Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2001-09-26
2004-05-11
Layno, Carl (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S003000
Reexamination Certificate
active
06735471
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to methods for performing a medical procedure, especially a procedure during which it is necessary to adjust the beating of the heart. More particularly, this invention relates to methods and systems of stimulating a nerve in order to modify the beating of a heart to allow a medical procedure to be performed or for blood flow to be controlled.
BACKGROUND OF THE INVENTION
The current leading cause of death in the United States is coronary artery disease in which the coronary arteries are blocked by atherosclerotic plaques or deposits of fat. The typical treatment to relieve a partially or fully blocked coronary artery is coronary artery bypass graph (CABG) surgery.
CABG surgery, also known as “heart bypass” surgery, generally entails using a graph to bypass the coronary obstruction. The procedure is generally lengthy, traumatic and subject to patient risks. Among the risk factors involved is the use of a cardiopulmonary bypass (CPB) circuit, also known as a “heart-lung machine,” to pump blood and oxygenate the blood so that the patient's heart may be stopped during the surgery.
Conventional CABG procedures are typically conducted on a stopped heart while the patient is on a (CPB) circuit. A stopped heart and a CPB circuit enables a surgeon to work in a bloodless, still operative field. However, there are a number of problems associated with CABG procedures performed while on CPB including the initiation of a systemic inflammatory response due to interactions of blood elements with the artificial material surfaces of the CPB circuit and global myocardial ischemia due to cardioplegic cardiac arrest. For these reasons, avoiding the use of CPB or cardioplegic cardiac arrest may help minimize post-operative complications.
One method, as disclosed in U.S. Pat. No. 5,651,378 to inventors Matheny and Taylor and in U.S. Pat. No. 5,913,876 to inventors Taylor et al., for facilitating coronary bypass surgery on a beating heart and thereby avoid the use of CPB and cardioplegic cardiac arrest includes stimulating the vagal nerve electrically in order to temporarily stop or substantially reduce the beating of the heart. This may be followed by pacing the heart to start its beating.
Another method, as disclosed in two published PCT applications, WO 99/09971 and WO 99/09973, both to inventor Puskas, involves stopping the beating of the heart during coronary bypass surgery using electrical stimulation of the vagal nerve in combination with administration of drugs. Another method, as disclosed in U.S. Pat. No. 6,060,454 to inventor Duhaylongsod, involves stopping the beating of the heart during coronary bypass surgery via the local delivery of drugs to the heart.
Although it is desirable to stop the heart for a period of time in order to allow the surgeon to accomplish a required task without interference from heart movement, i.e. a motionless operative field, it is undesirable to have the heart stopped for too long a period of time since the body needs, among other things, a constant supply of oxygen. In fact, it is particularly important to maintain sufficient blood flow, and therefore oxygen flow, to the brain. Stopping the heart for prolonged periods of time may cause damage to the patient.
It is thus important to be able to precisely control and coordinate the amount and duration of stimulation to the vagal nerve and the heart. One type of electrode arrangement that allows such precise control is an electrode tube which is suitable for insertion into a patient's trachea or esophagus. This arrangement provides a configuration of electrodes which can not only stimulate a variety of nerve fibers but may also be configured to stimulate the patient's heart, ventilate the patient's lungs and/or control pain during stimulation. This electrode arrangement also allows for sensing or monitoring of various physiological processes.
It would be desirable therefore to provide a method for controllably stopping or slowing the heart intermittently for diagnostic and therapeutic purposes.
Additionally, it would be desirable to provide a method for controllably stopping or slowing the heart intermittently in order to control blood flow.
Additionally, it would be desirable to provide a method for controllably stopping or slowing the heart intermittently in order to perform a medical procedure on the heart or another organ.
Additionally, it would be desirable to provide a means for coordinating stimulation of the heart and other body components.
Additionally, it would be desirable to provide a means for evaluating the stimulation output from a variety of electrodes to determine the best stimulation configuration.
SUMMARY OF THE INVENTION
One aspect of the present invention provides a method for evaluating stimulation during a medical procedure. A site is stimulated with a first electrode arrangement. The stimulation at the site is then evaluated to provide a first stimulation value. The first electrode arrangement may comprise one or more electrodes such as nerve stimulation electrodes, endotracheal electrodes, endoesophageal electrodes, intravascular electrodes, transcutaneous electrodes, intracutaneous electrodes, balloon-type electrodes, basket-type electrodes, umbrella-type electrodes, tape-type electrodes, suction-type electrodes, screw-type electrodes, barb-type electrodes, bipolar electrodes, monopolar electrodes, metal electrodes, wire electrodes, patch electrodes, cuff electrodes, clip electrodes, needle electrodes, probe electrodes, cardiac stimulation electrodes, pacing electrodes and epicardial electrodes.
The method may also involve stimulating the site with a subsequent electrode arrangement and evaluating stimulation to provide a subsequent stimulation value. The first stimulation and subsequent stimulation values may be continued with the electrode arrangement associated with the best stimulation value. The subsequent electrode arrangement may comprise one or more electrodes such as nerve stimulation electrodes, endotracheal electrodes, endoesophageal electrodes, intravascular electrodes, transcutaneous electrodes, intracutaneous electrodes, balloon-type electrodes, basket-type electrodes, umbrella-type electrodes, tape-type electrodes, suction-type electrodes, screw-type electrodes, barb-type electrodes, bipolar electrodes, monopolar electrodes, metal electrodes, wire electrodes, patch electrodes, cuff electrodes, clip electrodes, needle electrodes, probe electrodes, cardiac stimulation electrodes, pacing electrodes and epicardial electrodes.
Another aspect of the present invention provides a method of performing a medical procedure. A nerve is stimulated with a first electrode arrangement to adjust the beating of a heart to a first condition. Stimulation is evaluated from the first electrode arrangement to provide a first stimulation value. The nerve is then stimulated with a subsequent electrode arrangement and stimulation is evaluated from the subsequent electrode arrangement to provide a subsequent stimulation value. A desired electrode arrangement is selected based on the first stimulation value and the subsequent stimulation value and the nerve is stimulated with the desired electrode arrangement. The first and the subsequent electrode arrangements may comprise one or more electrodes such as nerve stimulation electrodes, endotracheal electrodes, endoesophageal electrodes, intravascular electrodes, transcutaneous electrodes, intracutaneous electrodes, balloon-type electrodes, basket-type electrodes, umbrella-type electrodes, tape-type electrodes, suction-type electrodes, screw-type electrodes, barb-type electrodes, bipolar electrodes, monopolar electrodes, metal electrodes, wire electrodes, patch electrodes, cuff electrodes, clip electrodes, needle electrodes, probe electrodes, cardiac stimulation electrodes, pacing electrodes and epicardial electrodes.
The medical procedure may be performed on an organ. Stimulation of the nerve may then be reduced or stopped to adjust the beating of a heart to a second condition. The nerv
Colson Michael A.
Euler David E.
Hill Michael R. S.
Jahns Scott E.
Keogh James R.
Berry Thomas G.
Latham Daniel W.
Layno Carl
Medtronic Inc.
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