Endocardial mapping and ablation system and catheter probe

• US 5,279,299 A
• Filed: 07/24/1992
• Issued: 01/18/1994
• Est. Priority Date: 02/15/1991
• Status: Expired due to Fees

• Current Assignee: Cardiac Pathways Corp. (Boston Scientific Corporation)
• Original Assignee: Cardiac Pathways Corp. (Boston Scientific Corporation)
• Inventors: Imran, Mir A.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US07/919,198
• Time in Patent Office: 543 Days
• Field of Search: 128/642, 128/786, 128/419 P
• US Class Current: 600/393
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• 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 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00107 Coatings on the energy applicator
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00869 Phase
• CPC Class Codes: A61B 2018/0091 Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1435 Spiral
• 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 5/6858 : with a distal basket, e.g. expandable basket
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems
• CPC Class Codes: Y10T 29/49222 : forming array of contacts or terminals
• CPC Class Codes: Y10T 29/49877 : of flexible wall, expansible chamber devices [e.g., bellows]

Abstract

Endocardial mapping and/or ablation system for introduction into a chamber of the heart formed by a wall by passage through a lumen leading to the chamber in the heart having blood therein comprising a catheter probe with proximal and distal extremities and having an elongate tubular member with at least one lumen extending therethrough extending the length thereof and with a distal extremity. A plurality of longitudinally and radially spaced apart electrodes are provided. An expandable device is secured to the distal extremity of the flexible elongate tubular member and is movable between a contracted position and an expanded position. The electrodes are mounted on the expandable device whereby when the expandable device is moved to the expanded position in a chamber of the heart the electrodes are moved into engagement with the wall forming the chamber of the heart in which the expandable device is disposed. An elongate element is coupled to the expandable device for moving the expandable device between the contracted and expanded positions. The expandable device has spaces therein through which the blood can flow when the expandable device is in an expanded position. Leads are in contact with the electrodes and extending through the flexible elongate tubular member. Electrical apparatus is connected to the leads for performing electrical functions with respect to the electrodes.

Claims

1. An endocardial mapping and/or ablation system for introduction into a chamber of the heart formed by a wall by passage through a lumen leading to the chamber in the heart having blood therein, comprising a catheter probe having proximal and distal extremities and comprised of an elongate flexible tubular member having at least one lumen extending therethrough extending the length thereof and having a distal extremity, a plurality of longitudinally and radially spaced apart electrodes, expandable means secured to the distal extremity of the flexible elongate tubular member and being movable between a contracted position and an expanded position, means mounting said electrodes on said expandable means whereby when said expandable means is moved to the expanded position in the chamber in the heart the electrodes are moved substantially simultaneously into engagement with substantially all of the wall forming the chamber of the heart in which the expandable means is disposed, said electrodes being sufficiently numerous so that the entire wall of the heart forming the chamber can be mapped without rotation of the catheter probe, means coupled to the expandable means for moving said expandable means between said contracted and expanded positions, said expandable means having spaces therein when in the expanded position through which the blood can flow and permitting substantially normal blood flow in the chamber during beating of the heart, lead means for effecting electrical contact with the electrodes and extending into said flexible elongate tubular member and electrical means connected to said lead means for performing electrical functions with respect to said electrodes.

2. A system as in claim 1 wherein said expandable means is sufficiently flexible so as to cause said electrodes to remain in contact with the wall of the chamber while permitting movement of the wall of the heart during contraction and expansion of the chamber.

3. A system as in claim 1 wherein said expandable means is comprised of at least one flexible tubular member having an outer surface and an inner surface and wherein said electrodes are accessible solely from said outer surface and wherein said leads are insulated.

4. A system as in claim 1 wherein said expandable means includes a plurality of flexible elongate elements which are circumferentially spaced apart and have proximal and distal extremities, wherein said proximal extremities are interconnected and wherein said distal extremities are interconnected.

