diffusion through the second wall structure.

Abstract: A sterile dual-purpose closed intermittent urinary catheter system that may be used as either a drain line or a collection bag. A catheter resides within an inner cavity of an extensible sheath and may be extracted from a forward end through an outlet hub for insertion into the urethra. A valve at a rearward end of the sheath may be opened to permit the sheath to function as a drain line, or closed to permit the sheath to function as a collection bag. The sheath has an extended length substantially longer than the catheter length, and may be compressed in an accordion fashion or folded to a compact packaged shape. The urine may be collected in the sheath with the valve closed, or drained straight into a toilet with the valve open. The system may have a source of lubrication to wet the catheter.

Abstract: An implantable biocompatible expander suitable for implantation into a urinary duct, comprises an elongated sinusoidal ring comprising at least two proximal prongs and at least two distal prongs, wherein the expander is resiliently deformable from a relaxed radially expanded orientation to a radially contracted orientation suitable for transluminal delivery through the urinary duct. The expander is configured to exert an outward radial force against a wall of the urinary duct when in-situ within the urinary duct. In particular, the expander is suitable for treatment of benign prostatic hyperplasia and configured for implantation into the prostatic urethra between, and substantially spanning the prostatic urethra between, the bladder neck and external sphincter.

Abstract: Devices and methods are provided for treating a patient having bladder pain and/or irritative voiding symptoms. The method includes administering to the patient's bladder lidocaine or another anesthetic agent continuously over a treatment period of 24 hours or more in an amount effective to achieve a therapeutic effect which is sustained beyond the end of the treatment period.

Abstract: An intermittent catheter has a catheter shaft extending between a proximal end portion and a distal end portion, with a drainage funnel associated with the distal end portion of the catheter shaft. A hydration device encircles at least a portion of the drainage funnel and defines a hydrating fluid-containing reservoir in fluid communication with at least one fluid-release port. The hydration device is configured to be manipulated by a user to move the at least one fluid-release port from a closed condition to an open condition to flow at least a portion of the hydrating fluid out of the reservoir via the at least one fluid-release port for covering at least a portion of the catheter shaft. After or while applying hydrating fluid to the catheter shaft, the hydration device may be dissociated from the drainage funnel for handling the intermittent catheter.

Abstract: Devices, systems, and methods for immobilizing an implanted catheter tip while the catheter is anchored relative to surrounding tissue. In one embodiment, a cannula system is included that incorporates a cinch tube for guiding the catheter to a target site within a body. The cinch tube may define a cinch window to receive therein a cinch member operable to immobilize and occlude the catheter. The cinch tube may also include an elongate opening proximate the cinch window. The elongate opening allows extraction of a portion of the catheter and subsequent severing of the catheter above the cinch window/occlusion site.

Abstract: A medical device for insertion and expansion in a body passageway. The medical device includes an inflatable device such as a balloon that is designed to be inflated and deflated while positioned in the body passageway. The inflatable device is inflatable by inserting a fluid in an internal cavity of the inflatable device. The inflatable device includes an outer surface that has a surface structure or micro-surface structure which is designed to at least partially penetrate into an inner wall of the body passageway when the inflatable device is inflated.

Abstract: A drug delivery system that can be deployed from a catheter and retained within the bladder for delivery of treatment drug solutions over a period of time. The delivery system includes an inflatable or expandable delivery element that can be collapsed within the catheter tip for navigation into the bladder before being inflated or expanded within the bladder. The inflated or expanded delivery element can engage the bladder walls or sized to be too large to be passed from the bladder such that the delivery element is retained within the bladder after inflation or expansion to administer a treatment drug solution over an extended period of time.

Abstract: A system for the delivery and repositioning of a stent is provided that allows the stent to be reconstrained after full or partial expansion for deployment to and removal from a target region.

Abstract: A medical device including an outer balloon, an inner balloon, and at least one delivery unit is disclosed. The outer balloon defines a first internal cavity that remains in fluid communication with a first inflation lumen. The inner balloon is disposed within the first internal cavity, and defines a second internal cavity that is in fluid communication with a second inflation lumen. Each delivery unit includes at least one needle configured to pierce a tissue and at least one reservoir containing a material. Further, inflation of the outer balloon or the inner balloon is structured and arranged to deliver the material into the tissue through the needle lumen.

