Dilatation catheter assembly with heated balloon

• US 5,035,694 A
• Filed: 05/15/1989
• Issued: 07/30/1991
• Est. Priority Date: 05/15/1989
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Orth, Jean C., Gaiser, John W., Kasprzyk, Daniel J.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/351,777
• Time in Patent Office: 806 Days
• Field of Search: 606/192, 606/194, 606/27, 606/30-33, 606/7, 606/159, 604/95, 604/96
• US Class Current: 606/27
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A balloon dilatation catheter having means to raise the temperature of the working surface of the balloon while the balloon is being inflated during an angioplasty procedure. In one embodiment, the balloon is provided with a thin electrically conductive layer in heat transfer relationship therewith preferably on the interior surface of the balloon. Electrical power at radio frequencies is preferred and a coaxial cable is employed to deliver such power to a conductive layer for heating the balloon. In another embodiment, the balloon itself is formed of electrically conductive material. A perfusion lumen may be provided through the balloon with one or more proximal inlet ports and one or more distal discharge ports in fluid communication with the lumen to allow blood to pass through the balloon when it is inflated during angioplasty procedures. This facilitates the flow of oxygenated blood distally of the catheter when the balloon is inflated thus allowing for extended balloon inflations, e.g., up to 30 minutes or more.

Claims

1. A balloon dilatation catheter having means to apply heat to atheroma within a patient'"'"'s artery during the dilation thereof, the catheter comprising:

(a) an elongated tubular member which has an inflation lumen extending therein;

(b) a flexible, relatively inelastic inflatable balloon on a distal portion of the tubular member which is adapted to receive inflation fluid from the inflation lumen extending therein;

(c) a singular, electrically conductive pathway which is coextensive with a substantial part of the working portion of the balloon and in radially conductive heat transfer relationship therewith and which has two ends adapted to be connected to an electrical power source in order to pass electrical current therethrough;

(d) a source for electrical current at a frequency of at least about 100 kilohertz; and

(e) means connected to the two ends of the electrical conductive pathway to pass electrical current therethrough from the source to resistively heat the conductive pathway and thereby increase the temperature of the part of the working portion of the inflatable balloon which is coextensive with the electrically conductive pathway.

2. The dilatation catheter of claim 1 wherein means are provided to determine the temperature of the surface of the working portion of the balloon in order to control the electrical current to the conductive pathway in response to the temperature determined.

3. The dilation catheter of claim 2 wherein the means to determine the temperature includes means to detect the resistance or inductance load in the conductive pathway of the balloon and the means to pass electrical current thereto.

4. The dilatation catheter of claim 3 including control means to compare the resistance or inductance of the load detected with a desired set point and to adjust the electrical current provided to the conductive pathway in response to the detected resistance or inductance.

5. The dilatation catheter of claim 1 wherein the electrically conductive pathway is a thin conductive layer which is coextensive with at least 30 percent of the outer surface area of the working portion of the inflatable balloon.

6. The dilatation catheter of claim 5 wherein the thin conductive pathway extends continuously in a pattern over the interior surface of the balloon.

7. The dilatation catheter of claim 5 wherein electrical current is supplied to the thin conductive pathway by means of a coaxial cable which extends through tubular body from the proximal end thereof to the inflatable balloon.

8. The dilatation catheter of claim 7 wherein the coaxial cable has inner and outer electrical conducting members and a dielectric disposed therebetween.

9. The dilatation catheter of claim 8 wherein one of said conducting members is electrically connected to one end of the conductive pathway at one end of the balloon and the other conductive member is electrically connected to the other end of the conductive pathway at the other end of the balloon.

10. The dilatation catheter of claim 8 wherein the inner and outer conducting members are formed of electrically conductive wire, foil or deposited layers.

11. The dilatation catheter of claim 10 wherein the electrical conductive members are formed from a material selected from the group consisting of copper, aluminum, silver, gold and alloys thereof.

12. The dilatation catheter of claim 8 wherein the dielectric is a cylindrically shaped member formed of a material selected from the group consisting of poltetrafluoroethylene and polyimide.

13. The dilatation catheter of claim 8 wherein the inner member has a tubular structure with an inner lumen extending therethrough which is adapted to receive a guidewire therein.

23. The dilatation catheter of claim 8 wherein the inner and outer electrical conducting members are tubular members.

24. The dilatation catheter of claim 23 wherein the inner electrical conducting member has an inner lumen adapted to receive a guidewire.

14. A balloon dilatation catheter having means to apply heat to atheroma within a patient'"'"'s artery during the dilatation thereof, comprising:

(a) an elongated tubular member having an inflation lumen extending therein;

(b) a flexible, relatively inelastic balloon on the distal portion of the tubular member having an interior which is adapted to receive inflating fluid from the inflation lumen within the tubular member;

(c) means to elevate the temperature of atheroma within the patient'"'"'s artery during the dilation thereof when the balloon is inflated;

(d) a perfusion lumen extending through at least the interior of the balloon;

(e) one or more inlet ports in the tubular member proximal to the balloon in fluid communication with the perfusion lumen which extends through the balloon; and

(f) one or more discharge ports in the tubular member distal to the balloon in fluid communication with the perfusion lumen extending therethrough, whereby oxygenated blood may pass through the inlet ports and the perfusion lumen extending through the balloon and out the discharge ports so as to flow distally to the catheter when the balloon is inflated within a patient'"'"'s artery.

