Abstract: A hemostatic guiding catheter is biased to curve toward the artery wall and the distal opening is shaped so its edge is congruent with the artery wall. One or more annular balloons are inflated to produce a barrier between the guiding/catheter and the artery wall stopping the flow of blood and thus hemostasis. The annular balloons may be biased to inflate more on the side away from the distal opening thus imparting a force vector toward the distal opening and/or biased to overhang their line of attachment like a foreskin over a penis to allow the hemostatic guiding catheter to move a short distance while the biased balloons maintain hemostasis.

Abstract: The present invention provides a hygroscopic coating on a balloon for an implantable device and methods of making and using the same.

Abstract: A catheter system, comprising a catheter having a distal end and a proximal end; a functional section situated close to the distal end of the catheter; an inner shaft having a guidewire lumen; an outer tubing, such that the outer tubing completely or partially surrounds the functional section; a guidewire outlet having a distal portion and a proximal portion, such that the guidewire outlet passes through the inner shaft and the outer tubing; a guidewire, such that the guidewire is situated on the distal end of the catheter inside the guidewire lumen and is guided out of the catheter through the guidewire outlet, such that the guidewire outlet is attached close to the distal end of the catheter and proximally of the functional section; a cutting device for severing the outer tubing in retraction of same is attached to the distal portion of the guidewire outlet.

Abstract: Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross-sectional configuration by a removable tubular restraint or by structural elements built into the wall of the expandable portion of the sheath. In one application, the sheath is utilized to introduce a formed in place orthopedic fixation rod such as for use in spinal fixation procedures, preparation of a spinal segment, or placement of a vertebral body spacer. The sheath can further comprise structural elements to permit re-collapse of the sheath under fluid pressure following completion of the procedure and prior to removal from the patient.

Abstract: A catheter having an elongated shaft with a proximal end, a distal end, and at least one lumen, and a distal portion of the shaft being at least in part within an outer sheath having a wedge-shaped distal end. In one embodiment, the outer sheath around the distal end of the shaft is the distal skirt section of the balloon. In an alternative embodiment, the outer sheath is a sleeve member having at least a portion located distal to the distal end of the balloon.

Abstract: Described here are expandable devices and methods for using them. The devices generally comprise a hub and a plurality of legs extending therefrom. In some variations, the hub may comprise one or more domed portions, tapered portions, or the like. The legs may comprise one or more straight segments, one or more curved segments, or a combination thereof. The devices may comprise one or more polymers, and/or one or more portions of the device may be configured to biodegrade. In other variations, the device may be configured to release one or more drugs therefrom. Additionally, in some variations the devices may be configured to be self-expandable from a low-profile configuration to an expanded configuration.

Abstract: A catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof. The device includes a wholly external wire guide structure secured to the tubular shaft by a figure-eight polymer sleeve.

Abstract: A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

Abstract: An interventional catheter for angioplasty and the like, comprising a catheter tube including an outer tubular member, an inner tubular member disposed within the lumen of the outer tubular member, and a balloon attached to the distal end of the outer tubular member and the distal end of the inner tubular member. The outer tubular member includes a first portion having a first stiffness and a second portion having a second stiffness less than the first stiffness. The inner tubular member has an inner surface having a first coefficient of friction and an outer surface having a second coefficient of friction greater than the first coefficient of friction.

Abstract: The present invention relates generally to the field of laryngeal mask airway devices. The invention provides for dual passageways in a laryngeal mask which permits a physician to effectively isolate the trachea from the esophagus. In one embodiment, the physician separately inserts an instrumentality (e.g., an endotracheal tube) into a patient's esophagus in order to isolate the stomach from the lungs, respectively. In another embodiment, the physician inserts an instrumentality (e.g., an endotracheal tube) into the trachea and inserts another instrumentality (e.g., a drainage tube) in the second passageway within the laryngeal mask in order to remove particles or fluids contained in the laryngeal mask that may cause problems if allowed to flow through the patient's trachea to the lungs.

