Abstract: A medical device that is at least partially formed of a novel metal alloy, which novel metal alloy improves the physical properties of the medical device.

Abstract: Medical devices, medical device components, and methods of making the same. For example, one embodiment provides a method of making a reinforcing member adapted and configured for use in a medical device. The method includes providing one or more structural elements adapted and configured for creating the reinforcing member, the one or more structural elements including a surface having a portion with an initial surface area, and treating at least the portion of the surface of the one or more structural elements to provide a final surface area that is greater than the initial surface area. The one or more structural elements are used in creating the reinforcing member. The reinforcing member can then be incorporated into the structure of the medical device.

Abstract: The present invention is directed to an intracorporeal device, preferably a guidewire, and method for making the device. The guidewire of the present invention is formed, at least in part, of a composite elongate core formed, at least in part, of precipitation hardened material. The elongate core members of the present invention will have an ultimate tensile strength and modulus of elasticity greater than the same for an identically dimensioned elongate member formed from superelastic NITINOL alone.

Abstract: Disclosed are medical devices comprising a coil, coated with a multi-layer coating system and possess the flexibility, lubricity and trackability desired in applications where such devices are utilized. The coating system comprises a non-hydrophilic polymer primer coat and a hydrophilic polymer topcoat. These coating materials do not comprise any cross-linkers or reactive functional groups, and do not require the use of a hazardous solvent. The multi-layer coating system is very thin; having a maximum dry thickness in the range of about 15 microns to about 40 microns. Also disclosed are methods for coating and using these medical devices. The coatings are applied at low temperatures, in an aqueous environment, and in such a way that the coil is coated discretely, without forming a thick layer between the coil portions. Such coating prevents substantial bridging between the loops of the coil, thus preventing the coil tip from being stiff or non-trackable.

Abstract: A catheter system for positioning of a medical instrument within a body. The catheter system includes a hub defining a main lumen therethrough for passage of the medical instrument. The catheter system also includes an elongate tubular member defining a lumen therethrough. The lumen of the elongate tubular member is in communication with the main lumen of the hub for further passage of the medical instrument. The elongate tubular member defines a first portion and a second portion. The catheter system also includes a reinforcement member that is fixedly coupled to and reinforces the elongate tubular member, the reinforcement member includes a first part, a second part, and a partition defined between the first and second parts. The first and second parts are adapted to selectively move away from each other along the partition to thereby move the first and second portions away from each other and to uncover the medical instrument.

Abstract: A sheath catheter used to compress and/or retrieve a filter from a body lumen. The sheath catheter includes an elongate proximal shaft and a distal recovery sheath. The proximal shaft includes a central lumen that accommodates a shaft portion of a solid core wire to provide the catheter with better pushability. The solid core wire further includes a coiled portion that extends within the recovery sheath from a distal end of the proximal shaft. The coiled portion of the core wire provides a transition in flexibility from the stiffer proximal shaft to the more flexible recovery sheath. The recovery sheath further includes a sheath lumen that is sized to receive the filter therein.

Abstract: An introducer sheath and a method for making the sheath. The sheath includes a fluoropolymer liner having a passageway extending longitudinally therethrough. An inner jacket is positioned longitudinally over the liner, and the inner surface of the inner jacket is bonded to the outer surface of the liner. An outer jacket is positioned longitudinally over the inner jacket, and the inner surface of the outer jacket is bonded to the outer surface of the inner jacket. A reinforcing coil is encapsulated within the inner jacket and the outer jacket.

Abstract: Splittable tubular devices and methods for making them are provided. In one embodiment, a tubular device includes a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends. The tubular device includes an outer tubular layer defining a circumference; and a reinforcing layer bonded to the outer tubular layer, the reinforcing layer including a circumferential interruption. To make a tubular device, an elongate tubular reinforcing structure may be folded into itself to define first and second longitudinal edges, and rolled until the longitudinal edges are disposed adjacent one another. The reinforcing structure may be attached to a tubular structure such that the longitudinal edges define a circumferential interruption extending along a length of the tubular structure.

