Abstract: A mammary prosthesis for augmentation mammoplasty is comprised of a shell containing an insoluble, fibrous material which when the shell is inflated with inflating fluid adjusts the feel and appearance of the inflated shell to approximate natural mammary tissue. The shell is sealed except for a valve which can be used to inflate the shell.

Abstract: A stent for maintaining fluid flow through a body passage in a patient comprises a tubular member having an inlet at one end, an outlet at the other end and a lumen extending from the inlet to the outlet. The preferred stent also includes at least one projection on the outer wall of the tubular member which enters the wall of the body passage when the stent is rotated in the proper direction. A kit also is disclosed which includes the stent and a tool for grasping and turning the stent from outside the patient's body.

Abstract: A balloon catheter with an unreinforced stem collapses compactly. A method of introducing a balloon catheter into the body passage of a patient consists of loading the balloon end of the catheter into the unattached sheath of an endoscope and passing the elongated tubular leg attached to the balloon through the lumen of a working channel of an unattached bridge of an endoscope; then joining the bridge and the sheath to form a unitary endoscope and introducing the balloon into the body passage of a patient. A kit is disclosed which includes a balloon catheter and a separate adapter which can be used to introduce inflating fluid into the balloon.

Abstract: The tissue expander includes a shell with a base layer and an expansion layer that define an expansion chamber therebetween. A conduit or fill tube extends from the shell and is the sole source of communication with the expansion chamber. The base and expansion layers are thermoplastically joined together by a major seam and a minor seam. The major seam is substantially concealed within the expansion chamber whereas the minor seam defines a border portion of the expansion chamber and is not concealed. The tissue expander can be of any selected size and shape. The base layer can be made expandable along with the expansion layer or nonexpandable as desired.

Abstract: The self-sealing tissue expander includes inner and outer layers of relatively nonflowable material and a median layer of flowable material. The median layer of flowable material which can include one or more sublayers of flowable material is under a predetermined compression imposed by the inner and outer layers due to a prestressing of the tissue expander shell during formation of the tissue expander. The self-sealing shell seals an opening in the shell wall following removal of an infusion needle. In all embodiments of the invention a needle stop member is provided to prevent the needle that accesses the fluid chamber from passing outwardly of the tissue expander. The need for a septum, a fluid conduit or a special fluid entry opening in the tissue expander shell is thus optional. The shell can also be made relatively more stretchable in some areas than in other areas.

Abstract: The female incontinence control device includes a conduit having inlet and outlet openings for receiving, conducting and discharging urinary fluid. The device also includes stabilizing structure for holding the conduit in its installed position relative to the urethra and bladder such that a drainage inlet opening can receive fluid from the bladder, and the outlet discharge opening is positioned outside the urethra. The conduit includes a manually actuatable drainage control valve adapted to be positioned outside the urethra. Manual actuation of the valve from a closed position to an open position is thus easily accomplished by manipulating an actuator member at a distal end portion of the conduit to selectively control urinary discharge from the conduit. The actuator member can be formed as an extension of a valve member or interconnected with the valve member through a flexible connecting link.

Abstract: A sterile, fully assembled, multi-component, penile erectile system which is to be surgically implanted in man for the treatment of erectile impotence includes at least one elongated, flexible cylindrical member with a pressure chamber for implanting into the pendulous penis; a pressure bulb to be implanted in the scrotal sac; tubing integrally connecting the pressure chamber and the bulb to form a closed system; and, a system for adding or subtracting fluid from the system. The tubing is reinforced so that it will not collapse under suction or kink when bent. In one embodiment the pressure bulb is a multi-stroke pump and in another embodiment there is a receptacle for storing any tubing in excess of that required to extend between two or more components in a given patient. A method of sterilizing and packaging the system so that it can be provided to a surgeon assembled, filled and sterile is also described.

