Catheter having ultrasonic device

• US 5,606,974 A
• Filed: 05/02/1995
• Issued: 03/04/1997
• Est. Priority Date: 05/02/1995
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Heart Rhythm Technologies, Inc. (Boston Scientific Corporation)
• Inventors: Maahs, Tracy D., Hayzelden, Robert C., Castellano, Thomas M.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/434,004
• Time in Patent Office: 672 Days
• Field of Search: 128/662.03, 128/662.06, 607/97, 607/101, 607/102, 601/2, 601/3, 604/22
• US Class Current: 600/462
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00243 cardiac

Abstract

A catheter includes a piezoelectric transducer mounted to the distal end of a catheter. In one embodiment, the piezoelectric transducer has the shape of a cylinder and in another embodiment, a convex shape with a mounting flange. In the cylindrical shape, a plurality of surface mounted temperature sensors are disposed within the piezoelectric transducer. The sensors are electrically insulated and a sealing technique prevents the leakage of body fluids from penetrating the interior of the catheter through the sensor bores. The cylindrical transducer is supported on mounting members so that it is accurately mounted and sealed while at the same time, the material used does not significantly dampen the transducer. The convex shape includes a temperature sensor at its tip.

Claims

1. A catheter comprising:

an elongated catheter tube having proximal and distal ends and an inner lumen extending the length of the tube;

an ultrasonic transducer mounted at the distal end of the catheter tube, the transducer having a wall with inner and outer surfaces, the transducer having a plurality of sensor holes formed completely through the wall of the transducer;

a temperature sensing device disposed within each sensor hole in the wall of the transducer; and

an adhesive disposed over each sensor hole on the outer surface of the transducer to seal the hole and the respective temperature sensing device thereby sealing the temperature sensing device from contact with fluids exterior to the transducer.

2. The catheter of claim 1 further comprising a flexible sheath disposed in and in contact with the sensor hole in the wall of the transducer wherein;

the temperature sensing device is disposed within the sheath in the wall of the transducer; and

the adhesive is disposed over the sensor hole on the outer surface of the transducer to seal the hole and disposed in contact with the interior of the sheath in contact with the temperature sensing device affixing the temperature sensing device and the sheath in the sensor hole and sealing the temperature sensing device from contact with fluids exterior to the sheath.

3. The catheter of claim 2 wherein:

the temperature sensing device comprises an electrical lead;

the flexible sheath has a length selected to be longer than the thickness of the wall of the transducer with the sheath disposed so that the extra length is disposed inside the transducer to provide a strain relief to the leads of the sensing device.

4. The catheter of claim 1 wherein the temperature sensing devices each comprises a thermocouple located substantially level with the outer surface of the transducer.

5. The catheter of claim 1 further comprising a matching layer disposed over the outer surface of the transducer, the properties of the matching layer selected to better match the ultrasonic transducer to tissue to which it may contact.

6. The catheter of claim 1 further comprising:

electrodes formed on the outer and inner surfaces of the transducer to conduct electrical signals to the transducer for excitation of the transducer; and

electrode leads for conducting electrical signals to and from the electrodes.

7. The catheter of claim 1 wherein:

the catheter further comprises an internal mounting member;

the ultrasonic transducer is mounted to the internal mounting member by an elastomeric member that positions the transducer properly in relation to the catheter and isolates the transducer mechanically from the catheter so that transducer vibrations are not significantly damped.

8. The catheter of claim 7 wherein:

the transducer has a hollow, cylindrical form;

the mounting member comprises two elastomeric members spaced apart from each other to properly align the transducer in the catheter and to isolate the transducer mechanically from the catheter so that transducer vibrations are not significantly damped.

9. The catheter of claim 8 further comprising:

an end member and a shaft member;

a first spacing member disposed between the transducer and the shaft member; and

a second spacing member disposed between the transducer and the end member;

wherein the first and second spacing members comprise a sealing and non-damping material that seals the interior of the catheter from external fluids and also isolates the transducer mechanically from the catheter so that transducer vibrations are not significantly damped.

10. The catheter of claim 1 wherein the wall of the cylindrical transducer comprises three sensor holes located 120 degrees apart.

