Abstract: A method of forming a medical device or components thereof, including the steps of providing a first component of said medical device which is formed a first material and providing a second polymeric material into a mold cavity to overmold a second component of the medical device over the first component, and wherein the second polymeric material is further injected with a blowing agent to form a foam, and to components and to the medical devices made therefrom.

Abstract: A guide catheter (16) for movement within a vessel (12) includes a tubular catheter assembly (20) having an exposed end (16B) that is positioned outside the vessel (12), and a catheter tip (16A) that is movable within the vessel (12) with manipulation of the exposed end (16B). In certain embodiments, at least one of a stiffness and a shape of the catheter tip (16A) can be adjusted between a first configuration (18) and a second configuration (318) with the exposed end (16B). As a result of this design, the physician can move the distal catheter tip (16A) with less resistance through narrow, tortuous vessels (12), the physician can accurately position the distal catheter tip (16A) in the ostium (12C), and the distal catheter tip (16A) is more likely to remain in position in the ostium (12C) when a guide wire and other treatment devices are directed through the guide catheter (16).

Abstract: The invention relates to a steerable catheter having a distal section with reduced variation in deflection path during deflection. The distal section of the catheter includes stripes of different material hardness along the length of the distal section affecting the directionality of catheter deflection upon the application of a deflection force like that applied by pull wires. The stripes result in preferential bending in a desired path with greater reproducibility.

Abstract: A system for arterial access for delivery of treatment devices is provided. In one embodiment, the system comprises a guidewire and a catheter. The catheter comprises a handle and a shaft. The shaft may be a steerable/deflectable tip shaft with a lumen adapted to allow passage of the guidewire at least partially there through. A passive sheath may also be provided to be delivered over the shaft. The handle controls the steerable/deflectable tip shaft and may be used to deflect the distal tip of the shaft.

Abstract: Methods and apparatuses for manipulating an elongated flexible shaft of a catheter provide case and reliability of positioning electrodes against or near tissue. Dual-bend flexible distal tips (30) may be used in combination with flat wires. In some embodiments, flat wires which are free to rotate upon initial bending of shaft segments are employed. In some embodiments, one or more transition segments (48) are used to relocate the satellite lumen-to-main lumen transition of pull wires (42, 40) away from a change in shaft stiffness.

Abstract: An introducer sheath that can include an elongate tubular member, such as a metallic tubular member, including a tubular wall defining a lumen and including a proximal portion and a distal portion. In some embodiments, a portion of the tubular member, such as the distal portion, can include a plurality of apertures defined in the tubular wall, and another portion, such as the proximal portion, can be free of apertures defined in the tubular wall. The portion including the apertures defined therein can be more flexible than the portion free of the apertures. A second tubular member can be disposed on or within the elongate tubular member, and can define a fluid tight pathway through the lumen. Additionally, a hub can be attached to the proximal portion of the elongate tubular member and in fluid communication with the fluid tight pathway.

Abstract: A component for use as or incorporation within a medical instrument navigable through body vessels of a human subject is provided. The component includes a tubular portion with an interrupted spiral defined by alternating cut and uncut sections. The interrupted spiral has a rigidity between that of a continuous cut spiral and an uncut tube. The rigidity of the interrupted spiral along its length may be varied by changing its pitch or the number of bridge members or the length of each bridge member. According to a method of manufacturing such a component, a tubular member and a cutting member are provided. At least one of the tubular member and the cutting member is moved though an angle defining a helical path with respect to the other, while the cutting member is alternated between cutting and not cutting the tubular member to form an interrupted spiral.

Abstract: Medical devices including a proximal tubular member, a distal tubular member, and an intermediate tubular member connecting the proximal tubular member to the distal tubular member, and related methods.

Abstract: The present invention relates generally to catheters for performing medical procedures including percutaneous transluminal coronary angioplasty. More particularly, the present invention relates to guide catheters, diagnostic catheters and balloon catheters with an improved shaft design. In a preferred embodiment, the present invention includes a catheter shaft comprising an elongate support member having an outer surface, the elongate support member preferably defining a lubricious liner; a first layer disposed over the lubricious liner, a second layer disposed over the first layer, a third layer disposed over the second layer, a fourth layer disposed over the third layer, and a fifth layer disposed over the fourth layer. In preferred embodiments, the first and third layers comprise an ultraviolet-curable epoxy which is cured to desired degrees at select axial locations on the shaft to provide desired stiffness.

