Shaped catheter device and method

• US 5,617,854 A
• Filed: 06/22/1994
• Issued: 04/08/1997
• Est. Priority Date: 06/22/1994
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Anand Munsif
• Inventors: Munsif, Anand
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/264,069
• Time in Patent Office: 1,021 Days
• Field of Search: 128/642, 607/119, 607/122, 607/123, 607/125, 607/148, 607/154, 607/156, 606/49-50
• US Class Current: 600/374
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00369 Heart valves
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: C08L 2201/12 Shape memory

Abstract

Pre-shaped cardiac catheters for mapping and selective ablation of a portion of cardiac circuitry includes a preshaped first curved portion for positioning around the ostium of coronary sinus and a second curved portion for maintaining the first curved portion in its desired position. The method involves introducing a catheter assembly, including a guide-wire and a preshaped catheter, to a location proximal the atrium. As the guide-wire is withdrawn from within the catheter, the catheter assumes its preshaped form at the target location. Alternatively, a catheter assembly, with or without a guide-wire, may be introduced to the target ablation site via a catheter sheath. The catheter includes an array of spaced apart electrodes on at least a portion of the catheter. Each electrode may be activated remotely to a preselected current level for a preselected time interval to ablate a target portion of cardiac circuitry adjacent the electrodes.

Claims

1. A cardiac catheter apparatus for treating atrial fibrillation by selectively mapping and ablating target endocardial portions of predefined cardiac circuitry in atrial cardiac chambers which comprises a plurality of individual preshaped catheters, each catheter comprising:

A. a preshaped, flexible, elongate tubular member manufactured of biocompatible shape memory material having a distal end and a proximal end and at least one lumen extending from said proximal end to said distal end;

B. a guide-wire slidably engaged within said lumen and extending an amount beyond said distal end of said tubular member;

C. a preshaped first curved portion at said distal end of said tubular member for positioning at a target portion of a cardiac chamber upon removal of said guide-wire;

D. a shaft at said proximal end of said tubular member;

E. a means for connecting said first curved portion and said shaft comprising at least one preshaped portion selected from the group consisting of one or more intermediate preshaped curved portions, one or more intermediate preshaped straight portions and combinations thereof;

F. an array of spaced-apart electrodes positioned around an outer surface of at least one part of at least one preshaped portion of said tubular member; and

G. insulated conductor means electrically connecting the individual electrodes to means outside of the catheter for selectively mapping and ablating electrically target portions of cardiac tissue adjacent said electrodes in said cardiac chamber;

said plurality of catheters including one catheter having a partially circular shaped distal portion, one catheter having a V-shaped distal portion, one catheter have a distal portion shaped for positioning horizontally of a cardiac chamber and one catheter having a distal portion shaped for positioning vertically of a cardiac chamber whereby lesions formed by the ablations produced by said plurality of catheters create an electrical maze pattern of the same type resulting from a surgical procedure for treating atrial fibrillation.

2. The cardiac catheter apparatus of claim 1 wherein said catheter having a partially circular shaped distal portion further includes second and third curved intermediate preshaped portions continuous with said first curved portion for securing said first curved portion around the ostium of the coronary sinus in a cardiac chamber upon the removal of said guide-wire and for increasing contact of said catheter with a target portion of tissue in said cardiac chamber.

3. The cardiac catheter apparatus of claim 1 wherein said catheter having a distal portion shaped for positioning vertically in a cardiac chamber further includes second and third intermediate curved portions continuous with said first curved portion and a notch positioned below said third curved portion, said notch being designed to fit a side of a mitral annulus located in a cardiac chamber thereby securing the catheter in position at said target portion.

4. The cardiac catheter apparatus of claim 1 wherein said plurality of catheters includes less than all of said preshaped catheters, said apparatus being effective to overcome atrial fibrillation by ablations which do not create said electrical maze pattern.

