Electrophysiology catheter and system for gentle and firm wall contact

• US 20060278248A1
• Filed: 08/18/2006
• Published: 12/14/2006
• Est. Priority Date: 06/02/2005
• Status: Abandoned Application

• Current Assignee: Stereotaxis, Inc.
• Original Assignee: Stereotaxis, Inc.
• Inventors: Viswanathan, Raju R.
• Application Number:
  US11/506,525
• Publication Number:
  US 20060278248A1
• Time in Patent Office: Days
• US Class Current: 128/899
• 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 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• 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 34/73 Manipulators for magnetic surgery
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for

Abstract

A method of applying an electrode on the end of a flexible medical device to the surface of a body structure, the method including navigating the distal end of the device to the surface by orienting the distal end and advancing the device until the tip of the device contacts the surface and the portion of the device proximal to the end prolapses. Alternatively the pressure can be monitored with a pressure sensor, and used as an input in a feed back control to maintain contact pressure within a pre-determined range.

Claims

1. A method of using a remote surgical navigation system to apply an electrode on the end of a flexible medical device to the surface of a body structure, the method comprising:

navigating the distal end of the device to the surface by orienting the distal end with the remote navigation system and advancing the device until the tip of the device contacts the surface and the portion of the device proximal to the end prolapses.

2. The method according to claim 1 wherein the electrode contacts the surface with greater than about 3 grams of force and less than about 15 grams of force.

3. A method of using a remote surgical navigation system to apply an electrode on the end of a flexible medical device to the surface of a moving body structure, the method comprising:

navigating the distal end of the device to the surface by orienting the distal end with the remote navigation system and advancing the device until the tip of the device contacts the surface and the portion of the device proximal to the end remains prolapsed during the entire range of motion of the surface.

4. The method according to claim 3 wherein the electrode contacts the surface with greater than about 3 grams of force and less than about 15 grams of force.

5. A method of applying an electrode on the end of a flexible medical device to the surface of moving body structure using a remote navigation system, the method comprising navigating the distal end of the device to the surface by orienting the distal end and advancing the device using the remote navigation system, monitoring the configuration of the distal end portion of the medical device for a prolapse, and operating the remote navigations system to maintain a prolapse during the entire range of motion of the surface.

6. The method according to claim 5 wherein the remote navigation system is a magnetic navigation system that orients the distal end by applying a magnetic field to orient a magnetically responsive element on the distal end of the device.

7. An electrode catheter having an electrode on the distal end, the distal end section having a bending modulus smaller than about 10⁻

5 N-m².

8. The electrode catheter according to claim 7 wherein the distal portion of the catheter is a radio-opaque shaft, such that any prolapse of the distal end is observable by x-ray imaging.

9. The electrode catheter according to claim 7 wherein the distal portion of the catheter is a radio-opaque shaft, such that any prolapse of the distal end is observable by x-ray imaging.

10. A method of applying an electrode on the end of a flexible medical device to the surface of moving body structure using a remote navigation system, the method comprising navigating the distal end of a guide sheath to a location facing the surface by orienting the distal end and advancing the guide sheath using the remote navigation system, deploying the flexible medical device through the guide sheath until it contacts the surface and prolapses sufficiently to maintain a prolapse during the entire range of motion of the surface.

11. The method according to claim 10 wherein the remote navigation system is a magnetic navigation system.

12. The method according to claim 10 wherein the remote navigation system uses servo motors and pull-wires to mechanically articulate the sheath

13. The method according to claim 10 wherein the remote navigation system uses electrostrictive elements to articulate the sheath.

14. An electrode catheter having an electrode at its distal tip, the portion of the catheter adjacent the distal tip having an effective bending modulus greater than 10⁻

5 N-m² and further comprising a force sensor at the distal tip.

15. A method of applying an electrode on the end of a flexible medical device to the surface of moving body structure using a remote navigation system, the method comprising navigating the distal end of the medical device having a force sensor thereon into contact with the surface;

and operating the remote navigation system to maintain the contact force between a predetermined minimum and a predetermined maximum.

16. The method according to claim 15 wherein the remote navigation system is a magnetic navigation system.

17. The method according to claim 15 wherein the remote navigation system uses servo motors and pull-wires to mechanically articulate a guide sheath through which the medical device is deployed.

18. The method according to claim 15 wherein the remote navigation system uses electrostrictive elements to articulate a guide sheath through which the medical device is deployed.

19. The method according to claim 15 wherein the force sensor includes a strain gauge.

20. A method of applying an electrode on the end of a flexible medical device to the surface of moving body structure using a remote navigation system, the method comprising navigating the distal end of a guide sheath to a location facing the surface, by orienting the distal end and advancing the device using the remote navigation system, deploying the flexible medical device having a pressure sensor thereon through the guide sheath until it contacts the surface and maintaining the contact force between the end of the medical device and the surface between a predetermined minimum and a predetermined maximum.