Dynamic derivation of the inflation behavior of a dilation catheter

Patent metadata

Field	Value
Publication number	US-12521533-B2
Application number	US-202318537178-A
Country	US
Kind code	B2
Filing date	Dec 12, 2023
Priority date	Dec 20, 2022
Publication date	Jan 13, 2026
Grant date	Jan 13, 2026

Abstract

A balloon catheter system has a catheter with a catheter shaft surrounding a lumen. A balloon is connected to a distal end of the catheter shaft such that a fluid inflation medium can be introduced into or removed from a balloon interior via the lumen. A pressure sensor is configured to measure an instantaneous pressure (p) of the inflation medium in the lumen during inflation and/or deflation of the balloon. A flow sensor is configured to measure an instantaneous volume flow (v) of the inflation medium during the inflation and/or deflation. An evaluation unit is configured to record the instantaneous pressure and the instantaneous volume flow and to determine therefrom a time curve of the flow resistance (R).

First claim

The invention claimed is:

1 . A balloon catheter system, comprising:
a catheter having a catheter shaft surrounding a lumen, a balloon connected to a distal end of the catheter shaft such that a fluid inflation medium can be introduced into and be removed from a balloon interior of the balloon via the lumen, a pressure sensor configured to measure inflation and/or deflation of the balloon, a flow sensor configured to measure a volume flow (v) of the inflation medium during the inflation and/or deflation, and an evaluation unit configured to record instantaneous pressure and the instantaneous volume flow during the inflation and/or deflation and to determine therefrom a time curve of the flow resistance (R).

2 . The balloon catheter system according to claim 1 , the evaluation unit determines the flow resistance (R) from at least one variable of the following variables:
a time point at which the balloon contacts a vessel wall of the patient during inflation, energy necessary for dilating a stenosis of the patient, and a time point at which the stenosis is dilated.

3 . The balloon catheter system according to claim 1 , wherein the catheter comprises a catheter port connected to the lumen, wherein the pressure sensor is configured to measure the instantaneous pressure at the catheter port and/or wherein the flow sensor is configured to measure the volume flow at the catheter port.

4 . The balloon catheter system according to claim 3 , wherein the system comprises a pump configured to control the inflation medium for the inflation and deflation, and wherein the flow sensor is integrated into a sensor unit configured to connect the pump to the catheter port.

5 . The balloon catheter system according to claim 3 , wherein the system comprises a pump configured to control the inflation medium for the inflation, and wherein the pressure sensor and the flow sensor are integrated into a sensor unit configured to connect the catheter port and the pump to one another.

6 . The balloon catheter system according to claim 5 , wherein the sensor unit is configured to transmit the measured instantaneous pressure and the measured instantaneous volume flow to the evaluation unit via a radio link.

7 . The balloon catheter system according to claim 3 , wherein the catheter port comprises an inlet lumen connected to the lumen of the catheter shaft, and wherein the balloon catheter system comprises a sensor unit comprising an outlet area for discharging the inflation medium from the sensor unit, wherein the outlet area is configured to positively engage in the inlet lumen.

8 . The balloon catheter system according to claim 1 , wherein the flow sensor comprises a Coriolis flow sensor.

9 . The balloon catheter system of claim 1 , wherein the system comprises a pump configured to control the inflation medium for the inflation and deflation.

10 . The balloon catheter system according to claim 9 , wherein the pressure sensor is integrated into the pump.

11 . The balloon catheter system according to claim 1 , comprising a data acquisition unit configured to input one or more parameters characterizing the catheter.

12 . The balloon catheter system according to claim 11 , wherein the evaluation unit is configured to use the one or more parameters in determining at least one variable from the flow resistance (R).

13 . A method for inflating a balloon of a catheter with a fluid inflation medium, comprising the steps:
measuring and recording an instantaneous volume flow (v) of the inflation medium and an instantaneous pressure (p) of the inflation medium during inflation and/or deflation of the balloon, and automatically determining a time curve of the flow resistance (R) during the inflation and/or deflation of the balloon from measured variables of the instantaneous pressure and the instantaneous volume flow.

14 . The method according to claim 13 , comprising automatically determining at least one variable of the following variables from the flow resistance (R):
a time point, at which the balloon contacts a vessel wall of the patient on inflation, energy necessary for dilating a stenosis of the patient, a time point at which the stenosis is dilated.

Assignees

• Biotronik Ag

Inventors

• Quint Bodo
• Risch Fabian

Classifications

• A61M2205/3334

  Measuring or controlling the flow rate · CPC title

• A61M2025/0001

  for pressure measurement · CPC title

• A61M25/10187

  Indicators for the level of inflation or deflation · CPC title

• A61M25/10181

  Means for forcing inflation fluid into the balloon · CPC title

• A61B5/02007

  Evaluating blood vessel condition, e.g. elasticity, compliance · CPC title