Ultrasonic marked cardiac ablation catheter

• US 5,840,030 A
• Filed: 06/21/1996
• Issued: 11/24/1998
• Est. Priority Date: 12/22/1993
• Status: Expired due to Fees

• Current Assignee: Sulzer Osypka GmbH
• Original Assignee: Sulzer Osypka GmbH
• Inventors: Cikes, Ivo, Ferek-Petric, Bozidar, Breyer, Branko
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/666,508
• Time in Patent Office: 886 Days
• Field of Search: 128/642, 128/660.03, 128/662.06, 607/9, 607/122, 600/439
• US Class Current: 600/439
• 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 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3929 Active markers
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• 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

A method and system for therapy of cardiac arrythmias is provided which uses a directional electric field applied via ablation electrode for cardiac ablation together with an ultrasonic imaging system including an ultrasonic marking transducer mounted fixedly in the vicinity of the ablation electrode and having ultrasonic sensitivity characteristics either in the same direction as the ablation field or in some other direction determined by a certain defined angle relative to the direction of the ablation field.

Claims

1. A cardiac ablation device comprising

an axially elongated catheter body (10, 28, 31, 35, 41, 57, 60, 71) for implantation in the human heart and having an ablation electrode (12, 34, 40, 55, 64, 70) adapted for contacting the heart;

said catheter body including an ultrasonic transducer assembly (13, 36, 42, 58, 62,

     72) at a location adjacent to said ablation electrode;

said catheter body including two electrical conductors (46,

     49), which are provided with terminals at the proximal end of the catheter, and which are adapted for transmitting a high frequency electrical signal to and from said transducer assembly (42) and for transmitting an ablation signal to said electrode (40);

said transducer assembly (13, 36, 42, 58, 62,

     72) being adapted to produce, in a direction radial to said axially elongated body at the location of the transducer assembly, a directional acoustic ultrasonic field (29, 32,

     65) when supplied with said high frequency electrical signal and said ablation electrode (12, 34, 40, 55, 64,

     70) being adapted to produce in a direction radial to said axially elongated catheter body at the location of the transducer assembly, a directional electric ablation field (30, 33,

     66) when supplied with said ablation signal; and

said transducer assembly and said ablation electrode being arranged in a predetermined mutual positional relationship so that the radial direction in which said electric ablation field is produced is exactly determined relative to the radial direction in which said acoustic ultrasonic field is produced.

2. Device according to claim 1, wherein direction of said electric ablation field (30) can be determined within the structures of the heart whenever direction of said acoustic field (29) within the structures of the heart is determined by means of processing of said electrical signal from said ultrasonic field, said processing providing the marker within an echocardiographic image pointing the direction of said acoustic field towards the echocardiographic scanner probe (27).

3. Device according to claim 1, wherein said ablation electrode (12, 34, 40, 55, 64, 70) is a plate of a maximum width of one quarter of the circumference of said catheter body.

4. Device according to claim 1, wherein said transducer assembly (13, 36, 42, 58, 62) comprises a platelet of a width of approximately one quarter of the circumference of said catheter body, and which is made of piezoelectric material having two metallized layers (37/38, 43/44) being the transducer electrodes polarizing said transducer in radial direction relatively to said catheter body.

5. Device according to any of claim 4, wherein said transducer assembly is a platelet having width and length such as to generate a directive characteristic (29, 32, 65) at its operation frequencies, the directivity of the main lobe not exceeding 60 degrees.

6. Device according to claim 4, wherein said piezoelectric platelet (36, 42) is covered on the outer side by an insulating and isolating layer (39, 45).

7. Device according to claim 1, having said electrode and said transducer assembly positioned near the tip of said catheter body (11, 56, 63, 73).

8. Device according to claim 1, wherein the mutual distance between the said ablation electrode and the said ultrasonic transducer assembly is less than half of the length of said transducer assembly.

9. Device according to claim 1, wherein the axis of the directivity of said electric ablation field (66) and the axis of the directivity of said acoustic ultrasonic field (65) coincide.

10. Device according to claim 1, wherein the axis of the directivity of said electric ablation field (30, 33) and the axis of the directivity of said acoustic ultrasonic field (29, 32) are at any fixed azimuthal angle including 180 degrees.

11. Device according to claim 1, wherein said electrode and said transducer assembly do not protrude unessentially from the outside profile of said catheter body.

12. Device according to claim 1, wherein said transducer assembly comprises a cylindrical array of piezoelectric transducers (75, 76, 77, 78) facing in all azimuthal directions.