5. A system as in claim 1 wherein said electrical means includes means for recording mapping potentials encountered by the electrodes in contact with the wall of the heart forming the chamber.

6. A system as in claim 1 wherein said electrical means includes means for supplying a high voltage at high frequency to selected electrodes to cause ablation in a preselected location in the wall of the heart forming the chamber.

7. In an endocardial mapping and/or ablation system for introduction into a chamber of the heart formed by a wall by passage through a lumen leading to the chamber in the heart having blood therein, a catheter probe having proximal and distal extremities and comprised of a flexible elongate tubular member having at least one lumen extending therethrough extending the length thereof and having a distal extremity, a plurality of longitudinally and radially spaced apart electrodes, expandable means secured to the distal extremity of the flexible elongate tubular member and being movable between a contracted position and an expanded position, means mounting said electrodes on said expandable means whereby when said expandable means is moved to the expanded position in the chamber in the heart the electrodes are moved into engagement with the wall forming the chamber of the heart in which the expandable means is disposed, means coupled to the expandable means for moving said expandable means between said contracted and expanded positions, said expandable means having spaces therein when in the expanded position through which the blood can flow, leads in contact with the electrodes and extending into said flexible elongate tubular member and electrical means connected to said leads for performing electrical functions with respect to said electrodes, said expandable means including at least one flexible elongate element in the form of a helix.

8. An endocardial mapping and/or ablation system for introduction into a chamber of the heart formed by a wall through a vessel having a lumen leading to the chamber in the heart, comprising a catheter probe having proximal and distal extremities and comprised of a flexible elongate tubular element having at least one lumen extending therethrough and extending the length thereof, a flexible cylindrical member secured to the distal extremity of the flexible elongate tubular element and movable between contracted and expanded positions, said cylindrical member having a plurality of circumferentially spaced-apart flexible arms having proximal and distal extremities which are secured to and form part of the cylindrical member, said arms having outer and inner surfaces, a plurality of longitudinally spaced apart electrodes carried by each of said arms on the outer surfaces of the arms and lead means for effecting electrical contact with the electrodes and secured to said arms and extending into the flexible elongate tubular element, said arms of said cylindrical member being capable of being bowed outwardly to cause said electrodes carried thereby to come into contact with the wall of the heart forming the chamber, said arms being sufficiently flexible to remain in contact with the wall of the chamber while permitting movement of the wall during contraction and expansion of said chamber, said electrodes being sufficiently numerous so that the entire wall of the heart forming the chamber can be mapped without rotation of the catheter probe.

9. A system as in claim 8 wherein said arms include spring-like members disposed within the same permitting yieldable movement of said arms as said arms are moved into engagement with the wall forming the chamber of the heart.

10. A system as in claim 9 wherein said spring-like members are proportioned to cause predetermined yieldable movement of portions of said arms.

11. A system as in claim 10 wherein said spring-like members are proportioned to cause the arms to bow outwardly in a predetermined shape to thereby more closely approximate the conformation of the extremities of said chamber in the heart.

12. A system as in claim 8 together with means coupled to said lead means for performing electrical functions with respect to said electrodes.

13. An endocardial mapping and/or ablation system for introduction into a chamber of the heart formed by a wall through a vessel having a lumen leading to the chamber in the heart, comprising a catheter probe having proximal and distal extremities and comprised of a flexible elongate tubular element having at least one lumen extending therethrough and extending the length thereof, a flexible cylindrical member secured to the distal extremity of the flexible elongate tubular element and movable between contracted and expanded positions, said cylindrical member having a plurality of circumferentially spaced flexible arms having proximal and distal extremities which are secured to and form part of the cylindrical member, said arms having outer and inner surfaces, a plurality of longitudinally spaced apart electrodes carried by each of said arms on the outer surfaces of the arms and lead means for effecting electrical contact with the electrodes and secured to said arms and extending into the flexible elongate tubular element, said arms of said cylindrical member being capable of being bowed outwardly to cause said electrodes carried thereby to come into contact with the wall of the heart forming the chamber, said arms being sufficiently flexible to remain in contact with the wall of the chamber while permitting movement of the wall during contraction and expansion of said chamber, said electrodes being sufficiently numerous so that the entire wall of the heart forming the chamber can be mapped without rotation of the catheter probe, electrical means coupled to said lead means for performing electrical functions with respect to said electrodes, said electrical means coupled to said lead means including a multiplexer mounted within the catheter probe and coupled to said lead means and a demultiplexer remote from the catheter probe connected to the multiplexer in the catheter probe.