Abstract: An inflatable bone tamp for performing a minimally invasive surgical procedure includes an inflatable structure having at least three contiguous lobes, that when inflated, cause the inflatable structure to exhibits an outwardly tapering expansion profile. By forming the inflatable structure such that the reduced-diameter junction(s) between the lobes has a greater wall thickness then the adjacent lobes, the durability and abrasion-resistance of the inflatable bone tamp can be increased.

Abstract: A self-introducing medical device that can be used for delivering drugs or other therapeutic fluids at a uniform rate over an extended area to an internal anatomical location of a patient's body. The device can also be used for aspirating excess fluid from an internal anatomical location of a patient's body.

Abstract: A method for delivering a therapeutic substance to a treatment site within a body lumen includes advancing a balloon catheter to the treatment site. A balloon of the balloon catheter is inflated and while the balloon is inflated, a primer that coats the treatment site and attracts the therapeutic substance thereto is delivered through a first fluid delivery lumen of the balloon catheter. The balloon of the balloon catheter is deflated for a predetermined period of time. The balloon of the balloon catheter is reinflated and while the balloon is reinflated, the therapeutic substance is delivered through a second fluid delivery lumen of the balloon catheter. The primer improves adherence of the therapeutic substance to the treatment site.

Abstract: A visceral pleura ring connector that may be utilized to anchor and seal the visceral pleura to a conduit or other device entering the lung from a non-native airway. The visceral pleura ring connector may be positioned around the visceral pleura and an insertion device and seal them together without having to make any holes in the pleura. The visceral pleura ring connector may be utilized with a pulmonary pleural stabilizer to hold the visceral pleura of the lung during surgical procedures involving accessing the lung or lungs of a patient directly through the lung and not the native airways.

Abstract: A method for producing a bioactive surface on an endoprosthesis, or on the balloon (3) of a balloon catheter (1) is described, wherein the surface (15) of the endoprosthesis, or the surface (4) of the balloon (3) is softened. The surface (15) of the endoprosthesis, or the surface (4) of the balloon (3) is moistened with a solution (6) of an active ingredient (7), and the solvent (8) is separated from the active ingredient (7). In addition, a balloon (3) of a balloon catheter (1) is disclosed, which comprises an uncoated surface (4), wherein an unencapsulated active ingredient (7) is embedded at least partially into the material of the surface (4). Furthermore, a balloon catheter (1) is described, which comprises a balloon (3) according to the invention. In addition, an endoprosthesis, particularly a polymer stent is described, which comprises an uncoated surface (15), wherein an active ingredient (7) is embedded at least partially into the material of the surface (15).

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having an occlusion element, an aspiration lumen, and a blood outlet port in communication with the lumen, a guide wire having a balloon, a venous return sheath with a blood inlet port, and tubing that couples the blood outlet port to the blood inlet port. Apparatus is also provided for occluding the external carotid artery to prevent reversal of flow into the internal carotid artery. The pressure differential between the artery and the vein provides reverse flow through the artery, thereby flushing emboli. A blood filter may optionally be included in-line with the tubing to filter emboli from blood reperfused into the patient.

Abstract: An angioplasty device and particle trap for use in removal of a particle from a small diameter vessel or vessel-like structure is disclosed. One embodiment includes a catheter for insertion into a vessel-like structure, the catheter having a catheter wall and a movable member, a trap operably connected to the catheter wall and to the movable member, wherein relative motion between the catheter wall and the movable member actuates the trap. In one embodiment, the expanded trap is formed from struts in a spiral-shaped configuration. In one embodiment, the contracted trap forms a waist to creates a pinch-point to trap particles. In one embodiment, the contracted trap forms a cocoon-like structure to further trap particles. In one embodiment, the angioplasty device includes a handle to actuate the trap from a contracted position to an expanded position and return to a contracted position. The handle provides rotational or longitudinal or both types of movement to actuate the trap.

