Method and apparatus for studying cardiac arrhythmias

• US 5,546,951 A
• Filed: 09/23/1994
• Issued: 08/20/1996
• Est. Priority Date: 07/20/1993
• Status: Expired due to Term

• Current Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Original Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Inventors: Ben-Haim, Shlomo
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/311,593
• Time in Patent Office: 697 Days
• Field of Search: 128/696, 128/697, 128/702, 128/705, 128/653.1, 128/662.03, 607/27, 607/14, 607/122
• US Class Current: 600/515
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/3621 : for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3627 : for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia

Abstract

This invention concerns an apparatus and method for the treatment of cardiac arrhythmias. More particularly, this invention is directed to a method for ablating a portion of an organ or bodily structure of a patient, which comprises obtaining a perspective image of the organ or structure to be mapped; advancing one or more catheters having distal tips to sites adjacent to or within the organ or structure, at least one of the catheters having ablation ability; sensing the location of each catheter'"'"'s distal tip using a non-ionizing field; at the distal tip of one or more catheters, sensing local information of the organ or structure; processing the sensed information to create one or more data points; superimposing the one or more data points on the perspective image of the organ or structure; and ablating a portion of the organ or structure.

Claims

1. A method for studying cardiac arrhythmias, which comprises the steps of:

(a) positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) sensing location information at the site;

(c) sensing body surface ECG while pacing from that site;

(d) processing sensed and derived information from steps (b) and (c) to create one or more date points; and

(e) repeating steps (a), (b), (c), and (d) one or more times to create sufficient data points for a map.

8. The method of claim 1, 2, 3, 4, 5, 6, or 7, which is a closed chest method.

2. A method for studying cardiac arrhythmias, which comprises the steps of:

(a) positioning the distal tip of each or one or more catheters at a site adjacent to or within the heart;

(b) sensing location information at the site;

(c) sensing body surface ECG while pacing from that site;

(d) processing sensed and derived information from steps (b) and (c) to create one or more data points;

(e) repeating steps (a), (b), (c), and (d) one or more times to create sufficient data points for a map; and

(f) transmitting the map to a receiving means.

3. A method for treating cardiac arrhythmias, which comprises the steps of:

(a) positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) sensing location information at the site;

(c) sensing body surface ECG while pacing from that site;

(d) processing sensed and derived information from steps (b) and (c) to create one or more data points;

(e) repeating steps (a), (b), (c), and (d) one or more times to create sufficient data points for a map; and

(f) ablating a portion of the heart.

4. A method for treating cardiac arrhythmias, which comprises the steps of:

(a) positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) sensing location information at the site;

(c) sensing body surface ECG while pacing from that site;

(d) processing sensed and derived information from steps (b) and (c) to create one or more data points;

(e) repeating steps (a), (b), (c), and (d) one or more times to create sufficient data points for a map;

(f) transmitting the map to a receiving means; and

(g) ablating a portion of the heart.

5. A method for studying cardiac arrhythmias, which comprises the steps of:

(a) positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) sensing location information at the site;

(c) pacing from that site;

(d) sensing body surface ECG;

(e) comparing body surface ECG measured at step (d) to body surface ECG morphology during reference arrhythmia;

(f) processing sensed and derived information from steps (b) and (e) to create one or more data points; and

(g) repeating steps (a), (b), (c), (d), and (e) one or more times to create sufficient data points for a correlation map.

6. A method for studying cardiac arrhythmias, which comprises the steps of:

(a) positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) sensing location information at the site;

(c) pacing from that site;

(d) sensing body surface ECG;

(e) comparing body surface ECG measured at step (d) to body surface ECG morphology during reference arrhythmia;

(f) processing sensed and derived information from steps (b) and (e) to create one or more data points;

(g) repeating steps (a), (b), (c) , (d), and (e) one or more times to create sufficient data points for a correlation map; and

(h) transmitting the correlation map of step (g) to a receiving means.

7. A method for treating cardiac arrhythmias, which comprises the steps of:

(a) positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) sensing location information at the site;

(c) pacing from that site;

(d) sensing body surface ECG;

(e) comparing body surface ECG measured at step (d) to body surface ECG morphology during reference arrhythmia;

(f) processing sensed and derived information from steps (b) and (e) to create one or more data points;

(g) repeating steps (a), (b), (c), (d), and (e) one or more times to create sufficient data points for a correlation map; and

(h) ablating a portion of the heart.

9. An apparatus for studying cardiac arrhythmias, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for sensing body surface ECG while pacing from that site;

(d) means for processing sensed and derived information from means (b) and (c) to create one or more data points; and

(e) means for repeating the functions of means (a), (b), (c), and (d) one or more times to create sufficient data points for a map.

