Abstract: A method for coating a medical device with a hydrophilic polymer is provided. One method of the present invention includes chemically binding under appropriate reaction conditions a hydrophilic polymer to a biomaterial surface. Another method of the present invention includes chemically binding under appropriate reaction conditions a hydrophilic polymer to a primer located on a biomaterial surface. Another method of the present invention includes chemically binding under appropriate reaction conditions a biomolecule to a hydrophilic polymer located on a biomaterial surface.

Abstract: The present invention relates to a shunt, and a method for treating catheters, more particularly shunts, wherein the catheter is made of a biocompatible material and adapted at least for insertion into the brain of a living organism and enzymes are impregnated, either directly or through a matrix forming system, into the interior of the lumen of the catheter. The enzymes impregnated have at least one of the following characteristics: (1) they require a confirmational form and either completely or substantially lose their activity upon dislocation from the interior of the lumen; (2) they require the presence of co-factors for activation which co-factors are also present in the interior of the lumen but are not otherwise present in the biological system in sufficient quantity to excite activation of the impregnated enzymes.

Abstract: The present invention provides an anti-thrombogenic and cellular-adhesion coating composition for blood-contacting surfaces. The coating comprises a covalent complex of from 1 to 30 hydrophobic silyl moieties of Formula I: wherein R1 is an C1-18 alkyl or C6-32 aryl group, each R2 is independently selected from the group consisting of C1-18 alkyl and C6-32 aryl, R3 is N or O, n is a number from 1 to 10, directly bound to a heparin molecule via covalent bonding, with an adhesive molecule directly bound to the heparin molecule. In one embodiment, the coating comprises benzyl-(1,2 dimethyl)disilyl heparin, wherein an adhesive molecule, such as fibronectin, is bound to the heparin.

Abstract: Medical instrumentation for intrusion of body cavities and canals, such as the gastrointestinal, urinal, vaginal and vascular tracts, is provided with unconventional surface structure replacing the conventional slippery low friction surfaces. Thus at least the surface zones of instrumentation surfaces tending to contact human tissue in ingress and egress are provided with a textured surface having a bidirectional coefficient of friction with the human tissue in the tracts being treated, which surface has the characteristic of favoring ingress movement into the work site and impeding egress movement out of the work site. The subject instrumentation with the specially textured surfaces includes viewing, therapeutic, surgical and biopsy instruments, catheters, guide cables, encompassing tubulation, and the like. This improved instrumentation expedites push endoscopy prodedures for example giving the surgeon a better feel for finding appropriate canal pathways and work sites.

Abstract: A stationary central dialysis catheter having a planar axially elongated sinuous tubular member having a plurality of axially extending lumens therein and at least a part having a predetermined two-dimensional shape including at least two portions of relative straightness connected by a curved portion region. At least two of said lumens each have at least one aperture for passage of fluid during dialysis, and said apertures are axially displaced from one another along said tubular member. A flexible sheath surrounding at least a part of the tubular member is peelably removable therefrom in situ. Ripcord means is provided in the form of a suture embedded in said flexible sheath and looped around at the distal portion to define a line of weakness separable first adjacent the suture loop for rupturing said sheath in a proximal direction.

Abstract: An enhanced antimicrobial antithrombogenic medical device is formed by using an oligodynamic metal and a noble metal with a polymer, and forming the mixture into a device. By using low concentrations of conductive polymers or ionophoric compounds, non-conductive, or highly plasticized polymers can be likewise blended into an iontophoretic-capable composition. The surface of the device may be treated with a solvent to remove the top surface of the polymer and create surface voids in the composition in order to expose previously encapsulated iontophoretic materials. This surface treatment results in a larger reaction area of the iontophoretic capable composition that produces larger yields of bacteriostatic oligodynamic ions for a longer duration thereby increasing the antimicrobial effectiveness of the composition. The surface of the antimicrobial composition may be treated with an anticoagulant such as heparin or heparin complexed with a quaternary ammonium salt for an added bacteriostatic effect.