Abstract: A cutting balloon assembly and a method for fabrication of the assembly is described. The cutting balloon assembly comprises a delivery catheter, an expandable balloon mounted on the catheter distal end, and a scoring mesh disposed around the expandable balloon. The scoring mesh comprises interlacing filaments that extend from a mesh proximal end towards a mesh distal end, form distal filament loops at said mesh distal end, and then return to the mesh proximal end. At least a part of the interlacing filaments forms one or more permanent links with neighboring filaments between the mesh proximal end and the mesh distal end.

Abstract: An expandable medical balloon having at least one static state, at least one expanded state, and at least one deflated state, the expandable medical balloon including at least one active region, the at least one active region including electroactive polymer.

Abstract: A balloon catheter assembly includes a first tubular member with a proximal portion and a distal portion and a lumen extending between the proximal portion and the distal portion. A balloon has a proximal waist length, a distal waist length and an expandable region therebetween disposed about the distal portion. A tie layer is disposed between the proximal waist length or distal waist length and the first tubular member. The tie layer comprises a polyester polymer and a polyamide polymer.

Abstract: A medical device, at least a portion of which is formed from a polymer composition including at least one liquid crystal block copolymer having at least one A block and at least one B block wherein the A block is a liquid crystal polymer block formed of repeating units comprising mesogenic groups and the B block is a non-liquid crystal polymer block.

Abstract: An intra pelvic cancer therapeutic agent perfusion apparatus and method for administering a cancer therapeutic agent to and recovering same from a cancer tissue site within the pelvis. The tip of a first sheath is percutaneously inserted into the femoral artery and the tip of a second sheath is inserted into the femoral vein. A first balloon catheter is inserted into the aorta through the femoral artery and a second balloon catheter is inserted into the vena cava through the femoral vein. The first balloon catheter is used to block the blood flow and the second balloon is inflated to form an intravenous closed region between the site of insertion in the vena cava and a lower limb side venous site. A body fluid containing a cancer therapeutic agent is administered to the intra arterial closed region through the first sheath and is removed therefrom through the second sheath.

Abstract: An epidural needle for placement of a pain management electrode includes an elongated bevel having a heel segment defined by a proximal rounded inner edge in which the heel has an electropolished radius of at least about 0.002 inch extending substantially continuously along the inner edge that defines the heel; a method for fabricating the needle.

Abstract: Two renal delivery members have two distal ports that are adapted to be positioned within two renal arteries via their corresponding renal ostia at unique locations along an abdominal aortic wall. A proximal coupler assembly is outside the body and is coupled to deliver material to the two distal ports for bi-lateral renal therapy. One or both of the delivery members may be self-cannulating into the corresponding renal ostium, or may be controllably steered into the respective ostium. Non-occlusive anchors may be coupled with one or both of the delivery members at anchoring positions in the renal artery or abdominal aorta to secure the renal delivery member within the renal artery. Renal-active fluid agents are coupled to the bi-lateral delivery system. Another renal therapy system cannulates a renal vein from the vena cava and controls a retrograde delivery of agents to the respective kidney.

Abstract: A non-compliant medical balloon comprises a base balloon including a pair of spaced-apart, generally conical end sections and a generally cylindrical center section connected therebetween. A braided fabric sleeve surrounds at least a portion of the base balloon, wherein the sleeve is formed of at least three substantially inelastic fibers intertwined in such a way that no two of the three fibers are twisted exclusively around one another. The sleeve is permanently affixed to the outer surface of the base balloon so as to prevent excessive expansion of the base balloon when the base balloon is internally pressurized.

Abstract: Methods and apparatus for a free-standing biodegradable patch suitable for medical applications, especially intravascular, minimally-invasive and intraoperative surgical applications are provided, wherein the patch comprises a free-standing film or device having a mixture of a solid fibrinogen component and a solid thrombin component that, when exposed to an aqueous environment, undergoes polymerization to form fibrin. In alternative embodiments the patch may comprise a solid fibrinogen component, with or without an inorganic calcium salt component. The patch may take a non-adherent form during delivery to a target location within a vessel or tissue, and thereafter may be activated to adhere to vessel wall or tissue, and may include a number of additives, including materials to improve the mechanical properties of the patch, or one or more therapeutic or contrast agents.

