Multiple compartmented balloon catheter with external pressure sensing

• US 5,865,801 A
• Filed: 07/18/1995
• Issued: 02/02/1999
• 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): STRIGHT, RONALD K
• Application Number:
  US08/503,843
• Time in Patent Office: 1,295 Days
• Field of Search: 604/20, 604/96, 604/97-99, 604/101-2, 604/104, 604/113-4, 604/22, 606/191-2, 606/194-5, 606/198, 606/108, 607/98-9, 607/113, 607/97, 607/101, 607/99, 607/104, 607/105, 128/640, 128/656, 128/658, 128/660.01, 128/660.02, 128/662.06, 128/673, 128/675, 128/748, 600/433, 600/435, 600/437, 600/438, 600/442, 600/486, 600/488, 600/561, 600/481, 600/483, 600/485, 600/487, 600/490, 600/493, 600/495, 600/497, 600/499, 600/500, 600/502 , 600/504, 600/505
• US Class Current: 604/103.07
• 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 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 apparatus 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 end and a distal end;

a dilatation balloon fixed to the catheter tubing near the distal end, said dilatation balloon including an interior wall means for 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 dilatation balloon further including an exterior wall means composed of respective outer wall portions of the dilatation compartments, said exterior wall means (i) defining an outer transverse profile of the dilatation balloon and (ii) being adapted to form a surface engagement with a tissue wall segment surrounding the balloon when the compartments are dilatated, said balloon profile assuming a nominal shape when all of the dilatation compartments are subject to the same pressure;

a balloon dilatation means for supplying a fluid under pressure individually to said dilatation compartments;

said dilatation means controllable to adjust the dilatation pressures to different values in at least first and second selected ones of the dilatation compartments, to controllably alter said balloon profile toward conformity with a profile of the tissue wall segment when dilatating the balloon toward and into said surface engagement; and

a pressure sensing means, mounted to said exterior wall means and adapted for positioning between the exterior wall means and said tissue wall segment during said surface engagement, for measuring the pressure between the dilatation balloon and the tissue wall segment.

2. The balloon catheter of claim 1 further including:

a heating means proximate said exterior wall means, for heating the tissue wall segment proximate the heating means when the exterior wall means and tissue wall segment are in said surface engagement.

3. The balloon catheter of claim 2 wherein:

said heating means comprises at least one thin film resistive heating element mounted to the exterior wall means.

4. The balloon catheter of claim 3 wherein:

said heating means further includes a bifilar lead including at least two wires, one wire connected to each of the opposite ends of the heating element.

5. The balloon catheter of claim 3 wherein:

said heating means further includes an indifferent electrode spaced apart from the heating element, a first conductor connected to the heating element, and a second conductor connected to the indifferent electrode.

6. The balloon catheter of claim 2 wherein:

said heating means comprises a plurality of heating elements mounted to said exterior wall means in circumferentially spaced apart relation about the dilatation balloon.

7. The balloon catheter of claim 1 wherein:

said dilatation balloon surrounds the catheter tubing and consists of four of said dilatation compartments, each compartment extending 90 degrees circumferentially about the catheter tubing.

8. The balloon catheter of claim 7 wherein:

said interior wall means include single partition walls shared by adjacent ones of the dilatation compartments.

9. The balloon catheter of claim 7 wherein:

said interior wall means and said exterior wall means are formed by a continuous sheet.

10. The balloon catheter of claim 1 wherein:

said balloon dilatation means includes a plurality of balloon inflation lumens formed in said catheter tubing, each of the balloon inflation lumens open to the proximal end of the catheter tubing, extending distally through the catheter tubing and open to an associated one of said balloon compartments.

11. The balloon catheter of claim 10 wherein:

said balloon dilatation means further includes a source of a fluid under pressure near the proximal end of the catheter tubing in fluid communication with the balloon inflation lumens near the proximal end of the catheter tubing, and a plurality of pressure regulating means for individually controlling the respective dilatation pressures of said fluid delivered to the balloon compartments via the associated balloon inflation lumen.

