Classifications

• • 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
  • A61B5/6856—Catheters with a distal loop
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/026—Measuring blood flow
  • A61B5/0275—Measuring blood flow using tracers, e.g. dye dilution
  • A61B5/028—Measuring blood flow using tracers, e.g. dye dilution by thermo-dilution
• • 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
  • A61B5/6857—Catheters with a distal pigtail shape

Definitions

• the invention relates to a catheter according to the preamble of claim 1.
• a so-called multi-um catheter In the context of diagnostic measures such. B. - hydrostati - see pressure measurements made with a single catheter with several separate channels and several lumens, a so-called multi-um catheter.
• the individual channels are led to the proximal end of the catheter outside the body and can be ⁇ connected via standardized connections to pressure transducers, with which the hydrostatic pressures at the lumen openings of the individual channels and the pressure difference or pressure gradient are measured.
• Such catheters can also be equipped with a temperature sensor, e.g. B. a small thermistor -2-
• a cold solution is channeled from the proximal end of the catheter into the blood vessel, e.g. B. injected the right ventricle of the heart, which after a certain time flows past the temperature sensor located in the direction of the distal end.
• the temperature drop at the location of the temperature sensor as a function of the flow time of the cooling solution in the blood circulation can then be used to determine the cardiac output; see. such as US Patents 4,502,488 and 4,105,022.
• the connections of the temperature sensor are guided in the catheter tube to the proximal end and are connected there via standardized connections to a small computer which directly provides the required measured values, such as the cardiac output in liters per liter Minute indicates.
• a small computer which directly provides the required measured values, such as the cardiac output in liters per liter Minute indicates.
• insertable catheters are also increasingly being used to carry out therapeutic measures in the circulatory system.
• These invasive, but not operative measures are based on the also in the above article by Cribier et al. described dilation of a heart valve stenosis.
• a valve stenosis of an aortic valve is pushed out, the balloon not being inflated lying in the stenosis area.
• the dilatation balloon is inflated to expand the stenosis.
• the process described is time consuming. All other activities are blocked, in particular during the input of the measured values into the evaluation computer and the evaluation time.
• the evaluation usually takes 2 to 4 minutes.
• the time factor in particular is a risk for the patient.
• the placed catheter can thus move out of its position or even fall out.
• Rhythm disorders can also occur, e.g. B. can be triggered directly by the mechanical contact of the catheter with the heart muscle. Due to the necessary long residence time of the catheter, blood loss can also occur at the insertion point of the catheter, which in turn changes the heart pumping behavior.
• the insertion of several catheters continues to be very troublesome for the patient.
• the measured values are available, then the stenosis after dilatation has again a measurement carried out in order to verify whether the stenosis' Actuals I has been expanded to the desired opening area.
• the invention has for its object to provide a catheter of the type in question, with which measurements for Diagnosis, in particular pressure measurements and the measurement of cardiac output can easily be carried out with the aid of the thermal modulation method, the same catheter being usable for further applications, in particular for the therapeutic use of the enlargement of constrictions.
• the catheter has at least one channel with a lumen and a temperature sensor, e.g. B. a thermistor, but their position is reversed in contrast to conventional catheters he.
• the position of the lumen provided for the injection of the refrigerant or also of several lumens lying next to one another for better mixing of the refrigerant with the blood flow is preferably at the distal end, this distal end preferably being bent, whereas the temperature sensor is located in the direction of the proximal end of the catheter . This enables direct measurements in the left heart for the first time.
• a refrigerant When a refrigerant is injected, it initially flows past the temperature sensor inside the catheter before it emerges from the lumen at the distal end of the catheter, as a result of which the temperature sensor is cooled. After emerging from the lumen, however, the refrigerant is again guided in the direction of the temperature sensor by the blood flow, so that the degree of cooling by the returning blood flowing past and the resulting temperature gradient can then be measured there.
