WO2021170694A2 - Système pour réaliser une angioplastie et procédé pour déterminer un diamètre d'un ballonnet d'un cathéter à ballonnet - Google Patents

Système pour réaliser une angioplastie et procédé pour déterminer un diamètre d'un ballonnet d'un cathéter à ballonnet Download PDF

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Publication number
WO2021170694A2
WO2021170694A2 PCT/EP2021/054629 EP2021054629W WO2021170694A2 WO 2021170694 A2 WO2021170694 A2 WO 2021170694A2 EP 2021054629 W EP2021054629 W EP 2021054629W WO 2021170694 A2 WO2021170694 A2 WO 2021170694A2
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WIPO (PCT)
Prior art keywords
electrodes
balloon
fluid
inner shaft
excitation
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PCT/EP2021/054629
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German (de)
English (en)
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WO2021170694A3 (fr
Inventor
Matthias Wesselmann
Yilmaz HUESEYIN
Bodo Quint
Amir Fargahi
Original Assignee
Biotronik Ag
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Application filed by Biotronik Ag filed Critical Biotronik Ag
Publication of WO2021170694A2 publication Critical patent/WO2021170694A2/fr
Publication of WO2021170694A3 publication Critical patent/WO2021170694A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6853—Catheters with a balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation

Definitions

  • the present invention relates to a system for performing an angioplasty according to the preamble of claim 1 and a method for determining a diameter of a balloon of a balloon catheter, which can be filled with an electrically conductive fluid, for performing an angioplasty.
  • Such a system comprises a balloon catheter which has a balloon that can be filled with an electrically conductive fluid and two electrodes arranged in the balloon.
  • the system also includes an evaluation unit that is electrically connected to the electrodes.
  • a balloon catheter with a balloon arranged, for example, in the region of the distal end of the balloon catheter is inserted into a blood vessel in order to widen a constriction of the blood vessel and thereby improve or restore a flow through the blood vessel.
  • Such an angioplasty can be used, for example, to widen constricted or blocked coronary vessels and is then referred to as percutaneous transluminal coronary angioplasty (abbreviated to PTCA).
  • a blood vessel as part of angioplasty takes place by filling the balloon of the balloon catheter with a fluid, for example an electrolyte solution.
  • a fluid for example an electrolyte solution.
  • an angioplasty which can also take place with the placement of a so-called stent, but optionally also without a stent, there is generally a desire to precisely determine the diameter of the balloon during filling in order to Performing the angioplasty to ensure that the blood vessel is dilated enough, but not overstretched.
  • EP 1 599 232 B1 for performing an angioplasty four electrodes are arranged on an inner shaft of a balloon catheter within a balloon, two of which serve as excitation electrodes and two as measuring electrodes.
  • An electrical resistance of the fluid filled into the balloon can be determined via the measuring electrodes in order to draw conclusions about the diameter of the balloon based on the resistance
  • the resistance of the (electrically conductive) fluid in the balloon is correlated with the cross-sectional area of the balloon and thus with the diameter of the balloon.
  • conclusions can be drawn about the absolute diameter or a relative change in diameter of the balloon.
  • an impedance measured between the electrodes is not determined solely by the electrical resistance of the fluid, but also other effects, for example a transition between the electrodes and the fluid, influence the impedance.
  • the object of the present invention is to provide a system and a method which enable a precise determination of the absolute diameter or at least a relative change in diameter of the balloon of the balloon catheter.
  • the evaluation unit is designed to apply at least one excitation signal to the electrodes and to measure at least one measurement signal via the electrode in order to use the at least one measurement signal to determine impedance values at different frequencies and to determine a characteristic value correlated with the electrical resistance of the fluid in the balloon .
  • two electrodes which are arranged inside the balloon that can be filled with the electrically conductive fluid, are used to determine the (absolute or relative) diameter of the balloon of the balloon catheter.
  • One or more excitation signals are applied via the electrodes and thus fed into the balloon.
  • One or more measurement signals resulting from the one or more excitation signals are also received via the electrodes, so that a characteristic value that is correlated with the electrical resistance of the fluid in the balloon can be derived from the measurement signals.
