Intravascular RF occlusion catheter

• US 6,120,499 A
• Filed: 01/03/1996
• Issued: 09/19/2000
• Est. Priority Date: 03/08/1994
• Status: Expired due to Term

• Current Assignee: Sichuan Jinwangtong Electronic Science & Technology Company Limited
• Original Assignee: Cardima, Inc.
• Inventors: Sung, Ruey, Samson, Gene, Dickens, Duane
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/582,600
• Time in Patent Office: 1,721 Days
• Field of Search: 606/27-31, 606/41, 606/42, 606/45-50, 607/100-102, 607/122, 128/642, 600/374
• US Class Current: 606/41
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• CPC Class Codes: A61B 2018/00434 Neural system

Abstract

The invention is directed to an intravascular device for occluding a patient'"'"'s blood vessel by coagulating blood in a desired location within the blood vessel to form occluding thrombus therein by means of RF electrical energy which preferably has a frequency of about 0.3 to about 1.5 megahertz. The intravascular device is particularly useful in terminating arrhythmia in a patient'"'"'s heart by occluding a coronary artery to terminate the flow of oxygenated blood to a region of the patient'"'"'s heart where aberrant signals causing the arrhythmia either originate or through which they are conducted. The device may also be used to occlude other blood vessels such as in the treatment of intracranial berry aneurysms.

Claims

1. An intravascular device for occluding a patient'"'"'s artery comprising:

a) an elongated shaft having a proximal and distal ends and a distal shaft portion which is configured to be advanced through a patient'"'"'s artery having an outer diameter not greater than 0.025 inch;

b) a first electrode on the distal end of the elongated shaft which has a concave distal face for emission of high frequency electrical energy;

c) a second electrode on the distal extremity of the elongated shaft spaced proximal to the distal end of the shaft;

d) a plurality of insulated electrical conductors, each conductor having a distal and electrically connected to one of said electrodes and having a proximal end electrically connected to an electrical connector; and

e) a source of high frequency electrical power electrically connected to at least one insulated electrical conductor by means of the electrical connector.

2. The intravascular device of claim 1 wherein the source of high frequency electrical power is a RF electrical power source.

3. The intravascular device of claim 2 wherein the RF electrical power source has an output with a frequency of about 0.3 to about 1.5 megahertz.

4. The intravascular device of claim 2 wherein the RF electrical power source has an output with a frequency of about 0.7 to about 1.2 megahertz.

5. The intravascular device of claim 1 wherein the catheter distal shaft portion has a diameter of at least about 0.01 inch.

6. The intravascular device of claim 1 wherein the distal shaft portion has an outer diameter of about 0.012 to about 0.018 inch.

7. The intravascular device of claim 1 wherein at least part of the elongated shaft has a thermoplastic fluoropolymer jacket on the exterior thereof.

33. The intravascular device of claim 1 wherein the concavity of the distal face of the first electrode is not greater than one-fourth the diameter of the distal face.

8. An intravascular device for occluding a patient'"'"'s artery comprising:

a) an elongated shaft having a proximal portion with a first outer diameter, a distal portion which is much shorter than the proximal portion and which is configured to be advanced through a patient'"'"'s artery by having a second outer diameter smaller than the first outer diameter of the proximal portion; and

including

an inner lumen extending within the proximal and distal portions of the elongated shaft,

an elongated core member disposed within the inner lumen of the elongated shaft,

a plurality of insulated electrical conductors having proximal and distal ends, and

an outer tubular member which is disposed about and extends along the elongated core member, defining at least in part the inner lumen;

b) at least one emitting electrode on the distal portion of the elongated shaft which is electrically connected to the distal end of an electrical conductor; and

c) an electrical connector electrically connected to the proximal of the electrical conductor electrically connected to the emitting electrode and configured to electrically connect at least the electrical conductor to a source of RF electrical energy.

9. The intravascular device of claim 8 wherein a plurality of emitting electrodes are longitudinally spaced along the distal portion and are electrically isolated from each other.

10. The intravascular device of claim 8 including a RF electrical power source with the electrical connectors connected thereto.

11. The intravascular device of claim 10 wherein the RF electrical power source has an output with a frequency of about 0.3 to about 1.5 megahertz.

12. The intravascular device of claim 10 wherein the RF electrical power source has an output with a frequency of about 0.7 to about 1.2 megahertz.

13. The intravascular device of claim 8 wherein the outer tubular member is formed of a plurality of braided individually insulated electrical conductors.

14. The intravascular device of claim 8 wherein the distal shaft portion has an outer diameter of about 0.01 to about 0.025 inch.

15. The intravascular device of claim 8 wherein the distal shaft portion has an outer diameter of about 0.012 to about 0.018 inch.

16. The intravascular device of claim 8 wherein the core member is formed of a material selected from the group consisting of stainless steel and a nickel-titanium alloy having pseudoelastic properties at body temperature.

17. The intravascular device of claim 8 wherein a thermoplastic fluoropolymer jacket is provided on the exterior of the outer tubular member.

18. The intravascular device of claim 8 wherein a temperature sensing element is provided in the distal portion of the device.

19. The intravascular device of claim 18 wherein the temperature sensing element is electrically connected to a pair of conductors which form at least in part the tubular member.

20. The intravascular device of claim 8 including an expandable member on the distal portion of the shaft to position the distal portion within a passageway of the patient'"'"'s artery.

21. The intravascular device of claim 20 wherein the expandable member is an inflatable balloon.

22. The intravascular device of claim 21 wherein the balloon is formed of elastic material.

23. The intravascular device of claim 8 wherein the emitting electrode is provided on the distal end of the shaft.

24. The intravascular device of claim 23 wherein the emitting electrode has a concave distal face.

25. The intravascular device of claim 24 wherein the concavity of the distal face in not greater than one-half the diameter of the distal face.