13. Device according to claim 12, wherein each of said piezoelectric transducers (75, 76, 77, 78) comprises two metallized layers (81/82, 83/84, 85/86, 87/88) being the transducer electrodes polarizing said transducers in radial direction relatively to said catheter body.

14. Device according to claim 12, wherein said transducers (75, 76, 77, 78) are fixed onto a reinforcement tubelet or rig (80, 90) by means of the conductive adhesive joint (79) which electrically connects the inner array of said transducer electrodes (81, 83, 85, 87) with said reinforcement (80, 90).

16. Device according to claim 1 further comprising

an electronic circuit means connectable or connected to said ablation electrode and to said transducer assembly, capable of transmitting signals into and receiving signals from said transducer assembly and said ablation electrode, in order to utilize said signals from said transducer for ranging and position assessment relative to outside and internal bodily structures.

17. Device according to claim 16, wherein said electronic circuit means are utilized for ablation procedure steering and measurement, in particular steering of the moment of the release of the ablation energy.

18. Device according to claim 16, wherein said electronic circuit means within an outside ultrasonic scanner connected to ablation energy generator are capable to localise an area in the ultrasonic echographic image only within which the release of ablation energy is required.

19. Device according to claim 16, wherein said piezoelectric transducer assembly is connected to said electronic circuit means via the said lengthwise conductors whereby said electronic circuit means being capable of detecting incoming electrical signals received from said piezoelectric transducer assembly and representing ultrasonic pulses.

20. Device according to claim 16, wherein said piezoelectric transducer assembly connected to said electronic circuit means via said lengthwise conductors whereby said electronic circuit means being capable of transmitting electrical signals to said transducer assembly for producing ultrasonic pulses.

21. Device according to claim 16, wherein said piezoelectric transducer assembly is connected to said electronic circuit means via the said lengthwise conductors whereby said electronic circuit means being capable of detecting incoming electrical signals received from said piezoelectric transducer assembly and representing ultrasonic pulses and whereby said electric circuit means being capable of transmitting electrical signals to said transducer assembly for producing ultrasonic pulses.

22. Device according to claim 21, wherein said electronic circuit means being capable of utilising said transmitted and received electrical signals for localisation of the position of said ablation electrode by means of A mode ranging.

23. Device according to claim 22, wherein said electronic circuit means being capable of utilising said transmitted and received electrical signals for localisation of the position of said ablation electrode by means of being capable of detection of coincidence of a predetermined position in either A, B, or M mode or velocity as measured in conjunction with outside ultrasonic scanner with the operators request for delivery of the ablation energy being satisfied only in case of such a coincidence.

24. Device according to claim 23, wherein said electronic circuit means being capable to generate electrical signals for producing ultrasound pulses and to detect echoes (150, 151, 152) from heart structures by means of transmission and reception of electrical signals representing ultrasonic pulses.

25. Device according to claim 23, wherein said electronic circuit means being capable to measure the distance (153) between said transducer (62) and the heart tissue (61).

26. Device according to claim 25, wherein said electronic circuit means being capable to generate a proximity function (155), characterising the variation of said distance (153) in time.

27. Device according to claim 23, wherein said electronic circuit means being capable to detect the QRS complex of the electrocardiogram (154).

28. Device according to claim 21, wherein said electronic circuit means being capable of utilising said transmitted and received electrical signals for localisation of the position of said ablation electrode by means of M mode distance measurement.

29. Device according to claim 21, wherein said electronic circuit means being capable of utilising said transmitted and received electrical signals for localisation of the position of said ablation electrode by means of introduction into B mode two dimensional image.

30. Device according to claim 21, wherein said electronic circuit means being capable of utilising said transmitted and received electrical signals for localisation of the position of said ablation electrode by means of Doppler velocity measurement.

33. Device according to claim 30, wherein said power of said ablation signal is delivered to said ablation electrode only when said transducer assembly is in proximity to said heart tissue.