15. A balloon dilatation catheter having means to apply heat to atheroma within a patient'"'"'s artery during the dilation thereof, the catheter comprising:

(a) an elongated tubular member having an inflation lumen extending therein;

(b) a flexible, relatively inelastic inflatable balloon having a cylindrically shaped working section when inflated on a distal portion of the tubular member which is formed at least in part of electrically conductive plastic material and which is adapted to receive inflation fluid from the inflation lumen extending therein to inflate the balloon and press the exterior surface of the working section thereof against atheroma adjacent thereto; and

(c) means to pass electrical current through the electrically conductive portions of the balloon to resistively heat the balloon and thereby increase the temperature of the exterior surface of the working section of the inflatable balloon.

16. A steerable balloon dilatation catheter having means to apply heat to atheroma within a patient'"'"'s artery during the dilation thereof, the catheter comprising:

(a) an elongated tubular member which has an inflation lumen extending therein;

(b) a flexible, relatively inelastic inflatable balloon on a distal portion of the tubular member which is adapted to receive inflation fluid from the inflation lumen extending therein;

(c) a torquable guide member which is secured within the catheter and which extends through the interior of the balloon and out the distal end thereof;

(d) a flexible body which is disposed about the portion of the guide member which extends out the distal end of the balloon;

(e) a singular, electrically conductive pathway which is coextensive with a substantial part of the working portion of the balloon in a radially conductive heat transfer relationship therewith and which has two ends adapted to be connected to an electrical power source in order to pass electrical current therethrough; and

(f) means connected to the two ends of the electrical conductive pathway to pass electrical current therethrough from the source to resistively heat the conductive pathway and thereby increase the temperature of the part of the working portion of the inflatable balloon which is coextensive with the electrically conductive pathway.

17. The steerable balloon dilatation catheter of claim 16 wherein the guide member is formed of electrically conductive material and passes electrical current to the electrically conductive pathway.

18. The steerable balloon dilatation catheter of claim 16 wherein the guide member is an inner member of a coaxial cable for passing electrical current to the electrically conductive pathway.

19. The steerable balloon dilatation catheter of claim 18 wherein the coaxial cable extends the length of the elongated tubular member through the inflation lumen thereof.

20. The steerable balloon dilatation catheter of claim 16 wherein the distal end of the tubular member is secured to the exterior of the proximal end of the balloon.

21. The steerable balloon dilatation catheter of claim 20 wherein the proximal end of the balloon has a shoulder which is secured about the coaxial cable and in electrical contact therewith.

22. A method of treating a stenotic region of a patient'"'"'s artery over an extended period of time, comprising:

(a) advancing a dilatation balloon catheter through the patient'"'"'s arterial system until the balloon of the catheter is disposed within the stenotic region;

(b) inflating the balloon to dilate the stenotic region thereby occluding the patient'"'"'s artery;

(c) applying heat to the stenotic region while the balloon is dilating the stenotic region; and

(d) perfusing blood through a lumen which passes through the interior of the balloon to maintain blood flow to tissue distal to the catheter.

25. A steerable balloon dilatation catheter having means to apply heat to atheroma within a patient'"'"'s artery during the dilatation thereof, the catheter comprising:

(a) an elongated tubular member which has an inflation lumen extending therein;

(b) a flexible, relatively inelastic inflatable balloon on the distal portion of the tubular member which has a cylindrically shaped working section when inflated and which is adapted to receive inflation fluid from the inflation lumen extending through the tubular member;

(c) an electrically conducting guide member which extends through the interior of the balloon and out the distal end thereof;

(d) a flexible body disposed about and secured to the portion of the guide member which extends out the distal end of the balloon;

(e) an electrically resistive heating means in a heat transfer relationship with the working portion of the balloon;

(f) a source for electrical current at a frequency above about 100 kilohertz; and

(f) means to pass electrical current from the source through the guide member to the electrically resistive heating means to raise the temperature thereof and thereby heat the working portion of the inflatable balloon.

26. The steerable dilatation catheter of claim 25 wherein the frequency of the electrical source ranges from about 100 kilohertz to about 100 megahertz.

27. The steerable dilatation catheter of claim 25 wherein the guiding member is secured within the catheter.

28. The steerable dilatation catheter of claim 27 wherein the electrically resistive heating means is a thin layer of conductive material which is secured to the working portion of the inflatable balloon and which is electrically connected to the guide member.

29. A method of dilating a stenotic region of a patient'"'"'s artery over an extended period of time, comprising:

(a) providing a balloon dilatation catheter having means to apply heat to atheroma within a patient'"'"'s artery during the dilation thereof, the catheter including;

(i) an elongated tubular member which has an inflation lumen extending therein;

(ii) a flexible, relatively inelastic inflatable balloon on a distal portion of the tubular member which is adapted to receive inflation fluid from the inflation lumen extending therein;

(ii) an electrically conductive means which forms an electrically conductive pathway for electrical current coextensive with a substantial part of the working portion of the balloon and in radially conductive heat transfer relationship therewith;

(iii) a source for electrical current at a frequency at least about 100 kilohertz; and

(iv) means to pass the electrical current from the source through the electrically conductive pathway to resistively heat the conductive means and thereby increase the temperature of the working portion of the inflatable balloon;

(b) advancing the dilatation balloon catheter through the patient'"'"'s arterial system until the balloon of the catheter is disposed within the stenotic region;

(c) inflating the balloon to dilate the stenotic region thereby occluding the patient'"'"'s artery;

(d) applying heat to the stenotic region while the balloon is inflated to dilate the stenotic region by directing the electrical current from the source thereof through the electrical conducting pathway to resistively heat up the conductive means and thereby the working portion of the balloon.