Dual balloon catheter and method of use

• US 6,632,196 B1
• Filed: 12/08/1998
• Issued: 10/14/2003
• Est. Priority Date: 07/18/1995
• Status: Expired due to Fees

• Current Assignee: CardioVascular Technologies, Inc.
• Original Assignee: Russell A. Houser
• Inventors: Houser, Russell A.
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): PATEL, NIHIR B
• Application Number:
  US09/473,828
• Time in Patent Office: 1,771 Days
• Field of Search: 604/21, 604/192, 604/96, 607/98, 128/634, 128/662.06, 128/670, 128/2
• US Class Current: 604/96.01
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• 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 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A balloon catheter includes an elongate pliable catheter tubing with a dilatation balloon fixed to the catheter tubing near its distal end. The dilatation balloon includes a first wall for dividing the balloon into a plurality of dilatation compartments adjacent one another and arranged angularly about the catheter tubing. Each dilatation compartment is fluid tight and in fluid isolation from other compartments. The compartments are individually controlled so the pressure within each balloon compartment may be adjusted as determined by the operator. The dilatation balloon includes a second wall means composed of the respective outer wall portions of the dilatation compartments which defines an outer transverse profile of the dilatation balloon and adapted to form surface engagement with the tissue segments surrounding the balloon when the compartments are dilatated. The exterior surface of the balloon dilatation compartments include pressure sensing means mounted thereon and adapted for positioning between the second wall and the tissue wall segment during surface engagement for measuring the pressure between the dilatation balloon and the tissue wall segment. The balloon compartments are individually controlled so the pressure within each balloon compartment may be adjusted by the operator. Alternative embodiments include thin film heating elements located on the exterior surface, thin film transducers having an ultrasonic imaging capability located on the exterior surface, drug delivery capabilities and a dual balloon arrangement.

Claims

1. A balloon catheter including:

an elongate and pliable catheter tubing having a proximal and a distal end;

a first dilatation balloon fixed to the catheter tubing near the distal end, extended lengthwise of the catheter and surrounding the catheter tubing;

a second dilatation balloon mounted to the catheter tubing near the distal end and proximally of the first dilatation balloon, extending lengthwise of the catheter and surrounding the catheter tubing, said second dilatation balloon including a first wall means for angularly dividing the balloon into a plurality of dilatation compartments adjacent one another and arranged angularly about the catheter tubing, each of the dilatation compartments being fluid tight and in fluid isolation from the other compartments, said second dilatation balloon further including a second wall means comprising respective outer wall portions of the dilatation compartments;

a first balloon dilatation means for supplying a fluid under pressure to the first dilatation balloon, and a second balloon dilatation means for supplying a fluid under pressure to the second dilatation balloon, each of said balloon dilatation means being adapted for dilating its associated balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon to provide a therapeutic effect at the surface engagement with the tissue wall segment; and

an expandable stent surrounding one of said first and second balloons and in a radially reduced state, said stent being adapted for radial expansion into a surface engagement with the tissue wall segment through the dilatation of the second dilatation balloon.

2. The balloon catheter of claim 1 wherein:

said stent is mounted to the second dilatation balloon.

3. The balloon catheter of claim 2, wherein the second balloon dilatation means is operable to supply said fluid to each of said dilatation compartments individually, to controllably alter a profile of the second dilatation balloon away from a nominal shape corresponding to a uniform pressure in all of the dilatation compartments, toward conformity with a tissue wall profile of the tissue wall segment.

4. The balloon catheter of claim 3 wherein:

the dilatation compartments extend lengthwise of the catheter tubing.

6. The balloon catheter of claim 3 further including:

multiple perforations through said second wall means, for allowing profusion of said fluid from within said dilatation compartments to said tissue wall segment.

7. The balloon catheter of claim 1, wherein the catheter includes at least one piezoelectric thin film transducer carried by the second dilatation balloon.

8. The balloon catheter of claim 1, wherein the second dilatation balloon includes one or more heating elements configured to provide a heat treatment to the tissue wall segment when the second dilatation balloon is dilated against the tissue wall segment.

9. The balloon catheter of claim 1, wherein the second dilatation balloon further comprises perforations in fluid contact with the balloon dilatation means, whereby dilating the second dilatation balloon comprises passing the fluid through the perforations.

