Abstract: A penile erection assist method and apparatus treats male impotence by providing physiologically active vasodilating drugs to the penile erectile tissues in a manner which minimizes pain therein. The penile erection assist device includes an implantable storage unit which is implanted remote from sensitive penile tissue. The drug is delivered to the penile erectile tissue through sterile thin tubing which is implanted into the patients body with the proximal end in fluid communication with the storage unit and the distal end configured to be positioned adjacent proximal penile erectile tissues. This configuration advantageously preserves the intact function of penile erectile tissues by minimally intruding therein. Further, the device and method can be employed with patients having various etiologic origins whether the need is acute or permanent, according to the needs of the patient.

Abstract: An anal dilator for treating anal disorders, such as fissure-in-ano, having a self-expanding means for slowly dilating the anal muscles to cause a relaxation of anal muscles thereby promoting healing. The anal dilator comprises three sections: a first end section positioned within the rectum, a second middle section positioned within the anal sphincter muscle, and a last end section outside of the body between the buttocks. The second middle section having a self-expanding element means may be a vegetable protein, such as laminaria japonica, or a non biologic substance, such as sponge rubber. Additionally, it may also contain medications for local or systemic delivery.

Abstract: An infusion device for use in delivering an infusate from an elongated infusion segment along an elongated section of a body vessel with either a relatively symmetric infusate distribution profile or asymmetric infusate distribution profile that concentrates infusate delivery proximally or distally along the infusion segment. The infusion segment is formed with an infusate distribution manifold for delivering infusate through a plurality of side wall exit ports in the elongated infusion segment having proximal and distal manifold end openings to which infusate is delivered in equal amounts to effect the relatively uniform infusate distribution profile or in relative proportions to effect the asymmetric infusate distribution profile. In differing embodiments, the infusate delivery is either fixed or may be adjusted by a proximal adjustable valve mechanism.

Abstract: Improved biocompatible liquid delivery compositions, which are useful for the formation of sustained release delivery systems for active agents, are provided. The compositions include liquid formulations of a biocompatible polymer or prepolymer in combination with a controlled release component. The controlled release component includes an active agent. These compositions may be introduced into the body of a subject in liquid form which then solidify or cure in situ to form a controlled release implant or a film dressing. The liquid delivery compositions may also be employed ex situ to produce a controlled release implant. Methods of forming a controlled release implant and employing the liquid formulations in the treatment of a subject are also provided.

Abstract: An implantable catheter defining a plurality of fluid exits responsive to a first range of pressure on a fluid agent for delivering substantially the same flow rate of the agent through each of the exits into spaced infusion sites and responsive to a second range of pressure less than a threshold pressure on the agent for inhibiting the flow of the agent from any of the exits into any of the sites. A first pressure in the first range is applied to the agent in the catheter for a first time period and a second pressure in the second range is applied for a second time period to the agent in the catheter so that substantially the same dosage of agent can be applied to each of the sites.

Abstract: Improved biocompatible liquid delivery compositions, which are useful for the formation of sustained release delivery systems for active agents, are provided. The compositions include liquid formulations of a biocompatible polymer or prepolymer in combination with a controlled release component. The controlled release component includes an active agent. These compositions may be introduced into the body of a subject in liquid form which then solidify or cure in situ to form a controlled release implant or a film dressing. The liquid delivery compositions may also be employed ex situ to produce a controlled release implant. Methods of forming a controlled release implant and employing the liquid formulations in the treatment of a subject are also provided.

Abstract: The invention provides an apparatus for remote delivery of an aerosolized liquid by laparoscopic technique, a method of delivering an aerosolized liquid into the body of an animal by means of the apparatus, and a kit that contains components of the apparatus.

Abstract: Gastrostomy ports are disclosed for reliably providing enteral feeding to a patient over long periods of time. Gastrostomy ports shown herein provide one-way valves which include a resilient valve member which is compressively fitted within a receiving cavity defined by a rigid compression collar. The valve member has a diaphragm portion defining a slit. The compression collar presses inwardly against the outer peripheral edge of the diaphragm portion to apply laterally compressive forces which bias the slit toward a normally closed position. Gastrostomy ports are further shown for accessing the interior of a body cavity or organ which are self retaining and resist inadvertent pull-out but can be atraumatically implanted and removed.

