Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1996-08-12
1998-05-12
Buiz, Michael
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604 96, A61M 3100
Patent
active
057498490
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The invention is in the general field of surgical devices and relates specifically to an improved single lumen valved balloon catheter structure that may be used with a guidewire to access target sites through tortuous, small diameter vessels with less likelihood of kinking or other malfunction.
BACKGROUND
Catheters are hollow tubes that are inserted through the vasculature or other internal body passageways to access a particular internal body site for various diagnostic or therapeutic purposes. Angiography catheters are used to deliver radiopaque agents to a target site to enable radiographic visualization of the site. In the treatment of localized diseases such as solid tumors, catheters are used to administer chemotherapeutic agents or vasoocclusive agents. Catheters are similarly used to deliver vasoocclusive devices (e.g. coils) to site of aneurysm. Inflatable catheters, often referred to as balloon catheters, are used to dilate vessels. These catheters have a distal balloon that is inflated once the target site in a vessel is reached by the distal end of the catheter.
There are three general types of balloon catheters: a double lumen type, a valved single lumen type and a single lumen, non-movable wire type. The double lumen type has concentric inner and outer lumens with the balloon being part of the outer lumen. A guidewire is extended through the inner lumen.
In the single lumen valved type, a guidewire carries a distal valve member that can be moved by axial manipulation of the guidewire to block the distal opening of the catheter. U.S. Pat. No. 4,813,934 describes several embodiments of single lumen valved catheters. Designs in which the valve is located within the catheter lumen at the distal end of the balloon as well as designs in which the valve is located exteriorly of the lumen are shown in the patent. U.S. Pat. No. 5,171,221 describes a single lumen valved balloon catheter assembly with an exteriorly located valve wherein the guidewire is axially moveable within the lumen of the catheter and has a proximal segment with a larger diameter than the distal segment. The tip portion of the catheter tube distal segment, distal to the balloon contains a soft, elastic insert that conforms to the configuration of the valve member on the guidewire such that when the valve member is pulled back against the tip, the distal opening of the catheter is blocked and the balloon can be inflated.
The present invention involves a balloon catheter that has a variable stiffness shaft that can be better advanced into distal vessels due to better trackability and proximal pushability than prior designs.
Catheters with variable stiffness shafts have been described for insertion through tortuous small vessels such as those found in the peripheral vasculature or organs such as the brain and liver. Such catheters are commonly used in combination with a flexible torqueable guidewire. In this procedure, the guidewire is advanced through the vessel and the catheter is threaded over the guidewire. At tortuous sites in the vessel, the assembly is advanced by alternately guiding the wire through the site and then threading the catheter over the advanced segment of the wire. In order to be useful in such applications, the catheter must meet demanding physical requirements so that it does not become locked against the guidewire or become kinked as it is passed through particularly tortuous segments of the vessel. In this regard, U.S. Pat. No. 4,739,768 describes a catheter with a variable stiffness shaft specifically designed to overcome problems associated with accessing tortuous, small vessels.
The specific catheter embodiments shown in U.S. Pat. No. 4,739,768 consist of coaxial assemblies of two tubes, one of which is relatively long and stiff and defines a proximal portion of the catheter and the other of which is relatively short and flexible and defines the distal end of the catheter. The flexible distal end allows the catheter to be advanced axially over sharper and/or more frequent wire bends wit
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Buiz Michael
Target Therapeutics Inc.
Truong Kevin
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