12. The balloon catheter of claim 1 further comprising:

a perfusion lumen contained within the catheter tubing, and open to the exterior of the catheter tubing at first and second locations proximal and distal relative to the balloon, respectively; and

wherein said balloon, when dilatated and in said surface engagement, substantially prevents passage of fluids between the catheter tubing and the tissue wall segment.

13. The balloon catheter of claim 12 wherein:

said pressure sensing means includes a plurality of piezoelectric transducing films, one of said films mounted to each one of said outer wall portions.

14. The balloon catheter of claim 1 wherein:

said dilatation balloon is constructed of a compliant material.

15. The balloon catheter of claim 1 wherein:

said dilatation balloon is constructed of an inextensible material.

16. The balloon catheter of claim 1 wherein:

said dilatation compartments extend longitudinally along the catheter tubing.

17. The balloon catheter of claim 1 further including:

multiple perforations through said exterior wall means, adapted for allowing perfusion of a fluid from within each of the dilatation compartments to the tissue wall segment.

18. A balloon catheter comprising:

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

a dilatation balloon mounted to the catheter tubing at the distal end and surrounding the catheter tubing and having an exterior surface;

a balloon dilatation means for supplying a fluid under pressure to the balloon to dilatate the balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon; and

a pressure sensing means mounted to an exterior surface of the dilatation balloon and disposed between the dilatation balloon and the tissue wall segment, said pressure sensing means being compressible to indicate a pressure between the dilatation balloon and the tissue wall segment.

19. The balloon catheter of claim 18 wherein:

said pressure sensing means comprises a plurality of piezoelectric pressure transducing films spaced apart from one another circumferentially with respect to an axis running lengthwise of said catheter tubing in the region of the dilatation balloon.

20. The balloon catheter of claim 19 wherein:

said dilatation balloon includes an interior wall means for dividing the balloon into a plurality of fluid tight compartments in fluid isolation from one another, and an exterior wall means, composed of respective outer wall portions of the balloon compartments cooperating to provide said balloon exterior surface; and

wherein said plurality of piezoelectric transducing film includes one piezoelectric transducing film mounted to each of the outer wall portions, each of the piezoelectric transducing films providing a pressure indication unique to its location between the dilatation balloon and the tissue wall segment.

21. The balloon catheter of claim 20 wherein:

said balloon dilatation means includes a plurality of balloon inflation lumens mounted within the catheter tubing, each one of the balloon inflation lumens being uniquely associated with one of the balloon compartments and in fluid communication with its associated balloon compartment;

a source of a fluid under pressure; and

a control means for coupling the source and the balloon inflation lumens, operable to selectively and individually set the fluid pressures in the respective pairs of balloon inflation lumens and compartments.

22. The balloon catheter of claim 19 further including:

a heating means mounted to said balloon exterior surface, for generating heat and thereby heating the tissue wall segment in the region of the heating means when the dilatation balloon and tissue wall segment are in said surface engagement.

23. The balloon catheter of claim 22 further including:

a heat responsive stent plastically deformed to a reduced-radius state in surrounding relation to the dilatation balloon;

wherein said heat responsive stent, responsive to heat generated by said heating means, tends to return to an enlarged radius state in which the heat responsive stent is adapted to become contiguous with and at least slightly radially expand the tissue wall segment.

24. The balloon catheter of claim 19 wherein:

said plurality of piezoelectric transducing films includes one piezoelectric transducing film mounted to each of the outer wall portions, each of the piezoelectric transducing films providing a pressure indication unique to its location between the dilatation balloon and the tissue wall segment.

25. The balloon catheter of claim 18 which:

said pressure sensing means comprises a plurality of enclosed fluid tight tubes spaced apart from one another circumferentially about the dilation balloon and containing a fluid, each of the tubes being compressible to alter the pressure of the fluid it contains.

26. A balloon catheter of claim 25 wherein:

said plurality of enclosed fluid filled tubes includes one fluid filled tube mounted to each of the outer wall portions, each of the fluid filled tubes providing a pressure indication unique to its location between the dilatation balloon and the tissue wall segment.

27. The balloon catheter of claim 18 wherein:

said pressure sensing means includes a plurality of compliant enclosed fluid filled tubes, said tubes having distal ends mounted to said balloon exterior surface.