Abstract: Methods and apparatus for a free-standing biodegradable patch suitable for medical applications, especially intravascular, minimally-invasive and intraoperative surgical applications are provided, wherein the patch comprises a free-standing film or device having a mixture of a solid fibrinogen component and a solid thrombin component that, when exposed to an aqueous environment, undergoes polymerization to form fibrin. In alternative embodiments the patch may comprise a solid fibrinogen component, with or without an inorganic calcium salt component. The patch may take a non-adherent form during delivery to a target location within a vessel or tissue, and thereafter may be activated to adhere to vessel wall or tissue, and may include a number of additives, including materials to improve the mechanical properties of the patch, or one or more therapeutic or contrast agents.

Abstract: A balloon catheter for the delivery of a medication comprises a balloon fixation portion and a medication infusion portion. The balloon fixation portion comprises an expandable balloon at the distal end of a tube, the balloon inflatable to a size sufficient to retain the catheter within the area of placement, and a check valve at the proximal end of the balloon fixation portion for inflation or deflation of the balloon. The medication infusion portion comprises a tube with a precise diameter lumen functioning to control the flow rate therethrough, the tubing having one or more holes along its distal portion for infusion of medication into the patient and means on its proximal end for attachment to an infusion pump. The balloon fixation portion and the medication infusion portion are independently produced and then joined along a distal portion of both to provide a unitary catheter for placement into the body.

Abstract: An autoinflating catheter and balloon assembly having an autoregulating structure to prevent overinflation of the balloon as a result of variable fluid flow rates through the catheter lumen. A tight-fitting elastomeric balloon is provided on the distal end of the catheter body, and the assembly is constructed so that at least a portion of the fluid flow through the lumen is directed to the balloon to inflate it. As the balloon is inflated, more and more of the fluid flow through the catheter is discharged from the catheter, thereby preventing overinflation of the balloon.

Abstract: In a medical guide wire 1, a flexible core wire 2 is made of austenitic stainless steel wire treated with a solid solution procedure, and drawn with a whole cross sectional reduction ratio as 90%-97.6%. Each time when the core wire 2 is subjected to a series of mechanical procedures, the core wire 2 is heat treated repetitively at low temperature subsequent to the mechanical procedures to improve a tensile strength characteristic of the core wire 2. The core wire 2 is twisted under the low heat treatment. Effectively used is a heat generated from a synthetic layer 6 when coating the layer 6 on the helical spring body 3. This makes it possible to increase the characteristic of the tensile strength of the core wire 2 with its thermal conductivity taken into consideration. Upon improving the tensile strength of the core wire 2, optimal conditions are achieved by observing a relationship between the tensile strength and the temperature which the core wire 2 exhibits when tightly drawn as a wrought-out procedure.

Abstract: The invention relates to bulking agents and apparatus and methods for using the disclosed bulking agents. The bulking agents can be used to treat such conditions as urinary and fecal incontinence, gastro-esophageal reflux, aneurismal blockages, and cosmetic deformities. The invention also relates to an injection method that reduces the injection pressure required to place the bulking agents.

Abstract: A catheter having an elongated shaft with a tubular member which forms at least a portion of the shaft and which is formed of a biaxially oriented thermoplastic polymeric material, and a method of forming the catheter shaft by radially and longitudinally expanding the tubular member to biaxially orient the polymeric material. A catheter of the invention has an improved combination of low bending stiffness, high rupture pressure, and high tensile strength, for improved catheter performance.

Abstract: A device for inducing satiety including an elongated device for insertion through a natural orifice and into a stomach of the patient. The distal end of the device includes a means for occupying space between the submucosal and muscularis layers adjacent a pyloric sphincter. The means has a collapsed state for delivery to a target site and an expanded state for implantation thereof.

