Catheter apparatus for treatment of heart arrhythmia

• US 7,311,705 B2
• Filed: 08/12/2004
• Issued: 12/25/2007
• Est. Priority Date: 02/05/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sra, Jasbir S.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/916,662
• Publication Number:
  US 20050038333A1
• Time in Patent Office: 1,230 Days
• Field of Search: 606/41, 606 48- 50, 607/101, 607/102, 607/122
• US Class Current: 606/41
• 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 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure

Abstract

A catheter apparatus is provided for use in the treatment of heart arrhythmia having a catheter shaft, a mapping and ablation catheter disposed within the shaft, and a control mechanism coupled to both the shaft and catheter. The catheter shaft includes a main body and a coaxial tip section joined to the main body. The tip section can be rotated about a central axis and curved away from the central axis in a controlled manner. The mapping and ablation catheter can be extended outward from the catheter shaft where it is able to take the form of a pre-stressed curve. The control mechanism controls axial rotation of the tip section, the degree of deflection of the tip section and longitudinal movement of the mapping and ablation catheter with respect to the catheter shaft. Preferably, the mapping and ablation catheter forms a pre-stressed loop when it is fully extended from the catheter shaft.

In another aspect of this invention, it provides a method for treatment of a heart arrhythmia having the steps of (1) obtaining cardiac image data from a medical imaging system, (2) creating a 3D model from this cardiac image data, (3) registering the 3D model to an interventional system, (4) positioning a catheter apparatus within a chamber of the heart, (5) displaying the catheter apparatus over the registered 3D model on the interventional system, (6) navigating the catheter apparatus within the heart guided by the registered 3D model, and (7) having the catheter apparatus ablate heart tissue at select locations.

Claims

1. A catheter apparatus of the type used in the treatment of heart arrhythmia comprising:

a catheter shaft having a main body and a coaxial tip section joined to the main body, the tip section having a tip distal end and being rotatable about a central axis and deflectable such that the tip section can be selectively curved away from the main body;

a mapping and ablation catheter slidably disposed within the catheter shaft, the mapping and ablation catheter having a catheter distal portion, the catheter distal portion being a pre-stressed curve whereby the mapping and ablation catheter curves as the catheter distal portion is extended axially from the catheter shaft and when the catheter distal portion is fully extended from the catheter shaft, all of the curve is substantially coplanar with a plane substantially perpendicular to the central axis at the tip distal end; and

a control mechanism coupled to both the catheter shaft and the mapping and ablation catheter whereby the control mechanism controls, with respect to the central axis, selective rotation and selective deflection of the tip section and controls selective axial movement of the mapping and ablation catheter with respect to the catheter shaft.

2. The apparatus of claim 1 wherein the curve forms a loop when the catheter distal portion is fully extended from the catheter shaft.

3. The apparatus of claim 2 wherein the loop has a diameter ranging from 10 mm. to 20 mm.

4. The apparatus of claim 2 wherein the loop has a selectively variable diameter and the control mechanism controls the diameter of the loop.

5. The apparatus of claim 4 wherein:

the control mechanism is a steering handle;

the steering handle has a first actuator mechanically connected with respect to the catheter shaft whereby actuation of the first actuator can independently rotate the tip section about the central axis and deflect the tip section away from the central axis; and

the steering handle has a second actuator mechanically connected with respect to the mapping and ablation catheter whereby actuation of the second actuator can independently move the mapping and ablation catheter axially within the catheter shaft and control the diameter of the loop formed by the mapping and ablation catheter.

6. The apparatus of claim 5 wherein the catheter apparatus is adapted to be displayed, when positioned in a chamber of the heart, over a 3D model registered with an interventional system, the 3D model being created from cardiac image data obtained from a medical imaging system, whereby the catheter apparatus can be navigated within the heart utilizing the registered 3D model.

7. The apparatus of claim 6 wherein the medical imaging system is a computer tomography (CT) system.

8. The apparatus of claim 7 wherein the heart arrhythmia is atrial fibrillation and wherein the 3D model is of the left atrium and pulmonary veins.

9. The apparatus of claim 6 wherein the mapping and ablation catheter has an electrode section at a distal end of the mapping and ablation catheter, the electrode section having a plurality of electrodes, and at least one electrode being adapted to take intracardial recordings of electrical activity and display the recordings on the interventional system.

10. The apparatus of claim 5 wherein the mapping and ablation catheter includes a spline.

11. The apparatus of claim 10 wherein the spline is fabricated from nickel-titanium having shape memory.

12. The apparatus of claim 1 wherein the catheter distal portion has an electrode section, the electrode section having a plurality of electrodes wherein each electrode is operable to ablate a selected area of heart tissue brought into contact with the electrode.

13. The apparatus of claim 12 wherein at least two electrodes are independently operable.

14. The apparatus of claim 12 wherein each pair of electrodes is separated by a non-ablating section.

15. The apparatus of claim 12 wherein each electrode includes a temperature recording site and an electrogram recording site.

16. The apparatus of claim 1 wherein the tip section is joined to the main body at a transition point, the tip section is pre-stressed to form a substantially 180°

curve with respect to the central axis at the transition point, the curve being substantially coplanar with the main body, and the control mechanism controls selective straightening of the tip section.

17. The apparatus of claim 1 wherein the heart arrhythmia is atrial fibrillation.