10. An apparatus for studying cardiac arrhythmias, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for sensing body surface ECG while pacing from that site;

(d) means for processing sensed and derived information from means (b) and (c) to create one or more data points;

(e) means for repeating the functions of means (a), (b), (c), and (d) one or more times to create sufficient data points for a map; and

(f) means for transmitting the map to a receiving means.

11. An apparatus for treating cardiac arrhythmias, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for sensing body surface ECG while pacing from that site;

(d) means for processing sensed and derived information from means (b) and (c) to create one or more data points;

(e) means for repeating the functions of means (a), (b), (c), and (d) one or more times to create sufficient data points for a map; and

(f) means for ablating a portion of the heart.

12. An apparatus for treating cardiac arrhythmias, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for sensing body surface ECG while pacing from that site;

(d) means for processing sensed and derived information from means (b) and (c) to create one or more data points;

(e) means for repeating the functions of means (a), (b), (c), and (d) one or more times to create sufficient data points for a map;

(f) means for transmitting the map to a receiving means; and

(g) means for ablating a portion of the heart.

13. An apparatus for studying cardiac arrhythmias, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for pacing from that site;

(d) means for sensing body surface ECG;

(e) means for comparing body surface ECG measured by means (d) to body surface ECG morphology during reference arrhythmia;

(f) means for processing sensed and derived information from means (b) and (e) to create one or more data points; and

(g) means for repeating the functions of means (a), (b), (c), (d), and (e) one or more times to create sufficient data points for a correlation map.

14. An apparatus for studying cardiac arrhythmias, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for pacing from that site;

(d) means for sensing body surface ECG;

(e) means for comparing body surface ECG measured by means (d) to body surface ECG morphology during reference arrhythmia;

(f) means for processing sensed and derived information from means (b) and (e) to create one or more data points;

(g) means for repeating the functions of means (a), (b), (c), (d), and (e) one or more times to create sufficient data points for a correlation map; and

(h) means for transmitting the correlation map to a receiving means.

15. An apparatus for treating cardiac arrhythmias, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for pacing from that site;

(d) means for sensing body surface ECG;

(e) means for comparing body surface ECG measured by means (d) to body surface ECG morphology during reference arrhythmia;

(f) means for processing sensed and derived information from means (b) and (e) to create one or more data points;

(g) means for repeating the functions of means (a), (b), (c), (d), and (e) one or more times to create sufficient data points for a correlation map; and

(h) means for ablating a portion of the heart.

16. An apparatus for guiding operator-performed intrabody mapping, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for sensing local information;

(d) means for processing sensed and derived information from means (b) and (c) to create one or more data points;

(e) means for repeating the functions of means (a), (b), (c), and (d) one or more times to create sufficient data points for a map;

(f) means for calculating gradients of mapped local information; and

(g) means for processing information from means (f) to indicate the next site for acquisition of local information.

17. An apparatus for guiding operator-performed intrabody mapping, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for repeating the function of means (a) and (b) one or more times to create sufficient data points for creating an image of the mapped surface;

(d) means for calculating the spatial distribution of the density information; and

(e) means for processing information from means (d) to indicate the next site for acquisition.

18. An apparatus for guiding operator-performed intrabody mapping, which comprises:

(a) means for positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) means for sensing location information at the site;

(c) means for repeating the function means (a) and (b) one or more times to create sufficient data points for creating an image of the mapped surface;

(d) means for calculating the spatial distribution of the density information;

(e) means for processing information from means (d) to indicate the next site for acquisition; and

(f) means for superpositioning the suggested next site for acquisition determined by means (e) on the image generated by means (c).

19. A method for prognosing the likelihood of successful treatment of cardiac arrhythmias of a patient, comprising:

(a) positioning the distal tip of each of one or more catheters at a site adjacent to or within the heart;

(b) sensing location information at the site;

(c) sensing electrical information;

(d) processing sensed information from steps (b) and (c) to create one or more data points;

(e) repeating steps (a), (b), (c), and (d) one or more times to create sufficient data points for a map; and

(f) evaluating the map to prognose the likelihood of successful treatment.

20. The method of claim 19, wherein said electrical activity is mapped in a closed chest method.

21. The method of claim 19, wherein said electrical activity is delayed diastolic potential.

22. The method of claim 19, wherein said electrical activity is pre-potential.

23. A method for automatic guidance of an operator-performed mapping procedure, said method comprising the steps of:

(a) recording the values of a mapped variable at a plurality of locations to prepare a map; and

(b) calculating spatial gradients of the mapped variables to identify the optimal site for further acquisition of information.

24. An apparatus for automatic guidance of an operator-performed mapping procedure, comprising:

(a) means for recording the values of a mapped variable at a plurality of locations to prepare a map; and

(b) means for calculating spatial gradients of the mapped variables to identify the optimal site for further acquisition of information.