Abstract: Spiral-wound materials, spirals, and shafts made therefrom that have wraps with edges that may nest within one another are described. Such edges allow the spiral to achieve a smaller bending radius, meaning tighter turns and more flexibility due to the ability of adjacent wraps to nest within each other when the shaft is bent. Spirals having wraps with edges capable of nesting can be used in the medical field for devices that track anatomy, such as endoscopes, colonoscopes, catheters, and the like.

Abstract: A catheter assembly includes a catheter body extending from a deflectable distal end to a proximal end, and the catheter body includes an actuator lumen. A housing is engaged to the proximal end of the catheter body. A flexible element extends from the housing through the actuator lumen to the deflectable distal end. The deflectable distal end is deflected by pushing and pulling of the flexible element. An actuator is movably coupled with the housing and connected to the flexible element. A tubular support is engaged around the flexible element and connected to the actuator, the tubular support moves with the actuator, and the tubular support substantially constrains lateral movement of the flexible element. The tubular support is telescopically received and engaged with an inner surface of the actuator lumen. The inner surface of the actuator lumen substantially constrains lateral movement of the tubular support and the flexible element.

Abstract: A sleeve steering and reinforcing device (10) includes a first, elongate, helical element (12) having spaced turns (14). At least one further, elongate, helical element (16) is co-axially arranged with the first helical element (12). The at least one further helical element (16) has a plurality of spaced turns (18) wound in an opposite direction to the turns (14) of the first helical element (12) such that the turns (14, 18) of the elements (12, 16) coincide at predetermined zones (20, 22), the zones (20, 22) being arranged along lines extending parallel to a longitudinal axis of the elements.

Abstract: Medical devices and methods for making and using the same. An example medical device may include an elongate core member having a proximal portion and a distal portion. A polymer jacket may be disposed about at least a portion of the core member. The jacket may include an outer surface. A lubricious coating may be disposed on the outer surface of the jacket. A coil may be disposed about at least a portion of the jacket. The coil may have an outer surface and may include a first section and a second section. At least a portion of the outer surface of the coil along the first section may be flush with or recessed below the outer surface of the polymer jacket. At least a portion of the outer surface of the coil along the second section may protrude from the outer surface of the polymer jacket, may be free of the coating, and may define a region of decreased lubricity.

Abstract: A wire guide includes a mandrel that has a proximal portion and a distal portion. A first coating with a low coefficient of friction is disposed on the proximal portion of the mandrel. A second coating is disposed on the distal portion of the mandrel, where the second coating provides a sub-structure. A third coating is disposed on the second coating, where the third coating comprises a surface that allows for easy maneuverability of the wire guide. The first coating on the proximal portion provides enough lubricity to keep the wire guide from becoming bound or stuck in a catheter or medical device while still allowing a user to have a good grip of the wire guide. The second coating on the distal portion provides lubricity for the wire guide, which allows the user to easily maneuver the wire guide through a vascular anatomy.

Abstract: A medical catheter tube containing a tetrafluoroethylene polymer, which has a wall thickness of 0.1 mm or below and exhibits a tensile strength (S1) at 1.0 mm displacement of 5.0 N/mm or above; and a process for the production of medical catheter tubes, characterized by molding a composition both a tetrafluoroethylene polymer and a lubricant having high affinity for the polymer by paste extrusion. The invention provides thin-wall medical catheter tubes excellent in elongation resistance, kink resistance and internal cavity lubricity.

Abstract: A medical device including a shaft having an elongated inner member and an elongated tubular reinforcing member disposed over at least a portion of the inner member. In some embodiments, at least a portion of the outer surface of the inner member is spaced from the inner surface of the reinforcing member, defining a space substantially free of any other structures of the device. In some embodiments, the shaft can include a tip structure disposed on a distal portion of the inner member. In some such embodiments, the reinforcing member has a distal end, and the tip structure is disposed on the distal portion of the inner member adjacent the distal end of the reinforcing member. Additionally, in some embodiments, the reinforcing member can include a plurality of apertures defined therein, for example, to enhance the flexibility or other such characteristics of all or portions of the reinforcing member.