Abstract: A biodegradable, biocompatible, resorbable infusion stent comprising a terpolymer of:(a) L(-)lactide,(b) glycolide, and(c) epsilon-caprolactone.This invention includes a method for treating ureteral obstructions or impairments by utilizing a biodegradable, biocompatible, resorbable infusion stent, and a method for controlling the speed of resorption of the stent.

Abstract: The tissue expander includes a closed shell structure having a shell wall formed of a needle-penetrable material with self-sealing characteristics. The shell defines a fluid expandable chamber. In some embodiments of the invention, a self-sealing layer of elastomeric material is joined or otherwise bonded to an inner surface of a non-flowable layer of elastomeric material. In other embodiments of the invention, the self-sealing layer is joined to the outer surface of a layer of non-flowable elastomeric material. The self-sealing layer may also be sandwiched between two layers of non-flowable elastomeric material. In a further embodiment the self-sealing layer constitutes the entire shell of the tissue expander. In all embodiments of the invention, a needle stop member is provided to prevent a needle that accesses the fluid chamber from passing outwardly of the tissue expander in the same direction in which it has accessed the fluid chamber.

Abstract: A balloon catheter with an unreinforced stem collapses compactly. A method of introducing a balloon catheter into the body passage of a patient consists of loading the balloon end of the catheter into the unattached sheath of an endoscope and passing the elongated tubular leg attached to the balloon through the lumen of a working channel of an unattached bridge of an endoscope; then joining the bridge and the sheath to form a unitary endoscope and introducing the balloon into the body passage of a patient. A kit is disclosed which includes a balloon catheter and a separate adapter which can be used to introduce inflating fluid into the balloon.

Abstract: The self-sealing tissue expander includes inner and outer layers of relatively nonflowable material and a median layer of flowable material, The median layer of flowable material which can include one or more sublayers of flowable material is under a predetermined compression imposed by the inner and outer layers due to a prestressing of the tissue expander shell during formation of the tissue expander. The self-sealing shell seals an opening in the shell wall following removal of an infusion needle. In all embodiments of the invention a needle stop member is provided to prevent the needle that accesses the fluid chamber from passing outwardly of the tissue expander. The need for a septum, a fluid conduit or a special fluid entry opening in the tissue expander shell is thus optional. The shell can also be made relatively more stretchable in some areas than in other areas.

Abstract: The catheter includes a user controlled incontinence portion that is combinable with a combination inflation/drainage member. The inflation/drainage member can be detached from the incontinence portion to provide a user controlled device. A magnetic valve is incorporated in the user controlled incontinence portion for magnetic actuation with an external magnet. The valve is normally closed and magnetically actuatable to an open condition. Removal of the external magnet from proximity to the penis enables the valve to assume its normally closed position. In one embodiment of the invention the valve includes a pressure relief feature. In another embodiment of the invention there is no pressure relief feature.

Abstract: A female incontinence control device includes a conduit having inlet and outlet openings for receiving, conducting and discharging urinary fluid. The device also includes stabilizing structure, which can be adjustable, for holding the conduit in its installed position relative to the urethra and bladder such that a drainage inlet opening can receive fluid from the bladder, and the outlet discharge opening is positioned outside the urethra. The conduit includes a magnetically actuatable drainage control valve adapted to be positioned between the urethral orifice and the labia majora. Magnetic actuation of the valve from a normally closed position to an open position is thus easily accomplished by manipulating a portable magnet at a distal end of the conduit outside the urethral opening to selectively control urinary flow through the conduit.

Abstract: A penile prosthesis consists of a pair of inflatable penile implants which each having a cylindrical body which contains a hydraulic system including a pressure chamber, a reservoir for pressurizing fluid, and a pump for transferring fluid under pressure to the pressure chamber to make it rigid. Each implant also contains a longitudinally compressible, but radially incompressible bellows in the reservoir which expands when the reservoir is empty and prevents the reservoir wall from collapsing. In one embodiment, a tube extends from the pump in the tip to the reservoir at the rear through the pressure chamber and there is a restricted orifice through which fluid can bleed back into the reservoir from the pressure chamber thus automatically controlling the length of time that the pressure chamber is pressurized and rigid.

