Method for carrying out hemodynamic measurements on a patient and flow-directed balloon catheter used for this

• US 5,035,246 A
• Filed: 06/30/1988
• Issued: 07/30/1991
• Est. Priority Date: 06/30/1987
• Status: Expired due to Fees

• Current Assignee: Stichting Foundation For The Administration of The Patent Rights of Dr H Goslinga
• Original Assignee: Hieltje Goslinga, Joannes H.A. Heuvelmans
• Inventors: Heuvelmans, Joannes H. A., Goslinga, Hieltje
• Primary Examiner(s): Smith, Ruth S.
• Assistant Examiner(s): LACYK, JOHN P
• Application Number:
  US07/213,694
• Time in Patent Office: 1,125 Days
• Field of Search: 128/672-675, 128/691-692, 128/713, 128/344, 604/96, 606/191, 606/192, 606/198
• US Class Current: 600/486
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/028 by thermo-dilution

Abstract

A method for carrying out hemodynamic measurements on a patient, using a low-directed balloon catheter, which is connected to a measuring unit and is at least provided with a distal measuring lumen and a balloon-inflating lumen, comprising the steps of inserting the catheter by way of a suitable vein and further by way of the right atrium and ventricle into the pulmonary artery until the distal end with the inflated balloon in wedge position is stuck in a branch thereof and closes off the latter. A proximal measuring lumen is provided a few centimeters apart from the distal measuring lumen. Then the pulmonary arterial pressure (PAP) is measured, as long as the catheter has not yet arrived in the wedge position, via both the proximal and distal measuring lumina and the two relevant, virtually identical pressure curves are simultaneously recorded.

In the wedge position of the catheter with the balloon inflated, the pulmonary arterial pressure (PAP) and the pulmonary capillary wedge pressure (PCWP) via both said measuring lumina are measured respectively.

A flow-directed balloon catheter for hemodynamic measurements for use with the above method, said catheter being provided with a distal measuring lumen, a balloon-inflating lumen, and a proximal measuring lumen a few centimeters apart from the distal measuring lumen.

Claims

1. Method for carrying out hemodynamic measurements on a patient, using a flow-directed balloon catheter, which is connected to a control and pressure-measuring unit and is at least provided with a distal measuring lumen and a balloon-inflating lumen, comprising the steps of inserting the catheter by way of a suitable vein until the distal end is positioned inside the thorax, subsequently inflating the balloon, inserting the catheter further by way of the right atrium and ventricle into the pulmonary artery until the distal end with the inflated balloon in wedge position is stuck in a branch thereof and closes off the latter, providing a proximal measuring lumen spaced closely to the distal measuring lumen, measuring the pulmonary arterial pressure (PAP) during insertion of the catheter into the pulmonary artery as long as the catheter has not yet arrived in the wedge position via both the proximal measuring lumen and the distal measuring lumen, and simultaneously recording the two relevant, virtually identical pressure curves with the measuring unit.

2. Method for carrying out hemodynamic measurements on a patient using a flow-directed balloon catheter which is connected to a control and pressure-measuring unit and is at least provided with a distal measuring lumen, a balloon-inflating lumen and a proximal measuring lumen spaced closely to the distal measuring lumen, said method comprising the steps of:

inserting the catheter by way of a suitable vein until the distal end is positioned inside the thorax;

subsequently inflating the balloon;

inserting the catheter further by way of the right atrium and ventricle into the pulmonary artery until the distal end with the inflated balloon in wedge position is stuck in a branch thereof and closes off said branch;

measuring pulmonary arterial pressure (PAP) during insertion of the catheter into the pulmonary artery as long as the catheter has not yet arrived in the wedge position via both the proximal measuring lumen and the distal measuring lumen;

measuring, in the wedge position of the catheter with the balloon inflated, the pulmonary arterial pressure (PAP) and the pulmonary capillary wedge pressure (PCWP) via the proximal measuring lumen and via the distal measuring lumen; and

simultaneously recording two relevant pressure curves with the measuring unit reflecting said measurement via the proximal measuring lumen and via the distal measuring lumen at all times so that the moment at which the catheter arrives in the wedge position can be clearly detected as said two curves diverge,

whereby simultaneous measurement of said pressures relative to each other is independent of interfering cardiac and respiratory influences.

7. Method according to claim 2 or 3, in which the catheter has a thermistor lumen near the distal end for a thermodilution measurement in order to determine the cardiac output (CO), the pulmonary vascular resistance PVR=(PAP-LAP)/CO being determined (wherein LAP is the left atrial pressure) by LAP˜

PCWP, the intra-thoracic pressure changes, cardiac and respiratory fluctuations which may occur during the measurement of PAP and PCWP having no influence.