Abstract: Gastrostomy feeding ports are disclosed which remain positively sealed after repeated and extensive use. In one embodiment, a valve housing defines an inner passageway to provide fluid communication into a long term indwelling catheter and includes a rigid compression collar portion which defines a valve member receiving cavity within the inner passageway. The resilient valve member has an outer peripheral edge which generally conforms in shape to the valve member receiving cavity but is larger in dimension than the cavity when uncompressed. The resilient valve member also includes an outer wall portion which extends away from the outer peripheral edge of the diaphragm portion and which generally conforms in shape to the cavity.

Abstract: Nasal applicators are an important aid for introducing powdery, pharmacologically active medicaments into the nasopharyngeal space of a patient. The present nasal applicator is based on a manually actuated compressed air source connected to an inflow channel (8) for generating a compressed air jet, a storage container (3) for the medicament and a metering device for making available a portioned-off quantity of the medicament which is caught by the compressed air jet and transported through an outflow channel (9) into the nose. The metering device consists of a metering drum (5) in which the storage container (3) for the medicament is formed by the interior of the metering drum (5). In addition, the inflow channel (8) is connected to one end of a metering channel (7) and the outflow channel (9) to the other end of the metering channel (7).

Abstract: A system and method for blood mixture fluid delivery to a patient includes fluid delivery conduits connected to the patient for delivering blood mixture fluid, a pump for controlled pumping of blood mixture fluid through the conduits to the patient, and an automatic control mechanism operatively connected to the pump for controlling the pump so that the blood mixture fluid is continuously delivered to the patient at a defined constant pressure.

Abstract: The present invention provides a retrofitted attachment to an existing bone sagittal saw or drill to cool bone during the cutting and/or drilling phase of surgery. The irrigation apparatus disperses sterile fluid from an attached intravenous bag via length of slim tubing. The tubing is attached to the saw or drill and held in place by C-shaped clips. Gravity simply forces a constant flow of sterile fluid from the suspended bag to the saw blade or drill to cool the bone. Additionally, an angled jet tip directs the flow of the coolant towards the saw blade for the most beneficial effects. Finally, a thumb operated button is located at the distal end of the device to control the flow of liquid.

Abstract: A tubing set and method for use with a system for providing pressurized fluid from a fluid source to a surgical site. The system includes a fluid source, a length of flexible tubing having one end connected to the fluid source and another end connected to a surgical instrument, and a peristaltic type pump into which a middle portion of flexible tubing is positioned so that the peristaltic type pump can pump fluid from the source to the surgical instrument by bearing on the exterior of the tubing. The improved tubing set also includes a by-pass section of tubing connected between the tubing inlet and the tubing outlet in parallel with the middle portion of the flexible tubing. The by-pass section provides pressure relief to the system so that pressure in the tubing will not build up distally of the location of the peristaltic pump.

Abstract: The present invention relates to the field of compositions of matter, disclosing compositions of matter which as aqueous solutions, may be used to perfuse a living or non-living subject in need of perfusion. The solutions according to the invention are typified by an aqueous solution comprising a polysaccharide oncotic agent, a physiologically compatible buffer, a simple hexose sugar, dissolved chloride salts of calcium, sodium and magnesium, and a dissolved organic salt of sodium. The solutions according to the invention are effective substitutes for blood. In addition the solution according to the invention may be used to preserve the biological integrity of the organs of a mammalian donor organism as shown by superior anatomical integrity of cryopreserved organs and tissues of subjects perfused with the solution of the invention.

Abstract: A plume and effluent collection device is disclosed for use with an endoscopic laser therapy device which is adapted to engage a biopsy port in a laser device. The collection device, is also engageable with a remote vacuum system, so that any plume or effluent from within a patient's body which migrates to the exterior through the biopsy port on the laser device, will be safely contained and removed from the operating environment. The device enhances the safety of Doctors and technicians using laser therapy devices.

Abstract: A novel cell seeded hollow fiber bioreactor is described as a potential bioartificial kidney. Renal cells are seeded along a hollow fiber in a perfused bioreactor to reproduce the ultrafiltration function and transport function of the kidney. Maintenance of tissue specific function and ultrastructure suggest that this bioreactor provides an economical device for treating renal failure as well as studying renal tubululogenesis in vitro.