15. A cardiac ablation device comprising

an axially elongated catheter body (10, 28, 31, 35, 41, 57, 60, 71) for implantation in the human heart and having an ablation electrode (12, 34, 40, 55, 64, 70) adapted for contacting the heart;

said catheter body including an ultrasonic transducer assembly (13, 36, 42, 58, 62,

     72) at a location adjacent to said ablation electrode;

said catheter body including two electrical conductors (46,

     49), which are provided with terminals at the proximal end of the catheter and which are adapted for transmitting a high frequency electrical signal to and from said transducer assembly (42) and for transmitting an ablation signal to said electrode (40);

said transducer assembly (13, 36, 42, 58, 62,

     72) being adapted to produce a directional acoustic ultrasonic field (29, 32,

     65) when supplied with said high frequency electrical signal and said ablation electrode (12, 34, 40, 55, 64,

     70) being adapted to produce a directional electric ablation field (30, 33,

     66) when supplied with said ablation signal;

said transducer assembly and said ablation electrode being arranged in a predetermined mutual positional relationship so that the direction of said electric ablation field is determined relative to the direction of said acoustic ultrasonic field;

wherein said transducer assembly comprises a cylindrical array of piezoelectric transducers (75, 76, 77,

     78) facing in all azimuthal directions;

wherein said transducers (75, 76, 77,

     78) are fixed onto a reinforcement tubelet or rig (80,

     90) by means of the conductive adhesive joint (79) which electrically connects the inner array of said transducer electrodes (81, 83, 85,

     87) with said reinforcement (80,

     90); and

wherein said transducers of said array are connected to the proximal end of said catheter body via lengthwise conductors (99, 102,

     104) running along and inside of the said catheter body and being connected to outer array of said transducer electrodes (98, 95,

     97) by means of joints (101, 103,

     105), said conductors being adapted to transmit high frequency ultrasonic signals to and from said transducer array, in such a way as that the signal of each single transducer of said transducer array is provided between said reinforcement and each single of said lengthwise conductors respectively.

31. A cardiac ablation device comprising

an axially elongated catheter body (10, 28, 31, 35, 41, 57, 60, 71) for implantation in the human heart, having an ablation electrode (12, 34, 40, 55, 64, 70) adapted for contacting the heart;

said catheter body including an ultrasonic transducer assembly (13, 36, 42, 58, 62,

     72) at a location adjacent to said ablation electrode;

said catheter body including two conductors (46,

     49), which are provided with terminals at the proximal end of the catheter, and are adapted for transmitting a high frequency electrical signal to and from said transducer assembly (42) and for transmitting an ablation signal to said electrode (40);

said transducer assembly (13, 36, 42, 58, 62,

     72) being adapted to produce a directional acoustic ultrasonic field (29, 32,

     65) when supplied with said high frequency electrical signal and said ablation electrode (12, 34, 40, 55, 64,

     70) being adapted to produce a directional electric ablation field (30, 33,

     66) when supplied with said ablation signal;

said transducer assembly and said ablation electrode being arranged in a predetermined mutual positional relationship so that the direction of said electric ablation field is determined relative to the direction of said acoustic ultrasonic field;

wherein said transducer assembly comprises a cylindrical array of piezoelectric transducers (75, 76, 77,

     78) facing in all azimuthal directions;

an electronic circuit means for connection to said ablation electrode and to said transducer assembly and for transmitting signals to and receiving signals from said transducer assembly and said ablation electrode, and for using said signals from said transducer for ranging and position assessment relative to outside and internal bodily structures;

said piezoelectric transducer assembly being connected to said electronic circuit means via lengthwise conductors whereby said electronic circuit means detects incoming electrical signals received from said piezoelectric transducer assembly representing ultrasonic pulses and whereby said electronic circuit means is capable of transmitting electrical signals to said transducer assembly for producing ultrasonic pulses;

said electronic circuit means being capable of utilizing said transmitted and received electrical signals for localization of the position of said ablation electrode by means of A mode ranging;

said electronic circuit means being further capable of utilizing said transmitted and received electrical signals for localization of the position of said ablation electrode by detection of coincidence of a predetermined position in either A, B, or M mode or velocity as measured in conjunction with an outside ultrasonic scanner, an operators request for delivery of the ablation energy being satisfied only in case of such a coincidence;

said electronic circuit means is capable of measuring the distance (153) between the said transducer (62) and the heart tissue (61), and of generating a proximity function (155), characterizing the variation of said distance (153) in time; and

wherein said electronic circuit means is capable of identifying crossing of said proximity function (155) over a preset and adjustable levels (156) within the measured distance (153).

32. Device according to claim 31, wherein said electronic circuit means being capable to modulate the power (157) of said ablation signal in such a way as to said power to appear only within a time interval between the time points (158, 159) wherein said proximity function (155) crosses the predetermined trigger level (156).

