Abstract: A system for controlling delivery of a physiological fluid internally to a patient from a balloon catheter. The system includes a controller, an inflation-fluid pressurizer for maintaining inflation fluid in an inflation-fluid conduit under pressure, and a physiological-fluid pressurizer for maintaining physiological fluid in a physiological-fluid conduit under pressure. The inflation-fluid pressurizer is connected to receive signals from the controller to cycle pressure in the inflation-fluid conduit between a balloon inflating pressure and a balloon deflating pressure. The physiological-fluid pressurizer is connected to receive signals from the controller to cycle pressure in the physiological-fluid conduit between a fluid delivery pressure and a resting pressure. The controller is programmed to synchronize signals to the inflation-fluid pressurizer with signals to the physiological-fluid pressurizer.

Abstract: A medical device for creating images of tissue within a body includes a disposable liquid-confining sheath supporting an elongate flexible drive shaft which carries an imaging device such as a ultrasound transducer. The device may include a trocar adapted to receive the sheath, the trocar permitting the device to be inserted into the body where no natural passageway exists, the trocar having a side-facing region adapted to maintain registry with the imaging device while the imaging device rotates. In another embodiment, the drive shaft includes an outer coil that is configured such that when the drive shaft is driven in the direction tending to decrease the diameter of the outer coil, the outer surface of the outer coil pressurizes liquid distally of the outer surface. The device optionally includes an inflatable balloon.

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: The device comprises a prosthesis designed as a hollow body compressed against the action of restoring spring forces to a cross section reduced relative to an expanded use position, and held in this position by a strippable sheath. After the sheath is stripped, the prosthesis automatically expands to a cross section corresponding to the use position. The sheath, which can be a meshwork in the approximate form of crocheted material, extends over the entire length of the prosthesis and consists of at least one continuous thread and at least one drawstring. The prosthesis, held in the radially compressed position by the sheath, can be mounted displacebly on a feed wire or non-axially-displacebly on the insertion end of a probe or a catheter.

Abstract: A method of forming a balloon for medical purposes comprising co-extruding in a tubular shape a base structural layer of a member selected from the group consisting oft polyamides, polycarbonates, polyesters and copolymers thereof and a heat sealable layer selected from the group consisting of polyethylene and copolymers thereof. The tubular member is then biaxially oriented by inflating the tube with a gas to a predetermined central diameter greater then the initial diameter of the tube and simultaneously heating the inflated tube to a temperature sufficient to biaxially orient the base structural layer. The member is then cooled the inflated tubular member and then elevated in temperature for a second time to the biaxially orienting temperature. The twice-heated tube is allowed to cool and the gas is withdrawn whereby the tubular member will assume a generally tubular shape and the main structural layer will remain biaxially orientated and the heat sealable layer will not be biaxially orientated.

Abstract: In an embodiment, a slit valve catheter has a generally tubular catheter body with an exterior surface exposed to an environment and an interior surface defining a lumen. The catheter further includes a valve which has a protuberance projecting radially from the catheter body.

Abstract: Rotating element catheters and catheter assemblies employ clutch assemblies for preventing rotational energy from being transmitted from a motor drive unit to the catheter element under defined circumstances. The catheter assembly includes an elongate member in which there is disposed a rotatable catheter drive cable. The catheter drive cable may have an operative element, e.g., an ultrasonic transducer or an artherectomy blade, distally mounted thereon for providing diagnostic or therapeutic functions to the physician. To control the rotation of the catheter drive shaft, the clutch assembly is configured such that the catheter drive shaft is operated in a drive mode (i.e., it is allowed to rotate) and in a release mode (i.e., it is prevented from rotating).

Abstract: A medical device, such as a stent or balloon of a balloon catheter which includes a body portion which has an exterior surface which contacts, at least in part, a vessel wall during treatment. The body portion is expandable from a first position, wherein the body portion is sized for insertion into the vessel lumen, to a second position, wherein at least a portion of the exterior surface is in contact with the lumen wall. The medical device includes a first coating disposed over at least a portion of the exterior surface of the body portion with the first coating including a drug or therapeutic substance which is intended for controlled release from the surface. The medical device further includes a second coating overlying at least a substantial portion of the first coating. The second coating includes a material that is generally impervious to elution of the drug or therapeutic substance therethrough when the body portion is in a first position when inserted into the vessel lumen.

Abstract: Implements, particularly medical instruments, formed at least in part of elongated polymer members, exhibit high torque fidelity after processing with tension, heat, and twisting. The processing orients the polymer in generally helical paths so that torque imposed at the proximal end can be transmitted to the distal end without substantial whipping, even if the implement follows a long and tortuous pathway. Applications include medical guidewires, catheters, and driveshafts.

Abstract: In an embodiment, a slit valve catheter has a generally tubular catheter body with an exterior surface exposed to an environment and an interior surface defining a lumen. The catheter further includes a valve which has a protuberance projecting radially from the catheter body.

