EP1221998A1 - Catheter pour l'examen combine du ventricule gauche, ainsi que des arteres coronariennes droite et gauche - Google Patents

Catheter pour l'examen combine du ventricule gauche, ainsi que des arteres coronariennes droite et gauche

Info

Publication number
EP1221998A1
EP1221998A1 EP00969412A EP00969412A EP1221998A1 EP 1221998 A1 EP1221998 A1 EP 1221998A1 EP 00969412 A EP00969412 A EP 00969412A EP 00969412 A EP00969412 A EP 00969412A EP 1221998 A1 EP1221998 A1 EP 1221998A1
Authority
EP
European Patent Office
Prior art keywords
catheter
lumen
balloon
contrast medium
outlet openings
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP00969412A
Other languages
German (de)
English (en)
Inventor
Thomas Wolffgram
Axel Krieter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP1221998A1 publication Critical patent/EP1221998A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/005—Devices for introducing or retaining media, e.g. remedies, in cavities of the body for contrast media
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/004—Multi-lumen catheters with stationary elements characterized by lumina being arranged circumferentially
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/125—Heart
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/007—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media

Definitions

  • the invention is based on a multi-lumen catheter with an expandable balloon, the balloon being connected to a first lumen, and with a second lumen, the second lumen having at least one outlet opening, and on a device for perfusing a contrast medium with a multi-lumen Catheter with an expandable balloon, the balloon being connected to a balloon pump via a first lumen, and with a second lumen, the second lumen having at least one outlet opening which is connected to a first contrast medium pump via the second lumen.
  • an X-ray contrast medium is pumped into the area of the heart to be examined using a catheter.
  • the volume or the change in volume of the left ventricle, hereinafter called the left ventricle, and the blood flow to the coronary arteries can be displayed on an X-ray screen using an X-ray camera.
  • Such examinations are used for the combined sequential angiographic representation of the left ventricle and coronary arteries in the case of clinical suspicion of coronary heart disease, diseases of the myocardium of the left ventricle (eg condition after myocardial infarction with reduced contractility of the myocardium), vitamins and others.
  • diseases of the myocardium of the left ventricle eg condition after myocardial infarction with reduced contractility of the myocardium
  • vitamins and others are used.
  • several catheters are used one after the other in the course of these examinations, with a catheter first being introduced into the femoral artery or the brachial artery via an access in the groin and then being advanced into the left ventricle.
  • Contrast medium is injected under pressure through a channel - hereinafter referred to as lumen - in the catheter with an opening at the catheter tip, while the filling of the left ventricle is visualized on a screen during several cardiac cycles by means of an X-ray camera.
  • the second stage of the investigation is to insert a second specially shaped catheter into the aorta to probe the left coronary artery instead of the first.
  • the current position of the catheter tip when advancing through the aorta can be followed by using radiopaque material until the aortic bulb is reached.
  • the entire contrast agent bolus is injected into the coronary artery under high pressure.
  • the left coronary artery appears in the X-ray image as a dark, branched vessel. Multiple repetitions of the contrast agent injection or several different X-ray projections are required for the display.
  • the aim of the investigation is, among other things: to find constriction-related constrictions that obstruct arterial blood supply and can lead to angina pectoris and, in later stages, to a heart attack.
  • the right coronary artery is displayed on the screen with the help of a third, also specially shaped special catheter.
  • This can be followed by the often difficult search for and representation of an existing aortocoronary bypass.
  • a disadvantage of the catheters for cardiac examination according to the prior art and the devices for perfusing a contrast medium with a multi-lumen catheter is that they are only suitable for examining an area of the heart - left ventricle, right or left coronary artery.
  • several catheters have to be inserted in the course of a normal full examination, which increases the time required for the examination and thus also the physical and psychological stress on the patient and the radiation exposure of the patient, doctor and auxiliary personnel.