Abstract: A catheter or balloon catheter includes a tube or balloon which is provided with a plurality of pores. A stimulus-responsive polymer is attached to the pores so that fluid transmission through the pores is controllable by a stimulus such as a change of pH, composition, and temperature. The catheter can administer a necessary limited amount of medicament to a locally limited site of a blood vessel only when necessary.

Abstract: Methods and devices for using nitric oxide (NO) to decrease or prevent the contraction of a smooth muscle in a non-respiratory-tract organ of an animal, the organ being one which contains or is surrounded by a biological fluid which is not blood, which method includes the step of introducing an effective amount of NO into the fluid.

Abstract: An open loop system for delivering fluid during hysteroscopic surgery. The system includes first and second fluid conduits in fluid communication with the uterine cavity of a patient. First and second measuring devices are provided for measuring the amount of fluid flowing into and out of the uterus. The measuring devices produce electronic signals which are communicated to a controller which uses them to calculate a value reflecting the difference in in-flow and out-flow. This difference is then compared with a preset value; if the preset value is exceeded, the surgeon knows the patient is absorbing too much fluid, and the procedure may be terminated.

Abstract: A reciprocating shaft device suitable for numerous uses, including as a tattoo device, with a balanced generally symmetrical configuration having an electromagnetic coil with a shaft slidably mounted concentrically within the coil. A cylindrical housing encloses the shaft and electromagnetic coil. Damping means within the cylindrical housing quiet any noise generated by vibration. The electromagnetic coil is driven from a power source through a timer circuit and a switching circuit, the switching circuit energizing the coil with the timer circuit controlling the rate or frequency of the switching cycle.

Abstract: Apparatus and surgical procedures are provided for completely coagulating endometrial tissue of the uterus by means of heated liquid in the distended uterus under direct view of a thermally insulated hysteroscope or under indirect view fluoroscopically using a thermally insulated hysterographic cannula and a radiopaque heated liquid.

Abstract: A blood processing system is described in which blood pressure readings obtained before and after passage of blood aspirated from an operative site through a membrane separator is used by a programmed controller to determine the hematocrit level of the blood and to add saline solution to adjust the hematocrit level to a desired level. The blood processing system contains a distributor cap to distribute wash solution to the inside of a filter to wash out additional blood cellular material within the filter. A precollector may be used remotely from the site of the blood processing system and later joined with the system to withdraw blood contained in the precollector for processing by the blood processing system.

Abstract: Apparatus for injecting a substance into the skin including vibrating means and a hollow needle coupled thereto and receiving an injectable substance from a source thereof coupled into the open end thereof. A peristaltic pump pumps the substance to the tattoo needle. A tattooing guide is secured to the apparatus for controlling the depth of the operation.

Abstract: An endoscopic kitner features a delivery tube with a continuous supply of absorbent material. The absorbent material is retractable into a housing as new absorbent material is placed in position for use. The spent absorbing material is movable into a housing for removal of the kitner. A hand-held drive mechanism is employed to advance the absorbent material.

Abstract: A method and an apparatus for carrying out the method, in which the necessary outflow of the aqueous humor which is continuously being renewed in the eye is ensured, and thus the normal intraocular pressure is maintained. For the treatment, the sclera undergoes operative lamellar incision for partial exposure of Schlemm's canal, and the portion which is opened out is held by a device which is not depicted. A medium is introduced into Schlemm's canal by a tube which is introduced into the circular canal of Schlemm by which the upstream trabecular tissue is hydraulically expanded and traumatically opened at several points and, at the same time, the points are wetted by the highly viscous medium.

Abstract: A coaxial configured dual lumen catheter for hemodialysis treatment and the like comprising an outer extraction lumen having an inner return lumen disposed therein configured to be coupled between a patient and a dialysis device, the outer extraction lumen and the inner return lumen are similarly configured to cooperatively form a proximal section coupled to the dialysis device, an arcuate intermediate section and a distal section to be placed into the patient wherein the cross-sectional area of the outer extraction lumen and inner return lumen in the arcuate section is greater than the cross-sectional area of the outer extraction lumen and the inner return lumen in the distal section to compensate for the increase in friction and turbulence created by the arcuate configuration and thereby more evenly distribute fluid flow pressure through the dual lumen catheter.

