Abstract: A catheter assembly comprises an elongate shaft having a proximal end and a distal end. The assembly also comprises a flexible distal tip having a proximal end coupled to the distal end of the elongate shaft and having a distal end. The flexible distal tip has at least one groove in a surface thereof.

Abstract: A balloon catheter that comprises an inner shaft, a balloon and a sleeve that defines a lumen. A portion of the inner shaft is positioned within the lumen and the balloon is engaged to the sleeve at least two engagement points.

Abstract: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer includes eUHMWPE and has at least a section that has been oxidized with a chromic acid solution to provide improved bondability.

Abstract: A guidewire lumen for a catheter includes a tubular portion and a sleeve bonded over less than an entire length of the tubular portion. The tubular portion is formed of a first material and the sleeve is formed of a second material. The second material may bond better to certain materials than the first material.

Abstract: Medical devices, and particularly intracorporeal devices for therapeutic or diagnostic uses, having a component chemically modified by plasma polymerization. The medical device comprises a substrate with a plasma polymerized functionality bonded to a surface of at least a section thereof. The plasma polymerized film on a first component of the medical device allows for bonding an agent or a second component to the first component. In one embodiment, the plasma polymerized film facilitates fusion or adhesive bonding of a first component to a second component formed of a material which is dissimilar to, incompatible with, or otherwise not readily bondable to the substrate material of the first component. In another embodiment, a bioactive agent is bonded to the plasma polymerized film on the component, for presenting or delivering the bioactive agent within a body lumen of the patient.

Abstract: Systems and methods are described for laser bonding polymer catheter components by using laser energy to create localized heat fusion bonds between two or more polymer catheter components.

Abstract: A removable hub and/or manifold structure, assembly, and methods, and medical devices including such hub and/or manifold structures. For example, a hub and/or manifold assembly that is adapted and configured to be removably attached to a shaft of an elongated medical device. The hub assembly can include a hub having a proximal portion and a distal portion, and a mechanical connection structure including a first body portion and a second body portion. The first and second body portions can be removably fastenable together about the distal portion of the hub and the proximal portion of a shaft to connect the hub to the shaft. Elongated medical devices including such a removable hub assembly and methods of attaching a removable hub assembly to a medical device are also disclosed.

Abstract: A steerable balloon catheter including a balloon catheter supported by a steerable guidewire having a deflectable distal tip. The guidewire comprises a longitudinal hypotube and a spring coil attached to the distal end of the hypotube and includes a longitudinally movable deflection member which is attached to the distal end of the spring coil and a tip retaining member which extends from the distal end of the hypotube to the distal end of the spring coil for providing very precise deflection of the distal tip of the balloon catheter.

Abstract: A ureteral access sheath adapted for insertion into a urethra includes an elongate tube extending between a proximal end and a distal end. A handle assembly is disposed at the proximal end and includes enlarged portions which inhibit migration of the sheath into the urethra. The enlarged portions are shaped like the bell of a horn with a concave, distally-facing outer surface and a convex, proximally-facing inner surface. The inner surface functions as a funnel while the outer surface is sized and configured to receive adjacent fingers of a user's hand held in its natural position. In an associated method, this shape of the handle assembly facilitates maintaining the sheath in a stationary position during insertion and removal of instrumentation. The handle assembly can be movable on the tube to facilitate variation of the sheath link in situ.

Abstract: A balloon catheter for interatrial septum dehiscence including an expandable and contractible balloon, and a shaft to which the balloon can be attached at the distal end thereof, wherein fixing members are provided at balloon mounting portions to be attached to the shaft. The fixing members are a pair of members in opposed relationship to each other at the ends of the balloon. The pair of members generally has an identical shape.

Abstract: Various coupling agents are disclosed to form lap joints between metallic and polymeric surfaces within catheters and other medical devices. The coupling agents disclosed in the present invention can be applied directly to a metallic surface, or the coupling agents may be incorporated within a polymeric material. In certain circumstances, the mere application of the coupling agent between the two dissimilar materials provides sufficient adhesive strength to form a fatigue-free lap joint bond. Alternative methods utilize coupling agents as primers for later thermal bonding and laser welding procedures that form lap joint bonds.