• the subsequent measurements to determine the systolic ejection time and Ejection quantity and the cardiac output can be carried out with an accuracy that is not inferior to the accuracy that could previously be achieved with a method of dispersion in which the temperature sensor r is not primarily cooled by the refrigerant flowing past the catheter.
• the catheter can also be equipped with a dilatation balloon to expand constrictions in the vascular system.
• the catheter then simultaneously has a device for determining the cardiac output and, in addition, devices for determining the pre- and post-stenotic blood pressure on both sides of the dietary balance.
• the cardiac output can be determined by different methods, such as B. by the injection of a heat solution according to US Pat. No. 4,217,910 or by an impedance change measurement after injection of a saline solution according to US Pat. No. 4,572,206.
• a simple method is the Thermodi 1 ution method already mentioned above.
• the blood pressure is advantageously measured hydrostatically at an opening located before or after the dialysis bal ion, each of which is connected to a channel leading to the proximal end of the catheter outside the body.
• This is the first time 'possible z. B. to correct a stenosis of the aortic valve in the left heart with the help of a single catheter, the catheter also being used to determine the measurements required for this intervention.
• the necessary for the evaluation of the measured values and for the therapeutic treatment time compared to the conventional method is drastically reduced, so that the risks mentioned above for the 'patients are noticeably smaller.
• the burden on the patient is significantly reduced by using only one catheter instead of three. Due to the simultaneous measurement of the pressure gradient, systolic ejection time, heart rate and cardiac output made possible with the catheter, the therapeutic measures can also be immediately validated by the available measurement values by immediately determining the cardiac output and the opening area of the stenosis calculated therefrom. Optionally, the mean pressure gradient can also be specified. The doctor has an overview of the progress of his interventions.
• FIG. 1 shows a catheter to be used as a dilatation catheter according to the invention
• FIG. 2 shows a section along 11-11 in FIG. 1;
• FIG. 4 schematically shows the position of the dilatation catheter according to FIG. 1 in the aorta and the left heart;
• Fig. 6 is a schematic representation of a small computer with a display device for a catheter according to the invention.
• Ffg. 1 denotes a catheter, in this case a dilatation catheter.
• the catheter consists of an elastic tube 2, which has three hollow channels 3, 4 and 5.
• At the distal end PT the tube is lifted in a circular shape (pigtail);
• lumens 6 which communicate with the channel 3.
• a dilatation balloon 7 is provided, which can be inflated via the channel 4.
• a thermistor 8 Further towards the proximal end is a thermistor 8, whose lead wires are guided centrally in the tube 2.
• the channels 3 and 4 are continued after a proximal connector block 10 in separate lines 11 and 12, each of which is provided at the end with a standardized connector 13 and 14, respectively.
• the dilatation balloon 7 can be inflated with a syringe via a shut-off valve at 14. Either refrigerant can via the connection piece 13 are passed through the catheter, which then exits at openings "6, or the terminal can be connected to a pressure transducer to hydro ⁇ static measure the blood pressure in the lumens. 6
• the leads 9 of the thermistor 8 are combined in a cable 15, which opens into a Nor connection 16. In this connection 16, a compensating bridge circuit for the thermistor 8 is also provided.
• the catheter in the distal region between the distal end 6 and the dilatation balloon 7 may have another thermistor 17 whose connecting wires guided in the tube 2 and sixteenge ⁇ 18 at the proximal end to a cable 19 to a corresponding terminal 20 are bordered '.
• the connection 20 is constructed like the connection 16 and accordingly again has an equalization circuit.
• a further opening 21 is provided which connects to the channel 5 in the Hose 2 communicates and opens after the proximal end piece 10 in a line 22 with a connector 23.
• the position of the catheter in the left heart 31 is shown in FIG. 4.
• the tube 2 of the catheter is inserted into the left heart via the main artery so that the distal curved end PT of the tube lies in the left ventricle and the dilatation balloon 7 in the area of the aortic valve 33.
• This arrangement is intended, for. B. serve to eliminate a stenosis of the aortic valve.
• the openings 6 and the thermistor 17 are in the left ventricle, the thermistor 8 and the opening 21 in the aorta.
• the proximal connections 16 and 20 of the thermistors are plugged into connections TH1 and TH2 of a small evaluation device 34 which has two display fields 35 and 36.