  • impedance values are determined at different frequencies.
  • the characteristic value correlated with the electrical resistance of the fluid in the balloon is determined from the impedance values, the characteristic value in turn being correlated with the diameter of the balloon and thus the (absolute or relative) diameter of the balloon can be determined from the characteristic value.
  • the excitation signal can be, for example, an AC voltage signal that is applied to the electrodes.
  • the measurement signal can be, for example, a current signal which is measured via the electrodes and corresponds to the current through the fluid in the balloon resulting from the voltage signal.
  • the fluid can be an electrolyte solution, for example.
  • the electrical conductivity of the electrolyte solution is known, for example in that the electrical conductivity of the electrolyte solution, which is used to fill the balloon when performing an angioplasty, is determined in advance by measurement, or by measuring the conductivity when performing the angioplasty, for example on site a Luer connector through which the electrolyte solution for filling the balloon is fed into the balloon catheter.
  • the evaluation unit is designed, for example, to apply an excitation signal with different frequency components to the electrodes and to measure a resulting measurement signal via the electrodes in order to determine impedance values at different frequencies using a frequency analysis of the measurement signal and to determine the impedance values with the electrical Resistance of the fluid in the balloon to determine correlated characteristic value.
  • An excitation signal that has different frequency components is thus fed in.
  • different frequency components are superimposed so that the resulting measurement signal also has different frequency components that can be analyzed by means of a frequency analysis, for example a Fourier analysis, and used to determine the impedance values at the different frequencies.
  • the evaluation unit can be designed to apply an excitation signal at a predetermined frequency to the electrodes in several successive measurements, the frequencies of the excitation signals differing in the different measurement processes.
  • a resulting measurement signal is measured via the electrodes in order to determine impedance values at different frequencies on the basis of the measurement signals received in the measurement processes.
  • the impedance values are thus obtained in different measurement processes and thus in a staggered manner.
  • a characteristic value which is correlated with the electrical resistance of the fluid in the balloon can then be determined from the impedance values.
  • the frequencies are, for example, in a range between 100 Hz and 50 kHz, for example between 1 kHz and 20 kHz.
  • the frequencies at which the impedance values are determined should be clearly different from one another and, for example, have a distance of several kilohertz from one another. From the evaluation of the measurement signal having different frequency components obtained in a (single) measurement process or the measurement signals obtained in different measurement processes, each assigned to an excitation frequency for determining the Impedance values at the different frequencies can result in a time delay in the determination of the diameter, but this is acceptable and does not represent a practical limitation, because inflation of a balloon usually takes place in a comparatively slow manner in order to minimize a traumatic intervention for the patient.
  • the diameter of the balloon that can be filled with the fluid is correlated with the electrical resistance of the fluid in the balloon.
  • the impedance measured between the electrodes is additionally influenced by a transition between the electrodes and the fluid, which is influenced, for example, by polarization effects and metal components in the fluid and can have a capacitive effect.
  • (resistive and / or capacitive) effects in supply lines between the evaluation unit and the electrodes can play a role (the supply lines should usually be electrically dimensioned in such a way that the effect of the fluid resistance is dominant and the electrical resistance of the supply lines is negligibly small).
  • an equivalent circuit diagram can be determined that models the electrical behavior of the electrodes and the fluid in the balloon.
  • a mathematical equation can be derived from the equivalent circuit diagram, on the basis of which the characteristic value for the resistance of the fluid can then be determined using the impedance values at the different frequencies.
  • the equivalent circuit has, for example, a first electrical resistance that models the electrical resistance of the fluid in the balloon.
  • a parallel circuit of a second electrical resistor and a capacitance is connected, which models a transition impedance between the electrodes and the fluid.
  • An equation for the (frequency-dependent) impedance of the arrangement of the electrodes and the fluid are established, based on which, using the measured impedance values at the different frequencies, the sizes of the first electrical resistance and the RC element determined by the second electrical resistance and the capacitance, for example by discrete evaluation or can be determined via a fit (for example a least squares optimization).
