Danforth Biomedical, Inc.

Jeff L Kraus

Michael J Horzewski

John W Danforth

Hugh R Sharkey

Robert D Lashinski

Nitin P Matani

Joseph R Shields

An elongated rod terminating in an abutment device with a lumen for passage of a guidewire is used to push an angioplasty balloon along the guidewire and through a vasculature to a location where treatment is needed. The balloon is fed by an inflation tube which remains independent of the guidewire and need not have axial rigidity. This combination of components permits one to exchange balloons without the need for a guidewire extending 100 cm or more outside the patient's body. Guidewire exchanges are also possible in cetain embodiments of the concept, and possibilities for perfusion are also presented. The guidewire passes through a tube inside the balloon which can also be used for perfusion of the patient's blood when the guidewire is withdrawn.

Catheter system with push rod for advancement of balloon along guidewire

A proximal adaptor for an over-the-wire angioplasty catheter is disclosed which contains a retractable catheter slitting element and a releasable guidewire seizing element, both of which are controllable by a manually operated element or elements accessible from the exterior of the adaptor.

Catheter adaptor with slitting blade and improved manual control and

An elongated rod terminating in an abutment device with a lumen for passage of a guidewire is used to push an angioplasty balloon along the guidewire and through a vasculature to a location where treatment is needed. The balloon is fed by an inflation tube which remains independent of the guidewire and need not have axial rigidity. This combination of components permits one to exchange balloons without the need for a guidewire extending 100 cm or more outside the patient's body. Guidewire exchanges are also possible in certain embodiments of the concept, and possibilities for perfusion are also presented. The guidewire passes through a tube inside the balloon which can also be used for perfusion of the patient's blood when the guidewire is withdrawn.

A seal for a medical device such as a catheter is formed between two parts of the device which are capable of movement relative to each other, either axially, rotationally or both. The seal is formed by opposing sealing surfaces on each of the two parts, the surfaces being sufficiently smooth and of sufficiently close proximity that liquids having viscosities on the order of those normally used in catheters will not pass between the surfaces due to such effects as surface tension and friction. In certain embodiments, the surfaces are arranged to permit liquid to pass at a controlled rate for purposes of perfusion when desired, or the surfaces can be moved relative to one another to achieve this capability.

Low profile high performance interventional catheters

A radially expandable intravascular medical device is disclosed. The device typically includes two members. The first member is an outer tube-shaped sheath which is radially expandable by being formed from elastic material or other means and having relatively low column strength. The second member is an inner portion extending throughout the outer tube. This inner portion includes a slit to allow it to expand radially as well. Using the structure diagnostic, therapeutic, or other desired objects may be conveyed through the device yet still enable the device to have a smaller cross-sectional area throughout most of its length than the object conveyed therethrough.

Radially-expandable tubular elements for use in the construction of

The inner tubular element of an annular over-the-wire dilatation balloon catheter defines the guidewire lumen extending through the catheter shaft and the balloon and is bonded to the balloon at the distal opening of the balloon. In accordance with the invention, the inner tubular element is constructed in two segments. The proximal segment is constructed of a polymer such as polyethylene which has a lubricious surface, while the distal segment is constructed of a polymer such as nylon, polyurethane, or a nylon/polyurethane blend, which lacks lubricity but forms a secure bond with the balloon at the distal opening. The bond by which the proximal and distal segments are joined is thus removed from the distal balloon opening, and accordingly less susceptible to failure upon pressurization of the balloon.

Lubricious yet bondable catheter channel sleeve for over-the-wire

An exchangeable catheter-guidewire system is disclosed in which the guidewire can be manipulated to seize and to release itself from the catheter body while both are in place in a vasculature or other body vessel. For balloon dilatation catheters, this arrangement permits one to transmit the fluid used for perfusion and/or balloon inflation through the same lumen through which the guidewire passes. Balloon catheters which utilize the invention have the capacity to secure the position of the guidewire relative to the catheter body, as well as to seal the lumen and balloon to retain fluid under pressure, both by remote control from the proximal end of the catheter. The seizure and sealing are achieved by a deformable section on the guidewire, which expands upon deformation to seize a tubular section of the catheter body. Two examples of deformation are given, the first occurring with a deformable section which is sufficiently flexible to gather into folds upon longitudinal compression, the folds being bulky enough to expand outward, and the second occurring with a deformable section which is inflatable. In either case, the guidewire in preferred embodiments is constructed as a hollow tube with a central rod which in both cases serves to enhance the longitudinal strength of the guidewire and, in the first case, also serves as a means of compressing and re-extending the deformable section of the tube. Either mechanism permits the construction of an exchangeable catheter system with the crossing profile of non-exchangeable systems.

Guidewire with reversible contact seal for releasable securement to

Low profile, high performance interventional catheters

A dilatation balloon catheter with a non-removable guidewire is disclosed in which the guidewire is joined to the catheter tube through a distortable element, preferably a twistable tube. The element provides a strong fluid-tight connection between the guidewire and catheter tube and yet permits the guidewire to be rotated relative to the catheter tube over a wide range of rotation, with little torsional stress on either the catheter tube, the balloon or any other element of the catheter construction. In preferred embodiments, the catheter construction further includes a column support tube inside the balloon, surrounding a segment of the guidewire toward its distal end, to prevent collapse of the balloon along its longitudinal axis as the balloon is advanced into a stenosis. In these embodiments, the distortable element is joined to the catheter tube through the column support tube which thus serves as an intermediate linkage.

Highly steerable dilatation balloon catheter system

A catheter, having a substantially fluid-tight seal is provided. The seal can be used in a number of catheters, including an angioplasty catheter. The seal includes surfaces that are independently movable relative to one another. The effectiveness of the seal depends on the proximity of the surfaces, the surface are at the interface, pressure differential and viscosity of the fluid. The seal is used in connection with providing fluid-tight channels with surfaces that are relatively movable and to circumvent the need to separate hydraulic channels from other channels so that catheters can be provided with fewer channels. Further, catheters and catheter systems with smaller shaft dimensions or larger hydraulic channel dimensions is made possible. Balloon catheters using this seal have enhanced torque delivery and directional control.

An angioplasty catheter system is disclosed which allows insertion and removal of a guidewire through the inner member of the catheter, yet which inner member includes a portion which is smaller than the cross-section of portions of the guidewire. Advancement and removal of the guidewire are achieved by forming the first portion of the inner member of the catheter shaft from material which is expandable, or which is sufficiently thin to be folded and temporarily secured in place using several techniques.

Angioplasty dilatation balloon catheter/guidewire system

A dilatation balloon catheter is disclosed with an inelastic balloon wrapped about a smaller section of a guidewire. During introduction across a region of a stenosis, the balloon is wrapped around a guidewire in such a way that the guidewire contained therein can rotated freely, but cannot advance independently of the balloon. The wrapped configuration is maintained by means of a temporary bond. Inflation of the balloon, following proper positioning of the catheter breaks the bond, permitting the balloon to unwrap from the guidewire contained therein. Typically, the distal end of the guidewire is tapered and the guide wire is controllably clamped to the catheter for advancement into the patient.

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San Jose, CA, United States of America

Jeff L Kraus