Physiologic low stress angioplasty

• US 5,496,311 A
• Filed: 05/02/1994
• Issued: 03/05/1996
• Est. Priority Date: 10/28/1988
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Lennox, Charles D., Abele, John E.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/236,393
• Time in Patent Office: 673 Days
• Field of Search: 606/27-31, 606/41, 606/42, 606/192, 606/194
• US Class Current: 606/28
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00088 using thermistors
• CPC Class Codes: A61B 2017/00132 Setting operation time of a device A61B2017/00123 takes precedence
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/044 the surgical action being effected by a circulating hot fluid
• CPC Class Codes: A61B 2090/063 for measuring volume
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 : Valves
• CPC Class Codes: A61M 25/10186 : One-way valves
• CPC Class Codes: A61M 25/10188 : Inflation or deflation data displays
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

Systems and methods for dilation of a body lumen, using an expandable dilatation catheter to simultaneously heat and apply pressure to tissue of the lumen and to expand and dilate the lumen including means constructed to produce and/or detect physiological response of the heated tissue to applied pressure.

Claims

1. A method of angioplasty, comprising:

providing a catheter having a liquid-expansible dilatation balloon and means for controllably providing heated liquid within the balloon to enable conductive heat transfer from the heated liquid, through the wall of the balloon,

inserting the catheter into a region of a blood vessel narrowed by plaque or stenotic tissue,

inflating said balloon to an initial subdilatation pressure sufficient to cause the balloon to engage the wall surface of the narrowed vessel in a conductive heat transfer relationship without substantially displacing the wall of the vessel,

increasing the temperature of the engaged vessel wall by conductive heat transfer from heated liquid within the balloon while controlling the inflating pressure, the temperature of said liquid within said balloon and the duration of treatment to cause a physiological response in which the heated wall of the vessel yields to said pressure of said dilatation balloon as a result of softening of the wall produced by said conductive heat transfer,

thereby enabling dilatation of said vessel to occur under relatively low stress conditions.

2. In the method of claim 1, controlling the pressure in said balloon to about 2 atmospheres or less.

3. In the method of claim 2 is maintaining said temperature in the range of about 60°

to 65°

C.

4. In the method of claim 1 initially maintaining said subdilatation pressure such that the flow of blood through the vessel is substantially blocked without widening the vessel visibly to the naked eye when observing said vessel by fluoroscopy.

5. In the method of claim 1 initially maintaining said subdilatation pressure such that the vessel does not widen by more than about 10%.

6. In the method of claim 1, after dilatation of said vessel, maintaining inflation of said balloon while reducing the temperature of said balloon.

7. In the method of claim 1, increasing the balloon temperature to a final temperature between 50°

C. and 70°

C. within about 10 to 15 seconds of said inflation to said subdilatation pressure, and holding said final temperature for a period up to about 60 seconds, and, thereafter reducing said balloon temperature while maintaining said inflation by terminating said heating of said fluid and allowing said balloon to cool for about 15 to 30 seconds.

8. In the method of claim 1 controlling the inflating pressure to prevent said pressure from exceeding said initial subdilatation pressure.

9. The method of claim 1 further comprising monitoring the progress of said angioplasty, and controlling the temperature, pressure or duration of treatment in response to the rate of change in the diameter of said vessel.

10. The method of claim 9 further comprising reducing the pressure, temperature of said balloon or duration of treatment if a rapid change in the diameter of said vessel indicative of cracking of the substance of said vessel wall occurs.

11. The method of claim 10 further comprising reducing the pressure, temperature or duration of treatment if the diameter of said vessel increases by about 25% or more in less than about 0.5 seconds.

12. In the method of any one of claim 9 to 11, monitoring said progress by fluoroscopy.

13. In the method of any one of claims 9 to 11 monitoring said progress by monitoring the change in pressure in said balloon.

14. The method of claim 1 in which a balloon is provided having a diameter substantially the same as that of healthy portions of the vessel.

15. The method of claim 1 or 14 a balloon is provided having an axial length slightly greater than the axial length of said region.

16. The method of claim 1 in which the inflatable balloon is provided with means for I² R heating of said inflation liquid.

17. A system for dilation of a body lumen, for use with an expandable dilatation catheter constructed to simultaneously heat and apply pressure to the tissue of the lumen to expand and dilate the lumen, comprising:

means constructed to detect physiological response of heated lumen tissue to applied pressure, said means including catheter control means responsive to the detected behavior of the heated tissue to control said catheter to enable dilatation of said lumen under relatively low stress conditions.

18. The system of claim 17 wherein said means to detect physiological response is constructed to detect yielding behavior of the lumen tissue contacted by said catheter, and said catheter control means is responsive thereto.

19. The system of claim 17 wherein said means to detect physiological response is constructed to detect change in the heat transfer characteristic of the tissue contacted by said catheter and said catheter control means is responsive thereto.

20. The system of claim 17 including means that prevents contraction of said catheter during cooling of said lumen tissue following said heating.

21. The system of claim 17 wherein said catheter control means includes a microprocessor and is arranged to receive feedbacks indicative of temperature and pressure applied by said catheter, said control means adapted to regulate heating and pressure applied by said catheter on the basis of said feedbacks and an algorithm implemented by said microprocessor.

