Apparatus and method for determining physiologic characteristics of body lumens

• US 5,275,169 A
• Filed: 01/15/1992
• Issued: 01/04/1994
• Est. Priority Date: 01/15/1992
• Status: Expired due to Term

• Current Assignee: Innovation Associates Catheter Company, LLC
• Original Assignee: Innovation Associates Incorporated (Walgreens Boots Alliance Incorporated)
• Inventors: Afromowitz, Martin A., Wolthuis, Roger A., Mitchell, Gordon L.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): NASSER, ROBERT L
• Application Number:
  US07/822,032
• Time in Patent Office: 720 Days
• Field of Search: 128/673, 128/774, 128/778, 128/775, 128/786, 128/782, 128/748, 128/692, 33/511, 33/512, 604/96-103
• US Class Current: 600/486
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00

Abstract

A system includes a catheter (10) having a low pressure balloon (42) at of one end thereof, a precise, low pressure, low volume fluid infusion means (41) and a pressure sensor (43). The balloon (42) is introduced to a body lumen, such as a blood vessel, and inflated to a pressure at or just above physiologic, typically being below 200 mmhg. From the balloon volume at a particular pressure, the internal cross-sectional area and diameter of the vessel can be calculated. Additional calculations can be made at other pressures below 200 mmhg to determine compliance of the vessel.

Claims

1. A method for determining a physiologic characteristic of a body lumen, said method comprising:

introducing an incompressible fluid to a balloon disposed within the body lumen;

measuring static pressure within the balloon;

measuring total volume of fluid within the balloon at at least one static pressure below 200 mm Hg; and

calculating the physiologic characteristic based on the measured volume at said at least one measured pressure.

2. A method as in claim 1 wherein the physiologic characteristic is an internal dimension.

3. A method as in claim 2, wherein the internal dimension includes a cross-sectional area.

4. A method as in claim 2, wherein the internal dimension includes an internal diameter.

5. A method as in claim 1, wherein the physiologic characteristic is lumen compliance and the calculating step comprises calculating the lumen compliance based on a difference in the measured volume of inflation medium between a first measured pressure and a second measured pressure.

6. A method as in claim 1, wherein the step of introducing incompressible fluid comprises introducing incompressible fluid by positive displacement and the volume measuring step comprises measuring the volume based on the amount introduced.

7. A method as in claim 1, wherein the body lumen is selected from the group consisting of blood vessels, the intestines, the urethra, and the cervix.

8. A method as in claim 1, wherein the step of introducing incompressible fluid comprises introducing the fluid at a substantially constant rate in the range from 10 to 1000 μ

l/sec.

9. A method as in claim 1, wherein the step of introducing incompressible fluid comprises introducing the fluid at a variable rate in the range from 10 to 1000 μ

l/sec.

10. A method as in claim 1, wherein said at least one static pressure is between 70 and 120 mm Hg.

11. A method as in claim 1, further including the steps of stopping and then reversing the introduction of fluid into the balloon at preselected values of fluid pressure and volume.

12. A method as in claim 11, wherein the preselected fluid pressure is in the range from 0 to 200 mm Hg.

13. A method as in claim 1, including the steps of determining fluid volume for a plurality of fluid pressures below 200 mm Hg, when the balloon is unconstrained and also when the balloon is within the body lumen.

14. A method as in claim 12, wherein the incompressible fluid is introduced by positive displacement and the volume is measured based on the amount displaced.

15. A method as in claim 1, wherein the balloon is generally cylindrical and internal dimension is calculated by dividing the measured volume by a known balloon length.

16. A method as in claim 2, wherein the body lumen is selected from the group consisting of blood vessels, the intestines, the urethra, and the cervix.

17. A method for determining wall compliance of a body lumen, said method comprising:

introducing an incompressible fluid to a balloon disposed within the body lumen;

measuring the static pressure within the balloon;

measuring the total volume of fluid within the balloon at at least two static pressures below 200 mm Hg; and

calculating the wall compliance based on an observed difference in the fluid volume between a first measured pressure and a second measured pressure.