Abstract: A medical device delivery system comprises an inner tube, a medical device disposed about a portion of the distal region of the inner tube, a medical device sheath disposed about the medical device, a medical device sheath retraction device extending proximally from the medical device sheath and an outer sheath disposed about a portion of the medical device sheath retraction device. The distal end of the outer sheath terminates at least one medical device length proximal of the medical device. The medical device sheath is movable relative to the outer sheath and relative to the inner tube.

Abstract: The present invention provides systems and methods for delivery of a stent or scaffold at a blood vessel or body lumen bifurcation. A method can include positioning a scaffold at a bifurcation of a main lumen into first and second branch lumens using a first expansion catheter, inflating a main balloon of the catheter to expand the proximal portion of the scaffold, positioning a second expansion system, and expanding the distal portion of the scaffold on a generally distal side of the bifurcation.

Abstract: The disclosed laryngeal mask airway device includes a rigid airway tube, a mask portion, and a viewing system. The mask portion is inflatable and can be inserted, when deflated, through a patient's mouth to a location near the patient's glottic opening. The mask portion also includes an epiglottis elevator bar and a distal end of the bar defines an aperture. The viewing system has a proximal end located outside the patient. The viewing system also has a distal end positioned so that light rays can pass from a portion of the patient's anatomy, through the aperture in the elevator bar, and into the distal end of the viewing system.

Abstract: The present invention relates to an expansible hollow part, having at least one opening, which consists of an elastic biocompatible material and which comprises at least one biologically active substance and, optionally at least one matrix compound. The invention also provides a method of producing said expansible hollow part, a medical device covered at least partially with said hollow part, a kit-of-parts comprising said hollow part of the invention and the use of said hollow part as a therapeutic device and for protecting a medical device.

Abstract: The present invention provides improved methods for forming and mounting a sleeve on a catheter shaft in order to form a distensible balloon catheter. The balloon is formed from a distensible sleeve that is treated to render one or both of its ends essentially non-distensible. The balloon is mounted on the catheter shaft by the non-distensible ends, without compromising the distensible operative portion of the balloon. The balloon may also be mounted using non-distensible tape or similar means to achieve a similar result.

Abstract: A temporary ostomy appliance is disclosed, including a catheter for extending through the abdominal wall into the intestine. The catheter may be a transcecal catheter for extending through the cecal valve into the ileum. A portion of a catheter that extends through the cecal valve is made collapsible when the catheter is empty. The collapsed portion expands to permit passage of effluent. A balloon carried on the catheter is preformed with a shape and size in order to permit inflation without elastic stretching of the balloon wall material. A filament is provided for permitting a portion of the catheter to be fastened to internal body tissue by surgical sutures or staples. In order to release the fastening without further surgery, the filament is withdrawn by pulling on a proximal portion outside the body.

Abstract: Embodiments include an infusion-occlusion system having a delivery catheter, a guide catheter adapted to receive the delivery catheter, and a guidewire with an occlusion device adapted to be received within the guide catheter. The guide catheter of the catheter kit may be provided with an occlusion device at the distal end of the guide catheter. The delivery catheter may have an accessory lumen, coaxial or co-linear lumen, a supporting mandrel, or an occlusion device at its distal end. Moreover, according to some embodiments, occlusion devices may be a single material or a composite balloon having an inner liner and an outer layer of different materials, a high compliance low pressure balloon, or a filter device that restricts particles from passing through but does not restrict fluid, such as blood. An inflation device with a large volume and low volume syringe can be used to inflate the balloon.

Abstract: An angioplasty balloon catheter and method of making and using the same. The balloon catheter may include a catheter shaft and a balloon coupled to the shaft. The balloon may include one or more cutting edges or member and may include a plurality of chambers defined therein.

Abstract: One embodiment of the invention concerns a medical implant with the basic body having an antioxidative substance.

Abstract: A multilayer film including a layer of sealing film, having main top and bottom surfaces, and a layer of thermoplastic polymer film, laminated to the layer of sealing film, on at least one of the main top and bottom surfaces. The sealing film has a composition and thickness imparting gas barrier character to the multilayer film, of which the layer(s) of thermoplastic polymer film by themselves lack such gas barrier character. Such multilayer film is usefully employed to form biologically compatible therapeutic articles such as medical balloons that are constructed to be inflated in vivo.