Abstract: Coated devices for introduction into bodies and methods for making and using them are provided, such as delivery sheaths, guidewire lumen cores, and elongate leads. In one embodiment, a tubular device includes a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends. The tubular device includes a relatively thin inner polyurethane liner including a coating on an inner surface thereof, e.g., providing a lubricious and/or hydrophilic lumen, and an outer layer surrounding the liner. In another embodiment, a lead is provided that includes a proximal end, a distal end, and at least one electrode on the distal end. A polyurethane cover surrounds at least a portion of an outer surface of the lead that include a coating, e.g., including a lubricious and/or hydrophilic material. Optionally, the cover may be removable from around the lead body.

Abstract: This disclosure relates to a fixed- or variable-length, wire-reinforced catheter for use in a human body or connected to a subcutaneous port implanted in a human body for use under a cyclical internal load and method of adaptation thereof, and more particularly, to a wire-reinforced catheter of increased internal diameter or reduced external diameter of fixed or variable lengths for the optimized transportation of blood under cyclical internal load and without damage.

Abstract: A catheter shaft includes an inner layer of a first polymeric material, an intermediate layer of a second polymeric material, an outer layer of a third polymeric material, a first wire reinforcing layer encapsulated between the inner and intermediate layers, and a second wire reinforcing layer encapsulated between the outer and intermediate layers. Typically, the first wire reinforcing layer includes one or more metallic wires helically wound in one direction and the second wire reinforcing layer includes one or more metallic wires helically wound in the opposite direction. The intermediate layer is bonded to the inner and outer layers, as by extruding layers over one another or by thermal lamination or reflow bonding. Typically, the intermediate layer has a larger yield strain and/or a lower flexural modulus and/or a lower durometer than at least one of the inner layer and the outer layer.

Abstract: A catheter having a shaft that has at least two spaced-apart lumens is disclosed. A retractable core wire is disposed within at least one of the lumens. The retractable core wire is manipulated by the user to impart variable stiffness to the shaft as the core wire is retracted and extended within the lumen. A catheter having substantially low profile bonds at the junctions where an inflatable balloon is attached to the catheter is also disclosed. The low profile bonds are created by recesses extending around the circumference of the distal end of the shaft, the proximal and distal ends of a stem, and the proximal end of a tip. The catheter having the low profile bond optionally has either a retractable or an embedded core wire. In examples, the catheter has at least one component formed from, co-extruded with, or coated with a lubricious material or a hydrophilic material.

Abstract: Methods and apparatus are disclosed for inserting flexible, multi-lumen catheters into blood vessels, and in particular, for inserting flexible, split-tip catheters into blood vessels. The invention accomplishes these objects by temporarily stiffening each catheter lumen and tip independently through use of intra-catheter stiffener elements disposed within the catheter lumens. This provides means for advancing the catheter/stiffeners assembly through a subcutaneous tunnel, and over a plurality of guidewires until a distal tip of the catheter is at a desired position within the vessel. The intra-catheter stiffener elements are sufficiently stiffening to allow advancing the catheter over guidewires, but sufficiently flexible to allow bending and looping of the catheter for proper placement within the vessel.

Abstract: A cannula assembly having a hollow elongate cannula with a proximal end, a distal end, and a central axis. A coiled reinforcing member is disposed along a portion of the hollow elongate cannula and is adapted to provide structural support to the elongate cannula. An intermediate reinforcing band is disposed on the elongate cannula between the proximal end and the distal end to reinforce a perforated section in the wall of the cannula and includes a forward edge, a rearward edge, at least one rib and at least one protrusion extending orthogonally from the forward edge and at least one protrusion extending from the rearward edge. A distal reinforcing band is disposed at the distal end of the elongate cannula and has a plurality of fingers that taper slightly inwardly toward the central axis of the hollow elongate cannula.

Abstract: A catheter tubing (2) consists of a composite comprising a first material (54) which mainly consists of a hydrophilic plastic material which absorbs moisture and which therefore swells in contact with e.g. blood, and a second material which essentially does not absorb moist but which forms reinforcing longitudinal strands (55) in the catheter tubing, which counteract that the catheter tubing is extended or becomes thicker because of the swelling capacity of the first polymeric material, such that the volume increase of the hydrophilic, first plastic material substantially results in an increase of the circumference of the tubing and hence of its diameter and flow area. A catheter is made of a catheter tubing of that type and can be included in an assembly (1) comprising a hub (4) having a front portion (11) provided with a pair of wings (29) extending outwards from the hub.