Abstract: A disposable applicator for introducing medicine into a body cavity is disclosed including a barrel and a plunger slidably positioned within the barrel. The barrel and plunger are preferably formed of a plurality of spirally wound paper layers. The plunger includes first and second opposing ends. The first end of the plunger is completely closed and serves as the working surface of the plunger. The second end of the plunger is substantially closed by inwardly crimped portions to prevent the accidental or inadvertent filling of the hollow plunger with a gel-like medicine rather than the barrel. A predetermined number of applicators, such as seven, are preferably packaged within a tubular container.

Abstract: The present invention relates to compositions for killing undifferentiated epithelial cells during cataract surgery on an eye to prevent posterior capsule clouding after the surgery and to a method for performing cataract surgery on an eye including injecting a cell-killing substance between the anterior capsule and the natural lens prior to removing the natural lens from the eye. The cell-killing substance is preferably an acid or base adjusted aqueous solution having a pH in the range between about 1.0 to below 6.5 or about above 7.5 to 14.0; or a hypotonic solution having a salinity less than 0.9% or a pH adjusted hypotonic solution having a salinity less than 0.9% and a pH either below 6.5 or above 7.5. The compositions of the present invention also incorporates a viscoelastic material, a dye or a mixture thereof, in combination with the cell-killing substance.

Abstract: Erectile dysfunction, particularly impotence, priapism and Peyronie's disease is treated by the transurethral administration of a therapeutically effective agent. The agents are administered to the urethra by means of a penile insert (1) having a rapidly releasing coating (4) containing the agent on its exterior surface or by means of an inserter (27) carrying an agent containing dose of agent (31) which can be displaced into the urethra.

Abstract: Catheter with a retractable cannula for delivering a plurality of chemicals comprising a flexible elongate member having a centrally disposed lumen and a plurality of circumferentially spaced apart lumens including first and second fluid passage lumens Flexible elongate member has proximal and distal extremities. An actuator member is slidably mounted in the centrally disposed lumen. Springs are disposed within the centrally disposed lumen and engage the actuator member for moving the actuator member between extended and retracted positions. A tool having a distal extremity is carried by the actuator member and has a flow passage therein extending through the distal extremity of the tool. First and second fittings are secured to the proximal extremity of the flexible elongate member and having passages therein in communication with the first and second fluid passage lumens in the flexible elongate element.

Abstract: A device designed for determining one or more medical variables in living organisms, comprises a part to be inserted into the tissue of the organism, which has an exchange channel with openings into the tissue. The device comprising a delivery unit connected with the exchange channel for the delivery of a perfusion fluid and its drainage after partial equilibration with the medical variable or quantity to be measured, i.e., preferably glucose concentration, and comparatively constant endogenous or exogenous marker variables. The device further comprising an analyzing unit for measuring the medical variable and one marker variable, and an evaluation unit for determining the actual concentration of the medical variable with the use of the marker variables.

Abstract: A device for treating hemorrhoids is formed from a hollow member having integral insertion and collar portions. Controlling means located within the member and running from the collar to at least partially the length of the insertion portion serve to control the maximum transverse section of the device. Reduction of the cross section eases insertion and extraction of the device. Release of the controlling means allows the device to resiliently return to its normal condition.

Abstract: A method for creating a propagatable, new combinant cell with differentiated function to replenish dwindling number of similar cells in diseased subjects. The new combinant cell is obtained by 1) removing a nucleated cell, which is of the same differentiative phenotype as the diseased cells, from a subject and isolating therefrom a karyoplast, 2) isolating from a source other than said subject a proliferation-prone cell which is of the same differentiative phenotype or which is predestined to become the same phenotype as the diseased cells and isolating therefrom a cytoplast, 3) fusing the cytoplast and karyoplast to form a propagatable, new combinant cell, 4) propagating the combinant cell in culture, and 5) transplanting the combinant cells into said subject. In another embodiment the karyoplast donor is histocompatible to said subject. In yet another embodiment a whole cell is used in lieu of a karyoplast for fusion with the cytoplast.