  • the risk of infection is also increased because at least three catheters have to be inserted.
  • the catheter according to the invention not only shortens the overall examination, but may also allow the patient to step away from the examination table at short notice during the X-ray examination times.
  • the specially shaped catheters for examining the coronary arteries have to be inserted into the coronary arteries and can lead to rupture and, in extreme cases, acute infarction there, in particular in the case of arteriosclerotic plaques close to the main stem. There is also a risk of artery dissection and relative ischemia caused by the highly concentrated low oxygen contrast agent. In the case of unfavorable anatomical conditions or variants or in the case of aortocoronary bypass surgery (ACVB), it may also be necessary to use more than two catheters To introduce examination of the coronary arteries.
  • ACVB aortocoronary bypass surgery
  • a possible means for isolating an area of the heart from another area is an expandable balloon, which is arranged, for example, on the catheter tip and can be expanded by a pump connected to the balloon by means of a lumen of the catheter.
  • a urological catheter is included two lumens and a balloon which is inflatable and deflatable by one of the two lumens.
  • the balloon is used to fix the catheter in the urethra when inflated.
  • the object of the invention is to provide a catheter and a device for perfusing a contrast medium, which enable a short and less stressful examination of the left ventricle and a non-selective simultaneous display of both coronary arteries.
  • the examination should be less dangerous for the patient, the exposure to X-rays for the patient, doctor and auxiliary staff should be reduced and, finally, an improved representation of the examined areas of the heart should also be achieved.
  • a multi-lumen catheter with an expandable balloon, the balloon being connected to a first lumen, and with a second lumen, the second lumen having at least one outlet opening, the outlet opening or the outlet openings of the second lumen between the balloon and a first end of the catheter are arranged, and wherein the catheter is used for angiography of coronary arteries, aortocoronary bypass vessels (ACVB) and other branches of the aorta and their branches.
  • ACVB aortocoronary bypass vessels
  • This catheter according to the invention has the advantage that it can be used to examine both the left ventricle and both coronary arteries, so that the risk of infection for the patient is reduced as a result of the absence of a catheter change.
  • An invasion of the coronary artery with the catheter tip can also be dispensed with, since the balloon, when expanded, prevents the outflow of blood and contrast medium from the aorta and thus leads to a Increases the contrast agent concentration in the area of the aortic root and the coronary artery.
  • As the balloon expands, its increase in volume even increases the physiological backflow of blood from the area of the aortic root into the coronary arteries.
  • the catheter has a third lumen with at least one outlet opening and that the outlet opening or the outlet openings of the third lumen are arranged between the outlet opening or the outlet openings of the second lumen and the first end of the catheter, so that several Areas of the heart can be examined without having to change the position of the catheter relative to the heart.
  • a device for infusing a contrast medium with a multi-lumen catheter with an expandable balloon, the balloon being connected via a first lumen to a balloon pump, with a second lumen, the second Lumen has at least one outlet opening, which is connected via the second lumen to a first contrast medium pump or syringe, and wherein the outlet opening or the outlet openings of the second lumen are arranged between the balloon and the first end of the catheter.
  • the catheter of the device according to the invention has a third lumen connected to a second contrast agent pump or syringe with at least one outlet opening and that the outlet opening or the outlet openings of the third lumen between the outlet opening or openings of the second lumen and the first end of the catheter are arranged.
  • the outlet opening or the outlet openings of the second lumen are arranged in the vicinity of the balloon, in particular at a distance of 0 to 60 mm from the balloon, so that the contrast medium can be injected into the aortic globe above the aortic valve and thereby one
  • Contrast enhancement is achieved in the coronary arteries, while the balloon at least partially prevents the outflow of blood and contrast agent into the ascending aorta.