28. A balloon catheter comprising:

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

a dilatation balloon mounted to the catheter tubing at the distal end and surrounding the catheter tubing and having an exterior surface;

a balloon dilatation means for supplying a fluid under pressure to the balloon to dilatate the balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon; and

a pressure sensing means mounted to an exterior surface of the dilatation balloon and disposed between the dilatation balloon and the tissue wall segment, said pressure sensing means being compressible to indicate a pressure between the dilatation balloon and the tissue wall segment, said pressure sensing means comprises a plurality of piezoelectric pressure transducing films spaced apart from one another circumferentially with respect to an axis running lengthwise of said catheter tubing in the region of the dilatation balloon;

a heating means mounted to said balloon exterior surface, for generating heat and thereby heating the tissue wall segment in the region of the heating means when the dilatation balloon and the tissue wall segment are in said surface engagement, wherein said heating means comprises at least one thin film resistive heating element mounted to the exterior surface.

29. The balloon catheter of claim 28 further including:

a means for monitoring the temperature proximate said resistive heating element.

30. The balloon catheter of claim 28 wherein:

said heating element comprises a dielectric sheet and a thin film resistive pattern formed on the sheet.

31. The balloon catheter of claim 28 wherein:

the heating means comprises a plurality of heating elements mounted to said exterior surface in circumferentially spaced apart relation about the dilatation balloon.

32. A balloon catheter comprising:

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

a dilatation balloon mounted to the catheter tubing at the distal end, extended lengthwise of the catheter and surrounding the catheter tubing;

a balloon dilatation means for supplying a fluid under pressure to the balloon to dilatate the balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon; and

a piezoelectric thin film arrangement including least one piezoelectric thin film mounted to an exterior surface of the dilatation balloon and adapted to be disposed between the dilatation balloon and the tissue wall segment.

33. The balloon catheter of claim 32 further including:

a signaling means for providing an ultrasonic signal to the piezoelectric thin film arrangement, for generating an ultrasound image of tissue proximate the dilatation balloon.

34. The balloon catheter of claim 33 wherein:

said signaling means includes a bifilar conductor means coupled to the piezoelectric thin film arrangement and extended to the proximal end of the catheter tubing.

35. The balloon catheter of claim 32 further including:

a means for sensing a voltage difference across a thickness of the piezoelectric film arrangement as an indication of a pressure between the tissue wall segment and the dilatation balloon.

36. The balloon catheter of claim 32 wherein:

said piezoelectric film arrangement comprises a plurality of piezoelectric thin films circumferentially spaced apart from one another to surround the dilatation balloon.

37. The balloon catheter of claim 32 wherein:

said dilatation balloon includes a first wall means for dividing the balloon into a plurality of fluid tight compartments in fluid isolation from one another; and

wherein said piezoelectric thin film arrangement includes a plurality of piezoelectric thin films, a different one of the thin films being adjacent each of the compartments.

38. A balloon catheter, comprising:

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

a dilatation balloon mounted to the catheter tubing at the distal end, extended lengthwise of the catheter and surrounding the catheter tubing;

a balloon dilatation means for supplying a fluid under pressure to the balloon to dilatate the balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon;

a piezoelectric thin film arrangement including at least one piezoelectric thin film mounted to an exterior surface of the dilatation balloon and adapted to be disposed between the dilatation balloon and the tissue wall segment; and

a means for sensing a voltage difference across a thickness of the piezoelectric film arrangement as an indication of a pressure between the tissue wall segment and the dilatation balloon, said sensing means includes a first bifilar conductor means including two wires coupled to opposite sides of the piezoelectric film arrangement and extended to the proximal end of the catheter tubing.

39. The balloon catheter of claim 38 further including:

a signaling means for providing an ultrasonic signal to the piezoelectric film arrangement for generating an ultrasound image of tissue proximate the piezoelectric film arrangement.

40. The balloon catheter of claim 39 wherein:

said signaling means includes a second bifilar conductor means coupled to the piezoelectric film arrangement and extended to the proximal end of the catheter tubing.

