Surgery – Instruments – Electrical application
Reexamination Certificate
1995-05-15
2002-06-04
Shay, David M. (Department: 3739)
Surgery
Instruments
Electrical application
C606S046000, C606S048000
Reexamination Certificate
active
06398782
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical devices and methods, and more particularly to a device and method for sealing a puncture site in a blood vessel wall.
BACKGROUND OF THE INVENTION
In modern medical practice, many clinical procedures require that a catheter or other device be percutaneously inserted into a blood vessel. Such clinical procedures include; diagnostic cardiac catheterization, percutaneous translumenal angioplasties or atherectomies, etc. In many of these procedures, the catheter or other device is typically inserted into the blood vessel by a technique known as the “Seldinger Technique”.
In accordance with the Seldinger Technique, a hollow bore needle is initially inserted into a blood vessel, such as the femoral artery, and a guide wire is subsequently advanced through the lumen of the needle into the blood vessel. The needle is then retracted, leaving the guide wire in place. Thereafter, a tubular introducer having a tapered dilator extending therethrough, is advanced over the guide wire and into the blood vessel. The tapered distal end of the dilator protrudes out of and beyond the distal end of the introducer, to slowly dilate the blood vessel puncture site to a size which is large enough to receive and allow passage of the introducer sheath. The guide wire and dilator are subsequently withdrawn, leaving the introducer sheath in place within the blood vessel. A catheter scope or other device is then passed through the introducer sheath and advanced through the vasculature to its desired location.
After the procedure has been completed, the catheter, scope, or other device and tubular introducer are extracted and removed from the puncture site. Direct pressure is customarily applied to the puncture site to maintain hemostasis, and to minimize hematoma formation. Despite such routine application of direct pressure to the puncture site following the procedure, some localized bleeding, bruising or hematoma formation often occurs. Additionally, other complications, such as pseudoaneurysm formation, may also occur.
The prior art has included a number of methods and devices which are purported to be capable of sealing a vascular puncture site following removal of the percutaneously inserted introducer or the like. For example, one product known by the trade name VASOSEAL™ (Datascope Corporation, Montvale, N.J.) comprises a bolus of collagenous material which is passed through an introducer into the vicinity of the blood vessel puncture site. The deployment of the collagenous material near the blood vessel puncture site is intended to promote coagulum formation, and resultant sealing of the blood vessel puncture site.
Additionally, devices for sealing of blood vessel wall punctures have been described in U.S. Pat. No. 4,829,994 (Kurth), U.S. Pat. No. 4,929,246 (Sinofsky), U.S. Pat. No. 4,744,364 (Kensey) and U.S. Pat. No. 5,108,421 (Fowler).
Also, U.S. patent application Ser. No. 07/959,337 (Taymor-Luria), of which this Application is a continuation-in-part, describes an electrosurgical blood vessel sealing probe which is insertable through a vascular sheath and subsequently retractable to a point where the distal tip of the probe is in contact with blood vessel wall puncture site. Thereafter, electrical energy is applied through the probe to effect electrocauterization or electrocoagulation of the blood vessel wall puncture site. The probe incorporates a guiding means to enhance the operator's ability to precisely position the distal tip of the probe in its intended position adjacent the blood vessel wall puncture site.
The present invention is directed to bipolar embodiments of the blood vessel sealing probe and method described in parent application Ser. No. 07/959,337 (Taymor-Luria), of which this application is a continuation-in-part.
SUMMARY OF THE INVENTION
This continuation-in-part patent application is directed to inventions which comprise bipolar embodiments of a blood vessel sealing probe of the general type disclosed in U.S. patent application Ser. No. 07/959,337. Also, this patent application is directed to methods and apparatus for facilitating operative positioning of a blood vessel sealing device at a location which is immediately adjacent, or at a specific spaced distance from, a blood vessel wall puncture site.
A first embodiment of a bipolar blood vessel sealing probe of the present invention generally comprises an elongate probe or catheter body having a bipolar electrode tip on the distal end thereof, and a bipolar connector on the proximal end thereof. In this embodiment, the bipolar connector is connectable to an electrical power source to provide a flow of electrical current from the connector to the bipolar electrode tip. A guide wire lumen may extend through at least a portion of the probe body, to facilitate advancement of the probe over a pre-inserted guide wire.
A second embodiment of a bipolar blood vessel sealing probe with the present invention generally comprises an elongate probe or catheter body having a single electrode at or near its distal end, and a guide wire which extends longitudinally therethrough so as to protrude out of and beyond the distal end of the probe or catheter body. The region of the guide wire immediately adjacent the distal end of the probe or catheter body forms a second bipolar electrode. Both the guide wire and the elongate probe or catheter body are connectable to an electrical power source to provide a flow of electrical current to the electrode located on the probe or catheter body and the electrode located on the guide wire. In this regard, the electrode located on the probe or catheter body and the electrode located on the guide wire combine to form a bipolar electrode tip whereby electrical energy passes between the probe or catheter body and the guide wire. The guide wire may remain fully or partially inserted into the blood vessel wall puncture so as to facilitate bipolar electrocauterization or electrocoagulation of the blood vessel wall puncture site.
Further in accordance with the invention, the bipolar blood vessel sealing probes of the above-summarized first and second embodiments are useable in combination with an electrical power source. The electrical power source preferably comprises a radio frequency alternating current generator. Because the bipolar probe of the present invention is capable of operating with minimal power, the electrical power source may be preset or limited so as to deliver radio frequency alternating current at power levels below 20 watts, and preferably about 1-10 watts. Additionally, it is preferable that the electrical power be delivered through the probe for discrete periods of time effective to produce electrocauterization or electrocoagulation of the blood vessel wall, while avoiding thermal damage or degradation to the blood vessel wall and/or surrounding tissue. In this regard, a timer may be provided to limit the individual periods of electrical current to approximately 30 seconds-60 seconds each. Additionally, or alternatively, a temperature sensor and feedback control apparatus may be utilized to decrease or terminate the electrical current flowing through the probe when the temperature at the distal end of the probe reaches a predetermined limit.
Further in accordance with the invention, there is provided a non-electrically-conductive guide wire which is usable in connection with the first embodiment of the bipolar blood vessel sealing probe.
Still further in accordance with the invention, there is provided an electrically-conductive electrode-guide wire which is usable with the second embodiment of the bipolar blood vessel sealing probe, said electrically conductive electrode-guide wire forms a second electrode adjacent the distal end of the probe or catheter body, as summarized hereabove with respect to the second embodiment.
Still further in accordance with the invention there are provided methods of sealing puncture sites in blood vessel walls using the bipolar probes and systems of the present invention. In gen
Currier Clifford E.
Evans David J.
Konno Mark A.
Mills Timothy C.
Mooney Charles R.
Cumberbatch Guy
Edwards Lifesciences Corporation
Shay David M.
Vinitskaya Lena
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