Abstract: The antithrombotic medical material of the present invention is a medical material having, on the surface, a coating comprising graft copolymer in which monomer containing a quaternary ammonium group and hydrophilic monomer are grafted to a hydrophobic polymer, and an anticoagulant such as heparin is fixed to a depth of at least 45% from the coating surface and, furthermore, the film thickness in which anticoagulant has been fixed is at least 3 m.

Abstract: A method for preventing adverse effects associated with the use of a medical device in a patient by introducing into the patient a device of which at least a portion includes a prophylactic or therapeutic amount of a nitric oxide adduct. The nitric oxide adduct can be present in a matrix coating on a surface of the medical device; can be coated per se on a surface of the medical device; can be directly or indirectly bound to reactive sites on a surface of the medical device; or at least a portion of the medical device can be formed of a material, such as a polymer, which includes the nitric oxide adduct. Also disclosed is a method for preventing adverse effects associated with the use of a medical device in a patient by introducing the device during a medical procedure and before or during said procedure locally administering a nitric oxide adduct to the site of contact of said device with any internal tissue.

Abstract: A medical device is described which has on a surface thereof a bio-compatible coating. This bio-compatible coating is formed from a composition which includes an aqueous emulsion or dispersion of a polycarbonate-polyurethane composition containing one or more internal emulsifying agents.

Abstract: A urological implant, in particular a vascular wall support for the urinary tract, is provided with a substantially tubular, inherently stable carrier, a spacer film bonded to the carrier surface, and an inhibitor film of a glycosamino glycan bonded to the spacer film.

Abstract: A method and apparatus for overpressure protection of a catheter from an indwelling catheter. A method in one embodiment includes injecting an agent into the catheter and relieving overpressures in the catheter during the injecting step. The agent is typically a declotting agent and the obstruction is typically a clot (e.g., blood clot). In one embodiment of the apparatus, a catheter includes a cannula and a first hub and a second hub, each of which are coupled to the cannula. The first hub is for receiving an agent which is placed into the cannula to remove an obstruction, and the second hub includes an overpressure relief valve for relieving an overpressure condition in the cannula. Other embodiments of the invention are also described.

Abstract: The present invention provides an anti-thrombogenic coating composition for blood-contacting surfaces. The coating comprises a covalent complex of from 1 to 30 hydrophobic silyl moieties of Formula I: ##STR1## wherein R.sub.1 is a C.sub.1-8 alkyl or C.sub.6-32 aryl group, each R.sub.2 is independently selected from the group consisting of C.sub.1-8 alkyl and C.sub.6-32 aryl, R.sub.3 is N or O, and n is a number from 1 to 10, directly bound to a heparin molecule via covalent bonding.

Abstract: A medical system for facilitating the removal of body matter including solids, liquids and gases from a body cavity. The system includes mechanical energy applied to the interior surface of a catheter or other type of body drainage conduit to substantially inhibit the adherence of body matter to the catheter, thus minimizing the likelihood of blockage in the catheter.

Abstract: A method for cleaning, decontaminating, and sterilizing catheters (10) using a combination of liquid and gaseous/plasma sterilization techniques to ensure the complete and efficient sterilization of a catheter (10). Angiographic dye and saline are removed from the interior (36) of the balloon (14) and its lumen (16). The outer surfaces of the catheter (10) and a guide wire lumen (18) of the catheter (10) are cleaned, decontaminated, and sterilized (42) with a liquid sterilant. The liquid sterilant fills a balloon (14) and a balloon lumen (16) of the catheter (10). The liquid sterilant is retained in the balloon (14) and the lumen (16) for a select amount of time. Thereafter, the liquid sterilant is drained from the balloon (14) and the balloon lumen (16). The filling, retaining, and draining steps are repeated until an interior (36) of the balloon (14) and the balloon lumen (16) are sterilized. Residual liquid sterilant is rinsed from the interior (36) of the balloon (14) and the balloon lumen (16).