Abstract: Apparatus and methods for treatment of an internal cavity are provided. The internal cavity is coated with a treatment solution. The treatment solution can include a solidifiable matrix with or without a drug or combination of drugs incorporated therein, or a drug solution without a solidifiable matrix. The treatment solution is coated onto at least a portion of the internal cavity, and acts as a slow-release drug delivery system.

Abstract: Devices and methods are provided for drug delivery. The device may include a housing configured for intraluminal deployment into a human or animal subject and first and second reservoirs within the housing, each reservoir having an actuation end, an opposed release end, and a plug moveable from the actuation end toward the release end. First and second drug formulations may be contained in the first and second reservoirs, respectively. The device may also include one or more actuation systems configured to drive the first and second plugs so as to drive the first and second drug formulations from the first and second reservoirs. The housing may include a porous membrane sidewall in fluid communication with the release ends of the first and second reservoirs, the porous membrane sidewall being configured to distribute the first and second drug formulations driven from the first and second reservoirs.

Abstract: A treatment for male erectile dysfunction comprising separately storing a lyophilized composition of vasoactive agents and a carrier gel, mixing said lyophilized composition of vasoactive agents and said carrier gel creating a homogeneous mixture and applying said homogeneous mixture to the meatus of the glans penis. A system for the treatment of male erectile dysfunction comprising a syringe coupling system for the storage, mixing and application of therapeutic compounds for the treatment of erectile dysfunction, said system further comprising a first syringe and a second syringe. The first and second syringes are filled with a lyophilized composition of vasoactive agents or a carrier gel. The system includes a locking device coupling said syringes to facilitate the transfer of said lyophilized composition of vasoactive agents and carrier gel between the syringes and a penile adapter for applying the therapeutic compounds for the treatment of erectile dysfunction to the meatus of the glans penis.

Abstract: Devices and methods are provided for transmucosal drug delivery. The transmucosal drug delivery device may include a housing configured for intralumenal deployment, such as intravaginally, into a human or animal subject; a drug-dispensing portion which contains at least one drug, the drug-dispensing portion being configured to dispense the drug from the housing by positive displacement; and a permeability enhancer-dispensing portion configured to release or generate a permeability enhancing substance to disrupt at least one region of a mucosal barrier adjacent to the housing at a selected time while intralumenally deployed in the human or animal subject. The device may be operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the permeability enhancing substance.

Abstract: Apparatus and methods for treatment of an internal cavity are provided. The internal cavity is coated with a treatment solution. The treatment solution can include a solidifiable matrix with or without a drug or combination of drugs incorporated therein, or a drug solution without a solidifiable matrix. The treatment solution is coated onto at least a portion of the internal cavity, and acts as a slow-release drug delivery system.

Abstract: A containing catheter for facilitating sequential treatment operations therethrough, is provided. The containing catheter comprises a median portion comprising an elongated, substantially tubular member, and a distal portion, comprising a distal stiff member. A catheterization apparatus is provided, comprising the containing catheter and an elongated inner catheter insertable into the containing catheter. A method of catheterization is provided, comprising providing the containing catheter, stiffening a portion of the containing catheter and inserting the stiffened containing catheter into a body conduit of a patient.

Abstract: Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. The system is configured to permit simultaneous tissue cutting and removal from a target site. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor's office or clinic.

Abstract: Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. An access sheath is provided with at least one lumen, and a lens attached thereto. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor's office or clinic.

Abstract: Disclosed is an assembly of parts for an endourological procedure, including a tubular sheath and an introducer, the tubular sheath being removably mounted on the introducer. The introducer comprises a security channel that is openable to shift a guidewire from a position inside the security channel to a position outside and next to the tubular sheath. Disclosed are also access sheaths and a method of performing an endourological procedure.

Abstract: Implantable drug delivery devices include a housing having a closed drug reservoir lumen bounded by a first wall structure and a hydrophilic second wall structure, and a drug contained in the drug reservoir lumen, wherein the first wall structure is impermeable to the drug and the second wall structure is permeable to the drug. Methods of providing controlled release of drug to a patient include deploying a drug delivery device in the patient releasing a drug from the drug reservoir lumen via diffusion through the second wall structure.