Abstract: A balloon catheter having an improved balloon waist design in which material is removed prior to thermal processing. In one embodiment, a series of patterned voids are formed in the balloon waist to reduce the amount of polymeric material and to better control flowing polymeric material during thermal processing.

Abstract: Intravascular device for matching impedances of portions of an intravascular circuit and limiting RF signal-induced heating of intravascular conductors. An intravascular device includes alternating conductive and dielectric layers and an electrically conductive coil in a configuration that effects an impedance-matching circuit. Another embodiment of an intravascular device has cylindrical inner and outer walls formed of an expandable, electrically conductive material, the inner and outer walls being separated by a compressible dielectric material. Varying the pressure in the lumen defined by the inner wall changes the spacing between the inner and outer walls, thereby changing the capacitance between the inner and outer wall. Another embodiment of an intravascular device includes one or more coaxial chokes for limiting heating caused by currents induced by RF signals. A conductive shield of the choke is formed of a conductive polymer to further reduce heating effects.

Abstract: An expansible tunneling apparatus and associated methods for creating an anatomic working space for a surgical procedure. Various embodiments of one and two piece apparatus that permit laparoscopic observation both during tunneling and during subsequent balloon dissection are disclosed. In a disclosed one piece embodiment, a tubular member has a bore extending therethrough and an open distal end. A lip is formed in the distal end of the tubular member to capture the distal tip of a laparoscope that is inserted into the tubular member to permit observation of the procedure both during tunneling to a desired location and during subsequent balloon inflation. An elongated neck of the balloon is secured to the tunneling member. The elongated neck permits the tubular member to be withdrawn slightly from the balloon after inflation to facilitate observation.

Abstract: An improved balloon catheter seal which may be used for attaching an inflatable balloon to a catheter body, especially when the balloon and catheter body are formed from dissimilar materials. The seal is formed by applying a layer of adhesive material between the inflatable balloon and the catheter body, and crimping a retaining ring over each seal junction. The invention is especially useful when joining a compliant balloon made from silicone to a catheter body made from polyurethane.

Abstract: A balloon catheter and a method of making a balloon catheter, having a balloon with a first layer and a second layer, the first layer having at least one impregnated section impregnated with a polymeric material compatible with a polymeric material forming the catheter shaft. At least a portion of the impregnated section is fusion bonded to the shaft. In a presently preferred embodiment, the impregnated section is adjacent to a section of the first layer which is not impregnated with the compatible polymeric material. The impregnated section provides improved bonding of the balloon to the catheter shaft while minimizing the effect of the bond on catheter performance characteristics such as profile and flexibility.

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: A catheter having an elongated shaft, an inflatable balloon on a distal shaft section, and a distal tip member bonded to a surface of the distal end of the balloon. The balloon has a proximal skirt section and a distal skirt section sealingly secured to the shaft, and an inflatable section therebetween with an interior in fluid communication with the at least one lumen of the shaft. The distal skirt section of the balloon has a proximal portion, and a distal portion with a smaller outer diameter than the proximal portion. Preferably, the distal tip member has a proximal section with an inner surface bonded to an outer surface of the distal portion of the distal skirt section, and a distal section extending beyond the distal end of the balloon.

Abstract: The invention relates to a method of increasing flexibility of joints between areas of plastic materials, and in particular the joint between a catheter shaft and a balloon neck involving welding the overlapping portions to create a joint region and applying a tensile force to the joint region, the force being of sufficient strength to elongate the joint region, thus thinning the joint region.

