Surgical perforation device with electrocardiogram (ECG) monitoring ability and method of using ECG to position a surgical perforation device

• US 7,270,662 B2
• Filed: 01/21/2004
• Issued: 09/18/2007
• Est. Priority Date: 01/21/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Baylis Medical Company Inc. (Boston Scientific Corporation)
• Inventors: Shah, Krishan, Visram, Naheed
• Primary Examiner(s): Peffley; Michael
• Assistant Examiner(s): VRETTAKOS, PETER J
• Application Number:
  US10/760,479
• Publication Number:
  US 20050159738A1
• Time in Patent Office: 1,336 Days
• Field of Search: 606 27- 52, 128/898
• 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 2018/00351 Heart
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

A device with a functional tip containing at least one active electrode capable of creating a controlled perforation in body tissue through the application of energy (e.g. Radio Frequency (RF)) is described. The position of the tip of the device can be determined in response to ECG measured at the tip and determined by a monitor coupled to the device. The device is useful to remove or perforate unwanted tissue in a controlled manner in any location in the body, particularly in the atrial septum for controlled transseptal puncture. In this application, the device is introduced into the right atrium, and the functional tip is then positioned against the atrial septum. ECG is used to locate the region of the fossa ovalis on the atrial septum. Energy is applied to create the perforation and ECG is monitored to determine if the perforation was created in a desired location.

Claims

1. A method for creating a channel through a cardiac septal material located in a body of a patient, said body having a body vasculature, said method using a surgical device comprising a substantially elongated member, said elongated member defining a proximal region and a longitudinally opposed distal region, said surgical device also comprising an active electrode for delivering a radio-frequency electrical current into said cardiac septal material, said active electrode being operatively coupled to said elongated member substantially adjacent said distal region, said method further using a grounding pad attachable to said patient for providing a return path for said radio-frequency electrical current, said method comprising:

introducing said surgical device into said body of said patient;

attaching said grounding pad to said patient;

positioning said active electrode at a first desired location in said body of said patient, said first desired location being substantially adjacent said cardiac septal material;

obtaining data about an electrical parameter of said cardiac septal material using said active electrode so as to substantially assess the position of said surgical device; and

creating said channel through said cardiac septal material by delivering said radio-frequency electrical current from said active electrode to said grounding pad, said radio-frequency electrical current being delivered through said cardiac septal material;

wherein said active electrode has a diameter of 0.04 cm or less.

2. The method as claimed in claim 1, further comprising advancing said active electrode through said channel and out of said cardiac septal material to a second desired location.

3. The method as claimed in claim 2 further comprising obtaining data about an electrical parameter of said cardiac septal material so as to substantially assess the position of said surgical device after advancing said active electrode.

4. The method as claimed in claim 1 wherein introducing said surgical device comprises introducing said surgical device into said body vasculature.

5. The method as claimed in claim 4 wherein introducing said surgical device into said body of said patient comprises inserting said surgical device into a dilator and a guiding sheath positioned in said body vasculature.

6. The method as claimed in claim 5 comprising maintaining said surgical device substantially fixed relatively to said cardiac septal material and advancing said dilator and said sheath over said surgical device through said channel.

7. The method as claimed in claim 5 comprising advancing substantially jointly said dilator, said sheath and said surgical device through said channel.

9. The method as claimed in claim 1, wherein said active electrode has a diameter of 0.04 cm.

10. The method as claimed in claim 1 wherein positioning said active electrode includes moving said active electrode relative to said cardiac septal material while monitoring said data about said electrical parameter of said cardiac septal material so as to substantially assess the position of said active electrode.

11. The method as claimed in claim 10 wherein the first desired location is determined in response to the observation of a distinctive change in said electrical parameter of said cardiac septal material.

12. The method as claimed in claim 11 wherein said electrical parameter of said cardiac septal material includes a voltage measured on said cardiac septal material, said first desired location being identified by a reduction in said voltage measured on said cardiac septal material.

13. The method as claimed in claim 11 wherein the first desired location is a fossa ovalis of the heart.

8. The method as claimed in claimed 1, comprising advancing said dilator, said sheath and said surgical device together through said channel.