  • the value of the first electrical resistance corresponds to the resistance of the fluid in the balloon, which is correlated with the diameter of the balloon, so that a value for the (absolute or relative) diameter of the balloon can be determined from this resistance value
  • the balloon catheter has an inner shaft which is at least partially arranged within the balloon.
  • the balloon can be expanded radially towards the inner shaft in order to expand or reopen a constriction in the blood vessel when performing an angioplasty.
  • the electrodes can be arranged fixedly on the inner shaft and are connected to the inner shaft, for example, as ring electrodes.
  • the ring electrodes can be arranged as metallic rings on the inner shaft or designed as metallized surfaces on the inner shaft.
  • electrodes on the inside of the balloon, for example through metallized surfaces, can also be used.
  • the metallized areas can also be created using conductive ink.
  • the balloon catheter can have a carrier element, for example in the form of a tube, which is arranged radially outside of the inner shaft, at least one section movable to the inner shaft, on which the electrodes are arranged.
  • the carrier element can, for example, be connected to the inner shaft at (exclusively) one axial location and is used to carry the electrodes fastened to the carrier element, for example as rain electrodes. Because the carrier element is only connected to the inner shaft at one axial location, a change in length on the inner shaft cannot be transferred to the carrier element and thus cannot lead to a change in the axial distance between the electrodes (which would otherwise lead to the electrical resistance of the fluid and thus the accuracy of the diameter measurement).
  • the inner shaft has an inner lumen for receiving a guide wire which is used to guide the balloon catheter.
  • a guide wire which is used to guide the balloon catheter.
  • the guide wire is usually made of a metal material and is therefore electrically conductive, it being possible to provide for one of the electrodes to make electrical contact with the guide wire, so that the electrode and the guide wire are at the same potential and thus disruptive effects due to an (indefinite) potential the guide wire can be avoided.
  • a first electrical conductor and a second electrical conductor are integrated into the inner shaft or arranged within a wall of the inner shaft and the electrodes are formed by the first electrical conductor and the second electrical conductor.
  • the inner shaft is designed in such a way that in each case a section of the first electrical conductor and the second electrical conductor can make electrical contact with the electrically conductive fluid Conductor is free to the balloon lumen or electrically conductive lumen, that is, it is not electrically isolated from the balloon lumen at this point by the wall of the inner shaft.
  • the first electrical conductor and the second electrical conductor preferably extend in an axial direction or coaxially to the inner shaft.
  • the object is also achieved by a method for determining a diameter of a balloon of a balloon catheter that can be filled with an electrically conductive fluid for performing an angioplasty.
  • the method is carried out using an evaluation unit which is electrically connected to two electrodes arranged in the balloon.
  • the method includes: applying at least one excitation signal to the electrodes and measuring at least one measurement signal via the Electrodes to determine the impedance width at different frequencies based on the at least one measurement signal and to determine a characteristic value correlated with the electrical resistance of the fluid in the balloon.
  • a system for performing an angioplasty comprises a balloon catheter which has a balloon that can be filled with an electrically conductive fluid, two excitation electrodes arranged in the balloon and two measuring electrodes arranged in the balloon, and an evaluation unit electrically connected to the excitation electrodes and the measuring electrodes , wherein the evaluation unit is designed to apply an excitation signal to the excitation electrodes and to measure a measurement signal via the measurement electrodes in order to use the measurement signal to determine a characteristic value correlated with the electrical resistance of the fluid in the balloon.
  • the excitation electrodes are arranged on end faces of the balloon that are axially spaced from one another along the balloon catheter.
  • a balloon of a balloon catheter typically has a cylindrical working area in the center.
  • This cylindrical work area in the middle is mainly used for angioplasty of the vessel.
  • a conical (essentially frustoconical) area also referred to as frustoconical end faces
  • the balloon necks are mainly used to attach the balloon to an inner and / or outer shaft of the balloon catheter.
  • an arrangement of the excitation electrodes on the end faces of the balloon is understood to mean an arrangement on the conical areas and / or the balloon necks, an arrangement on the conical areas being preferred.
