Axially activated hemostasis valve with lumen size selection

Details Axially activated hemostasis valve with lumen size selection Axially activated hemostasis valve with lumen size selection

1999-10-22

2002-10-01

Casler, Brian L. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S167010, C604S165020, C604S246000

Reexamination Certificate

active

06458103

ABSTRACT:

FIELD OF THE INVENTION
The present invention generally relates to the field of minimally invasive medicine. More particularly, the present invention relates to those devices, commonly known as y-adapters, which are used to prevent blood from exiting a patient during a minimally invasive procedure. Such procedures include but are not limited to angioplasty, atherectomy, stenting, angiography, venous filtration, liquid infusion, dialysis, and intravascular ultrasound. Those skilled in the art will recognize the benefits of applying the present invention to similar fields not discussed herein.
BACKGROUND OF THE INVENTION
Angioplasty has gained wide acceptance in recent years as an efficient and effective method for treating various types of vascular diseases. In particular, angioplasty is widely used for opening stenoses in the coronary arteries, although it is also used for treatment of stenoses in other parts of the vascular system. The most widely used form of angioplasty makes use of a guide catheter positioned within the vascular system of a patient. The distal end of the guide catheter is inserted into an introducer sheath which is then inserted into the femoral artery located in the groin of the patient and pushed distally up through the vascular system until the distal end of the guide catheter is located in the ostium of the coronary artery. The distal end of the guide catheter is normally curved so that the distal tip of the guide catheter is more easily directed to the coronary ostium of the patient. Typically, a Y-adapter assembly is releasably secured to the proximal end of the guide catheter. The proximal end of the guide catheter and the Y-adapter protrude outside the patient's body. The Y-adapter provides an entryway for subsequent insertion of additional angioplasty devices into the patient's vascular system through the guide catheter. Prior art Y-adapters typically includes a main body portion that is secured at its distal end to the guide catheter via a luer fitting. The Y-adapter further includes a side branch that defines an infusion port. The main body portion of the Y-adapter is configured to receive a dilatation balloon catheter.
The proximal end of the side branch and the main body portion typically include valves which are known as Tuohy-Borst valves. Tuohy-Borst valves are seals that minimize back-bleeding during the minimally invasive procedure. Each Tuohy-Borst seal includes a gasket having a through lumen and a threadably attached cap. The through lumen is configured to receive a shaft of a dilatation catheter or other minimally invasive device. The cap can be rotatably tightened to compress the gasket and thereby decrease the diameter of the through lumen to form a fluid tight seal about the shaft of the dilatation catheter. However, if the cap of the Tuohy-Borst seal is tightened too much, the dilatation catheter may be damaged or the flow of inflation fluid through the catheter may be restricted so as to make inflation of the balloon of the dilatation catheter difficult. On the other hand, tightening the cap too little may allow back-bleeding through the proximal ends of the side branch and the main body portion of the Y-adapter.
There is a continuing need for improved hemostasis and Y-adapters. Specifically, there is a need for a Y-adapter of efficient design which incorporates a valve member that provides an effective releasable seal about the shaft of a dilatation catheter and provides simplified physician use. The valve member would preferably provide a fluid tight seal about the dilatation catheter to prevent back-bleeding, while minimizing damage to the catheter. In addition, the seal formed by the vale member would not restrict the flow of inflation fluid through the dilatation catheter. It would also be advantageous to provide a valve member which may selectively seal about certain diameter devices while at the same time providing visual feedback as to diameter.


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