Abstract: The catheter includes a user-controlled incontinence portion that is combinable with a fluid drainage member to permit continuous bladder drainage into a fluid collection member. The fluid drainage member can be detached from the incontinence portion fo the catheter while the catheter is installed in the urethra and bladder to convert from a continuous drainage system to a user-controlled system. In some embodiments of the invention the fluid drainage member includes inflation lumen for inflating a bladder balloon and urethral cuff of the incontinence portion. In other embodiments of the invention the bladder engaging portion and the urethral cuff are noninflatable and can be either compressed or distended to facilitate insertion in the urethra and bladder. A palpatable valve means is palpatable through the penis to an open condition to permit user-controlled bladder drainage.

Abstract: The nocturnal penile tumescence and rigidity monitor includes a penile cuff formed on a nondistensible flexible membrane with an internal chamber defined therein. The chamber is initially filled with liquid from a reservoir until the cuff contacts the periphery of a flaccid penis. The flaccid penile diameter is correlated with the amount of liquid in the cuff by use of a weight sensor signal. During penile expansion, liquid in the cuff is displaced into the fluid reservoir and the tumescence is correlated with the amount of liquid displaced from the cuff by making a weight measurement of the reservoir after such liquid displacement. The weight sensor provides signals that permit a continuous plot of penile tumescence on a strip chart. When the penile tumescence is at a predetermined reference magnitude, a rigidity test is started.

Abstract: An implantable prosthesis for correcting erectile impotence includes at least one penile implant with a pressure chamber, an accumulator charged with fluid, tubing connecting the accumulator to the pressure chamber of the implant, a valve which is normally closed and a lever which can be moved to open the valve so that pressurizing fluid will flow from the accumulator into the pressure chamber.

Abstract: The infusion stent system includes a stent member having a plurality of openings provided in the wall of the stent along the entire length of the stent. An imperforate open ended guide tube member used for installation and infusion of the stent accommodates a core member that stiffens the guide tube member. The core member is relatively moveable in the guide tube member to provide selective flexibility at a proximal end of the guide tube member. The stent is positioned in the renal cavity, the ureter and bladder by being pushed along the guide tube member by a push catheter. Fluid is infused through a proximal end of the guide tube member when the core member is removed. The proximal end of the guide tube member can be located at any selected position within the stent. Thus fluid can be infused to any selected location in the stent by positioning the proximal end of the guide tube member at a desired location in the stent.

Abstract: The nocturnal penile tumescene and rigidity sensor device includes a flexible, foldable member that supports a relatively soft foam material and a relatively hard foam material. In one embodiment of the invention the relatively soft foam material and the relatively hard foam material cooperate with corresponding force-sensing resistors to detect changes in penile tumescence and rigidity. The relatively soft foam material detects changes in penile tumescence whereas the relatively hard foam material and its corresponding force-sensing resistor detect the presence and/or changes in penile rigidity. In another embodiment of the invention, a relatively soft foam material and a relatively hard foam material, formed of conductive foams, are shaped to contact a conductive strip with preselected different areas of surface contact in response to different levels of tumescence and rigidity. The change of contact area between the conductive foams and the conductive strip is detected and recorded.

Abstract: The flexible needle stop includes a normally unfolded needle impenetrable needle barrier formed of a flexible foldable material. The flexible foldable material can be a single layer sheet material, a wire mesh material and/or one or more layers of scale-like components arranged side by side. The scale-like components are physically unconnected and of a size that permits flexion of the needle stop that incorporates the scale-like components. The flexible needle stop member can include a bead-like periphery which affords the needle stop member with a resilient memory and helps restore the needle stop member to its normally unfolded condition after a folding restraint is removed. The needle stop can be freely disposed within a fill chamber of a tissue expander, attached to an inner surface of the fill chamber or incorporated in the shell wall of a tissue expander.