Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-01-29
2001-04-24
Yasko, John D. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S537000
Reexamination Certificate
active
06221057
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to hemostasis valves used in diagnostic, therapeutic and interventional vascular procedures, and more particularly to the sealing mechanisms in such devices and to related systems, including those for flushing.
BACKGROUND OF THE INVENTION
Hemostasis valves (also sometimes referred to as “Y-connectors” and “Touhy-Borst valves”) are commonly used in certain medical procedures. A guide catheter is connected to the distal end of the valve, and an operating instrument, such as a guide wire or balloon catheter, is inserted into the proximal end and through the guide catheter to the desired location in the patient. After the operating instrument is in place, the valve is closed to keep blood from leaking out of the patient (“hemostasis”).
One of the problems with current hemostasis valves is that they are cumbersome to operate, taking a long time to open and close. Most employ a Touhy-Borst sealing mechanism such as that described in U.S. Pat. No. 4,886,507. A threaded cap deforms an O-ring into a tapered opening until the O-ring clamps down on the operating instrument. Each time the operating instrument is adjusted, the cap must be unthreaded before and then rethreaded after the manipulation. During the time that the valve is open, blood leaks from the patient and/or contrast media is lost. Inaccurate blood pressure readings also occur. There is also a risk of air emboli when the valve is open, particularly when removing the operating instrument.
Another problem with prior art hemostasis valves, such as Touhy-Borst valves, is that significant mechanical force must be applied to the operating instrument in order to maintain the seal. This is particularly a problem at higher system pressures, and when pressure spikes occur, such as when flushing the system with saline or introducing contrast media. The often delicate drive shaft of the operating instrument can be crushed by the force of the seal. The high force seal also prevents moving the operating instrument while the valve is closed.
One attempt at addressing some of these problems is shown in the '507 patent. In addition to a Touhy-Borst, this design includes a membrane having a fixed circular opening for sealing shafts within a certain diameter range. This sealing arrangement, however, still relies solely on a mechanical sealing system which requires high shaft forces at high system pressures. It also incorporates the same threaded Touhy-Borst valve, which requires the cap to be manually threaded in order to close the valve. The fixed opening membrane would also be helpful only with operating instruments in a particular diameter range.
Hemostasis systems typically have a perfusion port used to flush the system with saline in order to prevent blood clots from being formed. This is done by a technician periodically during the procedure, which takes time and may interrupt the procedure. The blood pressure readings are also inaccurate during the flush.
What has been needed is a hemostasis valve which opens and closes easier, maintains a seal at higher pressures without damaging the instrument, and permits movement of the instrument while maintaining a seal. What has also been needed is a hemostasis system which reduces or eliminates the need for periodic flushing. What has also been needed is a hemostasis assembly which reduces blood loss and the risk of air emboli while the valve is open.
SUMMARY OF THE INVENTION
According to the present invention, a hemostasis valve, system and assembly are provided. The inventions can be used in a variety of diagnostic, therapeutic and interventional procedures, including angiography, angioplasty, stent placement, drug infusion, intravascular ultrasound, rotablation, and atherectomy.
In one aspect of the invention, a hemostasis valve comprises a valve body having a proximal end for receiving an operating device, a distal end for connection to a guide catheter, and a through-lumen in the valve body intermediate the proximal and distal ends. The operating device is inserted through the through-lumen and into the guide catheter. A chamber in the valve body surrounds the through-lumen and is filled with fluid under pressure. A collapsible membrane in a portion of the through-lumen is constructed and arranged such that the fluid pressure in the chamber assists in sealing the collapsible membrane around the operating device.
In another aspect of the invention, a hemostasis valve comprises a valve body having a proximal end for receiving an operating device, a distal end for connection to a guide catheter, and a through-lumen in the valve body intermediate the proximal and distal ends. The operating device is inserted through the through-lumen and into the guide catheter. The through-lumen comprises a proximal portion, a distal portion and an elastomeric sleeve therebetween. One of the proximal and distal portions of the through-lumen is rotatable relative to the valve body between a closed position wherein the elastomeric sleeve is twisted to seal around the operating device and an open position wherein the elastomeric sleeve is sufficiently untwisted to unseal the elastomeric sleeve from the operating device.
In another aspect of the invention, a system for flushing a vascular catheter comprises a hemostasis valve and a vascular catheter for insertion into a patient, sealingly connected to the hemostasis valve. A source for providing flushing fluid under pressure is in fluid communication with the hemostasis valve. A mechanism controls the flow of said flushing fluid from the source to the hemostasis valve at a rate of about between 0.10 to 10.0 cubic centimeters per minute, thereby continuously flushing the vascular catheter.
In another aspect of the invention, a hemostasis valve assembly comprises a hemostasis valve which is moveable between a closed position wherein liquid in fluid communication with a patient is sealed and an open position. An expandable reservoir in fluid communication with the liquid in the hemostasis valve is moveable between expanded and retracted positions. The expandable reservoir is constructed and arranged such that, when the hemostasis valve is moved to the open position, the expandable reservoir retracts toward the retracted position so as to force liquid out of the open hemostasis valve.
These and other advantages and features of novelty which characterize the invention are pointed out with particularity in the claims annexed hereto. However, for a better understanding of the invention and its advantages, reference should be made to the drawings which form a further part hereof, and to the accompanying descriptive matter in which there is illustrated and described preferred embodiments of the invention.
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Berry David
Ellis Donald G.
Holmes David R.
Schwartz Robert S.
Mayo Foundation for Medical Education and Research
Merchant & Gould P.C.
Yasko John D.
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