Endomyocardial monophasic action potential for early detection of myocardium pathology

• US 6,738,655 B1
• Filed: 10/03/2001
• Issued: 05/18/2004
• Est. Priority Date: 04/05/1999
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Sen, Luyi, Cui, Guanggen
• Primary Examiner(s): Layno, Carl
• Application Number:
  US09/958,452
• Time in Patent Office: 958 Days
• Field of Search: 600/509, 600/523, 600/373, 600/374, 600/375, 607/119, 607/122
• US Class Current: 600/374
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket

Abstract

A catheter-delivered electrode array is used to three dimensionally map the endomyocardial monophasic action potential (MAP). The catheter is used in a method for endomyocardial MAP mapping and for establishing diagnostic criteria for the cardiac myocyte injury. During allograft rejection, conduction impairment occurs within the atrial myocardium. Abnormalities of the terminal force of the P wave in Lead V1 (ptfV1) and dispersion of corrected atrial repolarization (Ta-TcD) represent interatrial conduction defects that accompanies the rejection process. Three dimensional endomyocardium monophasic action potential mappings are used to directly monitor the pathophysiological changes in cardiac myocytes. Changes in amplitude, duration and morphology of the action potential were recorded and used to detect the early rejection of the transplant organ with high sensitivity and specificity. Using this MAP-mapping system, the area of myocardium injury induced by a coronary artery occlusion or by ablation can be pin pointed.

Claims

1. An apparatus for three-dimensional interior mapping of endomyocardial monophasic action potential (MAP) of endomycardial tissue comprising:

a catheter with a distal and proximal end;

a wire basket disposed on said distal end of said catheter;

a plurality of electrodes forming an array of separated electrodes carried by said wire basket, said wire basket self-expandable by reason of resiliency of said wire basket to a size and stiffness sufficient to cause said electrodes to make intimate contact with said endomycardial tissue with point contact pressure at each electrode; and

a flexible cable disposed in said catheter electrically coupling said plurality of electrodes to said proximal end of said catheter.

2. The apparatus of claim 1 further comprising an electrophysiological analyzer coupled to said cable to record data from each of said plurality of electrodes and to analyze said data to generate a three-dimensional endomyocardium mapping of endomyocardial monophasic action potential from said plurality of electrodes.

3. A method of determining the myocardium injury/electrical-pathophysiology of cardiac myocytes comprising:

providing a catheter having with a distal and proximal end, and a wire basket disposed on said distal end of said catheter with a plurality of at least 64Ag/AgCl plated electrodes carried by said basket, having a flexible cable disposed in said catheter electrically coupling said plurality of electrodes to said proximal end of said catheter, and a sheath temporarily disposed over said basket to retain said basket in a collapsed configuration;

disposing said catheter in a heart chamber to be mapped,

telescopically removing said sheath from said basket to allow said basket to self-expand in said heart chamber, said basket being self-expandable by reason of resiliency of said basket to a size and stiffness sufficient to cause said electrodes to make intimate contact with said endomycardial tissue; and

recording and electrophysiologically analyzing a data signal from each of said plurality of electrodes to generate a three-dimensional endomyocardium mapping of endomyocardial monophasic action potential from said plurality of electrodes.

4. The method of claim 3 where recording and electrophysiologically analyzing said data signal from each of said plurality of electrodes comprises recording and electrophysiologically analyzing a maximum amplitude of the action potential (Amax) and the dispersion of the amplitude of the action potential (AP) from each of said plurality of electrodes to determine myocardium injury.

5. The method of claim 3 where recording and electrophysiologically analyzing said data signal from each of said plurality of electrodes comprises recording and electrophysiologically analyzing an action potential duration and dispersion of the action potential duration from each of said plurality of electrodes to determine myocardium injury.

6. The method of claim 3 where recording and electrophysiologically analyzing said data signal from each of said plurality of electrodes comprises recording and electrophysiologically analyzing a maximum diastolic potential from each of said plurality of electrodes to determine myocardium injury.

7. The method of claim 3 where recording and electrophysiologically analyzing said data signal from each of said plurality of electrodes comprises recording and electrophysiologically analyzing a maximum upstroke velocity (Vmax) of the MAP from each of said plurality of electrodes to determine myocardial injury.

8. The method of claim 3 where recording and electrophysiologically analyzing said data signal from each of said plurality of electrodes comprises recording and electrophysiologically analyzing a P wave in EKG lead V1 (ptf-V1) signal from each of said plurality of electrodes to determine myocardium injury.

9. The method of claim 3 where recording and electrophysiologically analyzing said data signal from each of said plurality of electrodes comprises recording and electrophysiologically analyzing a dispersion of the atrial repolarization (Ta-TcD) signal from each of said plurality of electrodes to determine myocardium injury.

10. The method of claim 9 where recording and electrophysiologically analyzing said data signal from each of said plurality of electrodes comprises recording and electrophysiologically analyzing a P wave in EKG lead V1 (ptf-V1) signal from each of said plurality of electrodes to determine myocardium injury.