11. A catheter comprising:

an elongated catheter tube having proximal and distal ends and an inner lumen extending the length of the tube;

a hollow, cylindrical piezoelectric transducer mounted at the distal end of the catheter tube, the transducer having a wall and inner and outer surfaces;

an internal mounting member;

one or more sensor holes formed completely through the wall of the transducer;

a temperature sensing device disposed within one or more of the sensor holes in the wall of the transducer; and

wherein the cylindrical ultrasonic transducer is mounted to the internal mounting member by an elastomeric member that positions the transducer properly in relation to the catheter and isolates the transducer mechanically from the catheter so that transducer vibrations are not significantly damped.

12. The catheter of claim 11 wherein:

the mounting member comprises two elastomeric members spaced apart from each other to properly align the transducer in the catheter and to isolate the transducer mechanically from the catheter so that transducer vibrations are not significantly damped.

13. The catheter of claim 11 further comprising:

an end member and a shaft member;

a first spacing member disposed between the transducer and the shaft member; and

a second spacing member disposed between the transducer and the end member;

wherein the first and second spacing members comprise a sealing and non-damping material that seals the interior of the catheter from external fluids and also isolates the transducer mechanically from the catheter so that transducer vibrations are not significantly damped.

14. The catheter of claim 11 further comprising:

an electrode formed on the outer surface of the transducer to conduct electrical signals to the transducer for excitation of the transducer;

an electrode lead for conducting electrical signals to and from the electrode;

wherein the electrode is selected and mounted to the transducer to receive electrical signals from outside the transducer and conduct those signals to the electrode lead.

15. The catheter of claim 11 further comprising:

a matching layer disposed over the outer surface of the transducer and over each sensor hole and sensing device, the properties of the matching layer selected to better match the ultrasonic transducer to tissue to which it may contact.

16. The catheter of claim 11 further comprising:

a thermally conductive adhesive disposed over each sensor hole on the outer surface of the transducer to seal the hole and the respective temperature sensing device thereby sealing the temperature sensing device from contact with fluids exterior to the transducer.

17. A catheter comprising:

an elongated catheter tube having proximal and distal ends and an inner lumen extending the length of the tube;

a mounting member disposed in the distal end; and

a hollow, piezoelectric transducer having a convex shape with an integral mounting flange, the transducer having a wall and inner and outer surfaces;

wherein the integral mounting flange of the transducer is mounted at the distal end of the catheter tube on the mounting member distal to the catheter tube so that the transducer forms the distal tip of the catheter.

18. The catheter of claim 17 wherein the ultrasonic transducer is mounted to the mounting member by an elastomeric member that positions the transducer properly in relation to the catheter, seals the catheter from the entry of external fluids, and isolates the transducer mechanically from the catheter so that transducer vibrations are not significantly damped.

19. The catheter of claim 18 further comprising:

an electrode formed on the outer surface of the transducer to conduct electrical signals to the transducer for excitation of the transducer;

an electrode lead for conducting electrical signals to and from the electrode;

wherein the electrode is selected and mounted to the transducer to receive electrical signals from outside the transducer and conduct those signals to the electrode lead.

20. The catheter of claim 19 further comprising:

a sensor hole formed completely through the wall of the transducer;

a temperature sensing device disposed within the sensor hole in the wall of the transducer; and

a thermally conductive adhesive disposed over the sensor hole on the outer surface of the transducer to seal the hole and the respective temperature sensing device thereby sealing the temperature sensing device from contact with fluids exterior to the transducer.

21. A catheter comprising:

an elongated catheter tube having proximal and distal ends and an internal mounting member at the distal end of the tube;

a hollow, cylindrical piezoelectric transducer mounted axially around the internal mounting member of the catheter tube, the transducer having a wall with inner and outer surfaces;

an elastomeric member positioned between the internal mounting member of the catheter tube and the inner surface of the wall of the transducer, said elastomeric member positioning the transducer properly in relation to the catheter and isolating the transducer mechanically from the catheter so that transducer vibrations are not significantly damped.

22. The catheter of claim 21, wherein the elastomeric member comprises one or more elastomeric O-rings.

23. The catheter of claim 22, wherein the catheter tube further comprises:

one or more retainer grooves in the internal mounting member;

wherein the O-rings are mounted in said retainer grooves.

24. The catheter of claim 21, further comprising:

one or more sealant beads positioned between the piezoelectric transducer and the catheter tube.