Abstract: An improved indwelling catheter adapted for long-term usage includes a stable enzyme coating to prevent occlusion of the catheter lumen. The enzyme coating includes a fibrinolytic and/or lipolytic enzyme incorporated in a catheter coating to resist or control proteolytic degradation, thereby maintaining the enzyme in an active state for dissolving clots and occlusions within the catheter lumen over an extended period of time.

Abstract: Method for in vivo introduction of a nucleic acid cassette into stem cells of intestinal epithelium. The nucleic acid cassette is introduced via vector solution. The vector solution can be delivered via the intestinal lumen in a variety of ways, including through an insertion device such as an endoscope, through catheters, through ligating and clamping the intestine after laparotomy or through slow release capsules. The vector solution once introduced into the intestinal epithelium is allowed to contact the stem cells for sufficient time for incorporation, usually between 1 and 48 hours. After sufficient incorporation, the insertion device and/or clamping and ligation procedure blockage are removed. Preferably, the procedure includes sufficient fluid to distend the intestine and provide additional access to the stem cells and the crypts.

Abstract: A system and method is provided which substantially eliminates the effect of air entrapped in tubing for delivering a liquid from a container. The inner diameter of the tubing is selected such that the gravitational force of the liquid from the container is greater than the surface tension of the liquid. A release agent may be used as a coating layer on the interior wall in addition to or alternatively from an expanded diameter.

Abstract: Catheters for removing interstitial fluid from a cerebral edema that comprises an edema drainage section terminating in a proximal tip linked to a fluid transport section terminating in a distal tip are disclosed. The edema drainage section comprises an outer wall, an inner drainage tube and an intermediate solute compartment that comprises a solute. Methods of removing fluid from a cerebral edema of an individual are disclosed, and comprise the steps of inserting the edema drainage section of the catheter into communication with the fluid of the cerebral edema and inserting the fluid transport section of the catheter into a fluid receptacle or the individual's peritoneal cavity. The fluid is drawn into the edema drainage section and emerges from the distal tip of the fluid transport section of the catheter.

Abstract: A surface of a foreign body exposed to the flowing blood of a living being which normally would promote the aggregation of platelets in that blood to form a layer affixed to that surface and thus restrict the flow of blood past that surface or to form a blood clot detachable from that surface which when detached could trigger a stroke, heart attack or partial loss of organ function, such as plastic tubing, a balloon or the end of a catheter surgically inserted in a blood vessel or a stent implanted therein, e.g.

Abstract: An improved indwelling catheter adapted for long-term usage includes a stable enzyme coating to prevent occlusion of the catheter lumen. The enzyme coating includes a fibrinolytic and/or lipolytic enzyme incorporated in a catheter coating to resist or control proteolytic degradation, thereby maintaining the enzyme in an active state for dissolving clots and occlusions within the catheter lumen over an extended period of time.

Abstract: The invention presents an antithrombotic resin which is prepared by blending at least one type of antithrombotics, in polyurethane or polyurethane urea polymerized by using at least one type of polyether diol selected from the group consisting of polyol containing a polyoxyethylene group expressed in formula (I).paren open-st.CH.sub.2 CH.sub.2 O.paren close-st..sub.n (I)(where n is a number-average degree of polymerization of 1 to 100) and polyol containing a polyoxyethylene group expressed in formula (II).paren open-st.CH.sub.2 CH.sub.2 CH.sub.2 CH.sub.2 O.paren close-st..sub.m(II)(where m is a number-average degree of polymerization of 1 to 100). This antithrombotic resin is capable of eluting the antithrombotic in the blood for a long time at high concentration. By using the antithrombotic resin of the invention, antithrombotic tube, antithrombotic film, antithrombotic coat, and others are obtained.