10. The balloon catheter of claim 9, wherein the fluid comprises a drug for treating the tissue wall segment.

11. The balloon catheter of claim 1, wherein the second dilatation balloon includes a reduced diameter area.

12. The balloon catheter of claim 11, wherein the reduced diameter area includes one of a helical configuration or a stepped configuration.

5. A balloon catheter comprising:

an elongate and pliable catheter tubing having a proximal end and a distal end;

a first dilatation balloon fixed to the catheter tubing near the distal end, extended lengthwise of the catheter and surrounding the catheter tubing;

a second dilatation balloon mounted to the catheter tubing near the distal end and proximally of the first dilatation balloon, extending lengthwise of the catheter and surrounding the catheter tubing;

a first balloon dilatation means for supplying a fluid under pressure to the first dilatation balloon, and a second balloon dilatation means for supplying a fluid under pressure to the second dilatation balloon, each of said balloon dilatation means being adapted for dilating its associated balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon; and

an expandable stent surrounding one of said first and second balloons and in a radially reduced state, said stent being adapted for radial expansion into a surface engagement with the tissue wall segment through the dilatation of the second dilatation balloon;

said second dilatation balloon includes a first wall means for angularly dividing the balloon into a plurality of dilatation compartments adjacent one another and arranged angularly about the catheter tubing, each of the dilatation compartments being fluid tight and in fluid isolation from the other compartments, said second dilatation balloon further including a second wall means comprising respective outer wall portions of the dilatation compartments; and

wherein the second balloon dilatation means is operable to supply said fluid to each of said dilatation compartments individually, to controllably alter a profile off the second dilatation balloon away from a nominal shape corresponding to a uniform pressure in all of the dilatation compartments, toward conformity with a tissue wall profile of the tissue wall segment, and

wherein the dilatation compartments are arranged helically around the catheter tubing.

13. A method of treating a wall segment of a tubular vessel, the method comprising:

introducing a catheter having a first dilatation balloon and a second dilatation balloon into the tubular vessel, said second dilatation balloon including a first wall means for angularly dividing the balloon into a plurality of dilatation compartments adjacent one another and arranged angularly about the catheter tubing, each of the dilatation compartments being fluid tight and in fluid isolation from the other compartments, said second dilatation balloon further including a second wall means comprising respective outer wall portions of the dilatation compartments;

advancing the catheter within the tubular vessel until the first dilatation balloon is adjacent to the wall segment;

dilating the first dilatation balloon against the wall segment of the tubular vessel to treat the wall segment;

deflating the first dilatation balloon;

advancing the second dilatation balloon until it is adjacent to the wall segment of the tubular vessel; and

dilating the second dilatation balloon against the wall segment of the tubular vessel to treat that wall segment.

14. The method of claim 13, wherein the catheter includes an expandable stent surrounding the second dilatation balloon and dilating the second dilatation balloon against the wall segment comprises expanding the stent against the wall segment.

15. The method of claim 13, wherein the catheter includes at least one piezoelectric thin film transducer carried by the second dilatation balloon and the method further comprises:

activating the piezoelectric thin film transducer.

16. The method of claim 13, wherein the catheter includes at least one radiopaque marker in proximity of the first dilatation balloon and advancing the catheter within the tubular vessel further comprises:

visualizing the position of the radiopaque marker in the tubular vessel.

17. The method of claim 13, wherein the catheter includes at least one radiopaque marker in proximity of the second dilatation balloon and advancing the second dilatation balloon until it is adjacent to the wall segment of the tubular vessel further comprises:

visualizing the position of the radiopaque marker in the tubular vessel.

18. The method of claim 13, wherein the second dilatation balloon includes one or more heating elements and dilating the second dilatation balloon against the wall segment of the tubular vessel to treat that wall segment further comprises activating the heating elements to treat the wall segment with heat.

19. The method of claim 13, wherein the second dilatation balloon comprises perforations in fluid contact with a channel used to dilate the second dilatation balloon and dilating the second dilatation balloon against the wall segment of the tubular vessel further comprises:

passing fluid through the perforations to treat the wall segment.

20. The method of claim 19, wherein the fluid comprises a drug intended to treat the wall segment.