34. A cardiac ablation catheter apparatus comprising

a catheter body having an elongation axis and adapted for implantation in a human heart,

ablation means, mounted with said catheter body, for receiving ablation energy from an ablation energy source and for generating an ablation field for ablating tissue,

said catheter body further mounting a transducer operable for generating an ultrasonic field for monitoring the proximity of said ablation electrode to tissue,

electronic circuit means, electrically connected to said transducer and to said ablation means, for monitoring the proximity of said ablation means to tissue and for modulating the ablation of tissue by said ablation means within the cardiac cycle in response to a selected proximity of said ablative means to tissue.

35. The apparatus of claim 34 wherein said electronic circuit means includes means for continuously monitoring the proximity of said ablation electrode to tissue.

36. The apparatus of claim 34 wherein said ablation means includes an electrode and wherein said ablation field includes an electric field generated by said electrode.

37. The cardiac ablation catheter apparatus of claim 36 wherein said ablation electrode generates a directional ablation electric field in first known direction relative to the catheter body, and wherein said transducer generates an ultrasonic field along a second known direction relative to the catheter body and having a known direction relative to the first direction of the ablation field.

38. The cardiac ablation catheter apparatus of claim 37 wherein said transducer generates a directional ultrasonic field, and wherein said first and second known directions are radial to said catheter body.

39. The cardiac ablation catheter apparatus of claim 36 wherein said electronic circuit means modulates the ablation energy received by said ablation electrode such that the ablation electrode ablates tissue only when said ablation electrode is within a selected distance of the tissue.

40. A cardiac ablation catheter apparatus comprising

a catheter body having an elongation axis and adapted for implantation in a human heart and adapted for twisting about the elongation axis,

said catheter body mounting an ablation means for receiving ablation energy for generating, in a known first direction, a directional tissue ablating field, said first direction being radial to the elongation axis of the catheter body, and

said catheter body further mounting a marker transducer operable for generating a directional ultrasonic field along a second known direction radial to the catheter body, said second direction being known relative to said first direction, such that said ablation field generated by said ablation means can be directed to a preferred volume of tissue by imaging said marker transducer and radially twisting the catheter body.

41. The apparatus of claim 40 wherein said ablation means includes an ablation electrode and wherein said ablation field includes an electric field generated by said ablation electrode.

42. A method for directing an ablation field toward a preferred cardiac tissue volume, comprising the steps of

providing a catheter body elongated along an elongation axis and adapted for implantation in a heart and adapted for twisting about the elongation axis,

mounting with the catheter body an ablation electrode for receiving ablation energy for generating, in a known first direction radial to the elongation axis of the catheter body, a directional ablation field,

mounting with the catheter body a marker transducer for producing, along a known second direction radial to the catheter body, a directional marker field, the known second direction being known relative to the known first direction,

implanting the catheter body and the ablation electrode and marker transducer

mounted therewith into the heart

imaging the marker field, and

positioning the ablation electrode such that the ablation field generated thereby is directed toward the preferred tissue volume by radially twisting the catheter in response the image of the marker field and the known first and second directions and the relationship therebetween.

43. A method for ablating cardiac tissue, comprising the steps of

providing a catheter body elongated along an elongation axis and adapted for implantation in a heart,

mounting with the catheter body an ablation electrode for placement proximate to tissue, the ablation electrode for adapted for receiving ablation energy for generation of an ablation field,

mounting with the catheter body a marker transducer for producing a marker field for monitoring the proximity of said ablation electrode to cardiac tissue,

implanting the catheter body, including the ablation electrode and marker transducer mounted therewith, into the heart,

supplying ablative energy to the ablation electrode for ablating tissue,

monitoring the proximity of the ablation electrode to the tissue to be ablated, and

modulating the ablation of tissue by the ablative electrode with the cardiac cycle in response to a preselected proximity of the ablative electrode to the tissue.

44. The method according to claim 43 wherein the step of implanting the catheter body includes the step of imaging the marker field generated by the marker transducer to facilitate directing the ablative field towards the tissue to be ablated.

45. The method according to claim 44 wherein the ablation electrode is adapted for generating, in a known first direction, a directional tissue-ablating electric field, said first direction being radial to the elongation axis of the catheter body, and wherein the marker transducer is adapted for generating, along a second known direction radial to the catheter body, a directional ultrasonic field, said second direction being known relative to said first direction, and wherein the step of positioning the ablative electrode adjacent includes radially twisting the catheter body, in response the image of the marker field and the known first and second directions, including the relationship therebetween, to place the ablation electrode adjacent tissue to be ablated.

46. The method according to claim 43 wherein the step of modulating includes the step of generating an ablation field only when the ablation electrode is within a selected distance of the tissue to be ablated.