Abstract: A method for coupling DNA to a glass substrate by aminating the glass substrate with an aminosilane, reacting DNA with a carbodiimide/imidazole solution to create a 5'-phosphorimidazolide, and reacting the aminated glass substrate and phosphorimidazolide to couple the DNA to the substrate.

Abstract: Lubricious coatings comprising a binder polymer having a vinyl moiety and a carboxylic acid moiety and a hydrophilic polymer are disclosed. The coatings can be applied to a variety of substrates such as, for example, catheters, stents, dilatation balloons, guide wires, endotracheal tubes, instruments, implants and other biomedical devices and can provide exceptional lubricity and abrasion resistance. Processes for applying the lubricious coatings in either one or two coating steps are also disclosed.

Abstract: A medical device having a bio-active coating is prepared by providing a polymeric substrate having hydroxyl and/or amine functionality on a surface thereof and applying the bio-active coating to the surface. The bio-active coating is the reaction product of two different reactions. The first reaction includes reacting the polymeric substrate with a hydrophilic, isocyanate-terminated spacer having at least one isocyanate group at its first and second ends. The second reaction includes reacting a remaining, unreacted isocyanate-terminated end of the spacer with a bio-active agent to bond the bio-active agent to the spacer.

Abstract: Article exhibiting at least one surface of glass, metal or hydrophobic polymer coated with blood-compatible surface layer, in which the biocompatible surface layer consists of an adsorbed hydrophobized water-soluble polymer. Process for providing said articles by adsorption of hydrophobized water-soluble polymer. Use of such a substrate material coated with said surface layer for manufacture of medical articles having a blood-compatible surface.

Abstract: An endoscope comprising a flexible tubular body characterized in that a coating layer of aliphatic resins is formed on at least one surface of the outermost layer portion of the flexible tubular body. The coating layer of aliphatic resins is formed by applying a coating agent containing an aliphatic prepolymer on the surface, followed by curing.

Abstract: A method of treating primary and recurrent atheromatous plaque development is provided. The method involves administering a therapeutically effective amount of SERP-1, admixed in a pharmaceutically acceptable carrier to the intimal or lumenal layer of arterial walls. Biologically active SERP-1 analogs are also provided.

Abstract: An improved method of making a medical device having immobilized heparin on a blood-contacting surface in which heparin is admixed with sufficient periodate to react with not more than two sugar units per heparin molecule in a buffer solution having a pH in the range of about 4.5-8. This mixture is reacted for at least 3 hours while protected from light and is then applied to the immobilized amine groups. This is an improvement over the prior art methods which included using an excess of periodate and then stopping the reaction at a desired point by the addition of glycerol since the conversion of only a few of the natural functional groups to aldehydes better preserves the antithrombotic bioeffectiveness of the heparin molecules bound to the surface. The invention also avoids the prior art steps of drying and reconstituting the heparin by providing a reacted mixture of heparin and periodate that can be stored as a stable liquid and applied directly to the aminated surface several days later.

Abstract: A lancet for obtaining a drop of blood by capillary puncture is formed by a needle having a coating thereon of a composition which precludes contact clotting activation of the blood sample.

Abstract: A solid substrate, the surface of which has been modified to introduce reactive groups of a hydrophilic nature thereon, the modification being provided by a primer comprising a first polysaccharide containing as reactive groups amino and hydroxyl groups; and a process for the preparation of such solid substrate.

Abstract: A surface of a foreign body exposed to the flowing blood of a living being which normally would promote the aggregation of platelets in that blood to form a coating firmly affixed to that surface and thus restrict the flow of blood past that surface or to form a blood clot detachable from that surface which when detached could trigger a stroke, heart attack or partial loss of lung function, such as plastic tubing, a balloon or the end of a catheter surgically inserted in a blood vessel or a stem implanted therein, e.g.