Abstract: A directionally limited illuminating balloon catheter includes a multi-lumen shaft having a distal end and a hollow balloon portion disposed at the distal end and inflated through the shaft, the balloon portion having a light source illuminating only a portion of the environment outside the balloon portion. The balloon portion can be have a directionally limited light source directing substantially all illumination towards the shaft. Also provided is a directionally illuminating balloon catheter kit including a set of illuminating catheters each having the light source with different sized illuminating areas to illuminate a different sized partial portion of the environment outside the balloon portion.

Abstract: A single operator exchange biliary catheter having a tubular member extending proximally from the proximal guidewire port. The tubular member defines a guidewire lumen extension adapted to permit the guidewire to be retracted from guidewire lumen and re-inserted therein. By retracting the guidewire from the guidewire lumen and into the guidewire lumen extension, fluid may be readily injected via the guidewire lumen without encountering resistance to fluid flow from the guidewire. The guidewire lumen extension also maintains guidewire lumen access such that the guidewire may be easily re-inserted into the guidewire lumen.

Abstract: A feeding tube device for delivering a substance into a stomach of a patient. The feeding tube may include an overlapping segment integrally formed with and extending from the distal end of the feeding tube, and an inflation lumen defined within the feeding tube. The overlapping segment may surround at least a portion of the distal end of the feeding tube to form a balloon structure in communication with the inflation lumen.

Abstract: A multichannel catheter for extracorporeal circulation of blood to a patient undergoing cardiovascular treatments or surgery has three independent channels, an obturator and an expandable balloon. The first channel is the largest and is of a size that allows for delivery of blood through outlet parts in the wall of the first channel to a patient in an amount sufficient to maintain the patient's metabolism and perfusion throughout the treatment or surgery. The obturator is longitudinally insertable into the first channel. The second and third channels are integrated into the wall of the first channel. The second channel is suitable for delivering a biologically active fluid to the heart and/or venting the left heart. The third channel is suitable for delivering a fluid to the balloon for its expansion. The catheter provides an improved means of preparing for or performing cardiovascular surgery on a patient using a cardiopulmonary machine for extracorporeal circulation of blood.

Abstract: A supraglottic airway device comprising a tube and a face plate assembly slidably installed on the tube, whereby upon insertion of the tube within the airway of a patient the face plate assembly is slid distally along the tube so as to substantially seal about the mouth of the patient. The supraglottic airway device further comprises an introduction tip assembly mounted on the tube substantially opposite the face plate assembly so as to guide the device into the patient airway and an expandable foam cuff located along the tube between the face plate assembly and the tip assembly so as to seat the device within the airway. The face plate assembly may further comprise tabs for substantially sealing within the nose of the patient.

Abstract: A catheter (10) for treating stenotic sites in the human body (e.g. in the azygos vein) includes an expandable portion (12) having, when expanded, an arched shape. The arched shape may extends over an angle (a) of at least 90° degrees, and preferably of between 90° and 120° degrees, with a radius (R) of less than 3 centimetres, and preferably between 2 and 3 centimetres. The expandable portion AZY (12) may include a flexible support member, and expandable members coupled to the support member to impart, when expanded, the desired arched shape to the flexible support member. Alternatively, the expandable portion (12) may includes an actuator member acting longitudinally of and sidewise to the expandable portion to impart thereto the desired arched shape.

Abstract: The invention relates to a novel pulsating medical device comprising: a catheter (1) designed to be inserted into a blood vessel, having a diameter and comprising a rod at its insertion end, termed part A; and an inflatable component (6) housed around part of the catheter (1), termed part B, said inflatable component (6) being designed to be connected to an inflation means (9) connected to the other end of said catheter (1) and termed part C, so that said inflatable component can be inflated/deflated in a pulsed manner, the diameter of part B of said catheter (1) being less than the diameters of parts A and C of said catheter (1), and the diameters of parts A and C of said catheter (1) being approximately equal.