Abstract: Methods and apparatus employed to locate body vessels and occlusions in body vessels finding particular utility in cardiac surgery, particularly minimally invasive cardiac surgery to locate cardiac arteries and occlusions in cardiac arteries are disclosed. An elongated vessel lumen probe incorporating a lumen probe element at or near the elongated vessel lumen probe distal end is advanced into the vessel lumen. A vessel surface probe manipulated by the surgeon and having a surface probe element sensor is employed to detect the lumen probe element and to follow the progress of the vessel lumen probe element as it approaches and is advanced through or is blocked by an occlusion. In the location of a coronary artery, the surface probe element sensor is moved about against the epicardium over the suspected location of the artery of interest until a surface probe element sensor of the present invention at the surface probe distal end interacts with the lumen probe element of the vessel lumen probe.

Abstract: A method and apparatus for delivering a medicine to a patient via the patient's respiratory system with control and efficiency. A nebulization catheter is positioned in the patient's respiratory system so that a distal end of the nebulization catheter is in the respiratory system and a proximal end is outside the body. In a first aspect, the nebulization catheter may be used in conjunction with an endotracheal tube and preferably is removable from the endotracheal tube. The nebulization catheter conveys medicine in liquid form to the distal end at which location the medicine is nebulized by a pressurized gas or other nebulizing mechanism. The nebulized medicine is conveyed to the patient's lungs by the patient's respiration which may be assisted by a ventilator. By producing the aerosol of the liquid medicine at a location inside the patient's respiratory system, the nebulizing catheter provides for increased efficiency and control of the dosage of medicine being delivered.

Abstract: Novel polymer shrink tubes, such as fluoropolymer shrink tubes and novel uses thereof. The polymer shrink tubes include at least one three-dimensional pattern formed along at least a portion of the inner surface of the tube. The polymer shrink tubes can be used for, for example, embossing a pattern into a polymer tube. Further use includes, for example, forming a catheter with at least one channel located in the catheter wall.

Abstract: A catheter assembly (10) including at least one introducer (12) defining passage (18) receiving elongate tubular member (20) having proximal end, distal end and lumen extending between. Elongate shape imparting element (32) received in lumen and imparting predetermined shape (26) to distal end of tubular member (20) when distal end of tubular member is extended beyond distal end of introducer (12). Distal end of shape imparting element (32) extends from lumen of tubular member (20) and is anchored proximally of distal end of introducer (12).

Abstract: An introducer assembly for accessing a target site in the anatomy of a patient includes a sheath having a proximal end and a distal end, and having a lumen extending therethrough. At least a portion of the sheath distal end has a curved configuration. A tapered dilator has a proximal end and a distal end, and is sized to be received in the sheath lumen. The dilator has a length such that at least a distal tip portion of the dilator extends beyond the distal end of the sheath when the dilator is received in the sheath lumen. The dilator may be formed of polyurethane, and has a stiffness not exceeding a stiffness of the sheath curved portion such that the sheath substantially maintains the curved configuration when the dilator is received in the sheath lumen.

Abstract: A catheter guidewire for facilitating introduction of a flexible catheter into the human body (e.g., into the bladder) has a proximal end having a first stiffness which is sufficient to facilitate guidance of a stiff plastic expansion sheath through the tissue. A distal end of the guide wire has a second stiffness, substantially less than the first stiffness, to avoid damage to internal walls of the bladder. Preferably, the guide wire incorporates an intermediate portion having a stiffness between the first stiffness value and the second stiffness value.

Abstract: An embolic coil delivery system includes a catheter and an embolic coil disposed within the catheter, the embolic coil including a coil wire and a fiber bundle. A method of producing an embolic coil delivery system includes: advancing a delivery sheath over a distal end of an embolic coil while applying tension to the embolic coil via a retaining device that is attached to the distal end of the embolic coil.