  • the diameter measurement takes place via four electrodes arranged in the balloon of the balloon catheter.
  • a Excitation signal fed in for example in the form of an alternating voltage signal that is applied to the excitation electrodes.
  • a resulting measurement signal is received via the measuring electrodes, which indicates a resulting voltage between the measuring electrodes and - because the measurement via the measuring electrodes is largely de-energized and the excitation electrodes can also be dimensioned over a large area - directly enables a characteristic value for the resistance of the fluid in the balloon to derive between the measuring electrodes.
  • the (absolute or relative) diameter of the balloon when performing the angioplasty can then be derived from the characteristic value
  • impedance values can also be determined at different frequencies, but may not be necessary because, due to the measurement via the (separate) measuring electrodes, the measuring signal measured between the measuring electrodes is determined by the electrical resistance of the fluid in the balloon and other effects only have negligible effects. Accordingly, in this refinement, the second resistor and the capacitance can be dispensed with in the equivalent circuit diagram described above.
  • the excitation electrodes are arranged on the front sides of the balloon. This can take place, for example, in that the balloon is metallized in sections on its end faces which are axially spaced from one another. For example, approximately frustoconical end faces of the balloon can be metallized in order to form the excitation electrodes on the end faces in this way. In one embodiment, the frustoconical end faces can be metallized by applying electrically conductive ink to the inside and / or outside of the frustoconical end faces.
  • the balloon catheter has an inner shaft on which the measuring electrodes are fixedly arranged.
  • the measuring electrodes are advantageously arranged axially between the front-side excitation electrodes.
  • the balloon catheter can have an inner shaft and a carrier element, for example in the form of a tube, arranged radially outside the inner shaft and movable at least with a section to the inner shaft, the electrodes being arranged on the carrier element.
  • the carrier element can for example (exclusively) be connected to the radially inner shaft at one axial location, but is otherwise axially movable to the inner shaft, which enables a change in length on the inner shaft not to result in a change in length on the carrier element and thus an axial distance of the measuring electrodes do not influence each other.
  • FIG. 1A shows a schematic view of a blood vessel at the beginning of an angioplasty
  • 1B is a schematic view of the blood vessel with an inserted balloon catheter
  • FIG. 1C shows a schematic view of the blood vessel after the angioplasty has been carried out
  • FIG. 2A shows a view of an exemplary embodiment of a balloon catheter with a balloon that can be filled with an electrically conductive fluid and electrodes arranged in the balloon, which are connected to an evaluation unit;
  • FIG. 2B shows a view of the arrangement according to FIG. 2A, but with a changed diameter of the balloon
  • 3 is a graphical view of the real part of an impedance measured between the electrodes, with a variable diameter; 4 shows an electrical equivalent circuit diagram of the arrangement of the electrodes and the electrically conductive fluid in the balloon;
  • Figure 5A is a graphical view of a first excitation signal at a first frequency
  • Figure 5B is a graphical view of a second excitation signal at a second frequency
  • Figure 5C is a graphical view of a third excitation signal at a third frequency
  • FIG. 7 is a view of an embodiment of a balloon catheter
  • Fig. 8 is a view of another embodiment of a balloon catheter
  • 9A is a view of yet another exemplary embodiment of a
  • Balloon catheter with electrodes arranged on a carrier element
  • FIG. 9B shows a view of the arrangement according to FIG. 9A, with the length of the balloon changed
  • FIG. 10 is a view of yet another exemplary embodiment of a
  • FIG. 11 is a schematic view of a balloon catheter in a patient
  • Fig. 12 is a view of a further embodiment of a balloon catheter.
  • 1A to 1C show schematic views of the implementation of an angioplasty for the purpose of expanding or reopening a blood vessel B, for example a coronary vessel (in this case referred to as percutaneous transluminal coronary angioplasty (PTCA)).
  • PTCA percutaneous transluminal coronary angioplasty
  • a balloon catheter 1 When performing an angioplasty, a balloon catheter 1 is usually brought into the area of a constriction E of a blood vessel B via a guide wire 2 (see FIGS. 1 A and 1B), so that the balloon catheter 1 is arranged with a, for example, at the distal end of the balloon catheter 1 Balloon 10 comes to rest in the area of the constriction E (FIG. 1B).