Abstract: An intraluminal prosthesis for intraluminal repair of body conduits, especially aortic aneurysms, is disclosed. The prosthesis includes a generally tubular, flexible graft (20) having a proximal open end (30) and at least one distal open end (31) terminating in a hem (33). A stent (21) can be disposed within the proximal open end (30) and is adapted to be attached to the body conduit (1). The hem (33) is inverted within the graft so that it is disposed as a cuff (34) within the graft. The hem (33) is arranged so that upon withdrawing the distal open end (31) from inside the cuff (34), the cuff will unfold and follow the distal open end to expose it to receive another stent for attachment to the body conduit (12) for intraluminal implantation of the graft. Preferably the hem is folded a second time within the cuff to form a second cuff (35) within the graft. The stents are preferably formed of a plexus of wires adapted to expand from a first narrow diameter to a second diameter to engage the body conduit.

Abstract: Treating a site within the body by, e.g., placing an endoprosthesis into the body, with a catheter having a proximal portion remaining outside the body and a shaft for positioning inside the body. The shaft includes in a distal portion a selectively expandable member which can be expanded from a small cross-sectional profile for receiving said endoprosthesis about said expandable member in a compact configuration and a large, expanded cross-sectional profile for expanding said prosthesis during placement into the body, and an elastic strip wrapped in helical fashion about said expandable member such that the strip is stretched when said expandable member is expanded to said large cross-sectional profile.

Abstract: A stent includes a main body of a generally tubular shape for insertion into a lumen of a vessel of a living being. The tubular main body includes a substantially biodegradable matrix having collagen IV and laminin that enclose voids within the matrix. The tubular main body also includes a biodegradable strengthening material in contact with the matrix to strengthen the matrix. The tubular main body is essentially saturated with drugs.

Abstract: Rotating element catheters and catheter assemblies employ clutch assemblies for preventing rotational energy from being transmitted from a motor drive unit to the catheter element under defined circumstances. The catheter assembly includes an elongate member in which there is disposed a rotatable catheter drive cable. The catheter drive cable may have an operative element, e.g., an ultrasonic transducer or an artherectomy blade, distally mounted thereon for providing diagnostic or therapeutic functions to the physician. To control the rotation of the catheter drive shaft, the clutch assembly is configured such that the catheter drive shaft is operated in a drive mode (i.e., it is allowed to rotate) and in a release mode (i.e., it is prevented from rotating).

Abstract: Apparatus and a method for treating an irregularity in a wall of a vessel of a patient defined by an irregular or afflicted wall portion with adjacent normal wall portions comprises a catheter having a distal end portion for being guided through the vessel to the site of the irregularity. A balloon associated with said distal end portion of the catheter for selective inflating to contact the walls of the vessel urges a stent carried by the distal end portion of the catheter in a constricted condition for passage through the vessel into an expanded form with the stent spanning the afflicted wall portion and contacting the adjacent wall portions. The catheter is formed with lumens for inflating the balloon, for receiving a guidewire for guiding the catheter through the vessel, and for connecting a port in the catheter proximate the afflicted wall portion to enable delivery of a therapeutic agent into the vessel to contact the stent and the irregular wall portion.

Abstract: A vascular filter comprises an emboli-capturing portion having a set of helical filter-wires joined at a central region and extending in a given direction along the blood vessel in a diverging relationship to the axis of the filter, the wires terminating in free ends constructed to engage the walls of said vessel. A major mid-portion of the length of the free ended wires are of generally helical form, cooperatively related to form an effective emboli capturing array. Anchoring is accomplished by a separate assembly formed of struts and anchoring devices. A parallelogram supporting strut assembly and other means for providing linear engagement with the wall of the vena cava are shown. The parallelogram structure is shown to have filter capability by itself as well.

Abstract: Shaped-medical devices, e.g. stents, having improved mechanical properties and structural integrity are disclosed. The devices comprise shaped polymeric hydrogels which are both ionically and non-ionically crosslinked and which exhibit improved structural integrity after selective removal of the crosslinking ions. Process for making such devices are also disclosed wherein an ionically crosslinkable polymer is both ionically and non-ionically crosslinked to form a shaped medical device. When implanted in the body, selective in-vivo stripping of the crosslinking ions produces a softer, more flexible implant having improved structural integrity.

Abstract: A sheath for use with an interventional device for tissue spectroscopy within a body includes a substantially cylindrical, flexible body having an open proximal end and a closed distal end. The flexible body securely receives interventional device via an interference fit. At least the distal end of the flexible body is formed of a material substantially transmissive of at least one of ultraviolet or visible light. For example, the material can be a polymeric materials such as polyurethane, polyethylene or polystyrene. The sheath can be disposable.

Abstract: A delivery system for delivery and deployment of devices having abrading portions within a patient's lumen. A lumen in a flexible catheter that extends proximally from a distal end of the catheter receives the device in a compact form. At least one impervious segment positioned in the lumen overlies the abrading portions of the device to shield and buffer the surface of the lumen from the abrading portions. The segment is of a relatively short length so that the catheter remains relatively flexible therealong to enable relative ease in the transit of the catheter through the patient's lumen to a delivery site. Additional segments may be disposed in the catheter distally of the segment or the segment may move with the device to the distal end to buffer the walls of the catheter during the deployment of the device. Additional segments mate with the segment so that engaged ones of the segments are relatively radial deflectable.

Abstract: A welding method for improving the durability and strength of fusion weld joints in metal structures; the method is especially beneficial for metal structures fabricated from nickel-titanium alloy (nitinol) and for medical devices.