26. The intravascular device of claim 25 wherein the concavity is not greater than one-fourth the diameter of the distal face.

27. The intravascular device of claim 8 including at least one sensing electrode on the distal portion of the shaft for detecting electrical activity within the patient'"'"'s artery.

28. The intravascular device of claim 8 wherein the core member is fixed within the inner lumen of the intravascular device.

29. The intravascular device of claim 28 wherein a temperature sensing element is provided in the distal shaft portion.

30. The intravascular device of claim 28 wherein an expandable member is provided on the distal shaft portion thereof to position the distal shaft portion within an arterial passageway.

31. The intravascular device of claim 30 wherein the expandable member is an inflatable balloon.

32. The intravascular device of claim 31 wherein the balloon is formed of elastic material.

34. The intravascular device of claim 8 including at least one sensing electrode on the distal shaft portion for detecting electrical activity within a patient'"'"'s blood vessel.

35. A method of treating a patient'"'"'s heart experiencing arrhythmia wherein an arterial vessel leading to a portion of the patient'"'"'s heart which causes or is involved with the arrhythmia is occluded, comprising:

a) providing an elongated intravascular device having at least one emitting electrode on a distal extremity thereof;

b) advancing the elongated intravascular device through the patient'"'"'s vascular system to the arterial vessel which is to be occluded; and

c) emitting RF electrical energy from at least one electrode on the distal extremity of the elongated intravascular device within the arterial vessel to coagulate blood to form thrombus therein which occludes the arterial vessel.

36. The method of claim 35 wherein the frequency of the RF electrical energy emitted into the arterial vessel at a frequency of about 0.3 to about 1.5 megahertz.

37. The method of claim 35 wherein the frequency of the RF electrical energy emitted into the arterial vessel at a frequency of about 0.7 to about 1.2 megahertz.

38. The method of claim 35 wherein the distal portion of the elongated device having at least one emitting electrode is advanced within the coronary artery to an arterial region having a native inner diameter of less than about 0.04 inch.

39. The method of claim 35 including controlling the temperature of the distal extremity of the elongated intravascular device between about 80°

and about 120°

C.

40. The method of claim 35 including detecting electrical activity by means of electrodes on the distal portion from within a coronary artery to ensure the proper location of the elongated device therein.

41. The method of claim 35 wherein the RF energy is concentrated within the arterial vessel to be occluded distal to an emitting electrode on the distal end of the intravascular device.

42. The method of claim 41 wherein the RF energy is concentrated distal to the electrode by means of a concave emitting surface on the distal end of the emitting electrode.

43. The method of claim 35 wherein the elongated intravascular device has at least one pair of sensing electrodes on the distal portion and electrical activity of the patient'"'"'s heart is detected within the coronary artery by the sensing electrodes to determine the location of tissue which causes or is involved with arrhythmic conditions within the patient'"'"'s heart.

44. A method of occluding a patient'"'"'s arterial vessel which directs blood to heart tissue causing or involved with arrhythmia in order to terminate such arrhythmia, comprising:

a) providing an elongated intravascular device having at least one emitting electrode on a distal extremity thereof;

b) advancing the elongated intravascular device through the patient'"'"'s vascular system until the at least one emitting electrode is at a location within the arterial vessel which is to be occluded; and

c) emitting RF electrical energy from the at least one emitting electrode within the arterial vessel to coagulate blood to form thrombus therein which occludes the arterial vessel.

45. The method of claim 44 wherein the frequency of the RF electrical energy emitted into the arterial vessel is at a frequency of about 0.3 to about 1.5 megahertz.

46. The method of claim 44 wherein the frequency of the RF electrical energy emitted into the arterial vessel is at a frequency of about 0.7 to about 1.2 megahertz.

47. The method of claim 44 wherein the distal portion of the elongated device having at least one emitting electrode is advanced within the arterial vessel to a region therein having a native inner diameter of less than about 0.04 inch where the emitted RF energy forms thrombus to occlude the arterial vessel.

48. The method of claim 44 including controlling the temperature of the distal extremity of the elongated intravascular device between about 80°

and about 120°

C. when emitting RF energy.

49. The method of claim 44 including detecting electrical activity by means of electrodes on the distal portion from within the coronary artery to ensure the proper location of the elongated intravascular device therein.

50. The method of claim 44 wherein the RF energy is concentrated within the arterial vessel to be occluded distal to an emitting electrode on the distal end of the intravascular device.

51. The method of claim 44 wherein the RF energy is concentrated distal to the electrode by means of a concave emitting surface on the distal end of the emitting electrode.

52. An intravascular device for therapeutic or diagnostic procedures, comprising:

a) an elongated shaft having a proximal portion with a first outer diameter, a distal portion which is much shorter than the proximal portion and which has an outer diameter less than about 0.025 inch; and

including

an inner lumen extending within the proximal and distal portions of the elongated shaft,

an elongated core member disposed within the inner lumen of the elongated shaft and extending within the distal portion of the elongated shaft,

at least one insulated electrical conductor having proximal and distal ends, and

an outer tubular member which is disposed about and extends along the elongated core member, defining at least in part the inner lumen;

b) at least one emission electrodes on the distal portion of the elongated shaft which is electrically connected to the distal end of an electrical conductor; and

c) an electrical connector electrically connected to the proximal end of the intravascular device which is configured to electrically connect at least one electrical conductor to a source of RF electrical energy.

53. The intravascular catheter of claim 52 wherein the distal portion has an outer diameter less than 0.022 inch.