Abstract: A ventilator manifold is disclosed which includes a port for attachment and detachment of an accessory device thereto without interruption of continuous respiratory support of the patient. A particular embodiment of an accessory device described herein includes a suctioning device for removal of fluids from a patient's lungs during respiratory support. The manifold includes an accessory access port which has a normally closed valve therein which remains closed regardless of the pressure changes within the manifold. The normally closed valve is positioned in the port such that insertion of an accessory device adaptor therein forces the normally closed valve to an open position. Removal of the adaptor of the accessory device allows the normally closed valve to return to its closed position, thus allowing continued operation of the respiratory system even when no accessory device is present in the accessory device access port.

Abstract: Polymeric surfaces of medical devices or components of medical devices are provided that have enhanced biocompatibility properties. The polymeric surface presents an anti-thrombogenic, fibrinolytic or thrombolytic interface with body fluids such as blood during implantation or medical procedures. The biocompatibility enhancing agent is secured to the polymeric substrate by a spacer molecule which is covalently bound to the polymeric substrate which had been subjected to radiofrequency plasma treatment with a water vapor medium.

Abstract: A medical device and a method for its manufacture. The function of the medical device requires exposure of the device to the tissue of a patient. The device has a tissue-exposed portion constructed to release an agent that inhibits adverse reaction to the presence of the device defined by a polymeric surface-layer overlying in a supported manner a polymer defining a reservoir. The reservoir incorporates the agent in a manner that permits substantially free outward release of the agent from the reservoir and the overlying layer defines metering outward passages constructed to control the outward migration of the agent to enable prolonged release of the agent from the surface of the medical device to prevent the adverse reaction due to the presence of the device.

Abstract: A hollow operating needle for an ultrasonic surgical probe for fragmenting and removing material from the body has an elongated tapered portion which is coupled at its larger end portion to an ultrasonic motor for receiving and transmitting vibrations along the length of the needle to the operating end of the needle, with the needle defining at least one generally rectangular opening extending co-axially from the operating tip end and having the intersections of the longer sides of the at least one opening and the operating tip end being beveled, whereby a substantial portion of irrigating fluid supplied adjacent the operating end portion of the needle reaches the operating tip end of the needle and the surgical site and another substantial portion of the fluid passes through the at least one opening without reaching the operating tip of the needle.

Abstract: A system and method is provided which substantially eliminates the effect of air entrapped in tubing for delivering a liquid from a container. The inner diameter of the tubing is selected such that the gravitational force of the liquid from the container is greater than the surface tension of the liquid. A release agent may be used as a coating layer on the interior wall in addition to or alternatively from an expanded diameter.

Abstract: In accordance with the present invention, there are provided prosthetic articles having polyurethane coatings with biologically active compounds incorporated within the interstices of the polymer. Methods for the preparation of such articles are also provided. Thus, a polyurethane coating is applied to a prosthetic article, the coating then swelled (without significantly dissolving the polymer) so that substantial quantities of biologically active compounds can be incorporated within the interstices of the polymer. Upon long term exposure of a prosthetic article of the invention to physiological conditions, the biologically active compound is slowly released by the treated polymer. The biologically active compound is, therefore, released only at the site where it is desired, i.e., where the prosthetic article is positioned.

Abstract: Articles having a graft polymer with a net ionic charge bonded to a polymeric substrate surface provide an improved method for administering a bioactive agent having a net ionic charge. The [articles are] method is especially useful [as] for thromboresistant and/or antimicrobial medical devices.

Abstract: An implantable medical device is provided which comprises a fixed tissue incorporating an amount of an albumin-binding dye effective to form a coating of endogenous albumin on said device when the device is in contact with a physiological fluid containing albumin. These albumin-binding dyes have been found to significantly reduce calcification when incorporated in tissue heart valves. A method of increasing the albumin-binding ability of an implantable medical device is also provided.

Abstract: An improved indwelling catheter adapted for long-term usage includes a stable enzyme coating to prevent occlusion of the catheter lumen. The enzyme coating includes a fibrinolytic and/or lipolytic enzyme incorporated in a catheter coating to resist or control proteolytic degradation, thereby maintaining the enzyme in an active state for dissolving clots and occlusions within the catheter lumen over an extended period of time.