Abstract: A balloon catheter comprises a balloon, an inner shaft, an outer shaft and a transition shaft. The transition shaft has a proximal portion and a distal portion joined by a tapered portion. The proximal portion has a diameter greater than the distal portion. The proximal portion has a first end portion engaged to at least a portion of the outer shaft at a first engagement site. At least a portion of the proximal waist is engaged to the proximal portion of the transition shaft at a second engagement site. At least a portion of the end region of the inner shaft is engaged to the distal portion of the transition shaft at a third engagement site. The distal portion extends through the balloon wherein at least a portion of the distal waist of the balloon is engaged to the distal portion of the transition shaft at a forth engagement site.

Abstract: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved strong bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer has at least a section with a gas plasma-etched or chemical solution-etched surface for improved bondability. Another aspect of the invention is directed to a balloon in which the balloon first layer has a proximal end section bonded to an outer surface of the shaft and the balloon second layer has a proximal end section bonded to an inner surface of the shaft, and, in one embodiment, at least a section of the balloon first layer has a gas plasma-etched or chemical solution-etched surface.

Abstract: A tubular instrument including a hollow wall portion and a connector arranged to be used with a guide-wire. The guide-wire has a distal end portion and a proximal end portion, the distal end portion of the guide-wire is arranged to be extended to some interior position within the body of a living being, with the proximal end portion of the guide-wire being located outside the being's body. The connector is located at the distal end of the instrument and is arranged to be readily manipulated by a twisting action to connect the instrument onto the guide-wire for sliding movement therealong.

Abstract: Balloon catheters having the strength and maximum inflated diameter characteristics of an angioplasty balloon and having the recovery characteristics during deflation of an elastic embolectomy balloon. The balloon catheter can be made in very small sizes and has a lubricious and chemically inert outer surface. The balloon catheter is easy to navigate through tortuous passageways, is capable of rapid inflation and deflation and has high burst strengths. Balloon covers having these same characteristics are also described for use with conventional embolectomy balloons or angioplasty balloons.

Abstract: Disclosed is a method for attaching a sensor to an inflatable balloon. The method involves bonding the sensor to the balloon with an adhesive while the balloon is in an expanded state and then collapsing the balloon after the adhesive has at least partially cured. The method reduces the possibility of a failure of the bond between the sensor and the balloon. The method is particularly useful in the construction of a tissue ablation catheter for forming a lesion along a substantially circumferential region of tissue wherein a sensor is used for monitoring the temperature of the tissue being ablated.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

Abstract: A process for forming a heat weld between a catheter shaft and a surrounding balloon comprises selecting an elongate catheter shaft formed of thermoplastic polymeric material that is opaque to red and near-infrared light, and selecting a balloon formed of thermoplastic polymeric material that is transparent or translucent to red and near-infrared light. While a neck of the balloon is fitted in close contact around a distal portion of the catheter shaft, a laser beam of red and near-infrared light is applied through the balloon neck to impinge on the underlying opaque distal shaft, which is heated thereby. Heat from the shaft is conducted into the surrounding balloon neck so that adjacent annular portions of both components melt and mix. The molten materials are allowed to cool, forming a secure weld joint between the neck and the shaft. The process yields strong, flexible bonds between balloons and catheter shafts that may be selected from a wide variety of materials.

Abstract: The present invention is directed to balloon catheter having a compression member securing one or more balloon skirts to the catheter shaft. The compression member may be a band or coil that sealing secures the balloon skirt to a catheter shaft. Metallic compression members may be swaged to compress the skirt against the shaft, and thus provide a uniform seal between the balloon skirt and the catheter shaft. The compression members are especially useful when the balloon is formed of a fluoropolymer, such as expanded polytetrafluoroethylene (ePTFE) or polyterafluoroethylene (PTFE).

Abstract: The medical balloon catheter of the present invention comprises a catheter shaft composed of a distal end shaft and a proximal end shaft and a balloon on the distal end of the distal end shaft, wherein the proximal end shaft is composed of a single member and the distal end portion of the proximal end shaft is lower in rigidity than the other parts thereof. The present invention also provides a medical balloon catheter having a structure in which a tube for passing a guidewire inside thereof is arranged so as to pass inside the balloon and the balloon and tube are fused together in the vicinity of the distal end of the catheter, wherein the ratio of the outer diameter of the small-diameter portion on the distal end side of the tube to the outer diameter of the proximal end portion is no less than 0.85.