Abstract: Disclosed is an assembly of parts for an endourological procedure including a tubular sheath and an introducer, the tubular sheath being removably mounted on the introducer. The tubular sheath includes a first and a second lumen of which the second lumen is openable to shift a guidewire from a position inside the second lumen to a position outside and next to the tubular sheath. Disclosed are also access sheaths and a method of performing an endourological procedure.

Abstract: Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. Patient benefit is achieved through improved outcomes, reduced pain, especially peri-procedural pain, and reduced recovery times. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor's office or clinic. Distension is achieved mechanically, rather than with liquid distension media, thereby eliminating the risk of intravasation.

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: 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 1N 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 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: Systems and methods for delivery of therapeutic and/or diagnostic compositions to an interventional site having diseased or newly treated tissue are provided. Integrated interventional catheter systems incorporating surfaces coated with a diagnostic or therapeutic composition, or ports for infusing a diagnostic or therapeutic composition prior to, during or following an interventional procedure are provided.

Abstract: A flushing device (8) usable in the catheterization of a bladder includes a flexible container (9) defining a compartment (12) adapted to be filled with a liquid, and a connector (10) attached to the container (9). The connector (10) is adapted to be connected to a catheter, and the connector (10) is provided with an opening (11). The flexible container (9) is interconnected with the connector (10) via a lumen (13), such that liquid is allowed to pass through the connector (10) in the lumen (13) from the flexible container (9) and exit through the opening (11). The flexible container further includes a non-return valve (14) arranged in the lumen (13). A kit including such flushing device (8) is also described.

Abstract: Implantable medical devices and treatment methods are provided, particularly for use in the bladder. The device is configured for retention in the bladder for at least a portion of the drug delivery period and includes at least one biodegradable component such that following a biodegradation at a selected time, the retention function is lost and the device or portions thereof are resorbed and/or excreted. The method may include deploying into the bladder of a patient a device having a device structure housing a drug formulation comprising at a drug; releasing drug from the device structure into the bladder; and then, changing the composition of urine in the bladder, e.g., by altering the pH, to trigger degradation of at least part of the device structure to enable the device structure or parts thereof to be excreted from the bladder.

Abstract: An implant delivery system can be configured to deliver an inflatable implant into a bladder via a urethra. The delivery system can comprise an elongate tubular body, an inflation tube and an implant decoupler. The tubular body can comprise a central lumen configured to hold an inflatable implant in an initial un-inflated state for delivery of the implant into the bladder. A method of use can include passing a distal tip of the elongate tubular body into the bladder. The implant can be inflated and released into the bladder.

Abstract: A drug delivery system that can be deployed from a catheter and retained within the bladder for delivery of treatment drug solutions over a period of time. The delivery system includes an inflatable or expandable delivery element that can be collapsed within the catheter tip for navigation into the bladder before being inflated or expanded within the bladder. The inflated or expanded delivery element can engage the bladder walls or sized to be too large to be passed from the bladder such that the delivery element is retained within the bladder after inflation or expansion to administer a treatment drug solution over an extended period of time.

Abstract: A catheter based drug delivery system for minimally invasive delivery of treatment drugs into a bladder wall. The catheter system can include a delivery tip for deforming the bladder wall before forming jets of drug solution that penetrate the bladder wall for needleless delivery of the treatment drugs directly to the diseased tissue. The delivery tip can also have graduated markings for providing visual indicators of the relative depth of the delivery tip in the bladder wall and the alignment of the formed jets with the particular layers of the bladder wall.

Abstract: Method and surgical instrument for treating prostate tissue including a surgical instrument having a main body, a needle deployment port, a needle, first and second handles and a lockout release mechanism to limit needle extension. Additionally, a kit includes the surgical instrument, together with a cystoscope, and optionally a syringe and reservoir of ethanol. The method includes needle-less injection and visualizing the ethanol injection by delivering both an echogenic agent and ethanol either by needle or needle-less injection or by providing an ultrasonically visible marker near the tip of the ethanol delivery cannula. The method also includes extending the needle transversely of the instrument housing using a link assembly.