Abstract: A catheter having a mandrel secured to the catheter or constrained within a dedicated lumen. In one embodiment, the catheter has an inner tubular member and an outer tubular member with a sidewall configured to define a mandrel lumen longitudinally along an inner surface of the outer tubular member or along an outer surface of the inner tubular member. The mandrel lumen may be configured to allow the mandrel to be exchanged to adjust the handling characteristics of the catheter. The mandrel may occupy an intermediate portion of the catheter shaft, or may extend from the proximal end to within proximal or distal shaft sections of the catheter. In coronary artery applications, the mandrel is configured to support the catheter as it bends through the aortic arch and enters the coronary artery.

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: Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Ultrasound catheter devices generally include an elongate flexible catheter body with one or more lumens, an ultrasound transmission member extending longitudinally through the catheter body lumen and a distal head coupled with the transmission member and positioned adjacent the distal end of the catheter body for disrupting occlusions. Improved features of ultrasound catheters include catheter bodies and ultrasound transmission members with increasing distal flexibility, guidewire tubes allowing contact between a guidewire and an ultrasound transmission member, distal heads with improved guidewire lumens, and torquable proximal housings for enhancing disruption of blood vessel occlusions.

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, and, in one embodiment, tapering the tubular member to form a bending stiffness transition. 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 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 hypotube for an intravenous catheter device is disclosed which includes a tubular shaft having a tubular wall defining a lumen. The shaft includes a main section integrally connected to a distal section. The distal section includes a first section connected to the second section and disposed between the second section and the main section. The second section includes an elongated stinger.

Abstract: A balloon catheter having a multilayered shaft with variable flexibility along the length of the shaft. In a presently preferred embodiment, the multilayered shaft has a multilayered outer tubular member and an inner tubular member, both the inner and outer tubular members having sections along which the flexibility and/or diameter of the tubular members decrease. These diameter and flexibility transition sections along the outer tubular member are preferably aligned with transitions along the inner tubular member, to provide improved catheter performance.

Abstract: A medical tubing being flexible and kink-free as gas insufflation tubing and non-collapsible as suction/irrigation tubing is provided. The tubing is lightweight and thin-walled. The tubing has a generally rigid but thin walled with a structural shape or is generally soft and thin-walled tubing with a hard re-enforcement.

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 method and apparatus for reducing mitral regurgitation. The apparatus is inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

Abstract: A tubular medical catheter having a least one region of selectively varied lamination is provided herein.

Abstract: A balloon catheter for medical treatment of a patient, including therapeutic dilatation or deployment of medical devices such as stents or grafts. The balloon catheter has an “over-the-wire configuration, including a proximal hub defining an inflation port and a guidewire port, a flexible shaft defining an inflation lumen and a guidewire lumen, a balloon near a distal end of the catheter, and a distal guidewire port. At least a portion of the shaft has an inner tubular body defining at least a portion of the guidewire lumen, surrounded by an outer tubular body defining at least a portion of the inflation lumen. A proximal portion of the inner body is reinforced by a hypotube, which provides much greater column strength and torsional stiffness. A distal end of the hypotube provides a graduated flexibility transition with a distal spiral-cut segment, in which the pitch of the spiral cut pattern decreases to provide increasing flexibility.

Abstract: A medical device includes at least four layers including a first material and a second material having a different stiffness than a stiffness of the first material, wherein at least one of the layers varies in thickness axially along the device.

Abstract: A catheter, for example, a balloon catheter has a first and second section and a transition between the sections. The sections and the transition are arranged to enhance catheter deliverability.

Abstract: A bowel management system includes a waste collection catheter having at least two distinct sections. The first section is patient proximal when disposed in the patient's rectum and has durometer hardness in the range of about 50A to about 90A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5A to about 49A. A selectively collapsible, substantially spherical retention balloon is attached coaxially and exterior of the first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most end of the first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient.

Abstract: The present invention provides a polymeric treatment for curved regions in shaft assemblies that increases curve retention without affecting the flexibility within these regions. More specifically, the present invention modifies the underlying crystalline morphology of a polymer in order to decrease crystal fracturing. In particular, the present invention treats polymeric materials suitable for catheter construction with a nucleating agent.