Abstract: A process for forming a heat weld between a catheter shaft and a surrounding balloon comprises selecting an elongate catheter shaft formed of thermoplastic polymeric material that is opaque to red and near-infrared light, and selecting a balloon formed of thermoplastic polymeric material that is transparent or translucent to red and near-infrared light. While a neck of the balloon is fitted in close contact around a distal portion of the catheter shaft, a laser beam of red and near-infrared light is applied through the balloon neck to impinge on the underlying opaque distal shaft, which is heated thereby. Heat from the shaft is conducted into the surrounding balloon neck so that adjacent annular portions of both components melt and mix. The molten materials are allowed to cool, forming a secure weld joint between the neck and the shaft. The process yields strong, flexible bonds between balloons and catheter shafts that may be selected from a wide variety of materials.

Abstract: An improved balloon catheter seal which may be used for attaching an inflatable balloon to a catheter body, especially when the balloon and catheter body are formed from dissimilar materials. The seal is formed by applying a layer of adhesive material between the inflatable balloon and the catheter body, and crimping a retaining ring over each seal junction. The invention is especially useful when joining a compliant balloon made from silicone to a catheter body made from polyurethane.

Abstract: A catheter to be used without a guidewire which includes a support wire shaft formed of metal, a balloon mounted on a distal portion of the catheter, and an inflation shaft for inflating the balloon, wherein a core wire may be interchangeably inserted into the support wire shaft when the catheter is within a human body to change the stiffness and improve control thereof. In one embodiment, the portion of the support wire shaft that extends just proximal of, through and distal of the balloon is formed entirely of a metal wound coil. The flexibility characteristics of this support wire shaft can be controlled by varying the pitch of the wound coil and the thickness of the wire or ribbon it is made from. An overjacket is also provided on the metal wound coil portion to hold pressure within the inflation lumen and provide a suitable material for bonding a distal end of the balloon to the support wire shaft.

Abstract: An improved balloon catheter seal which may be used for attaching an inflatable balloon to a catheter body, especially when the balloon and catheter body are formed from dissimilar materials. The seal is formed by applying a layer of adhesive material between the inflatable balloon and the catheter body, and crimping a retaining ring over each seal junction. The invention is especially useful when joining a compliant balloon made from silicone to a catheter body made from polyurethane.

Abstract: A balloon catheter construction is disclosed wherein bands are used to mechanically attach a balloon to a catheter shaft. The bands provide a mechanical seal that secures the balloon to the catheter shaft without the use of an adhesive and prevents fluid loss from the interior of the balloon. Fillets may be provided at the ends of the balloon and band to provide a smooth transition region between the shaft and the balloon for facilitating advancement through a blood vessel.

Abstract: Laser welding is used to attach a laser-transparent component portion to an absorbing component portion at a laser weld joint area. The transparent component portion includes a first weld surface and a first taper locking surface formed opposite from the first weld surface. The absorbing component portion includes a second weld surface and a second taper locking surface formed opposite from the second weld surface. Prior to laser welding, the first and second taper locking surfaces cooperate to force and lock the first and second weld surfaces into abutting engagement at a predetermined pressure. A laser beam is then directed toward the first and second weld surfaces to permanently attach the component portions together. The first and second taper locking surfaces maintain the predetermined pressure during the laser welding process.

Abstract: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved strong bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer has at least a section with a gas plasma-etched or chemical solution-etched surface for improved bondability. Another aspect of the invention is directed to a balloon in which the balloon first layer has a proximal end section bonded to an outer surface of the shaft and the balloon second layer has a proximal end section bonded to an inner surface of the shaft, and, in one embodiment, at least a section of the balloon first layer has a gas plasma-etched or chemical solution-etched surface.