3. Method for carrying out hemodynamic measurements on a patient using a flow-directed balloon catheter which is connected to a control and pressure-measuring unit and is at least provided with a distal measuring lumen, a balloon-inflating lumen and a proximal measuring lumen spaced closely to the distal measuring lumen, said method comprising the steps of:

inserting the catheter by way of a suitable vein until the distal end positioned inside the thorax;

subsequently inflating the balloon;

inserting the catheter further by way of the right atrium and ventricle into the pulmonary artery until the distal end with the inflated balloon in wedge position is stuck in a branch thereof and closes off said branch;

measuring pulmonary arterial pressure (PAP) during insertion of the catheter into the pulmonary artery as long as the catheter has not yet arrived in the wedge position via both the proximal measuring lumen and the distal measuring lumen

measuring, in the wedge position of the catheter with the balloon inflated, the pulmonary arterial pressure (PAP) and the pulmonary capillary wedge pressure (PCWP) via the proximal measuring lumen and via the distal measuring lumen

simultaneously recording two relevant pressure curves with the measuring unit reflecting said measurement of said pulmonary arterial and pulmonary capillary measurement of said pulmonary arterial and pulmonary capillary wedge pressures at all times so that the moment at which the catheter arrives in the wedge position can be clearly detected as said two curves diverge, whereby simultaneous measurement of said pressures relative to each other is independent of interfering cardiac and respiratory influences; and

incidentally inflating the balloon in the wedge position of the catheter and measuring said pulmonary arterial and pulmonary capillary wedge pressures simultaneously via the two measuring lumina in the uninflated and inflated state of the balloon so as to produce virtually identical and mutually different pressure curves on the measuring unit as a result of which the wedge position is exactly determined and a reliable measure of the pulmonary arterial and pulmonary capillary wedge pressures is guaranteed.

4. Method according to claim 3, comprising the step of simultaneously measuring the pulmonary arterial pressure (PAP) and pulmonary capillary wedge pressure (PCWP) via the proximal measuring lumen and via the distal measuring lumen in a spontaneously assumed and upward-displaced wedge position of the catheter with the uninflated balloon producing thereby mutually different pressure curves on the measuring unit, as a result of which the moment at which the catheter without inflated balloon spontaneously arrives in an upward-displaced wedge position can be clearly detected due to the two said curves diverging and an alarm can be given.

5. Method according to claim 3 further comprising the step of generating a gradient curve equal to the difference between the pulmonary arterial pressure and the pulmonary wedge capillary pressure and which is completely independent of respiration and independent of intrathoracic pressure changes due to respiration and which is representative of cardiac output and pulmonary vascular resistance, said gradient curve presenting an exact end-diastolic pressure gradient having an important predictive value to a patient'"'"'s prognosis.

6. Method according to claim 3 further comprising the step of fixing the distal tip of the catheter within the pulmonary artery by inflating the balloon so as to facilitate an improved measurement of the pulmonary artery pressure measured via the proximal measuring lumen through the avoidance of catheter sway or catheterwhip effect.

8. Method for carrying out hemodynamic measurements on a patient using a flow-directed balloon catheter which is connected to a control and pressure-measuring unit and is at least provided with a distal measuring lumen, a balloon-inflating lumen and a proximal measuring lumen spaced closely to the distal measuring lumen, said method comprising the steps of:

inserting the catheter by way of a suitable vein until the distal end is positioned inside the thorax;

subsequently inflating the balloon;

inserting the catheter further by way of the right atrium and ventricle into the pulmonary artery until the distal end with the inflated balloon in wedge position is stuck in a branch thereof and closes off said branch;

measuring pulmonary arterial pressure (PAP) during insertion of the catheter into the pulmonary artery as long as the catheter has not yet arrived in the wedge position via both the proximal measuring lumen and the distal measuring lumen;

simultaneously recording the two relevant, virtually identical pressure curves with the measuring unit;

measuring, during the insertion of the catheter by way of the right atrium and ventricle into the pulmonary artery or during removal of the catheter therefrom the pressure on one side and on the other side of a valve selected from the group consisting of the tricuspid valve, the pulmonary valve and both tricuspid and pulmonary valves, by means of the proximal and distal measuring lumina and recording the pressure gradient over the said valve on the measuring unit by means of two pressure curves.