Abstract: A spiral cut transition member is disclosed for controlling the transition in stiffness of a catheter from a stiffer more pushable proximal section to a more flexible and trackable distal section and increasing kink resistance. The transition member has a spiral cut provided therein to vary the flexibility of the transition member over its length. The pitch of the spiral cut can be varied to facilitate a gradual transition in flexibility along the catheter. The transition member may be used in conjunction with any type of catheter including single-operator-exchange type catheters, over-the wire type catheters, and/or fixed-wire type catheters.

Abstract: An improved apparatus and method to catheterize passages is disclosed. The present invention provides a catheter having a soft flexible pre-formed distal tip, that when used in combination with commercially available guidewires of variable stiffness, results in the ability to control the direction and angle of wire advancement allowing cannulation of body passages, including those that arise at acute angles. The catheter can have a longitudinal axis, a proximal section and a distal section having a soft flexible pre-formed tip having a curvature of ninety degrees or greater and shape retention. The catheter can have an inner wall that defines a lumen that runs along said longitudinal axis forming a single continuous tube, a reinforcement braid disposed over the inner wall, and an outside covering disposed over the reinforcement braid. A spacer can be added between said wall liner and said reinforcement braid in the proximal end.

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: An apparatus and method for providing a co-extruded, tapered multi-layer shaft. A co-extruded, tapered multi-layer shaft may be fabricated by selecting a first material for the inner layer of the shaft and a second material for the outer layer of the shaft. The first and second materials are then co-extruded by a co-extrusion system including a puller with programmable tapering capabilities. The system forms a hollow tubing having an inner layer and an outer layer, wherein the tubing has the desired tapered characteristics. The result is a tapered tubular shaft having an inner layer and an outer layer.

Abstract: A multiple lumen catheter having a soft, tapered multiple lumen distal tip for insertion into a body vessel. One of the lumens is sized to pass over a guidewire such that the catheter can be inserted into the body vessel using the Seldinger technique. At least one medical implement lumen is used for placement or positioning of a biomedical sensor or other medical implement. For example, at least one optical fiber passing through the medical implement lumen may transmit and receive light at the distal tip for measuring oxygen saturation of the blood. The catheter may have a cylindrical catheter body to which the soft distal tip attaches. The soft tip reduces the possibility of vessel or tissue puncture and abrasion. The tip is constructed of a soft plastic or pliable material that yields easily when force is applied.

Abstract: A catheter assembly includes a catheter body that extends from a distal end to a proximal end. The catheter body includes a delivery lumen, and an actuator lumen, where the actuator lumen extends from a position near or at the distal end to an intermediate portion that does not extend through the proximal end of the catheter body. The catheter body optionally includes an accessory lumen that extends from at or near the distal end and terminates at an intermediate portion that does not extend through the proximal end surface of the catheter body, for example, on a side wall.

Abstract: An endovascular device (1, 100, 200, 300) having a distal end (2), a proximal end (4) and a body portion (3) therebetween. The body portion is made of a multiple filament helically wound row (A) of wires (5), provided with a sealing coating (14) on the inside surface or the outside surface or both. The device may be a catheter (1), a sheath, an introducer, a delivery device, a pusher (100), an embolization coil delivery device (300), or a receptacle (208) for an expandable prosthesis (220) used with a delivery device (200). From 2 to 12, and preferably from 4 to 8, wires (5) are used in the row, and fewer wires may be used proceeding toward the distal end (2) for greater flexibility. The helically wound row of wires transmits torque and provides pushability to the device while resisting kinking, and enables a small outside diameter for reaching very small vessels and extending through very tortuous vessels.

Abstract: A variety of devices for use in accessing the subarachnoid space are described. In several embodiments an introducer sheath is disclosed having three main sections, a distal portion, an intermediate portion, and a proximal portion. The distal portion and intermediate portion form a first bend, and the intermediate portion and the proximal portion form a second bend, giving the overall device a general L-shape, S-shape, C-shape, or a three dimensional Z-shape. Apparatuses for attaching an introducer sheath to the skin of a patient are also discussed, as are methods for using, shaping and sizing an introducer sheath.

Abstract: An medical device include a shaft having an elongated inner tubular member and an elongated tubular reinforcing member disposed over a portion of the inner tubular member. In some embodiments, the reinforcing member is disposed about a proximal portion of the inner tubular member such that a distal portion of the inner tubular member is free of the reinforcing member. In some embodiments, the at least a portion of an outer surface of the inner tubular member is spaced from an inner surface of the reinforcing member. In some embodiments, the shaft can include a tip structure disposed on the distal portion of the inner tubular member. In some such embodiments, reinforcing member has a distal end, and the tip structure is disposed on the distal portion of the inner tubular member adjacent the distal end of the reinforcing member.