Abstract: A low-pressure balloon, and method of forming same by the steps of: preheat a thin film of thermoplastic polymeric material to a sufficient temperature; forming two halves of the balloon on said thin film of thermoplastic polymeric material by vacuum suction; isolating the two halves of the balloon from said thin film of thermoplastic polymeric material; bonding the two halves together on their edges to form the low-pressure balloon by radio-frequency welding method; and inverting the low-pressure balloon from inside out to turn the rough bonded edge of the two halves into the interior side of the balloon.

Abstract: It is an object of the present invention to provide a balloon catheter in which the inner tube is prevented from slackening after balloon inflation, improving the rewrapping of the balloon, discontinuity in the rigidity of the joined portions of the outer tube and the balloon is lessened, which prevents breakage, and the catheter advances through blood vessels better and passes more easily through narrow segments, preventing the catheter from “accordioning” and enhancing insertion force transmission. The balloon catheter pertaining to the present invention has a catheter shaft (1) with a double-tube structure comprising an outer tube (4) and an inner tube (5), and a balloon (3) disposed at the distal end portion of this catheter shaft (1).

Abstract: A balloon catheter comprises a balloon, an inner shaft, an outer shaft and a transition shaft. The transition shaft has a proximal portion and a distal portion joined by a tapered portion. The proximal portion has a diameter greater than the distal portion. The proximal portion has a first end portion engaged to at least a portion of the outer shaft at a first engagement site. At least a portion of the proximal waist is engaged to the proximal portion of the transition shaft at a second engagement site. At least a portion of the end region of the inner shaft is engaged to the distal portion of the transition shaft at a third engagement site. The distal portion extends through the balloon wherein at least a portion of the distal waist of the balloon is engaged to the distal portion of the transition shaft at a forth engagement site.

Abstract: An apparatus for delivery of biologically active materials comprises a catheter and balloon having micro-needles or pores. In the apparatus, the balloon can have a polymer coating containing the biologically active material, and the apparatus can include a sheath surrounding the balloon. In one embodiment the biologically active material is delivered through lumens in the micro-needles. Another embodiment of the invention is an apparatus for delivery of biologically active materials comprising a catheter with a balloon disposed thereon and a shockwave generator for producing a shockwave for delivering the biologically active material to a body lumen. Methods for delivery of biologically active materials are also disclosed.

Abstract: A catheter comprises a catheter shaft, at least one sleeve and at least one collar. At least a portion of the catheter shaft having a medical balloon mounted thereon. The medical balloon defines at least one waist which comprises a first waist portion and a second waist portion. The at least one sleeve has an upper surface and a lower surface. A first portion of the lower surface is engaged to the first waist portion. The at least one collar comprises a first collar portion and a second collar portion. The first collar portion is engaged to at least a portion of the upper surface of the at least one sleeve and the second collar portion is welded to the second waist portion of the medical balloon.

Abstract: A balloon catheter having an improved maneuverability. The catheter includes an elongated catheter shaft with proximal and distal ends, proximal and distal shaft sections, a balloon on the distal catheter shaft section having proximal and distal shaft sections, a guidewire receiving lumen extending along at least a portion of the catheter shaft to the catheter shaft distal end, and a tip member on a distal end of the catheter. A proximal end of the tip member is spaced distally apart from the distal end of the catheter shaft and is in fluid communication therewith. The distal balloon shaft is sealingly secured to the catheter shaft and the tip member.

Abstract: A balloon dilatation catheter has a relatively stiff and strong proximal cannula made of a material such as for example metal hypotubing. The distal end of the catheter includes an inflatable medical device or balloon, an inflation lumen and a guidewire lumen. A transition assembly is positioned between the proximal cannula and the distal end section. This transition assembly has a stiffening member within a transition tube, and provides for a flexible transition between the two components of diverse stiffness, namely the proximal cannula and the flexible distal end portion. A proximal end of the stiffening member may float within a distal end of the proximal cannula, but the stiffening member distal end is affixed to the shaft. The dilatation catheter may have a rapid exchange configuration, and is generally used in conjunction with a guiding catheter.