  • the balloon is immediately above the
  • Aortic root positioned and synchronized with the
  • the outlet opening or the outlet openings of the third lumen in the vicinity of the first end of the catheter, in particular at a distance of 0 to 50 mm from the first end of the catheter, so that contrast medium can be injected into the left ventricle for illustration.
  • a supplement to the invention provides that the outlet opening or the outlet openings of the second lumen are arranged in the vicinity of the first end of the catheter, in particular at a distance of 0 mm to 60 mm from the first end of the catheter, so that the left ventricle can be examined the catheter is advanced into the left ventricle and the contrast medium can then be injected into the interior of the left ventricle below the aortic valve.
  • the distance between the outlet opening or openings of the second lumen and the outlet opening or openings of the third lumen approximately corresponds to the inner longitudinal diameter of the left ventricle and is in particular 60 mm to 140 mm, so that in one position of the catheter, both the left ventricle and the coronary arteries can be filled with contrast medium.
  • the balloon can be filled with gas or liquid, so that an inexpensive and unproblematic medium for filling the balloon is available.
  • a further embodiment of the invention provides that the balloon is conical in the expanded state and that the diameter of the balloon increases with increasing distance from the first end of the catheter, so that in principle also the use of the balloon for a controlled permanent inflation of approx. 4 to 5 Seconds duration is possible.
  • the lumen of the aorta is not completely reduced by the catheter, but about two thirds of the diameter previously determined by echocardiography. This ensures that there is sufficient residual blood flow to all peripheral and especially cranial arteries.
  • the catheter has X-ray reflecting markings in the region of the outlet openings of the third lumen and / or in the region of the outlet openings of the second lumen, or is echo-tight, so that the catheter according to the invention can be positioned easily and reliably in the heart ,
  • the catheter is curved at its end, so that due to its pig-tail, circular or spiral shape, it cannot penetrate the coronary arteries and cannot cause any other injuries to the heart.
  • the balloon pump can be controlled by an EKG device, so that the contrast medium concentration can be increased with the least possible impairment of the cardiac activity or the circulation of the patient.
  • the balloon pump inflates the balloon during certain cardiac phases, in particular during systole or diastole or an independently selected phase region of the cardiac cycle or continuously over several cardiac cycles, so that the penetration of contrast medium into the coronary arteries is supported; the systolic blood flow remains unimpeded.
  • This effect which results from the increase in volume of the balloon, corresponds to the effect with which blood is pumped into the coronary arteries during diastole.
  • the balloon pump deflates the balloon during certain cardiac phases, in particular during systole or diastole or an independently selected phase region of the cardiac cycle or continuously over several cardiac cycles, so that the artery and other arteries can be represented are.
  • first and the second contrast medium pump can be controlled by an EKG device and that the first contrast medium pump for the second lumen and the second contrast medium pump for the third lumen during certain cardiac action phases, in particular, however, diastolic, or also continuously several cardiac cycles (heartbeats) to promote contrast medium in the catheter, so that with the economical use of contrast medium in the areas of the heart to be examined there is the greatest possible local concentration of contrast medium and thus also a good one
  • Blood flow conditions in the heart reflecting representation of the areas of the heart to be examined is possible on the X-ray screen.
  • the pressure through the first lumen, second lumen and / or third lumen is measurable in the vicinity of the balloon and / or the outlet openings, so that a measurement of the pressures in the left ventricle and aortic root, which should precede a coronary angiography, is possible without additional stress for the patient and almost without extending the overall examination time.
  • pharmacologically active substances in particular for thrombolysis therapy after acute myocardial infarction, are injected through second lumen and / or third lumen, so that the pharmacologically active substances achieve a better local concentration than systemic administration.