5. The cardiac catheter apparatus of claim 1, wherein the shape memory material comprises nitinol.

6. A cardiac catheter apparatus for treating atrial fibrillation by selectively mapping and ablating target endocardial portions of predefined cardiac circuitry in atrial cardiac chambers which comprises a plurality of individual catheter assemblies, each catheter assembly comprising:

A. a sheath assembly, including an elongate tubular sheath having a distal end and a proximal end and a lumen therethrough and a guide-wire slidably engaged within said lumen and extending an amount beyond said distal end of said sheath; and

B. a preshaped catheter manufactured of biocompatible shape memory material for slidable engagement within said lumen after said sheath is positioned proximal to a target portion of a cardiac chamber and after removal of said guide-wire, said catheter comprising;

1. a preshaped, flexible, elongate tubular member made of shape memory material having a distal end and a proximal end;

2. a preshaped first curved portion at said distal end for positioning at a target portion of a cardiac chamber;

3. a shaft at said proximal end of said catheter;

4. a means for connecting said first curved portion and said shaft comprising at least one preshaped portion selected from the group consisting of one or more intermediate preshaped curved portions, one or more intermediate preshaped straight portions and combinations thereof;

5. an array of spaced-apart electrodes positioned around an outer surface of at least one part of at least one preshaped portion of said catheter; and

6. insulated conductor means electrically connecting the individual electrodes to a means outside of said catheter for selectively recording and ablating electrically target portions of cardiac tissue adjacent said electrodes in said cardiac chamber;

said plurality of catheter assemblies including one assembly having a catheter having a partially circular shaped distal portion, one assembly having a catheter having a V-shaped distal portion, one assembly having a catheter having a distal portion shaped for positioning horizontally in a cardiac chamber and one assembly having a distal portion shaped for positioning vertically in a cardiac chamber whereby lesions formed by the ablations produced by said catheters create an electrical maze pattern of the same type resulting from a surgical procedure for treating atrial fibrillation.

7. The cardiac catheter apparatus of claim 6 wherein said catheter having a partially circular shaped distal portion further includes second and third curved intermediate preshaped portions continuous with said first curved portion for securing said first curved portion around the ostium of a coronary sinus in the right atrium and for increasing contact of said catheter with a target tissue portion in said atrium.

8. The cardiac catheter apparatus of claim 6 wherein said catheter having a distal portion shaped for positioning vertically in a cardiac chamber further includes second and third intermediate curved portions continuous with said first curved portion and a notch positioned below said third curved portion, said notch being designed to fit a side of the right atrium thereby securing the catheter in position at said target portion.

9. The cardiac catheter apparatus of claim 6 wherein each catheter assembly further includes a substantially solid dilator between said sheath and said lumen.

10. The cardiac catheter apparatus of claim 6 wherein said plurality of catheter assemblies includes less than all of said assemblies, said apparatus being effective to overcome atrial fibrillation by ablations which do not create said electrical maze pattern.

11. The cardiac catheter of claim 6, wherein the shape memory material comprises nitinol.

12. A method for treating atrial fibrillation by selectively disrupting predetermined target endocardial portions of predefined cardiac circuitry in atrial cardiac chambers which employs a plurality of cardiac catheters, each catheter comprising (I) a preshaped, flexible, elongate, tubular member manufactured of biocompatible shape memory material having a distal end and a proximal end and a lumen extending from said proximal end to said distal end;

(II) a guide-wire slidably engaged within said lumen and extending an amount beyond the distal end of said tubular member;

(III) a preshaped first curved portion at said distal end of said tubular member for positioning proximal to a target portion of an atrium upon removal of said guide-wire;

(IV) a shaft at the proximal end of said tubular member;

(V) a means for connecting said first curved portion and said shaft comprising at least one preshaped portion selected from the group consisting of one or more intermediate preshaped curved portions, one or more intermediate straight portions and combinations thereof;

(VI) an array of spaced-apart electrodes positioned around an outer surface of at least one part of at least one preshaped portion of said tubular member; and