Abstract: A fluid path set for a fluid delivery system includes a tube coil that is designed to optimally position one or more volumes of a pharmaceutical within an ionization chamber to optimally measure and prepare a pharmaceutical dose for administration to a patient. The tube coil may be maintained in a desired dimensional geometry by means of a core structure around which the tube coil is positioned.

Abstract: The catheter includes an inner column and an outer elastic member. The inner column is bendable wherein the column strength and flexibility of the inner column are adjusted by axially tensioning the outer elastic member. The inner column comprises a helical spring, slotted or slit tube, or individual links that, when axially compressed by advancement forces or by tensioning an elastic outer sheath, assume a straight or other pre-determined geometry. The column strength and flexibility of the catheter may be adjusted during introduction of the catheter into a body lumen as necessitated by the conditions encountered, as well as made highly flexible when left in position.

Abstract: An intracorporeal catheter, such as a guiding catheter, employed for intraluminal procedures is disclosed. The catheter generally has an elongated catheter shaft including a polymeric inner layer and a non-radiopaque outer polymeric layer, along with a radiopaque reinforcing structure disposed between the inner and outer layers. In one embodiment, the reinforcing layer consists of multiple drawn filled tubes braided or wound together. The drawn filled tubes may have a stainless steel outer jacket clad over a radiopaque inner core, or the drawn filled tubes may have a radiopaque outer jacket clad over a stainless steel core. In another embodiment, the reinforcing layer may consist of multiple wires containing radiopaque alloys braided or wound together, wherein at least two of the wires consist of different radiopaque alloys. The strands of the reinforcing structure may have a circular or a rectangular transverse cross-sectional shape.

Abstract: A deployment device for deploying stents, stent-grafts and other implants into a patient includes a catheter (112) with a containment sheath (116). Held onto the catheter (112) is a stent-graft structure (120). The containment sheath (116) extends over the entirety of the stent graft section (122) so as to constrain it in its entirety on the catheter (112), until the sheath (116) is removed. The containment sheath (116) extends from the distal position (126) of the stent graft section (122) to the tip (114) and then into the central lumen (128) of the catheter (112). It may extend throughout the lumen (128) to the proximal end of the deployment device (10), in other words to the external manipulation section of the delivery device (10). The sheath (116) is withdrawn by pulling towards the external manipulation section of the delivery device. As this is effected, the containment sheath (116) is pulled over the end (114) of the catheter and into the central lumen (128) of the catheter (112).

Abstract: A catheter having a catheter layer composed of a composition containing ETFE and PTFE in a weight ratio of 99:1 to 45:55, wherein there is got a luminal internal surface consisting of a material that exhibits lubricity substantially identical with that of PTFE and has a resistance to radioactive rays not had by PTFE.

Abstract: A catheter is fabricated by joining a first catheter body segment, the first segment including a braided or coiled filament reinforcing layer contained within an outer layer, to a second catheter body segment by thermal fusion in a zone including an interface between the first segment and the second segment and at a temperature causing ends of the filament reinforcing layer in the zone to extend outward within the outer layer. Following thermal fusion, the extending ends of the filament reinforcing layer are removed.

Abstract: A flexible channel to be incorporated into an endoscopic insertion portion having a flexible portion at least in part of its length, for the purpose of providing a flexible passage internally of the endoscopic insertion portion. The flexible channel is composed of a flexible tube with a helical groove on and around its outer periphery, and a reinforcing coil fitted in the helical groove on the flexible tube. At the root of the helical groove, angular projections are formed at intervals in the longitudinal direction and the reinforcing coil is tightly pressed tightly against the angular projections.

Abstract: Spiral-wound materials, spirals, and shafts made therefrom that have wraps with edges that may nest within one another are described. Such edges allow the spiral to achieve a smaller bending radius, meaning tighter turns and more flexibility due to the ability of adjacent wraps to nest within each other when the shaft is bent. Spirals having wraps with edges capable of nesting can be used in the medical field for devices that track anatomy, such as endoscopes, colonoscopes, catheters, and the like.