Abstract: An ampoule is disclosed having a stopper slidably mounted therein adjacent the proximal end and a rubber diaphragm secured to the distal end. An aperture barrier is provided in the ampoule between the proximal and distal ends, and has an aperture sealed by a plug. Sterile acidified liquid local anaesthetic is contained in an proximal compartment defined in the ampoule by the barrier and the stopper. Sterile alkaline neutralizing reagent is contained in the distal compartment defined in the ampoule by the barrier and the rubber diaphragm. In use, the ampoule is placed in the barrel of a hypodermic syringe, and is then manually advanced in the barrel toward the distal end of the syringe to cause the proximal end of the hypodermic needle of the syringe, which proximal end extends into the barrel of the syringe, to perforate the rubber diaphragm and communicate with the distal compartment of the ampoule. The distal end of the hypodermic needle is then inserted into the oral tissues of the patient.

Abstract: A pre-slit injection site (34) includes a housing (40) with a flow path therethrough. A first end (42) of the housing (40) carries a pre-slit septum (52). One form of a blunt cannula (98), usable with the injection site (34), carries a locking member (100). When the pre-slit injection site (34) slidably receives the blunt cannula (98), the locking member (100) latches to the injection site (34) and creates a mechanically coupled unit. Another form of the cannula (280) includes a tube having a tapered distal end region (298) and having elongate discharge slots (294) for reducing contact surface area and for directing the flow laterally out of the cannula. The cannula may also include a rounded lead post (330), an annular barb (394), and axially oriented grooves (268). A blood sampling system utilizing an in-line pre-slit injetion site (492) and a shielded blunt cannula (512).

Abstract: The end of a bronchoalveolar lavage catheter is coupled to an adaptor manifold which has a pressure port that allows communication to occur between the lumen at the center of the bronchoalveolar lavage catheter and an air pressure tube leading to a pressure transducer. Air pressure impulses from the air passageways of a patient are then communicated to the pressure transducer and converted into electronic signals capable of providing useful feedback to medical personnel. One form of feedback constitutes real-time pressure waveforms which are monitored to detect the existence at the tip of the bronchoalveolar lavage catheter of significant wedging-related conditions of interest to medical personnel attempting to effect wedging of the distal tip of the bronchoalveolar lavage catheter. The significant wedging-related conditions comprise conditions of correct wedging, ineffectual wedging, precluded wedging and overwedging.

Abstract: A method is provided for the treatment of grafts such as tissue or organs prior to transplantation into a suitable host. The grafts are incubated, coated, or perfused with TGF-.beta. for an effective time for the uptake of the agent into the grafts and induction of its biological effects. The thus-treated graft is then transplanted into a compatible host, preferably a human host.

Abstract: A method and device for use in delivering or withdrawing fluid to or from the vascular system of bone marrow, wherein a tubular conduit is inserted into bone and fluid is delivered or withdrawn to or from a reservoir through a seal means surrounding a head attached to one end of the conduit in communication with bone marrow at the opposite end of the conduit. Access to bone marrow is achieved by implanting an improved intramedullary catheter of the present device within a bone and creating a reusable passage via a conduit placed between bone marrow and the outer surface of bone or skin.

Abstract: An anasesthesia set which includes a straight epidural cannula with a ground opening, a spinal cannula which is longer and thinner than the epidural cannula and which is insertable therein such that its front end projects from the epidural cannula, and a catheter adapted to be advanced through the epidural cannula. The tip of the epidural cannula is bent and the opening is directed sideward. A hole is formed in the outer wall of the bend of the tip. The hole is centered on the longitudinal central axis of the epidural cannula and is smaller than the outer diameter of an epidural catheter. The tip of the spinal cannula enters the spinal channel straightly, whereas the epidural catheter is deflected from the spinal channel and introduced into the epidural space.

Abstract: An apparatus and method for protecting users of invasive instruments from inadvertent skin puncture by providing the user with an article of protective clothing and an invasive instrument both designed so that the instrument will become entangled with the clothing during contact, thereby preventing penetration of the skin.

