Catheter system having controllable ultrasound locating means

• US 6,233,477 B1
• Filed: 08/09/1999
• Issued: 05/15/2001
• Est. Priority Date: 10/20/1997
• Status: Expired due to Term

• Current Assignee: Irvine Biomedical, Inc. (Abbott Laboratories)
• Original Assignee: Irvine Biomedical, Inc. (Abbott Laboratories)
• Inventors: Tu, Hosheng, Chia, Weng-Kwen Raymond
• Primary Examiner(s): Casler, Brian L.
• Application Number:
  US09/370,603
• Time in Patent Office: 645 Days
• Field of Search: 600/407, 600/424, 600/437, 600/373, 607/122
• US Class Current: 600/424
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• 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 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6856 with a distal loop
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction

Abstract

An improved catheter system having ultrasound locating capabilities comprising a locator catheter and an ultrasound receiver catheter resulting in an effective electrophysiology procedure without undesired side effects of using a conventional x-ray imaging system. Said catheter system comprising a locator catheter consisted of at least one electrode and an ultrasound crystal secured on the locator catheter; and a reference catheter comprising three or more ultrasound crystal beacons which have pre-determined locations with reference to an external locating calibration system, wherein said external locating calibration system constantly calibrates the coordinates of the beacons on the reference catheter, having at least one ultrasound beacon is movable/controllable by a beacon deployment means.

Claims

1. A catheter system comprising:

a locator catheter comprising a catheter shaft having a distal tip section, a distal end, a proximal end and at least one lumen extending therebetween, wherein at least one electrode is secured at said distal tip section;

a handle attached to the proximal end of said catheter shaft;

an ultrasound crystal secured on the catheter shaft proximal to the distal end for transmitting ultrasound signals;

a connector secured to the proximal end of said handle;

a reference catheter comprising at least three ultrasound crystal beacons for receiving the ultrasound signals transmitted from the ultrasound crystal secured to the locator catheter, wherein at least one beacon is movable on said reference catheter and controllable by a beacon deployment mechanism at the handle, said beacons having coordinates that are pre-set with reference to an external location calibration system, wherein said beacons can emit and receive ultrasound signals;

said external location calibration system for receiving signals from the crystal beacons and constantly calibrating the coordinates of the beacons on the reference catheter; and

a data acquisition computer connected to the location calibration system for determining the location of the locator catheter.

2. The catheter system of claim 1, wherein said ultrasound crystal beacons on the reference catheter are made of piezoelectric materials.

3. The catheter system of claim 2, wherein the shape of said ultrasound crystal beacons on the reference catheter is selected from the group consisting of a cylinder, a donut, a ring, a spiral, and a mesh.

4. The catheter system as in claim 3 further comprising a steering mechanism at the handle for controlling the steering of the distal tip section of said locator catheter.

5. The catheter system of claim 4, wherein said steering mechanism provides a plurality of deflectable curves on the distal tip section of said locator catheter.

6. The catheter system of claim 3, wherein the at least one electrode is selected from the group consisting of a cylindrical tip electrode, a ring electrode, a spiral electrode, and a mesh electrode.

7. The catheter system as in claim 3, further comprising said reference catheter being located outside the body of a patient.

8. The catheter system as in claim 3, further comprising said reference catheter being located inside the body of a patient, wherein said reference catheter comprises:

a delivery shaft having a distal end, a proximal end, and at least one lumen extending therebetween;

a handle attached to the proximal end of said delivery shaft;

a connector secured to the proximal end of said handle; and

a spiral element being located within the delivery shaft under non-deployed state.

9. The catheter system as in claim 6, further comprising a material of said electrode being selected from the group of platinum, iridium, gold, silver, tungsten, stainless steel, and Nitinol.

10. A method for operating a catheter system to contact a target tissue in a heart chamber for an electrophysiology study, the catheter system comprising a locator catheter comprising a catheter shaft having a distal tip section, a distal end, a proximal end and at least one lumen extending therebetween, wherein at least one electrode is secured at said distal tip section;

a handle attached to the proximal end of said catheter shaft;

an ultrasound crystal secured on the catheter shaft proximal to the distal end;

a connector secured to the proximal end of said handle; and

a reference catheter comprising at least three ultrasound crystal beacons which have pre-determined locations with reference to an external locating calibration system, wherein at least one beacon is movable on said reference catheter and controllable by a beacon deployment mechanism at the handle and said ultrasound beacons can emit and receive ultrasound signals;

the method comprising the steps of;

percutaneously introducing the reference catheter under non-deployed state through a blood vessel to the heart chamber;

deploying the catheter to position the at least three ultrasound crystal beacons;

locating the at least three ultrasound crystal beacons in reference to an external calibration system;

constantly calibrating the location of the crystal beacons on the reference catheter;

percutaneously introducing the locator catheter through a blood vessel to the heart chamber;

deflecting the distal section of said locator catheter about a transverse axis to position the tip section;

determining the coordinates of the locator catheter; and

intimately contacting the electrode with the target tissue for an electrophysiology study.

11. The method for operating a catheter system to contact a target tissue in a heart chamber for an electrophysiology study as in claim 10, the catheter system further comprising a RF generator, wherein radiofrequency current is delivered to the target tissue through the at least one electrode.

12. The method for operating a catheter system to contact a target tissue in a heart chamber for an electrophysiology study as in claim 10, wherein said ultrasound crystal beacons on the reference catheter are made of piezoelectric materials.

13. The method for operating a catheter system to contact a target tissue in a heart chamber for an electrophysiology study as in claim 10, wherein the shape of said ultrasound crystal beacons on the reference catheter is selected from the group consisting of a cylinder, a donut, a ring, a spiral, and a mesh.

14. The method for operating a catheter system to contact a target tissue in a heart chamber for an electrophysiology study as in claim 10, further comprising a steering mechanism at the handle of the locator catheter for controlling the steering of the distal tip section of said locator catheter.

15. The method for operating a catheter system to contact a target tissue in a heart chamber for an electrophysiology study as in claim 14, wherein said steering mechanism provides a plurality of deflectable curves on the distal tip section of said locator catheter.

16. The method for operating a catheter system to contact a target tissue in a heart chamber for an electrophysiology study as in claim 10, wherein the at least one electrode is selected from the group consisting of a cylindrical tip electrode, a ring electrode, a spiral electrode, and a mesh electrode.