18. A method as in claim 17, wherein the step of introducing incompressible fluid comprises introducing said fluid by positive displacement and the volume is measured based on the amount displaced.

19. A method as in claim 17, wherein the step of calculating the wall compliance comprises calculating wall compliance as a percentage increase between a first measured volume at a first pressure and a second measured volume at a second higher pressure.

20. A method as in claim 17, wherein the body lumen is selected from the group consisting of blood vessels, the intestines, the urethra, and the cervix.

21. A method for calculating cross-sectional area at a location within a body lumen, said method comprising:

inflating a balloon to a preselected pressure while the balloon is unconstrained;

determining the internal volume of the unconstrained balloon at the preselected inflation pressure;

introducing the balloon while uninflated to the location within the body lumen;

inflating the balloon to the preselected pressure at the location;

determining the internal volume of the balloon while inflated at the location; and

calculating the cross-sectional area at the location based on the difference between the unconstrained volume and the volume at the location.

22. A method as in claim 21, wherein the preselected pressure is below 200 mm Hg.

23. A method as in claim 21, further comprising calculating cross-sectional area at a plurality of different preselected pressures, whereby compliance of the body lumen may be determined.

24. A system for measuring a physiologic characteristic of a body lumen, said system comprising:

a catheter body having a proximal end, a distal end, and an inflation lumen extending from the proximal end to near the distal end;

an inflatable balloon disposed near the distal end of the catheter body and being connected to the inflation lumen;

means for introducing a measured volume of inflation medium through a proximal end of the inflation lumen to inflate the inflatable balloon to a pressure of up to 200 mm Hg;

means for measuring the pressure of the inflation medium within the balloon; and

means for calculating the physiologic characteristic based on the value of the measured volume of inflation medium at one or more pressures below 200 mm Hg.

25. A system as in claim 24, wherein the inflatable balloon when inflated is generally cylindrical and has a length in the range from 3 Mm to 10 Mm and a diameter in the range from 1 to 5 mm.

26. A system as in claim 24, wherein the means for introducing a measured volume of inflation medium comprises a syringe.

27. A system as in claim 24, wherein the pressure measuring means comprises a pressure sensor disposed within the balloon.

28. A system as in claim 24, wherein the catheter body further includes a pressure measurement lumen extending from the balloon to the proximal end, wherein the pressure measuring means comprises a pressure sensor disposed near the proximal end of the pressure measurement lumen.

29. A system for measuring an internal dimension of a body lumen, said system comprising:

a catheter body having a proximal end, a distal end, and an inflation lumen extending from the proximal end to near the distal end;

an inflatable balloon mounted near the distal end of the catheter body and being connected to the inflation lumen;

means for introducing a volume of an incompressible medium through a proximal end of the inflation lumen to inflate the inflatable balloon;

means for measuring the pressure of incompressible medium within the balloon; and

means for calculating the internal dimension of a location within the body lumen based on the difference between (a) the volume of inflation medium required to produce a preselected pressure of inflation medium within the balloon when the balloon is unconstrained and (b) the volume of inflation medium required to produce the same pressure of inflation medium within the balloon when the balloon is at the location.

30. A system as in claim 29, wherein the catheter body includes at least a second lumen which is connected at its distal end to the interior of the inflatable balloon and wherein the means for measuring pressure is connected to said second lumen.

31. A system as in claim 29, wherein the means for measuring pressure comprises a pressure sensor disposed within the interior of the inflatable balloon.

32. A system as in claim 29, wherein the means for measuring pressure comprises a pressure sensor disposed at or near the proximal end of the inflation lumen.

33. A system for connection to a balloon catheter for determining a physiologic characteristic of a body lumen, said system comprising:

means for introducing a measured volume of incompressible fluid to the balloon catheter;

means for receiving a signal corresponding to static pressure within the balloon from the catheter; and

means for calculating the physiologic characteristic based on the value of the measured volume of inflation medium at one or more measured pressures below 200 mmhg.

34. A system as in claim 33, wherein the means for introducing comprises a syringe operatively connected to a position controlled motor.

35. A system as in claim 33, wherein the means for calculating comprises a microprocessor which is connected to both the positioned controlled motor and the pressure means for receiving.