Guiding catheter for the coronary sinus

• US 6,021,340 A
• Filed: 07/07/1998
• Issued: 02/01/2000
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Cardima, Inc.
• Inventors: Dickens, Duane, Randolph, Yvonne
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/111,438
• Time in Patent Office: 574 Days
• Field of Search: 600/373-375, 600/433-435, 600/585, 600/381, 604/96, 604/97, 604/280-282, 606/41
• US Class Current: 600/381
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/125 Heart
• 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: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

A guiding catheter for delivery of intravascular devices to a patient'"'"'s coronary sinus. The guiding catheter has a relatively stiff proximal section and a relatively flexible distal section, the latter being about 1 to about 6 inches in length and being configured to subselect a branch cardiac vein leading to the coronary sinus. The distal shaft section preferably has a proximal portion which has a flexibility greater than that of the proximal shaft section, and a distal portion which has a flexibility greater than that of the proximal portion of the distal shaft section, and at least one of the distal portion and the proximal portion being shaped with a bend to facilitate entry within the patient'"'"'s coronary sinus. An inflatable balloon may be disposed on the distal shaft section. The guiding catheter is particularly suitable for delivering an intravascular device for sensing electrical activity into a cardiac vein to detect such activity from within the blood vessel.

Claims

1. A guiding catheter for directing an intravascular device within a patient'"'"'s coronary sinus, comprising:

a) an elongated shaft having a proximal end, a distal end, a port in a distal tip of the shaft, and an inner lumen extending to and in fluid communication with the port in the distal tip which is configured to slidably receive the intravascular device;

b) a relatively stiff proximal shaft section of the elongated shaft;

c) a relatively flexible distal shaft section of the elongated shaft having a length of about 2.5 to about 15 centimeters and having a proximal portion having a flexibility greater than that of the proximal shaft section, and a nontraumatic distal portion having a flexibility greater than that of the proximal portion, at least a section of the lumen in the distal portion being axially aligned with the port in the distal tip of the shaft, and at least one of the portions of the distal section being shaped with a bend to facilitate entry within the patient'"'"'s coronary sinus; and

d) an adapter on the proximal end of the elongated shaft to provide access to the inner lumen extending within the elongated shaft.

2. The guiding catheter of claim 1 wherein an expandable occluding member is provided on the distal section of the catheter shaft.

3. The guiding catheter of claim 2 wherein the expandable occluding member is an inflatable balloon.

4. The guiding catheter of claim 3 wherein the elongated catheter shaft has an inflation lumen extending therein from the proximal end to a location spaced proximally from the distal end and wherein the balloon has an interior which is in fluid communication with the inflation lumen.

5. The guiding catheter of claim 1 wherein the distal section of the elongated shaft has a length of about 5 to about 13 centimeters.

6. The guiding catheter of claim 1 wherein the proximal shaft section is formed of a polymer material having a hardness of about 60 to about 85 D (Shore).

7. The guiding catheter of claim 1 wherein the distal shaft section is formed of a polymer material having a hardness of about 80 A to about 60 D (Shore).

8. The guiding catheter of claim 1 including an intermediate section having a flexibility greater than the proximal shaft section and less than the distal shaft section.

9. The guiding catheter of claim 8 wherein the intermediate shaft section has a hardness of about 30 to about 60 D (Shore).

10. The guiding catheter of claim 8 wherein the intermediate shaft section has a length of about 1 to about 8 centimeters.

11. The guiding catheter of claim 8 wherein the intermediate shaft section has an expandable occluding member.

12. The guiding catheter of claim 11 wherein the expandable occluding member is an inflatable balloon.

13. The guiding catheter of claim 12 wherein the elongated shaft has an inflation lumen extending therein and the inflatable balloon has an interior in fluid communication with the inflation lumen.

14. The guiding catheter of claim 1 wherein the distal portion of the distal shaft section is formed of a polymer material having a hardness of about 80 A to about 20 D (Shore).

15. The guiding catheter of claim 1 wherein the proximal portion of the distal shaft section is formed of a polymer material having a hardness of about 30 D to about 60 D (Shore).

16. The guiding catheter of claim 1 wherein the distal section of the elongated shaft has a length of about 2 to about 7 centimeters.

17. The guiding catheter of claim 1 wherein the inner lumen is configured to slidably receive a guidewire therein.

18. The guiding catheter of claim 1 wherein the proximal section, proximal portion of the distal section, and distal portion of the distal section are formed of polymeric materials having different Shore Durometer hardnesses.

19. The guiding catheter of claim 1 wherein the port in the distal tip is directed away from a longitudinal axis of the proximal shaft section.