  • FIG 3 shows a schematic representation of the heart with a catheter according to the invention
  • 4 a heart with a device according to the invention.
  • FIG. Fig. Lb shows the catheter 1 along the section line I-I.
  • a first lumen 3, a second lumen 5 and a third lumen 7 can be seen in this illustration.
  • a balloon 9 is inflated or deflated with a liquid or a gas through the first lumen 3.
  • the balloon 9 is shown in an inflated or expanded state.
  • the connection between the first lumen 3 and the balloon 9 takes place through outlet openings 11. It can also be clearly seen that the balloon 9 in the inflated state has a conical or frustoconical shape, the diameter of the balloon 9 increasing with distance from a first end 13 of the Catheter 1 increases.
  • outlet openings 15 are connected to the second lumen 5 of the catheter 1. Contrast medium can be pumped through the second lumen 5 and emerges from the outlet openings 15 below the balloon 9.
  • the catheter 1 has a cross section according to FIG. 1c. Only the second lumen 5 and the third lumen 7 are still present.
  • Markings 17 which reflect X-rays and are thus recognizable on an X-ray image.
  • the catheter 1 according to the invention can be positioned in the heart of the patient, specifically in such a way that the outlet openings 15 are located in the area of the aortic root. If, in this position, contrast medium is conveyed through the second lumen 5 and this contrast medium emerges from the outlet openings 15, then the contrast medium reaches the coronary arteries during the diastole and allows them to be displayed on the screen. To support this process, the balloon 9 is expanded at the same time.
  • the first end 13 of the catheter 1 there are further markings 19. With the aid of the markings 19, which reflect X-rays, the first end 13 can be positioned in the left ventricle and the position of the first end 13 can be checked on the X-ray screen. Also in the immediate vicinity of the first end 13 are outlet openings 21 which are connected to the third lumen 7. The cross section through the catheter 1 in the region of the outlet openings 21 is shown in FIG. 1d. The distance between the outlet openings 15 and the outlet openings 21 corresponds approximately to the length of the left ventricle, so that when the first end 13 of the catheter 1 is inserted into the left ventricle, the outlet openings 15 automatically in the region of the aortic root are positioned. This ensures that both the left ventricle and the coronary arteries can be filled with contrast medium without the position of the catheter 1 having to be changed with respect to the heart.
  • FIG. 2 shows a second exemplary embodiment of a catheter 1 according to the invention.
  • the same components have been given the same reference numerals. With regard to their explanation, reference is made to the description of FIG. 1.
  • the catheter 1 can be designed with a smaller diameter, which facilitates its introduction through a lock in the groin or enables a smaller lock. In addition, the manufacturing costs are reduced.
  • the balloon 9 is arranged in the immediate vicinity of the first end 13 of the catheter 1. In order to examine the left ventricle, the catheter is pushed through the aorta into the left ventricle until the first end 13 of the catheter 1 lies against the side of the left ventricle opposite the aortic valves or is in the immediate vicinity of this side. In this position the balloon 9 is deflated, ie it lies against the catheter 1 and has no function in this position.
  • the Examination of the left ventricle is done in a conventional manner.
  • the catheter 1 is withdrawn somewhat, namely until the outlet openings 15 are in the area of the aortic root or the coronary arteries.
  • the balloon 9 is positioned in the aorta and, as described above, can increase the concentration of the contrast medium in the conor arteries. Moving the catheter 1 during an examination is much easier to do than changing a catheter and is also quicker to perform, so that the examination time and the burden on the patient are reduced.
  • FIG. 3a shows a heart 23 with catheter 1 according to the invention in systole.
  • the catheter 1 projects into the left ventricle 24, while the balloon 9 is positioned above the aortic root 25.
  • the balloon 9 is deflated, ie it lies essentially flat against the catheter 1 and thus causes only a slight flow resistance for the outflowing blood in the aorta 27 indicated by arrows 30.
  • a coronary stenosis 28 is also indicated, which results has that the tissue 29 located behind the coronary stenosis 28 in the flow direction is poorly supplied with blood.
  • a contrast medium (not shown) being conveyed into the coronary arteries 31.