(VII) insulated conductor means for electrically connecting the individual electrodes to a device outside of the catheter for selectively mapping and ablating electrically target portions of cardiac tissue adjacent said electrodes in said atrial cardiac chamber;

which method comprises the steps of;

A. introducing through a blood vessel a cardiac catheter containing a tubular member selected from the group consisting of a tubular member having a partially circular shaped distal portion, a tubular member having a V-shaped distal portion, a tubular member having a distal portion shaped for positioning horizontally in a cardiac chamber and a tubular member having a distal portion shaped for positioning vertically in a cardiac chamber into a cardiac chamber proximal to a target portion of said chamber;

B. removing said guide-wire from within said tubular member to shape said distal portion of said tubular member to its preshaped form;

C. recording one or more satisfactory depolarization potentials from the tissue at said target portion;

D. remotely activating at least one of the electrodes on said catheter to a preselected current level for a preselected time interval to selectively ablate said target portion of said cardiac circuitry to produce a lesion;

E. removing said catheter from said cardiac chambers; and

F. repeating steps A-D above sequentially with each individual catheter set forth in the group in A above other than the catheter used in step A above and repositioning said catheters for positioning horizontally and vertically in a cardiac chamber until steps A-E reproduce the pattern of lesions shown in FIGS. 13, 15, 19 and 21 with the exception that when said catheters are repositioned in a cardiac chamber, step A consists of reintroducing said guide wire and step D is omitted until said catheter is positioned proximal to its final target portion;

whereby the resultant multiple lesions create an electrical maze of the same type resulting from a surgical procedure for treating atrial fibrillation.

13. The method of claim 12 wherein the step of introducing at least one of said catheters is through a great vein until the tip of said guide-wire rests across a tricuspid valve.

14. The method of claim 12 wherein the step of introducing at least one of said catheters is through a blood vessel passageway selected from the group consisting of the superior vena cava and the inferior vena cava.

15. The method of claim 12 wherein the electrode is activated to said preselected current level using between about 15 volts and about 40 volts.

16. The method of claim 12 wherein the electrode is activated for a preselected time interval of between about 25 seconds and 35 seconds.

17. The method of claim 12 wherein step F consists of repeating steps A-D with less than all of the individual catheters set forth in Group A, said method being effective to overcome atrial fibrillation by ablations which do not create said electrical maze pattern.

18. The method for treating atrial fibrillation by selectively disrupting predetermined target endocardial portions of predefined cardiac circuitry in atrial cardiac chambers which employs a plurality of individual catheter assemblies, each catheter assembly comprising (A) a sheath assembly, including an elongate tubular sheath having a distal end and a proximal end and a lumen therethrough and a guide-wire slidably engaged within said lumen and (B) a preshaped catheter manufactured of biocompatible shape memory material for slidable engagement within said lumen after said sheath is positioned proximal to a target portion of a cardiac chamber and after removal of said guide-wire, said catheter comprising:

(1) a preshaped, flexible, elongate tubular member having a distal end and a proximal end;

(2) a preshaped first curved portion at said distal end for positioning proximal to a target portion of a cardiac chamber;

(3) a shaft at said proximal end of said catheter;

(4) a means for connecting said first curved portion and said shaft comprising at least one preshaped portion selected from the group consisting of one or more intermediate preshaped curved portions, one or more intermediate preshaped straight portions and combinations thereof;

(5) an array of spaced-apart electrodes positioned around an outer surface of at least one part of at least one preshaped portion of said catheter; and

(6) insulated conductor means electrically connecting the individual electrodes to means outside of said catheter for selectively mapping and ablating electrically a target portion of cardiac tissue adjacent said electrodes in said cardiac chamber;

which method comprises the steps of;

A. introducing a catheter assembly selected from the group consisting of catheter assemblies which include a catheter with a preshaped distal portion selected from the group consisting of a catheter having a partially circular shaped distal portionr, a catheter having a V-shaped distal portion, a catheter having a distal portion shaped for positioning horizontally in a cardiac chamber and a catheter having a distal portion shaped for positioning vertically in a cardiac chamber through a blood vessel into a cardiac chamber proximal to a target portion of said chamber,