  • a fluid for example an electrolyte solution
  • the balloon 10 is expanded radially so that the blood vessel B in the area of the constriction E is expanded and there is sufficient flow after the angioplasty has been performed allows (Fig. IC).
  • the balloon catheter 1 is connected outside of a patient to an actuating device 17, via which the balloon 10 can be filled with a fluid via a fluid line extending along the balloon catheter 1.
  • the actuating device 17 can be actuated manually, for example, and for this purpose is configured, for example, in the manner of a bellows.
  • the actuating device 17 can also be implemented by an electrical pumping device.
  • FIGS. 2A and 2B An embodiment of such a balloon catheter 1 is shown in FIGS. 2A and 2B.
  • the balloon catheter 1 has an inner shaft 11 over which the balloon 10 is arranged.
  • the interior of the balloon 10 can be filled with a fluid, in particular an electrolyte solution, via a fluid line in the balloon catheter 1 (not shown) in order to inflate the balloon 10 in this way and thus enable a blood vessel B to expand.
  • the inner shaft 11 can be designed as a dual-lumen shaft which has an inner lumen 110 through which the guide wire 2 extends so that the balloon catheter 1 can be displaced along the guide wire 2.
  • the inner shaft 11 has a lumen for supplying fluid (fluid line).
  • the balloon catheter 1 has an inner shaft 11 which is at least partially surrounded by an outer shaft (also referred to as an over-the-wire arrangement).
  • the distal end of the balloon is connected to the inner shaft 11 and the proximal end of the balloon is connected to the distal end of the outer shaft.
  • the inner shaft has the lumen for the guide wire.
  • the fluid line (supply) takes place via the lumen between the inner shaft and the outer shaft.
  • electrodes 12, 13 are arranged on the inner shaft 11, via which impedance values ZI, Z2 can be measured, which are correlated with the diameter d1, d2 and on the basis of which the diameter d1, d2 is absolute or relative (in the sense of a change in diameter ) can be determined when performing an angioplasty.
  • FIG. 3 shows a graphic representation of the real part of the impedance Z measured between the electrodes 12, 13 as a function of a change in diameter at the balloon 10 (in percent).
  • 0% corresponds to an initial diameter of approx Balloon 10 is expanded radially starting from this initial diameter. From Fig. 3 it can be seen that there is a roughly linear relationship between the real part of the impedance and a change in diameter.
  • the impedance is determined via two electrodes 12, 13 which are connected to an evaluation unit 14 via supply lines 140.
  • the evaluation unit 14 is usually arranged outside of a patient, wherein the supply lines 140 extend inside the balloon catheter 1 and thus connect the evaluation unit 14 to the electrodes 12, 13 inside the balloon 10.
  • the impedance within the balloon 10 is determined via (precisely) two electrodes 12, 13, via which excitation signals are applied and measurement signals are received
  • the impedance obtained via the electrodes 12, 13 is determined not only by the electrical resistance of the fluid located in the balloon 10, but also by effects that result, for example, from a transition between the electrodes and the fluid.
  • the diameter d1, d2 of the balloon 10 can be approximately linearly correlated with the electrical resistance of the fluid in the balloon 10, so that the resistance of the fluid in the balloon body can be deduced from the measurement via the electrodes 12, 13.
  • other effects which have a disruptive effect must be factored out in order to enable a precise determination of the (absolute or relative) diameter d1, d2 of the balloon 10 when performing an angioplasty.
  • the arrangement of the electrodes 12, 13 and the fluid 10 can be modeled using the electrical equivalent circuit diagram shown in FIG. 4.
  • a first resistor R2 models the electrical resistance of the fluid in the balloon 10
  • a parallel connection of a second electrical resistor RI and a capacitance CI models other effects, in particular a current transfer between the electrodes 12, 13 and the fluid and is determined, for example, by polarization effects .