22. The system of claim 17 including timing means constructed and arranged to provide timing of the duration of the dilatation based upon the physiological response to said heat and applied pressure.

23. The system of claim 17 in combination with a catheter constructed to heat said lumen tissue by conductive heat transfer through a wall of said catheter exposed to said lumen tissue.

24. The system of claim 23 wherein said catheter is a balloon catheter fillable with an electrically conductive liquid and associated heating means for producing said heat comprises rf electrodes within said balloon and means to apply rf energy thereto in a manner to heat said liquid by I² R losses.

25. The system of claim 17 wherein said catheter is a fluid inflatable catheter and said catheter control means is an inflation control means.

26. The system of claim 17 wherein said means to detect physiological response comprises a pressure sensor constructed and arranged to sense the fluid pressure in said catheter and detect reduction in said pressure that results due to pressure-responsive yielding behavior of the heating lumen tissue, said catheter control means responsive to said detected change in pressure, to increase the volume of inflation of said catheter.

27. The system of claim 26 where said means to detect physiological response includes a volume sensor indicating change in the inflated volume of said inflatable catheter.

28. The system of claim 25 wherein said inflation control means includes a servo motor-driven syringe pump.

29. The system of claim 28 including a position transducer for measuring the displacement of said syringe pump, thereby to indicate the volume of said inflatable catheter.

30. The system of claim 25 including means that prevent deflation of said catheter during cooling of said lumen tissue following said heating.

31. The system of claim 30 wherein said means to prevent deflation is a fluid check valve.

32. The system of claim 25 further including means for measuring the temperature of fluid within said inflatable catheter.

33. The system of claim 25 wherein said catheter control means comprises a controller constructed to receive signals indicative of the pressure or volume and the temperature of said inflatable catheter, the controller constructed to control said inflation and temperature in response to said signals, for further treatment.

34. The system of claim 17 further including display means to provide a read-out indicative of the physiological response of said tissue under treatment.

35. The system of claim 34 wherein said read-out indicates pressure applied by said catheter, heating by said catheter and volume of said catheter.

36. A system for dilation of a body lumen comprising:

an inflatable dilatation balloon catheter and associated heating means arranged to simultaneously apply heat via conductive heat transfer from said balloon to lumen tissue and pressure to said tissue,

and means constructed to detect physiological response of heated lumen tissue to applied pressure, said means including catheter control means responsive to the detected behavior of the tissue to control said catheter to enable dilatation of said lumen under relatively low stress conditions.

37. The system of claim 36 wherein said catheter control means is adapted to increase the inflation of said balloon in reaction to detected yielding behavior of the lumen tissue contacted by said catheter.

38. The system of claim 36 or 37 wherein said means to detect physiological response is constructed to detect change in the heat transfer characteristic of said lumen tissue and to reduce the heating on the basis of such detected change.

39. The system of claim 36 wherein said catheter control means comprises a controller under control of a programmed microprocessor.

40. The system of claim 39 wherein said program of said microprocessor is adapted to increase an inflation set point of an inflation pressure controller in reaction to feedback from said catheter indicating yielding behavior of the heated lumen tissue.

41. The system of claim 39 wherein the microprocessor is programmed to produce heating of lumen tissue at a pressure below normal dilatation pressure.

42. The system of claim 36 wherein said inflatable dilatation balloon catheter is an angioplasty catheter, carrying an inflatable angioplasty balloon.

43. A method for dilation of a body lumen, comprising:

employing a system comprising the combination of an expandable dilatation catheter constructed to simultaneously heat and apply pressure to the tissue of the lumen and to expand and dilate the lumen;

and means constructed to detect physiological response of heated lumen tissue to applied pressure, said means including catheter control means responsive to the detected behavior of the tissue to control said catheter to enable dilation of said lumen under relatively low stress conditions.

44. The method of claim 43 wherein said means to detect physiological response is constructed to detect yielding behavior of the lumen tissue constructed by said catheter, and said catheter control means is responsive thereto.

45. The method of claim 43 wherein said means to detect physiological response is constructed to detect change in the heat transfer characteristic of the tissue contacted by said catheter and said catheter control means is responsive thereto.

46. The method of claim 43 wherein said dilation is employed to remodel a lumen.

47. The method of claim 43 wherein said dilation is employ for angioplasty.

48. The method of claim 43 including terminating a step of said procedure after a measured period from the time of detection of a physiological response.

49. The method of claim 43 employing timing means constructed and arranged to provide timing of the duration of the dilatation based upon the physiological response to said heat and applied pressure.

50. The method of claim 43 wherein the initial temperature of heating is between 50°

C. and 70°

C.

51. The method of claim 43 wherein said catheter is a balloon catheter filled with liquid and the wall of said lumen is heated by heating the liquid, with heat transfer by conduction from said liquid across the wall thickness of the balloon to the tissue of the wall with which said balloon is engaged.

52. The method of claim 51, wherein the liquid within said balloon is electrically conductive and said liquid is heated by I² R losses as a result of radio frequency electric currents applied to said liquid.