Abstract: Microcannulae are constructed with multiple components in a composite design, allowing the microcannulae to have varying mechanical and delivery properties that will enable ophthalmic treatments by minimally invasive means. The microcannula includes at least one flexible, tubular communicating element with an outer diameter of 350 microns or less, a proximal connector for introduction of materials, energy or tools. It may also include a reinforcing member attached to the communicating element, which may be designed to create variable stiffness along the length of the microcannula. The microcannula may also include other features such as a signal beacon near the distal tip.

Abstract: A catheter comprising an elongate tubular member having a proximal end, a distal end, and a passageway defining a lumen extending between the proximal and distal ends. The elongate tubular member comprises a relatively stiff proximal section and a relatively flexible distal section. The proximal section includes an inner tubular liner, a first stiffener comprising a metal alloy, and a second stiffener comprising a non-metal alloy. The first and second stiffeners are coaxially wound exterior to the proximal inner liner. The distal section includes a distal inner tubular liner and the second stiffener coaxially wound exterior to the distal inner liner. The first stiffener terminates before reaching the distal section.

Abstract: A malleable cannula has a body with a proximal end and a distal end, the body having a wall defining a lumen extending from the proximal end to the distal end. A reinforcement member extends along the lumen, the reinforcement member having an interior side facing the lumen and an exterior side facing away from the lumen. A malleable member extends along a portion of the exterior side of the reinforcement member. The malleable member may be constructed of a tube with a wire slidably received within the tube and may include an anchor.

Abstract: A medical device (10) including a tube (11) having a highly uniform and repeatable inner and outer diameter, the tube (11) possessing good trackability, pushability and torquability, and the tube (11) being highly resistant to collapse, necking or kinking during use. The tube (11) first includes a metal coil (14) in a stressed, radially expanded condition, the metal coil (14) preferably being formed as a flat wire. The tube (11) also includes a metal braid (16) extending over at least part of the coil (14). The tube (11) further includes a polymeric bonding layer (18) positioned over and contacting at least the coil (14). The polymeric layer (18) is preferably heat-shrinkable shrinkable tubing made of one or more of nylon or polyurethane. The tube (11) optionally includes an inner liner (20) beneath and in contact with at least part of the coil (14), the liner (20) preferably being composed of PTFE.

Abstract: Elongated medical instruments adapted to be permanently or temporarily implanted in the mammalian body or used to access a site in the body to facilitate introduction of a further medical device, and methods and apparatus for deflecting the distal end and imparting curves in distal segments of such medical instruments within the body by manipulation of a proximal segment of the instrument outside the body are disclosed. Multiple portions of distal segments of a single one or distal segments of coaxially arranged distal segments of deflectable coiled wires are formed each having a line of spacers each functioning as a backbone along a side of the wire coil and formed in a variety of ways. One or more elongated movable wire extends through a coil lumen to one or more attachment point distal to each portion that can be pushed to widen and/or pulled to narrow the spacing of coil turns across the coil diameter from the line to induce a bend in all more proximal portions.

Abstract: A catheter includes a tube formed of plastic, a helical spring coil formed of metal and a ribbon which is longitudinally substantially non-extendable. The coil is coaxially disposed within the tube and substantially coextensive longitudinally with the tube. The ribbon is disposed within the coil, proximal ends of the ribbon and the coil being secured together, and the ribbon distal end being secured to the coil body at a predetermined point of the coil body adjacent but substantially proximally spaced from the coil distal end. The ribbon precludes substantial longitudinal extension of the coil body intermediate the coil proximal end and the predetermined point, thereby to limit longitudinal extension and increase the pull strength of the catheter.

Abstract: A large diameter, flexible, kink-resistant, delivery catheter or sheath for percutaneous delivery of a contained and implantable medical device in the vasculature of a patient. The delivery catheter or sheath includes a reinforcement such as a flat wire coil with uniform spacing between the turns, which is compression fitted about an inner, lubricous PTFE tube. The delivery catheter or sheath further includes an outer tube of a heat formable polyamide material which is heat formed and compressed through the spaces between the turns of the wire coil to mechanically connect to a roughened outer surface of the inner tube. A polymeric radiopaque marker tube may be positioned at the distal end of the coil and between the inner and outer tubes for radiographic visualization. A side port may also be positioned there at for the infusion of contrast media.