  • an equation for the impedance Z as it can be measured when an alternating voltage U is applied to the electrodes 12, 13 on the basis of a current I obtained, can be set up as follows:
  • the real part is determined by both the resistor R2 and the RC element of the parallel circuit determined by the resistor RI and the capacitance CI
  • the imaginary part is determined solely by the RC element.
  • values for the electrical resistance R2 of the fluid in the balloon 10 and the combination of the resistance RI with the capacitance CI in the RC element can be determined by excitation at different frequencies f takes place and impedance values are determined at different frequencies f.
  • an alternating voltage signal can be applied to electrodes 12, 13 as the excitation signal.
  • a measurement of impedance values at different frequencies can take place here by staggered measurements, in that - as shown in FIGS the impedance value at the respective frequency fl, f2, f3 is determined from a resulting current I.
  • an excitation signal U can alternatively be used which - as illustrated in FIG Frequencies fl, f2, f3 takes place.
  • the impedance values can be determined from a frequency analysis, for example using a Fourier analysis. From the impedance widths obtained in this way, using the above equation, a value for the resistance R2 can be determined directly and the (absolute or relative) diameter d1, d2 of the balloon 10 can be determined therefrom. Alternatively, a fit to the impedance values can be carried out in order to determine a value for the resistor R2.
  • the frequencies fl, f2, f3 of the excitation are, for example, in a range between 100 Hz and 50 kHz, for example in a range between 1 kHz and 20 kHz. For frequencies below 100 Hz, measurements are usually significantly disturbed, so that a sufficient signal-to-noise ratio cannot be obtained. For measurements above 50 kHz, the equivalent circuit diagram according to FIG. 4 does not represent a sufficient approximation for the electrical arrangement of the electrodes 12, 13 and the fluid, because inductive effects also play a role.
  • the frequencies fl, f2, f3 of the excitation should be sufficiently far apart, for example by a few kilohertz.
  • the diameter dl, d2 is correlated with the electrical resistance of the fluid in the balloon 10, which is determined in particular by the electrical conductivity of the fluid 10 and the cross-sectional area of the balloon 10. If the electrical conductivity of the fluid 10 is known, the determination of the resistance value R2 a value for the absolute diameter dl, d2 or a relative change in diameter of the diameter dl, d2 of the balloon 10 can be obtained.
  • the electrodes 12, 13 are usually applied to a different potential U1, U2, as shown in FIG. 13 to apply.
  • a current flow results between the electrodes 12, 13, which can be evaluated via the evaluation unit 14 in order, as described above, to derive a value for the electrical resistance of the fluid in the balloon 10 therefrom.
  • one of the electrodes 12, 13 (in the illustrated embodiment, the electrode 12) can be electrically contacted with the guide wire 2, so that the guide wire 2 is at the same potential U1 as the associated electrode 12. In this way, an indeterminate potential on the (electrically conductive) guide wire 2 is avoided, so that interference can be suppressed.
  • the electrodes 12, 13 - in contrast to the embodiment according to FIGS. 2A, 2B, in which the electrodes 12, 13 are fixedly arranged on the inner shaft 11 - are arranged on a carrier element 15 which is arranged radially outside of the inner shaft 11.
  • the carrier element 15 is implemented, for example, by a hose section that is axially connected to the inner shaft 11 at only one point and is thus mechanically decoupled from the inner shaft 11 in such a way that a change in length on the inner shaft 11 is not converted into a change in length on the carrier element 15.
  • an electrical resistance of the fluid in the balloon 10 is measured not via two electrodes, but via a total of four electrodes, two of which are used as excitation electrodes 18, 19 and two serve as measuring electrodes 12, 13.
  • the electrodes 12, 13, 18, 19 are each connected to an evaluation unit 14 via which an excitation signal (via the excitation electrodes 18, 19) is fed in and a measurement signal (via the measurement electrodes 12, 13) is received.
  • the excitation electrodes 18, 19 are arranged on the end faces 100, 101 of the balloon 10 and are formed, for example, by metallized surfaces on the conical end faces 100, 101 of the balloon 10.