Abstract: A flexible catheter comprising a flexible, cylindrical member having a bore therethrough and including an intra-luminal chord within the wall of the cylindrical member or the lumen of the cylindrical member to prevent the collapse thereof and facilitate the removal of broken portions thereof.

Abstract: A medical material which comprises an oil-soluble vitamin hydrophobically bound to a hydrophobic moiety containing macromer which is bound to the surface of a polymeric substrate via a copolymer is described. Suitable macromers include for example glycidyl methacrylate-linoleic acid. Suitable polymeric substrate materials include, in particular, cellulose. Methods for producing said medical material are also provided.

Abstract: Articles comprised of bioactive agents coupled to or repelled by a graft polymer (made, for example, from monomers such as N-(3-aminopropyl) methacrylamide hydrochloride (APMA), 2-acrylamido-2-methylpropane sulfonic acid (AMPS), acrylamide (AAm), and acrylic acid (AA)) which is in turn bonded to a polymeric substrate surface. The articles are useful as thromboresistant and/or antimicrobial medical devices.

Abstract: Vascular grafts, shunts, patches or valves are formed of material tolerated by the body and are lined or coated with gold to form a non-thrombogenic surface. Methods of manufacture are also disclosed.

Abstract: A medical device and a method for its manufacture. The function of the medical device requires exposure of the device to the tissue of a patient. The device has a tissue-exposed portion constructed to release an agent that inhibits adverse reaction to the presence of the device defined by a polymeric surface-layer overlying in a supported manner a polymer defining a reservoir. The reservoir incorporates the agent in a manner that permits substantially free outward release of the agent from the reservoir and the overlying layer defines metering outward passages constructed to control the outward migration of the agent to enable prolonged release of the agent from the surface of the medical device to prevent the adverse reaction due to the presence of the device.

Abstract: Articles comprised of 2-acrylamido-2-methyl propane sulfonic acid (AMPS) polymer on a blood-contacting substrate or the like are useful in medical devices in which antithrombogenic characteristics and slippery surfaces are required.

Abstract: There are disclosed devices for conditioning a blood flow which include at least one element with portions which are exposed to the blood and are deformable cyclically at a frequency comparable to the frequency of the heartbeat, in which the cyclically deformable portions have a continuous coating of biocompatible carbonaceous material comprised of carbon crystals having a density of greater than 2.1 grams per cubic centimeter applied by sputtering directly on and completely covering at least those portions of the device which are exposed to the blood.

Abstract: Disclosed is a blood sampling apparatus containing an anticoagulant composition which allows for the accurate analysis of blood electrolyte concentrations. The claimed apparatus comprises a receptacle, a blood inlet and the disclosed anticoagulant composition which does not unduly bind sodium, potassium or calcium ions from the sampled blood.

Abstract: The catheter with atraumatic drug delivery tip can be sued to access remote tortuous blood vessels and to deliver defined doses of medication over a desired length of the accesses vessel. The guidewire of the catheter helps guiding the catheter to a desired location and can be used to control release of medication in axial as well as in radial direction inside the vessel. The catheter is designed with sections of different flexibility.

Abstract: A hemodialysis catheter having a concentric outer lumen for inflow and a concentric inner lumen for outflow is disclosed. The hemodialysis catheter is used in conjunction with an adapter and with flexible extenders as a catheter assembly. The adapter has channels into which the concentric lumens extend and sealingly divides the lumens into a non-concentric branched arrangement. The flexible extenders couple to the branched lumens or to the adapter and may be doubled over and fastened in grooves in the adapter to stop fluid flow through the catheter. The flexible extenders preferably terminate in coupling mechanisms such as luer slips or luer locks. The catheter is provided with a soft atraumatic tip which has radial holes and a distal hole coupled to the inner lumen of the catheter. The outer lumen which terminates proximally of the tip also has radial holes.