20. The guiding catheter of claim 1 wherein the port in the distal tip has a diameter equal to the diameter of the lumen.

21. An intravascular assembly including

a) a guiding catheter for directing an intravascular device within a patient'"'"'s coronary sinus, comprising:

an elongated shaft having a proximal and distal ends, a port in the distal end and an inner lumen extending to and in fluid communication with the port in the distal end,

a relatively stiff proximal shaft section of the elongated shaft,

a relatively flexible distal shaft section of the elongated shaft having a length of about 2.5 to about 15 centimeters and having a proximal portion having a flexibility greater than that of the proximal shaft section, and a nontraumatic distal portion having a flexibility greater than that of the proximal portion, and at least one of the portions of the distal section being shaped with a bend to facilitate entry within the patient'"'"'s coronary sinus; and

an adapter on the proximal end of the elongated shaft to provide access to the inner lumen extending within the elongated shaft; and

b) slidably disposed within the inner lumen of the guiding catheter, an intravascular device for detecting electrical activity of a patient'"'"'s heart from within a cardiac vein thereof which includes an elongated shaft, a plurality of sensing electrodes on a distal extremity of the intravascular device and individual electrical conductors electrically connected to the sensing electrodes.

22. The intravascular assembly of claim 21 wherein the intravascular device has a length greater than a length of the guiding catheter so that the proximal end of the intravascular device extends out the proximal end of the guiding catheter when the distal extremity of the intravascular device having sensing electrodes thereon extends out the distal end of the guiding catheter.

23. The intravascular assembly of claim 21 wherein the distal section of the elongated shaft has a length of about 2 to about 7 centimeters.

24. The intravascular assembly of claim 21 wherein the inner lumen is configured to slidably receive a guidewire therein.

25. A method of detecting electrical activity within a patient'"'"'s heart, comprising:

a) providing a guiding catheter having

an elongated shaft having a proximal and distal ends, a port in the distal end and an inner lumen extending to and in fluid communication with the port in the distal end,

a relatively stiff proximal shaft section of the elongated shaft,

a relatively flexible distal shaft section of the elongated shaft having a length of about 2.5 to about 15 centimeters and having a proximal portion having a flexibility greater than that of the proximal shaft section, and a nontraumatic distal portion having a flexibility greater than that of the proximal portion, and at least one of the portions of the distal section being shaped with a bend to facilitate entry within the patient'"'"'s coronary sinus; and

an adapter on the proximal end of the elongated shaft to provide access to the inner lumen extending within the elongated shaft;

b) advancing the guiding catheter through the patient'"'"'s peripheral venous system into a right atrium of the patient'"'"'s heart;

c) guiding the distal end of the guiding catheter through the coronary sinus ostium into the coronary sinus;

d) advancing an intravascular device having sensing electrodes on a distal portion thereof through the inner lumen of the guiding catheter until the distal portion of the intravascular device having sensing electrodes thereon extends out the port in the distal end of the guiding catheter; and

e) detecting electrical activity by means of the sensing electrodes on the distal portion of the intravascular device.

26. The method of claim 25 including ablating heart tissue causing or involved with the sensed electrical activity.

27. The method of claim 25 wherein the guiding catheter includes an expandable occluding member on the elongated shaft, and further including inflating the expandable occluding member before the detection of the electrical activity.

28. The method of claim 25 wherein the inner lumen of the guiding catheter is configured to slidably receive a guidewire, and wherein the step of advancing the guiding catheter further includes advancing the guiding catheter over the guidewire.

29. The method of claim 25 further including the step of guiding the distal end of the guiding catheter into a branch vein which drains into the coronary sinus.

30. A guiding catheter for directing an intravascular device within a patient'"'"'s coronary sinus, comprising:

a) an elongated shaft having proximal and distal ends, a port in the distal end, a first inner lumen extending therein to a location proximal to a distal extremity of the shaft, and a second inner lumen extending to and in fluid communication with the port in the distal end;

b) a proximal shaft section of the elongated shaft;

c) a distal shaft section of the elongated shaft having a length of about 2.5 to about 15 centimeters and being shaped with a bend to facilitate entry within the patient'"'"'s coronary sinus;

d) an expandable occluding member on the distal shaft section having an interior in fluid communication with the first inner lumen; and

e) an adapter on the proximal end of the elongated shaft to provide access to the first and second inner lumens extending within the elongated shaft.

31. The guiding catheter of claim 30 wherein the expandable occluding member is an inflatable balloon.

32. The guiding catheter of claim 30 wherein the length of the distal section shaped with a bend is at least about 2.5 cm.