Abstract: The embolic protection device (10) has an expandable tubular structure supporting a filter mesh material (12). The embolic protection device is compressed to a small diameter for insertion into a patient's aorta, then expanded within the aorta with the filter mesh material positioned to allow blood to enter sidebranch vessels connected to the aorta and to prevent embolic material from entering the sidebranch vessels. The filter mesh material may be configured with waves or undulations (26) for increased surface area and/or with two layers of mesh material to provide additional protection against embolization and to prevent inadvertent occlusion of the sidebranch vessels.

Abstract: A sheath for use in introducing a catheter or other medical instrument into a vessel in the body of a patient. The sheath includes an elongate sheath tube formed of a flexible material which has proximal and distal extremities and a passage extending therethrough A backflow adapter is secured to the proximal extremity of the elongate sheath tube. The backflow adapter has a central opening therein in registration with the passage in the sheath tube. A normally closed primary valve is disposed in the central opening of the backflow adapter and is movable le to an open position. A normally open secondary valve, movable to a closed position, may be configured in the backflow adapter proximal the sheath tube and distal the primary valve. The primary and secondary valves when open permit a catheter or other medical instrument to be inserted into the sheath.

Abstract: A colonic overtube 1 for maintaining a sigmoid colon in a straightened configuration has a proximal end 2 for location externally of a colon, and a distal end 3 for insertion into a colon. A colonoscope lumen 4 extends through the overtube 1 to facilitate passing the overtube 1 over a colonoscope. The overtube 1 has a convoluted corrugation 5 which extends along the entire length of the overtube 1 from the proximal end 2 to the distal end 3. The corrugated configuration of the overtube 1 provides the overtube 1 with laterally flexibility so that the overtube 1 may flex substantially without kinking during advancement of the overtube 1 through a colon. A flexible seal, in the form of a tubular silicone sheath 6 of film material, is provided at the distal end 3 of the overtube 1 for sealing between the overtube 1 and a colonoscope extending through the colonoscope lumen 4.

Abstract: An over-the-wire balloon dilatation catheter has a stainless steel hypotube catheter shaft, an intermediate sleeve section bonded to the shaft and a distal balloon section connected to the sleeve section. The sleeve section is forced from relatively flexible polymer materials and includes an inner core tube which defines a guide wire lumen extending only through a distal portion of the catheter (including its sleeve and balloon sections) to facilitate fast balloon catheter exchanges. A distal end of the hypotube shaft is crimped laterally and the core tube is nested and bonded within the crimp to provide a proximal outlet for the guide wire lumen. The hypotube shaft provides an inflation lumen for the balloon, with the inflation lumen being continued as an annular inflation lumen through the sleeve section where an outer sleeve is bonded about the core tube and extends from the distal end of the hypotube shaft to the balloon section.

Abstract: An intravascular catheter having a shaft, at least a portion of which includes a braid reinforcement with a plurality of axial members disposed between the helical members that form the braid. The axial members provide a number of advantages including: maintaining one-to-one correspondence in axial manipulation; maintaining uniform flexibility in several planes of flexure; reducing the likelihood of causing a curling effect; increasing the strength of connections between shaft segments; uniformly increasing stiffness of the catheter; and increasing the burst strength of the catheter. By positioning the axial members between the helical members, the axial members do not create a protrusion and do not become fixed to any adjacent polymer layer. Thus, the benefits of axial members are retained, without creating the undesirable effects of friction caused by an axial protrusion and without creating the undesirable effects of limited flexure caused by an adjacent polymer layer becoming fixed to the axial member.

Abstract: A cannula having an elongated tubular flexible body reinforced to prevent kinking in which the distal end of the tube is inserted in the heart and is provided with openings allowing blood to enter the lumen or bore of the tube. A cage structure is located at the tip to maintain the tissue walls of the heart spaced from the openings and prevent obstruction to permit the free flow of blood. In a two-stage cannula, openings also are provided at an intermediate portion of the tubular body spaced slightly from the distal end. This portion also is provided with a cage structure to maintain the openings separated from tissue or organ walls that might otherwise clog the openings.