• the blood temperature can then be displayed in ° C in the left display field, as can the cardiac output after correspondingly pressing a shift key 37. If the hydrostatic blood pressure is measured via the lumens 6 and 21, the corresponding connections 13 and 23 can be plugged into plugs P1 and P2 in the evaluation device 34. In the right display the blood pressure P, the pressure gradient P can then. the systolic ejection quantity SAM and the flap opening area K ⁇ F are displayed after correspondingly pressing a shift key 38.
• the device also has an on / off switch 39, calibration buttons 40 and a start button 41.
• a refrigerant is injected into the left ventricle of the heart via the connection 13 and the Kana-1 3 Openings 6 emerges.
• the dilatation balloon 7 is not inflated in this case.
• the arrangement of the openings 6 in the curved region PT of the distal end results in a very good swirling of the refrigerant in the blood, which is then pumped through the aortic valve 33 through cardiac activity and flows past the thermistor 8.
• the temperature profile at this thermistor over time is shown in FIG. 5 and designated Tl. The beginning of the injection is shown with the vertical arrow on the time axis t.
• the start button 41 was pressed. It can be seen that the temperature drops relatively quickly. This is due to the fact that the refrigerant in the catheter tube 2 flows past the thermistor 8 in the aorta before it emerges from the openings 6.
• the temperature drop 1 depends on the absolute blood temperature, the amount of refrigerant sprayed, the thermal insulation between the channel 3 and the thermistor 8 and the blood circulation.
• the measured temperature profile in the falling region of the curve T1 is a superimposition from the primary cooling of the thermistor when flowing through the catheter and after a certain time through a further cooling, which is triggered by the recirculation of the blood from the openings 6 into the aorta. Already from the shape of the curve, such. B.
• the initial drop in Temperaturver1 and the renewed rise can be made with the appropriate calibration of the evaluation device using the calibration keys 40 conclusions about the cardiac output.
• Another possibility is to record the temperature profile at the second thermistor 17. This temperature profile is shown in dashed lines in FIG. 5 and designated T2.
• This thermistor 17 is also cooled by the refrigerant flowing past in the catheter tube 2, the start of cooling being later than in the first thermistor. The Cooling is also faster, the lowest temperature is lower than in the first thermistor 8. This is due to the fact that this second thermistor 17 is in the immediate vicinity of the openings 6 from which the refrigerant flows and is pumped towards the aortic valve, whereby it passes the thermistor 17 directly again.
• this temperature profile T2 also comes about through a superimposition of two cooling effects. Since the blood mixed with the refrigerant is transported away relatively quickly in the direction of the aortic valve, the temperature at the second thermistor 17 rises correspondingly faster. In the evaluation device 34 the dashed areas in Fig. 5 between the two Te perturver1 on Tl and T2 can also be evaluated with regard to the cardiac output.
• the pre- and post-stenotic blood pressure and the pressure gradient are known from the hydrostatic pressure measurements via the openings 6 and 21.
• the cardiac output, the systolic ejection time, the pressure gradient and, accordingly, the opening area of the aortic valve 33 are calculated and displayed in the evaluation device using known formulas.
• the dilatation balloon 7 is then inflated and the stenosis is thereby opened and expanded.
• the catheter 1 described can also be used in a conventional manner for diagnostic purposes alone, in particular in that a further opening 21 and a further temperature sensor 17 are provided in a conventional arrangement. This also ensures universal use of the same catheter for dietary purposes and determination of the cardiac output in the antegrade direction on the pulmonary kl appe, tri kuspidal kl appe and nitral valve.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Medical Informatics (AREA)
• Biophysics (AREA)
• Pathology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Physics & Mathematics (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Hematology (AREA)
• Cardiology (AREA)
• Physiology (AREA)
• Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

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• 1987
  • 1987-04-27 DE DE19873714027 patent/DE3714027A1/de active Granted
• 1988
  • 1988-04-21 WO PCT/DE1988/000240 patent/WO1988008274A1/de not_active Application Discontinuation
  • 1988-04-21 EP EP88903184A patent/EP0313595A1/de not_active Withdrawn
  • 1988-04-27 US US07/301,760 patent/US5009234A/en not_active Expired - Fee Related

Non-Patent Citations (1)

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