41. The balloon catheter of claim 39 further including:

a multiplexing means near the proximal end of the catheter tubing, for alternatively;

using the first bifilar conductor means to sense the voltage difference; and

using the first bifilar conductor means to provide the ultrasonic signal to the piezoelectric film arrangement.

42. The balloon catheter of claim 39 wherein:

said piezoelectric film arrangement comprises a plurality of piezoelectric thin film transducers spaced apart from one another circumferentially and surrounding the dilatation balloon.

43. A balloon catheter comprising:

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

a dilatation balloon mounted to the catheter tubing at the distal end, extended lengthwise of the catheter and surrounding the catheter tubing;

a balloon dilatation means for supplying a fluid under pressure to the balloon to dilatate the balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon; and

a compliant fluid filled tube arrangement including at least one enclosed compliant fluid filled tube mounted to an exterior surface of the dilatation balloon and adapted to be disposed between the dilatation balloon and the tissue wall segment.

44. The balloon catheter of claim 43 further including:

a means for sensing a pressure difference within the at least one enclosed compliant fluid filled tube as an indication of the pressure between the tissue wall segment and the dilatation balloon.

45. A balloon catheter comprising:

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

a dilatation balloon mounted to the catheter tubing at the distal end, extended lengthwise of the catheter and surrounding the catheter tubing;

a balloon dilatation means for supplying a fluid under pressure to the balloon to dilatate the balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon;

a plurality of compliant fluid filled tubes mounted to an exterior surface of the dilatation balloon and adapted to be disposed between the dilatation balloon and the tissue wall segment; and

a means for sensing a pressure difference within each compliant fluid filled tubes as an indication of the pressure between the tissue wall segment and the dilatation balloon, wherein said pressure sensing means includes a digital pressure measuring device for measuring the internal pressure of each said compliant fluid filled tube.

46. A balloon catheter comprising:

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

a dilatation balloon having an exterior surface, said dilatation balloon mounted to the catheter tubing at the distal end and extending lengthwise along the catheter tubing;

a plurality of thin film resistive heating elements mounted to said exterior surface of the dilatation balloon;

a balloon dilatation means for supplying a fluid under pressure to the balloon to dilatate the balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon, with said resistive heating elements disposed between the dilatation balloon and the tissue wall segment; and

a plurality of piezoelectric thin film pressure transducers mounted to said exterior surface, with a different one of the pressure transducers being adjacent each of the resistive heating elements.

47. The balloon catheter of claim 46 wherein:

said dilatation balloon includes a wall means for dividing the balloon into a plurality of fluid tight compartments in fluid isolation from one another; and

said plurality of thin film resistive heating elements include a different one of said heating elements mounted adjacent each of said compartments.

48. A balloon catheter comprising:

an elongate and pliable catheter tubing having a proximal end and a distal end, and a dilatation balloon having an exterior surface, said dilatation balloon mounted to the catheter tubing at the distal end and extending lengthwise along the catheter tubing;

a piezoelectric thin film mounted to said exterior surface of the dilatation balloon;

a thin film resistive heating element mounted to the exterior surface and adjacent the piezoelectric thin film; and

a balloon dilatation means for supplying a fluid under pressure to the balloon to dilatate the balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon, with the piezoelectric thin film and the thin film resistive heating element disposed between the dilatation balloon and the tissue wall segment.

49. A balloon catheter comprising:

an elongate and pliable catheter tubing having a proximal end and a distal end, and a dilatation balloon having an exterior surface, said dilatation balloon mounted to the catheter tubing at the distal end and extending lengthwise along the catheter tubing;

a piezoelectric thin film mounted to said exterior surface of the dilatation balloon;

a thin film resistive heating element mounted to the exterior surface and adjacent the piezoelectric thin film;

a balloon dilatation means for supplying a fluid under pressure to the balloon to dilatate the balloon into a surface engagement with a tissue wall segment surrounding the dilatation balloon, with the piezoelectric thin film and the thin film resistive heating element disposed between the dilatation balloon and the tissue wall segment; and

a means for sensing a voltage difference across a thickness of the piezoelectric thin film as an indication of pressure between the tissue wall segment and the dilatation balloon.