Abstract: The present invention relates generally to catheters for performing medical procedures including percutaneous transluminal coronary angioplasty. More particularly, the present invention relates to guide catheters, diagnostic catheters and balloon catheters with an improved shaft design. In a preferred embodiment, the present invention includes a catheter shaft comprising an elongate support member having an outer surface, the elongate support member preferably defining a lubricious liner; a first layer disposed over the lubricious liner, a second layer disposed over the first layer, a third layer disposed over the second layer, a fourth layer disposed over the third layer, and a fifth layer disposed over the fourth layer. In preferred embodiments, the first and third layers comprise an ultraviolet-curable epoxy which is cured to desired degrees at select axial locations on the shaft to provide desired stiffness.

Abstract: A venous catheter comprises a flexible plastic tubular body having a center lumen. A plurality of drainage openings are formed in a reinforced opening-containing section of the body. Reinforcement is embedded in the body within the reinforced opening-containing section. The reinforcement includes a series of annular ringlets each formed of a few tightly wound helical turns. The ringlets can be non-interconnected, or interconnected by a helical connecting part by forming the ringlets and connecting parts from a continuous wire. The drainage openings are disposed in spaces formed between successive ringlets.

Abstract: A medical shaft or tubing includes an elongate tubular member having a proximal end and a distal end. The shaft also includes a tubular wall extending between the proximal and distal ends to define a first lumen. The elongated tubular member further comprises a second lumen extending through at least a portion of the tubular member. The tubular wall additionally includes a reinforcing element that surrounds at least a portion of the first lumen and that surrounds and overlaps at least a portion of the second lumen.

Abstract: Steerable electrophysiology catheters for use in mapping and/or ablation of accessory pathways in myocardial tissue of the heart wall and methods of use thereof are disclosed. The catheter comprises a catheter body and handle, the catheter body having a proximal section and a distal section and manipulators that enable the deflection of a distal segment of the distal tip section with respect to the independently formed curvature of a proximal segment of the distal tip section through a bending or knuckle motion of an intermediate segment between the proximal and distal segments. A wide angular range of deflection within a very small curve or bend radius in the intermediate segment is obtained. At least one distal tip electrode is preferably confined to the distal segment which can have a straight axis extending distally from the intermediate segment. The curvature of the proximal segment and the bending angle of the intermediate segment are independently selectable.

Abstract: The catheter assembly comprises a tubular body having a proximal end and a distal end and a thermoresponsive distal tip portion fixed to the distal end of the catheter.

Abstract: A sheath is composed of a biocompatible material which has a stiffness and moldability such that it can easily be deformed by hand by the physician prior to implantation, or by means of a guiding or shaping tool such as the dilator, stylet and or guide wire during placement within the body cavity. Similarly, it has a suppleness such that it may be molded by its disposition within the body cavity without trauma to the tissues. Yet, it has sufficient stiffness and moldability such that it retains a shape which has been imparted to it by a shaping tool when in the body cavity, even when left unsupported or unconfined in a body cavity or subject to normal bodily fluid, blood or air flow. However, once the shaping or forming tool has been removed, the sheath will tend to stay in its molded shape in a body cavity without generating a resilient force or displacement which returns it to its original shape.

Abstract: A medical device (110) including a catheter shaft (111) and a unitarily and continuously formed portion (108) having a varying durometer, and optionally including an expandable balloon (18, 118). One or both of the unitarily and continuously formed portion (108) and the balloon (18, 118) are made from an irradiation cross-linked or cross-linkable mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The aromatic molecule can be 1,3,5 triethyl benzene; 1,2,4 triethyl benzene; and 1,3,5 triisopropyl benzene. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein.

Abstract: A guiding catheter for use in coronary angioplasty and other cardiovascular interventions which incorporates a plurality of segment of selected flexural modulus in the shaft of the device. The segments which have a different flexibility than the sections immediately proximal and distal to them, creating zones in the catheter shaft which are either more or less flexible than other zones of the shaft. The flexibility and length of the shaft in a given zone is then matched to its clinical function and role. A mid-shaft zone is significantly softer than a proximal shaft or distal secondary curve to better traverse the aortic arch shape without storing too much energy. A secondary zone section is designed to have maximum stiffness to provide optimum backup support and stability.