Abstract: This application describes example antimicrobial compositions that may be used alone or in combination with catheters and catheter insertion sites. According to another aspect, the application describes catheters which may employ one or more protection devices, such as cleaning caps, protective caps or both.

Abstract: Implantable drug delivery devices are provided lo have a deployment shape for implantation in the body and a retention shape for retention in the body. The device may have one or more elongated drug reservoirs containing a drug, mid the drug reservoir may be formed from a deformable material. In one case, a first filament is attached to the first end of the drug reservoir and second filament is attached to the second end of the drug reservoir, wherein a fastener is positioned about the first and second filaments to permit shortening and prevent lengthening of the filaments with reference to the ends of the daig reservoir, as a means for transforming the device from the implantation shape to the retention shape.

Abstract: Apparatus and methods for treatment of an internal cavity are provided. The internal cavity is coated with a treatment solution. The treatment solution can include a solidifiable matrix with or without a drug or combination of drugs incorporated therein, or a drug solution without a solidifiable matrix. The treatment solution is coated onto at least a portion of the internal cavity, and acts as a slow-release drug delivery system.

Abstract: A prostate therapy system is provided that may include any of a number of features. One feature of the prostate therapy system is that it can access a prostate lobe transurethrally. Another feature of the prostate therapy system is that it can deliver condensable vapor into the prostate to ablate the prostate tissue. Another feature of the prostate therapy system is that it can aspirate tissue from the prostate. Yet another feature of the prostate therapy system is that it can rotate during delivery of vapor and aspiration of tissue. Methods associated with use of the prostate therapy system are also covered.

Abstract: A prostate therapy system is provided that may include any of a number of features. One feature of the prostate therapy system is that it can access a prostate lobe transurethrally. Another feature of the prostate therapy system is that it can deliver condensable vapor into the prostate to ablate the prostate tissue. Another feature of the prostate therapy system is that it can aspirate tissue from the prostate. Yet another feature of the prostate therapy system is that it includes a cutter that can rotate during delivery of vapor and aspiration of tissue. Methods associated with use of the prostate therapy system are also covered.

Abstract: A prostate therapy system is provided that may include any of a number of features. One feature of the prostate therapy system is that it can access a prostate lobe from the urethra. Another feature of the prostate therapy system is that it can deliver condensable vapor into the prostate to ablate the prostate tissue. Another feature of the prostate therapy system is that it can aspirate tissue from the prostate. Yet another feature of the prostate therapy system is that it can rotate during delivery of vapor and aspiration of tissue. Methods associated with use of the prostate therapy system are also covered.

Abstract: Implantable drug delivery devices are provided that are deformable between a relatively straightened shape suitable for deployment and a retention shape suited to retain the device within the bladder or other body cavity. While in the body cavity, the devices release drug from solid drug units housed in the devices. The devices are designed to house the solid drug units in a way that exposes one or more sides of the solid drug units to the fluid at the in vivo site of deployment. Methods for using the devices for administering drug and making the devices also are provided.

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: 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: Implantable medical devices and treatment methods are provided, particularly for use in the bladder. The device is configured for retention in the bladder for at least a portion of the drug delivery period and includes at least one biodegradable component such that following a biodegradation at a selected time, the retention function is lost and the device or portions thereof are resorbed and/or excreted. The method may include deploying into the bladder of a patient a device having a device structure housing a drug formulation comprising at a drug; releasing drug from the device structure into the bladder; and then, changing the composition of urine in the bladder, e.g., by altering the pH, to trigger degradation of at least part of the device structure to enable the device structure or parts thereof to be excreted from the bladder.

Abstract: Implantable devices and methods for controlled drug delivery are provided. The device includes a device structure deformable between a retention shape and a low profile shape for deployment in the bladder of a patient and has a drug reservoir lumen in which a drug formulation is housed. The device also includes a buoyancy retention portion, which includes a volume of entrapped air or a gas-generating or effervescent powder Which will generate a volume of entrapped air following contact with urine in the bladder. The buoyancy retention portion may include a water permeable and/or biodegradable wall, which can release the entrapped air following drug release, to cause the device to sink into the bladder neck to facilitate device expulsion without the need for a device retrieval medical procedure.