Abstract: The invention is an endothelial cell procurement and deposition kit for collecting fat from a patient, processing said fat to produce an endothelial cell deposition product, and depositing said product on the surface of a graft, all under sterile conditions established and maintained within the components of said kit comprised of: fat collection means for collecting subcutaneous fat from a patient; digestion means connectable to said fat collection means to maintain sterility during reception of said fat and for retaining said fat under sterile conditions during rinsing and digestion to produce a digested product; endothelial cell isolation means connectable to said digestion means for maintaining sterile conditions during reception of said digested product and for separating and isolating microvessel endothelial cells from said digested product to produce an endothelial cell product; cell deposition means connectable to said isolation means for maintaining sterile conditions during reception of said endothel

Abstract: Ocular perfusion during intraocular surgery of the anterior or posterior ocular cavity is optimized through the method of using a gas pump having a discernible and controllable output pressure to pressurize a reservoir of liquid infusate, which is supplied under pressure to a surgical infusion instrument for perfusion of the selected ocular chamber (Gas Forced Liquid Infusion, GFLI). The infusate selection and the infusate pressure can be controlled with a high degree of accuracy and both can be rapidly varied by audible command. Preferentially a human sensible indication of pressure is constantly available at the gas pump.

Abstract: An implantable injection chamber device comprising a housing which encloses an injection chamber and has at least one wall that can be pierced with a hollow needle, and a bore provided in a wall of the chamber, there being further provided connecting means for connecting a catheter to the bore, and in which the connecting means comprise a tube of pliable material which is connected to the bore and in operation extends through a bore in a first member of the connecting means, at least a part of said first member surrounding the tube relatively tightly and said part being provided with a plurality of radially disposed longitudinal grooves; and a second member of the connecting means is provided, which in operation surrounds the part of the first member that is provided with longitudinal grooves and is capable of pressing inwardly the parts of the first member between the longitudinal grooves.

Abstract: A method for rendering a gallbladder dysfunctional without surgical removal comprises the steps of infusing the gallbladder with methyl-tert-butyl ether (MTBE), then, while the gallbladder is so infused, irradiating the gallbladder with an ultrasound beam in such an ultrasound delivery format as not to elevate the average temperature of the gallbladder more than five degrees Centigrade over the period of treatment, and then removing the MTBE from the gallbladder.

Abstract: The disclosure of this application is directed to a medicament injection adjunct which provides a source of sterile air for loading into a medicament syringe prior to use of the syringe for withdrawing liquid medicament from a multi-dose vial. The disclosure also describes the sequence of steps involved in loading the syringe with sterile air. Embodiments involving inclusion of the adjunct in a tandem medicament package and also use of the adjunct in hospital wards or outpatient areas are also described.

Abstract: An implantable filtration and collection device for collecting a filtrate containing a physiological constituent of the body present in an interstitial body space. The device is operable with a negative pressure generating source to withdraw the filtrate from the interstitial body space. The device includes a porous filter made of a material compatible for long-term patency inside the body and adapted to be implanted inside the body in fluid communication with the interstitial space. The pores in the filter are sized not to exceed a predetermined dimension corresponding to the size of the physiological constituent being filtered. A collector in the form of an elongate tube is connected to the filter and and serves to communicate the filtrate externally of the body where it may be withdrawn from the collector by a negative pressure generating source.

Abstract: A device for the sustained release of active substance comprises a wall defining a cavity for the reception of active substance, the wall being of impermeable material and having one or more ports therethrough. Sections of hydrogel material are within the cavity, the hydrogel, in use, being swollen to cover the ports in the cavity wall. Active ingredient is released from the container only through the hydrogel covering the ports. In this way sustained and controlled release of the active substance from the device is obtained.

Abstract: A novel method is disclosed for the stimulation of the differentiation of bone marrow cell which is based on the administration of an effective amount of a tellurium compound which has a stimulating effect on bone marrow cells.

Abstract: Ocular perfusion during intraocular surgery of the anterior or posterior ocular cavity is optimized through the method of using a gas pump having a discernible and controllable output pressure to pressurize a reservoir of liquid infusate, which is supplied under pressure to a surgical infusion instrument for perfusion of the selected ocular chamber (Gas Forced Liquid Infusion, GFLI). The infusate selection and the infusate pressure can be controlled with a high degree of accuracy and both can be rapidly varied by audible command. Preferentially a human sensible indication of pressure is constantly available at the gas pump.

Abstract: Disclosed is a system for administering medication through the nasal passage of a patient into the patient's stomach. The system includes a connector having a body member with the passageway therein and extending between open ends in the body member. At each of these ends is a series of flanges with tapered edges. One of these ends is inserted into a tube extending through a patient's nose and into the patient's stomach. The other end is connected to either a suction or feeding pump at the appropriate time by a nurse. Within the body member is a port through which medication is introduced. A valve at the port either opens or closes the passageway as required.