Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
2000-05-26
2003-07-29
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C604S066000, C604S067000
Reexamination Certificate
active
06600941
ABSTRACT:
BACKGROUND OF THE INVENTION
It is well known in the art to determine the pH in body fluids by using an electrode cell assembly and immersing the measuring electrode into a sample of the bodily fluid. The pH is known to be the symbol for the negative logarithm of the H
+
ion concentration. The pH value of the blood indicates the level of acidity of the blood. High blood acidity, which is reflected by a low pH indicates that the organs of the body are not being provided with enough oxygen, which can ultimately prove harmful.
It is also known in the art to measure tissue pH in myocardial tissue. Measurement of pH in myocardial tissue has been used to determine the presence of myocardial ischemia, as indicated by tissue acidosis which is reflected by a decrease in pH. During cardiac surgery, the aorta is cross clamped and the myocardium is deprived of its blood and nutrient supply, creating the potential for damage to the heart from ischemia. Ischemia can be diagnosed by monitoring the pH of the myocardium which falls significantly and becomes acidotic during ischemia.
There is an ongoing need, however, for further improvements in methods for diagnosing and treating ishemic tissue.
SUMMARY OF THE INVENTION
While ischemia or tissue acidosis, in cardiac tissue has been measured, systems and methods to prevent and/or reverse tissue, and in particular, cardiac acidosis were unknown. Surgeons did not know how to reverse tissue acidosis once discovered. The present invention relates to systems and/or methods of using tissue pH measurements to diagnose ischemia and to gauge the conduct of an operation, based on these pH measurements, so as to prevent and/or reverse tissue ischemia/acidosis. The current invention provides methods by which tissue acidosis can be corrected once discovered.
The present invention relates to pH-guided management of tissue ischemia or the use of pH measurements of tissue as a system for controlling diagnostic and/or surgical procedures. A preferred embodiment of the invention relates specifically to an apparatus and method which is applicable to patients undergoing cardiac surgery. It employs a tissue electrode and monitor and comprises a series of steps that, in a preferred embodiment, are aimed at achieving a homogeneous distribution of cardioplegic solution during aortic clamping, and at insuring adequate revascularization of ischemic segments of the myocardium. The method using pH-guided myocardial management guides the conduct of operations, prevents damage to the heart, extends the safe period of oxygen deprivation, and improves the outcome of patients undergoing heart surgery.
The use of the pH-guided myocardial management system to identify ischemic segments of a myocardium can provide a user with options for specific courses of conduct, both during and after, the surgical procedure. These options include: effecting an optimal delivery of preservation solutions to the heart to reduce ischemia, assessing the adequacy of coronary revascularization following a heart surgery procedure, identifying viable but nonfunctioning heart muscle, prompting changes in the conduct of the surgical procedure, monitoring the pH of the heart muscle post-operatively and evaluating the efficacy of newer myocardial protective agents.
There are several methods of delivery of a pH electrode, used in pH-guided myocardial management, to a site of interest. The electrode can be delivered manually by the user. The electrode can also be delivered by a catheter through a percutaneous incision. The electrode can also be delivered by an endoscope, a colonscope or a laparoscope to a site of interest. Thus, in a preferred embodiment of the invention, the method can be applied to other tissue measurements such as brain tissue, kidney tissue, musculo-cutaneous flaps or the small or large intestines. In another embodiment, the pH of transplanted organs, such as liver or kidney, can be measured to assist in the diagnosis and/or treatment of rejection since acidosis is an early sign of rejection.
Other systems and methods can also be used to measure pH, including, in certain applications, surface pH measurements, magnetic resonance measurements, or optical methods using fiber optic probes or endoscopes.
When a user has found that tissue acidosis is present at a site of interest, the user can effect an optimal delivery of preservation fluids, or cardioplegia fluids, to the heart to raise the pH of the site. Several systems that provide optimal delivery of the cardioplegia solutions to the site are available to the user. These include: altering the flow rate of the preservation fluid, altering the temperature of the fluid, altering the site of delivery, repositioning the tip of the catheter, selectively directing the preservation fluid through the manifold, applying direct coronary artery pressure on the proximal portion of the artery, occluding the left main coronary artery with a balloon catheter, inflating the balloon of a retrograde coronary sinus catheter, administering a bolus of cardioplegia through the orifice of a right coronary artery and accelerating a surgical procedure.
When a user has found that tissue acidosis is present at a site of interest, the user can also prompt changes to the conduct of the surgical procedure to raise the pH of the site. Several alternatives for changing the surgical procedure are available to the user. These include: determining the need for revascularization of a specific segment of the myocardium, changing the order of revascularization, providing for additional revascularization, changing the operation or the surgeon to reduce ischemic time, canceling an operation and delaying the weaning of a patient from cardiopulmonary bypass.
The pH electrode itself can have a cable connected to a silver wire where the silver wire is an Ag/AgCl (silver/silver chloride) wire. The cable and wires are encased in a housing which is encased in shrink tubing. The electrode has a glass stem which houses the silver wire, a thermistor, a pH sensor, and a gelled electrolyte. The electrode has a bendable joint which allows the user to adjust the positioning of the electrode prior to or during use and which facilitates electrode removal after chronic insertion. The glass stem is pointed to allow direct insertion into tissues. In a preferred embodiment, the glass stem is made of lead glass.
The electrodes can be used in a probe that can be delivered to a site within the human body using a catheter and/or endoscope. The sensor can be connected to a data processing system such as a personal computer that can be used to record and process data. The computer can be programmed using a software module to control system operation and indicate to the user the status of the patient and changes in system status and operation. The system can also prompt the surgeon as to indicated changes in a surgical procedure in progress. The computer can be connected to a controller that operates a fluid delivery system and various temperature and pressure sensors can provide data for the monitoring system regarding patient status.
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Bowditch & Dewey LLP
E-Monitors, Inc.
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