Abstract: An improved balloon catheter which includes a purge mechanism for purging air from the catheter prior to use. The purge mechanism is sized to allow air to pass through, but highly restricts the flow of liquids. Air remaining in the catheter after purging is allowed to diffuse through the balloon prior to use. The mechanism is especially useful with low-pressure, gas-permeable, compliant balloons.

Abstract: An apparatus for delivery of biologically active materials comprises a catheter and balloon having micro-needles or pores. In the apparatus, the balloon can have a polymer oating containing the biologically active material, and the apparatus can include a sheath surrounding the balloon. In one embodiment the biologically active material is delivered through lumens in the micro-needles. Another embodiment of the invention is an apparatus for delivery of biologically active materials comprising a catheter with a balloon disposed thereon and a shockwave generator for producing a shockwave for delivering the biologically active material to a body lumen. Methods for delivery of biologically active materials are also disclosed.

Abstract: An improved balloon catheter seal which may be used for attaching an inflatable balloon to a catheter body, especially when the balloon and catheter body are formed from dissimilar materials. The seal is formed by applying a layer of adhesive material between the inflatable balloon and the catheter body, and crimping a retaining ring over each seal junction. The invention is especially useful when joining a compliant balloon made from silicone to a catheter body made from polyurethane.

Abstract: A catheter comprises a catheter shaft, at least one sleeve and at least one collar. At least a portion of the catheter shaft having a medical balloon mounted thereon. The medical balloon defines at least one waist which comprises a first waist portion and a second waist portion. The at least one sleeve has an upper surface and a lower surface. A first portion of the lower surface is engaged to the first waist portion. The at least one collar comprises a first collar portion and a second collar portion. The first collar portion is engaged to at least a portion of the upper surface of the at least one sleeve and the second collar portion is welded to the second waist portion of the medical balloon.

Abstract: The invention is directed to a catheter assembly and the method for forming the same. The catheter includes an elongated shaft having proximal and distal sections, and further includes an inflatable balloon on a portion of the distal shaft section and in surrounding relation thereto. The balloon has proximal and distal tapered regions and an intermediate region longitudinally disposed therebetween. The proximal and distal tapered regions each has a first end adjacent the intermediate region and a second end opposite the first end. The wall thickness of the proximal and distal tapered regions, may, increase from the first end to the second end. A fluid-tight bond is formed between the catheter shaft and at least a section of at least one of the proximal and distal tapered regions at the second end thereof. The bond is preferably a fusion bond. At least a portion of the either or both the proximal and distal tapered regions in the bond interface is at least partially crystalline.

Abstract: A catheter comprises a first component and a second component. The first component has a first outer diameter and the second component has a second outer diameter. At least a portion of the first component being bonded to at least a portion of the second component. When the at least a portion of the first component is bonded to the at least a portion of the second component the first outer diameter is substantially equal to the second outer diameter. A heat shrink material being utilized to bond the at least a portion of the first component to the at least a portion of the second component.

Abstract: Apparatus for creating an anatomic space in tissue in a body including an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A blunt tip is secured to the distal extremity of the tunneling shaft. A balloon assembly is provided. The balloon assembly is removably secured to the tunneling shaft. The balloon assembly includes a deflated collapsed balloon. A sheath encloses the balloon and is carried by the tunneling shaft. The sheath has a weakened region extending longitudinally thereof permitting the sheath to be removed to release the balloon.

Abstract: A tie layer insert is disclosed to aid in bond formation between an expandable balloon and a distal portion of a catheter shaft. The tie layer insert can be a single layer applied directly to the structural surfaces, or alternatively, the tie layer may be incorporated into a preformed polymeric insert. In the latter embodiment, the polymeric insert may include several layers of polymeric material. During the manufacturing process, the preformed polymeric insert is positioned between the distal portion of the expandable balloon and the catheter shaft. The entire distal region is then processed to form a sealably bonded expandable balloon to the distal end of the catheter shaft.