14. A system as in claim 13 wherein the demultiplexer is connected to the multiplexer by leads extending through a lumen in the flexible elongate tubular element.

15. A system as in claim 13 for use in ablation as well as mapping and wherein said electrodes on said arms are provided in bipolar pairs and wherein said electrical means includes a high voltage source for supplying high voltage to at least one selected bipolar pair to cause ablation in the wall of the chamber in a preselected location.

16. A system as in claim 15 wherein said high voltage source supplies a multiplexed voltage to the catheter probe and wherein said catheter probe includes a high voltage demultiplexer in close proximity to the cylindrical member and connected to the high voltage multiplexer.

17. A system as in claim 16 together with a pull wire extending through said at least one lumen and through said cylindrical member and adapted to engage the distal extremity of said cylindrical member for causing movement of the distal extremity axially toward the proximal extremity of the cylindrical member for causing the outward bowing of the arms, the leads connecting the multiplexer to the demultiplexer extending through a lumen in said flexible elongate tubular element, said flexible elongate tubular element being provided with a mandrel, said mandrel having a hole extending therethrough, said pull wire extending through said flexible elongate tubular element and through said cylindrical member and through the hole in the mandrel, said pull wire having an enlargement on the distal extremity thereof so that it cannot be pulled through the hole in the mandrel and serving to move the distal extremity of the cylindrical member toward the proximal extremity to cause movement of the cylindrical member from its normal contracted position to an expanded position.

18. An endocardial mapping and/or ablation system for introduction into a chamber of the heart formed by a wall through a vessel having a lumen leading to the chamber in the heart, comprising a catheter probe having proximal and distal extremities and comprised of a flexible elongate tubular element having at least one lumen extending therethrough and extending the length thereof, a flexible cylindrical member secured to the distal extremity of the flexible elongate tubular element and movable between contracted and expanded positions, said cylindrical member having a plurality of circumferentially spaced flexible arms having proximal and distal extremities which are secured to and form part of the cylindrical member, said arms having outer and inner surfaces, a plurality of longitudinally spaced apart electrodes carried by each of said arms on the outer surfaces of the arms and lead means for affecting electrical contact in contact with the electrodes and secured to said arms and extending into the flexible elongate tubular element, said arms of said cylindrical member being capable of being bowed outwardly to cause said electrodes carried thereby to come into contact with the wall of the heart forming the chamber, said arms being sufficiently flexible to remain in contact with the wall of the chamber while permitting movement of the wall during contraction and expansion of said chamber, said cylindrical member comprising first and second mandrels having openings therein and wherein said cylindrical member is formed of a sheet of material having end portions which overlap each other and are secured to said first and second mandrels.

19. A catheter probe for use in endocardial mapping/and or ablation system comprising a flexible elongate element having proximal and distal extremities and having at least one lumen extending therethrough, a flexible cylindrical member secured to the distal extremity of the flexible elongate element and being movable between a normal contracted position and an expanded position, said cylindrical member having a plurality of circumferentially spaced apart longitudinally extending flexible arms having proximal and distal extremities which are secured to form a part of the cylindrical member, each of said arms having an outer surface and an inner surface, a plurality of spaced apart electrodes carried by said arms and being accessible solely from the outer surfaces of each of the arms and conductor means for effecting electrical contact including conductors carried by said arms connected to said electrodes and extending to the proximal extremity of the flexible elongate element.