  • the measuring electrodes 12, 13 are arranged on an inner shaft 11 of the balloon catheter 1 and are arranged axially within the excitation electrodes 18, 19.
  • An excitation signal in the form of an alternating voltage can be applied via the excitation electrodes 18, 19.
  • a measurement signal in the form of an alternating voltage (essentially without current) resulting between the electrodes 12, 13 is measured via the measuring electrodes 12, 13, which enables the electrical resistance of the fluid in the balloon 10 to be measured via the measuring electrodes 12, 13
  • To determine measurement at a single excitation frequency because the signal measured via the measuring electrodes 12, 13 is essentially determined by the electrical resistance of the fluid in the balloon 10.
  • Leads for connecting the excitation electrodes 18, 19 and the measuring electrodes 12, 13 to the evaluation unit 14 are in turn laid along the balloon catheter 1 to the evaluation unit 14 outside a patient, analogously to what is shown in FIG. 11.
  • two electrical conductors 141, 142 are integrated or arranged in the inner shaft 11 or in the wall 111 of the inner shaft, which conductors extend coaxially to the inner shaft 11. This can be implemented, for example, by extrusion or during an extrusion of the inner shaft 11.
  • a section of each of the two electrical conductors 141, 142 forms the measuring electrodes 12, 13.
  • the inner shaft 11 or the wall 111 has a recess 112, 113 so that the electrically conductive Lumen can electrically contact the respective section of the electrical conductors 141, 142 or come into physical contact.
  • no additional volume is required for the conductors for structural reasons, ie in particular that the inner shaft or the catheter system retains its optimum diameter. To do this, the electrical
  • Conductors 141, 142 are not separately or additionally electrically isolated by the integration.
  • a balloon catheter of the type described can be used to perform an angioplasty, in particular a percutaneous transluminal coronary angioplasty (PTCA).
  • PTCA percutaneous transluminal coronary angioplasty
  • a balloon of the balloon catheter can be filled, for example, with an electrolyte solution, but optionally also with another fluid that has an (at least slight) electrical conductivity.
  • a procedure of the type described can be used to determine a diameter of the balloon of the balloon catheter when performing an angioplasty with improved precision, with an absolute diameter or a relative change in diameter being able to be recorded.

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Abstract

L'invention concerne un système pour réaliser une angioplastie, qui comprend un cathéter à ballonnet (1) muni d'un ballonnet (10) pouvant être rempli d'un fluide électriquement conducteur et de deux électrodes (12, 13) disposées dans le ballonnet (10), et une unité d'évaluation (14) reliée électriquement aux électrodes (12, 13). L'unité d'évaluation (14) est conçue pour appliquer au moins un signal d'excitation (U) aux électrodes (12, 13) et pour mesurer au moins un signal de mesure (I) par l'intermédiaire des électrodes (12, 13) afin de déterminer à l'aide dudit au moins un signal de mesure (I) des valeurs d'impédance (Z1, Z2) à des fréquences différentes et de déterminer une valeur caractéristique corrélée avec la résistance électrique du fluide dans le ballonnet (10).
PCT/EP2021/054629 2020-02-27 2021-02-25 Système pour réaliser une angioplastie et procédé pour déterminer un diamètre d'un ballonnet d'un cathéter à ballonnet WO2021170694A2 (fr)

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CN117481617A (zh) * 2023-11-15 2024-02-02 苏州心岭迈德医疗科技有限公司 一种震波球囊装置

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EP1599232B1 (fr) 2003-02-21 2013-08-14 Electro-Cat, LLC Systeme pour mesurer des parties transversales et des gradients de pression dans des organes intracavitaires

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EP1599232B1 (fr) 2003-02-21 2013-08-14 Electro-Cat, LLC Systeme pour mesurer des parties transversales et des gradients de pression dans des organes intracavitaires

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117481617A (zh) * 2023-11-15 2024-02-02 苏州心岭迈德医疗科技有限公司 一种震波球囊装置
CN117481617B (zh) * 2023-11-15 2024-04-26 苏州心岭迈德医疗科技有限公司 一种震波球囊装置

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