Abstract: A steerable catheter having a shaft with one or more internal stiffeners coextruded within the shaft along a portion of its length. The internal stiffeners have a higher or lower hardness than the body of the catheter shaft. The overall stiffness of the shaft varies along its length for improved steerability.

Abstract: A catheter device having an elongated tubular member with a proximal end and a distal end, and a needle disposed near the distal end. In one embodiment, the needle has a rigid, penetrating tip coupled to a flexible portion by an overlapping joint. The flexible portion enables the needle to bend to a penetrating angle relative to the distal end of the elongated tubular member and penetrate a body tissue without kinking.

Abstract: A guiding catheter for use in coronary angioplasty and other cardiovascular interventions which incorporates a plurality of segment of selected flexural modulus in the shaft of the device. The segments which have a different flexibility than the sections immediately proximal and distal to them, creating zones in the catheter shaft which are either more or less flexible than other zones of the shaft. The flexibility and length of the shaft in a given zone is then matched to its clinical function and role. A mid-shaft zone is significantly softer than a proximal shaft or distal secondary curve to better traverse the aortic arch shape without storing too much energy. A secondary zone section is designed to have maximum stiffness to provide optimum backup support and stability.

Abstract: An improved catheter system having an ultrasonic imaging transducer coupled to a drive cable disposed within a lumen of a flexible tubular catheter body. An improvement including a reconfiguration of the ferrites in the hub assembly, such that the need for the gap between the ferrites is removed. A strain relief member is provide to increase the strength of the electrical transmission lines to enable them to withstand the tensile forces caused by either flushing and/or pull-back operations. A device which allows the electrical transmission lines to extend their length when placed in tension may also be employed to provide strain relief to the electrical transmission lines. Another improvement includes a counter-wound coil structure, which may either expand or contract as the drive cable is being rotated to strengthen the drive cable. The distal tip of the catheter body may be redesigned to provide a lumen which allows for the release of flushing fluids through a distal port in the guidewire lumen.

Abstract: An endoscope comprising a control section and a shaft extending from the control section. The shaft has a frame with a one-piece tube along a majority of a length of the shaft. The tube comprises a superelastic alloy and slots into the tube along at least one-section of the tube. Superelastic properties of the superelastic alloy allow the tube to bend proximate the slots without substantial permanent deformation of the tube. The superelastic alloy provides the shaft with adequate stiffness and torque resistance to be inserted into a patient's body.

Abstract: A delivery apparatus for self-expanding stents may be utilized to safely deliver stents to a target site. The apparatus has an outer sheath forming an elongated tubular member having distal and proximal ends and an inside and outside diameter. The apparatus also includes an inner shaft located coaxially within the outer sheath. The inner shaft has a distal end, a proximal end and a longitudinal axis extending therebetween. At least a portion of the inner shaft is made from a flexible coiled member. The shaft preferably includes a stop attached thereto, the stop being proximal to the distal end of the sheath. Lastly, the apparatus includes a self-expanding stent located within the outer sheath, wherein the stent makes frictional contact with the outer sheath and the shaft is disposed coaxially within a lumen of the stent. During deployment of the stent, the stent makes contact with the stop.

Abstract: A catheter having a mandrel secured to the catheter or constrained within a dedicated lumen. In one embodiment, the catheter has an inner tubular member and an outer tubular member with a sidewall configured to define a mandrel lumen longitudinally along an inner surface of the outer tubular member or along an outer surface of the inner tubular member. The mandrel lumen may be configured to allow the mandrel to be exchanged to adjust the handling characteristics of the catheter. The mandrel may occupy an intermediate portion of the catheter shaft, or may extend from the proximal end to within proximal or distal shaft sections of the catheter. In coronary artery applications, the mandrel is configured to support the catheter as it bends through the aortic arch and enters the coronary artery.

Abstract: A catheter system includes a catheter having a proximal end, a distal end, and a lumen extending therein. An elongate mender slidably disposed in the lumen has a distal end located proximate the distal end of the catheter. An administering tip is disposed at the distal end of the catheter and is configured to express a bolus of liquid in response to positive pressure in a distal portion of the lumen created by movement of the elongate member distally in the lumen. The present invention also includes a method of administering a liquid to a treatment site. The distal end of the catheter is transluminally positioned proximate the treatment site. The catheter is charged by placing a bolus of the liquid in a distal end of the lumen between a distal tip of the catheter and a distal end of the elongate member. The elongate member is then moved distally within the lumen to express the bolus from the distal end of the catheter.