Apparatus & method for determining physiologic characteristics of body lumens
First Claim
1. A method for determining a physiological characteristic at a location within a body lumen, said method comprising:
- introducing an incompressible medium into a balloon to inflate the balloon to at least one preselected pressure while the balloon is within a calibration lumen having a predetermined, fixed diameter;
determining the internal volume of the balloon while inflated within the calibration lumen at the preselected inflation pressure;
introducing the balloon while uninflated to the location within the body lumen;
introducing the incompressible medium into the balloon to inflate the balloon to the preselected pressure at the location;
measuring the internal volume of the balloon while inflated at the location; and
determining the physiological characteristic at the location based on the difference between the volume of the balloon while inflated within the calibration lumen and the measured volume at the location.
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Accused Products
Abstract
Disclosed are a system, apparatus, and method for determining a physiologic characteristic of a body lumen that include determining, at one or more selected pressures, the volume of incompressible medium infused into a balloon 54 of catheter 24 while the balloon is placed in each of (a) a lumen having a predetermined, fixed diameter and (b) a desired location of a body lumen having an unknown diameter. In certain variations, the physiologic characteristic (e.g., diameter, cross-sectional area) is determined by calculating the difference in the volume of infused medium between (a) and (b) at at least one static pressure. Other physiologic characteristics (e.g., compliance) are determined by calculating the difference in infused medium for (b) at at least two static pressures.
46 Citations
38 Claims
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1. A method for determining a physiological characteristic at a location within a body lumen, said method comprising:
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introducing an incompressible medium into a balloon to inflate the balloon to at least one preselected pressure while the balloon is within a calibration lumen having a predetermined, fixed diameter;
determining the internal volume of the balloon while inflated within the calibration lumen at the preselected inflation pressure;
introducing the balloon while uninflated to the location within the body lumen;
introducing the incompressible medium into the balloon to inflate the balloon to the preselected pressure at the location;
measuring the internal volume of the balloon while inflated at the location; and
determining the physiological characteristic at the location based on the difference between the volume of the balloon while inflated within the calibration lumen and the measured volume at the location. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A system for measuring a physiological characteristic of a body lumen, said system comprising:
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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 determining the physiological characteristic 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 constrained within a lumen having a predetermined, fixed diameter and (b) the volume of inflation medium required to produce the preselected pressure of inflation medium within the balloon when the balloon is at the location within the body lumen. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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36. A system for connection to a balloon catheter, said balloon catheter having a proximal end, a distal end, an inflation lumen extending from the proximal end to near the distal end, and an inflatable balloon mounted near the distal end of the catheter body and connected to the inflation lumen, said system for determining a physiologic characteristic of a body lumen and comprising:
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means for introducing a measured volume of incompressible medium 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 (a) the value of a first measured volume of inflation medium at a preselected pressure when the inflatable balloon is constrained within a lumen having a predetermined, fixed diameter, and (b) the value of a second measured volume of inflation medium at the preselected pressure when the inflatable balloon is disposed within the body lumen. - View Dependent Claims (37, 38)
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Specification