B. benching said guide-wire;

C. advancing said sheath over said guide-wire;

D. withdrawing said guide-wire from said chamber and said blood vessel;

E. introducing said catheter through said sheath into said cardiac chamber;

F. benching said catheter at said target position;

G. withdrawing said sheath such that said distal portion of said catheter is positioned at said target position;

H. recording one or more satisfactory depolarization potentials from the cardiac tissue at said target portion;

I. remotely activating at least one of the electrodes on said catheter to a preselected current level for a preselected time interval to selectively ablate said target portion of said cardiac circuitry to produce a lesion;

J. removing said catheter from said cardiac chamber; and

K. repeating steps A-J above sequentially with each catheter assembly set forth in A above other than the catheter used in step A and repositioning catheters for positioning horizontally and vertically in a cardiac chamber until steps A-J reproduce the positions shown in FIGS. 13, 15, 19 and 21 with the exception that when said catheters are repositioned step A consists of reintroducing said sheath and said guide wire through said blood vessel into a cardiac chamber at a target portion of said chamber;

whereby the resultant multiple lesions create an electrical maze of the same type resulting from a surgical procedure for treating atrial fibrillation.

19. The method of claim 18 wherein the step of introducing said catheter assembly comprises introducing the catheter sheath/guide-wire assembly through one of the blood vessel passageways including the superior vena cava and the inferior vena cava.

20. The method of claim 18 wherein the electrode is activated to said preselected current level using between about 15 volts and 40 volts for ablation of said target tissue.

21. The method of claim 20 wherein the electrode is activated for said preselected time interval of between about 25 seconds and about 35 seconds.

22. The method of claim 18 wherein step K consists of repeating steps A-J with less than all of the individual catheter assemblies set forth in Group A, said method being effective to overcome atrial fibrillation by ablations which do not create said electrical maze pattern.

23. A cardiac catheter for selectively mapping and ablating target endocardial portions of predefined cardiac circuitry in atrial cardiac chambers which comprises:

A. a preshaped, flexible, elongate tubular member manufactured of biocompatible shape memory material having a distal end and a proximal end and at least one lumen extending from said proximal end to said distal end;

B. a guide-wire slidably engaged within said lumen and extending an amount beyond said distal end of said tubular member;

C. a preshaped portion at said distal end of said tubular member for positioning at a target portion of a cardiac chamber upon removal of said guide-wire;

D. a shaft at said proximal end of said tubular member;

E. an array of spaced-apart electrodes positioned around an outer surface of at least one part of said preshaped distal portion of said tubular member; and

F. insulated conductor means electrically connecting the individual electrodes to means outside of the catheter for selectively mapping and ablating electrically target portions of cardiac tissue adjacent said electrodes in said cardiac chamber.

24. A cardiac catheter assembly for selectively mapping and ablating target endocardial portions of predefined cardiac circuitry in atrial cardiac chambers which comprises:

A. a sheath assembly, including an elongate tubular sheath having a distal end and a proximal end and a lumen therethrough and a guide-wire slidably engaged within said lumen and extending an amount beyond said distal end of said sheath; and

B. a preshaped catheter manufactured of biocmpatible shape memory material for slidable engagement within said lumen after said sheath is positioned proximal to a target portion of a cardiac chamber and after removal of said guide-wire, said catheter comprising;

1. a flexible, elongate tubular member made of shape memory material having a distal end and a proximal end;

2. a preshaped distal end for positioning at a target portion of a cardiac chamber;

3. a shaft at said proximal end of said catheter;

25. an array of spaced-apart electrodes positioned around an outer surface of at least one part of said preshaped distal end;

and

5. insulated conductor means electrically connecting the individual electrodes to a means outside of said catheter for selectively mapping and ablating electrically target portions of cardiac tissue adjacent said electrodes in said cardiac chamber.