Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-08-31
2001-04-10
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06213995
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates broadly to flexible polymer tubing having braided elements. This invention particularly relates to tubing having braided elements capable of carrying an electrical and/or optical signal.
2. State of the Art
Catheters are generally elongate flexible tubular devices intended to be inserted into body vessels, such as through the vascular system. It is well known to imbed wires in the wall of a catheter in order to impart torsional stiffness and kink resistance to the catheter, and structural rigidity sufficient to maintain an open lumen within the catheter. In addition, particular cardiovascular electrode catheters are used to electrically stimulate and/or monitor the heart, and in some cases, to modify the heart tissue. These catheters are provided with a signal transmitting element, e.g., a conductive element, extending a length of the catheter.
For example, U.S. Pat. No. 5,057,092 to Webster, Jr. discloses a catheter having a polymeric inner wall defining a central lumen for the passage of fluids or a guidewire therethrough, a reinforcing non-conductive braided mesh around the inner wall, and another polymeric outer wall about the braided mesh. Electrodes are provided at the distal end of the catheter, and a plurality of conductive wires extend the length of the catheter, coupled at their distal ends to the electrodes and couplable at their proximal ends to an electrostimulator or recorder. In one embodiment, the uninsulated conductive wires are built into the braided mesh. To prevent a short circuit, Webster, Jr. teaches that the conductive wires must run parallel within the braid, and not cross each other. As such, Webster, Jr. teaches that the conductive wires should be non-insulated and non-overlapping.
U.S. Pat. No. 5,630,806 to Inagaki et al. discloses a catheter having a inner layer defining a lumen, a spiral wound radiopaque reinforcement layer having one or more like spiral wound elements, each of which does not cross itself or overlap another. In one embodiment, the spiral wound elements are uninsulated conductors which permit the reinforcement layer to conduct signals as well as provide reinforcement. However, having the same elements function as both conductors and reinforcements is not particularly desirable as elements which provide the desired conductivity may not provide the desired reinforcement, and elements which provide the desired reinforcement may not provide the desired conductivity.
U.S. Pat. No. 5,591,142 to Van Erp discloses a catheter having a reinforcement braid made exclusively of like electrically conductive wires. The braid is located between two tubular layers of the catheter. The wires of the braid are separately insulated and grouped into at least two bundles which are then woven together, i.e., crisscrossed, about an inner layer of the catheter. Each of the wires of the braid can function as a conductor, and may be color coded to facilitate identifying the proximal and distal ends of particular conductors for coupling to sensor devices. However, such a design is limiting in that electrically conductive wires may not provide the most satisfactory reinforcement for a particular catheter. For example, in some situations, as recognized by U.S. Pat. No. 5,057,092 to Webster, Jr., discussed above, non-conductive braid elements may provide structural advantage for manipulating the catheter.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide a flexible tubing having the capability of transmitting signals along its length and which also has desirable structural properties.
It is another object of the invention to provide a biocompatible medical-grade tubing for use in an electrode catheter.
It is a further object of the invention to provide a method of manufacturing tubing for use in an electrode catheter.
In accord with these objects, which will be discussed in detail below, a flexible preferably medical-grade tubing is provided which includes a wall made from a preferably biocompatible material and a plurality of braided elements forming a braid within the wall of the tube. The braided elements include one or more signal transmitting elements, and one or more metallic or non-metallic structural elements having structural properties different from the signal transmitting elements.
The biocompatible material is preferably a cross-link bonding polymer, and most preferably a polyimide matrix. In manufacture of the tubing, one or more layers of the polymer are coated on a mandrel and permitted to cure to form an inner layer of the tubing. The braid is then woven about the inner layer. Then, one or more layers of the polymer are coated over the braid and inner layer and permitted to cure to form an outer layer of the tubing which preferably forms a cross-linked and adhesion bond to the inner layer and provides a relatively homogenous structure. According to one preferred, but optional, aspect of the invention, one or more layers of the resin of the inner layer and/or the outer layer of the tubing is formed of a cross-linking polymer provided with polytetrafluoroethylene (PTFE) particles suspended therein such that the inner surface of the lumen, and/or the outer surface of the tubing, is lubricous. Furthermore, optionally, one or more layers of the resin of the tubing is formed of a cross-linking polymer provided with radiopaque, antimicrobial, antifungal, and/or antithrombotic particles suspended therein
In one embodiment, the signal transmitting elements are conductive wires, e.g., a sensor conductor or thermocouple, which are electrically insulated. In another embodiment, the signal transmitting elements are optical fibers. Additionally, both conductive wires and optical fibers may be provided within the braid of the tubing. The structural elements are chosen to provide a degree of torsional stiffness, kink resistance, and/or luminal rigidity to the tubing which is different than would otherwise be provided solely with the signal transmitting elements. Each of the braid elements may have circular, non-circular, or substantially flat cross-sectional shapes.
With the above embodiments, the flexible tubing of the invention is particularly adapted for use in an electrode catheter, yet is versatile and capable of being used in other devices which require a relatively smaller diameter flexible tubing capable of transmitting a signal.
Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.
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Daniel Stevie
Steen Brett
Gallagher Thomas A
Gordon David P.
Jacobson David S.
Kennedy Sharon
Phelps Dodge High Performance Conductors of SC and GA, Inc.
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