  • This process is illustrated in Fig. 3b. It shows the heart during diastole, ie that the left ventricle 24 increases its volume and thus wants to suck blood back out of the aorta 27. This is prevented by the aortic valves 33, which are closed due to the pressure difference between the left ventricle 24 and aorta 27.
  • the beginning of backflow of blood from the aorta 27 in the direction of the left ventricle 24 leads to the fact that blood or contrast medium, which emerges from the outlet openings 15 of the catheter (see FIGS.
  • the contrast medium has been indicated by the fact that the coronary arteries 31 filled with contrast medium are blackened.
  • the balloon 9 is inflated during the diastole, so that its volume increases and thus it supports or reinforces the backflow of blood or contrast medium from the area of the aortic root up to the balloon 9 into the coronary arteries.
  • the expansion of the balloon 9 is indicated in Fig. 3b by arrows.
  • the balloon 9 is deflated and contrast medium is transferred from the outlet openings 21 (see FIG. 1) into the left ventricle 24 pumped. 3 that the left ventricle 24 and both coronary arteries 31 can be examined without the position of the catheter 1 having to be changed. This simplifies the examination and the time required is drastically reduced by X-ray images for position control can be kept to a minimum. As a result, the exposure to X-rays for patients, doctors and auxiliary staff also decreases. At the same time, the display of the examined areas of the heart 23 is improved.
  • the fourth lumen 4 shows a heart 23 with an inserted catheter 1 and the further components of a device according to the invention for the perfusion of contrast media.
  • the first lumen 3 of the catheter 1 is connected to a balloon pump 35.
  • the second lumen 5 is connected to a first contrast medium pump 37, while the third lumen 7 is connected to a second contrast medium pump 39.
  • the balloon pump 35 and the first and second contrast medium pumps 37 and 39 are controlled by an EKG device 41, which is connected to the patient 43, shown in a highly simplified manner. It is thereby achieved that the balloon 9 is deflated during the systole and inflated during the diastole.
  • the time of perfusion of the contrast medium can also be controlled.
  • the contrast medium in the heart can be viewed via an X-ray camera 45 23 are displayed on a screen 47.
  • the embodiment of the catheter 1 shown in FIG. 4 has a so-called PIG-TAIL, ie its first end 13 is curved in the form of a spiral, so that injuries to the heart wall or unintentional penetration into one of the coronary arteries 31 is avoided.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Apparatus For Radiation Diagnosis (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un cathéter (1) à lumens multiples et un dispositif pour injecter par perfusion des agents de contraste radiographiques ou des substances à action pharmacologique, à l'aide duquel des agents de contraste radiographiques ou des substances à action pharmacologique peuvent être introduits dans le ventricule gauche du coeur, les artères coronariennes et d'autres sorties de l'aorte, sans impliquer de changement de cathéter. Cette mesure est moins contraignante pour le patient, en particulier dans le cas d'examens angiographiques, du fait que la durée de l'examen, celle de l'exposition aux radiations, le risque de troubles du rythme cardiaque inhérents à ce type d'examen, de même que le risque d'infarctus et d'infection sont sensiblement réduits.
EP00969412A 1999-10-06 2000-10-05 Catheter pour l'examen combine du ventricule gauche, ainsi que des arteres coronariennes droite et gauche Withdrawn EP1221998A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE1999147907 DE19947907A1 (de) 1999-10-06 1999-10-06 Katheter für die kombinierte Untersuchung des linken Ventrikels sowie der rechten und der linken Koronararterien
DE19947907 1999-10-06
PCT/EP2000/009715 WO2001024867A1 (fr) 1999-10-06 2000-10-05 Catheter pour l'examen combine du ventricule gauche, ainsi que des arteres coronariennes droite et gauche

Publications (1)

Publication Number Publication Date
EP1221998A1 true EP1221998A1 (fr) 2002-07-17

Family

ID=7924537

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00969412A Withdrawn EP1221998A1 (fr) 1999-10-06 2000-10-05 Catheter pour l'examen combine du ventricule gauche, ainsi que des arteres coronariennes droite et gauche

Country Status (5)

Country Link
EP (1) EP1221998A1 (fr)
JP (1) JP2003511111A (fr)
AU (1) AU7913800A (fr)
DE (1) DE19947907A1 (fr)
WO (1) WO2001024867A1 (fr)

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JP2003511111A (ja) 2003-03-25
AU7913800A (en) 2001-05-10
WO2001024867A1 (fr) 2001-04-12
DE19947907A1 (de) 2001-04-19

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