20. A catheter probe as in claim 19 wherein said conductor means connected to the electrodes includes insulated conductors.

21. A catheter probe as in claim 19 wherein each of said arms includes a spring-like element disposed therein.

22. A catheter probe as in claim 21 wherein at least certain of said spring-like elements are provided with a predetermined configuration to provide a conformation to the arms as they are bowed outwardly so as to conform more closely to the wall of the chamber of the heart.

23. A catheter probe for use in endocardial mapping/and or ablation system comprising a flexible elongate element having proximal and distal extremities and having at least one lumen extending therethrough, a flexible cylindrical member secured to the distal extremity of the flexible elongate element and being movable between a normal contracted position and an expanded position, said cylindrical member having a plurality of circumferentially spaced apart longitudinally extending flexible arms having proximal and distal extremities which are secured to form a part of the cylindrical member, each of said arms having an outer surface and an inner surface, a plurality of spaced apart electrodes carried by said arms, conductor means for effecting electrical contact including conductors carried by said arms connected to said electrodes and extending to the proximal extremity of the flexible elongate element, said conductor means including a multiplexer, said multiplexer being disposed in close proximity to the cylindrical member and being connected to the conductors connected to the electrodes and leads extending from the multiplexer through a lumen to the proximal extremity of the flexible elongate element.

24. A catheter probe for use in endocardial mapping/and or ablation system comprising a flexible elongate element having proximal and distal extremities and having at least one lumen extending therethrough, a flexible cylindrical member secured to the distal extremity of the flexible elongate element and being movable between a normal contracted position and an expanded position, said cylindrical member having a plurality of circumferentially spaced apart longitudinally extending flexible arms having proximal and distal extremities which are secured to form a part of the cylindrical member, each of said arms having an outer surface and an inner surface, a plurality of spaced apart electrodes carried by said arms, conductor means for effecting electrical contact including conductors carried by said arms connected to said electrodes and extending to the proximal extremity of the flexible elongate element, a mandrel disposed in the distal extremity of the cylindrical member, said mandrel having a hole extending therethrough and a pull wire extending through said flexible elongate element and said cylindrical member and through the hole in the mandrel, said pull wire having an enlargement on the distal extremity thereof which is of a size so that it cannot be pulled through the hole in the mandrel and serving to move the distal extremity of the cylindrical member toward the proximal extremity of the cylindrical member when the pull wire is pulled to cause movement of the cylindrical member from its normal contracted position to an expanded position.

25. A catheter probe for use in endocardial mapping/and or ablation system for introduction into a chamber of the heart formed by a wall by passage through a lumen leading to the chamber in the heart, the catheter probe comprising an elongate tubular member having at least one lumen extending therethrough extending the length thereof and having a distal extremity, a plurality of longitudinally and radially spaced apart electrodes, expandable means for moving said electrodes into engagement with the wall secured to the distal extremity of the flexible elongate tubular member and being movable between a contracted position and an expanded position, said expandable means including at least one flexible elongate element in the form of a helix, means mounting said electrodes on said expandable means whereby when said expandable means is moved to the expanded position in a chamber in the heart the electrodes are moved into engagement with the wall forming a chamber of the heart in which the expandable means is disposed and means coupled to the expandable means for moving said expandable means between said contracted and expanded positions, said expandable means having spaces therein through which the blood can flow, means in contact with the electrodes and extending into said flexible elongate tubular member.

26. A catheter probe as in claim 25 wherein the means coupled to the expandable means includes first and second members rotatably mounted with respect to each other, one end of said flexible elongate element being secured to one of said first and second members and the other end of said flexible elongate element being secured to the other of said first and second members and torque wire means secured to one of said first and second members for causing rotation of said one member with respect to the other member for causing movement of said at least one flexible elongate element between contracted and expanded positions.