DE102008013860A1 - Catheter device for treatment of septum of heart, has coupling device arranged at proximal end in proximity of catheter tip to transport and position occluder, where sensor is provided in area of catheter tip for imaging - Google Patents

Abstract

The device (2) has a flexible catheter sheath (4) surrounding a catheter cavity (6). A coupling device (14) is arranged at a proximal end (10) in the proximity of a catheter tip (12) to transport and position an occluder (16) designed for occlusion of a defect of a septum of a heart. A sensor (18) e.g. optical image sensor, is provided in an area of the catheter tip for imaging. The sensor is designed and arranged in such a manner that a visual field covers an area lying around the occluder coupled to the coupling device or covers an area lying before the catheter tip. Independent claims are also included for the following: (1) a medical examination and treatment device comprising a catheter device (2) a method for minimally invasive intervention at a septum of a heart.

Description

The The invention relates to a catheter device for implantation of a Occluder designed to occlude a septal defect a flexible catheter sheath surrounding a catheter lumen and at its proximal end near the Catheter tip a device for transport and positioning the occluder is arranged.

The The invention further relates to a medical examination and Treatment device with such a catheter device.

To In the 1990s, abnormalities were observed in the septum of the heart - the so-called septum - usually by surgical operations Treated in the open heart. It was a congenital or by Disease acquired gap in the septum by one artificial implant, a so-called occluder, closed. Such a procedure was a high risk and a long one Recovery time for the patient. For several years There is also the possibility of such defects in the Septic wall minimally invasive with the help of specially designed for perform designed catheters.

at This minimally invasive method becomes a thinner flexible one Hollow body or catheter from the groin or arm of the Patients entered intravenously and advanced through the bloodstream until the body-facing (proximal) end of the catheter - the catheter tip - the gap to be treated in the septum in the heart center reached.

Of the with the catheter tip via a releasable coupling device associated occluders, typically two in relation their symmetry axis arranged one behind the other and one opposite, made of an elastically deformable wire and / or plastic braid formed retention screens, it is in the gap inserted in the septum of the heart so that each a screen is positioned on each side of the septum. Both Umbrellas are connected by a waist, over which cylindrical inner surface of the Occluder to the Catheter device is coupled. After reaching the final position the occluder is decoupled from the coupling from the catheter tip. The umbrellas are unfolded and each take a flattened Form, what to seal and to close the gap in the septum leads. The final form of the unfolded umbrellas is imprinted on the screens in advance. For the intravenous Transport the occluder with the aid of the catheter device the screens are biased in a tapered or "folded" position held.

To Such an intervention on the heart becomes the catheter pulled back over the bloodstream and thus removed. In most cases, a single application of the method is sufficient to to achieve a lasting healing success.

In Correspondence of the class and the form of a gap in the Septum of the heart may be an occluder of appropriate shape and size provided for closure and stabilization of the septum become. Fleece inserts in the retention screens can support the sealing of the opening in the septum.

In the habilitation thesis of Dr. Ewert, "Interventional Closure of Atrial Defects: Special Indications and New Therapeutic Strategies", Humbold-Universität Berlin (2002) is a method for the closure of atrial septal defects under ultrasound control described. An echocardiogram is performed during the procedure in order to assess the heart structure and heart function. In addition, the therapy is supported and monitored via a transesophageal ultrasound probe. The disadvantage here is that a large number of additional devices is necessary and that the placement of the ultrasound probe is very uncomfortable for the patient.

In the US 2003/0144694 discloses an occluder transportable via a catheter device. Such a catheter device is for example from WO 2004/103223 known.

Although the minimally invasive approach faces significant progress an open heart surgery, so go with such an intervention nevertheless substantial risks for the Patients along. The object of the present invention is therefore to a catheter and associated medical examination and treatment facility with which the risk of a Intervention on the heart septum compared to previously known and practiced concepts further lowered and the probability a comprehensive treatment success can be increased.

In With respect to the catheter device, the object according to the invention thereby solved that in the area of the catheter tip at least one imaging sensor is provided.

Conveniently, If the catheter device is part of a medical examination and treatment device, wherein the imaging sensor via a guided in Katheterholraum signal line with a located outside of the catheter device image processing and playback device is connected to and in real time Transfer image information from the location of an intervention.

The Invention is based on the consideration that a large Disadvantage of previous catheters and their handling consists in that these with the help of external fluoroscopy (angiography) be administered in the heart, leaving the patient and the medical Staff during this procedure X-rays are exposed. In addition, there is the disadvantage that in the X-ray image either the catheter and / or the area of the septum to be treated of the heart relatively bad is visible, especially when using a cost-effective conventional X-ray method with two-dimensional Imaging characteristics. By injecting contrast agents can Although the central heart region is shown more clearly and with more contrast However, there are patients who are allergic to contrast media react, leading to dangerous complications can. Due to the limited resolution of the representation in angiographic x-ray fluoroscopy thus the risk that an occluder will not be placed correctly and thereby complications can be caused, or at least one repeat intervention is required.

to Avoiding such difficulties, it is now envisaged an imaging element in the front part of a catheter device to arrange "live images" of the location of the minimally invasive procedure, d. H. straight from the heart, to one externally established playback device, eg. B. a computer-controlled Visualization system with attached monitor to transfer. With this imaging element can on the one hand, the input and implementation the catheter device through the vessels, ventricles and Heart valves are tracked, which in particular the risk of a "puncture" by the vessel walls is lowered. To the others can use it to accurately position the occluder in the gap to be closed in the septum of the heart are monitored and checked. On a particularly undesirable in children and possibly In the long term harmful application of X-rays can therefore be dispensed with altogether.

advantageously, the imaging sensor is configured and aligned so that his field of view one to the to the coupling device of Catheter device coupled, in transport configuration covering occluder lying around area. This means, the imaging sensor "looks" - related on the approximately cylindrical around a central axis arranged catheter sheath - im Essentially radially outward, depending on the specific arrangement and possibly also according to the type and operating principle of the sensor through the occluder "through".

In alternative embodiment, it is provided that the field of view the imaging sensor above all lying in front of the catheter tip Covering space, so based on the insertion direction of the catheter forward "looks", which is particularly appropriate for monitoring the insertion process and the feed, z. B. through a heart valve, is.

optimally, the imaging sensor combines the two options mentioned, has a particularly wide field of vision both in radial as well as in the forward direction. Alternatively, if the space permits, even several be provided imaging elements or sensors that different Cover viewing directions.

advantageously, is the imaging sensor opposite the catheter sheath displaceable in the longitudinal direction of the catheter device. For example, it may be provided that the sensor from a in close to the coupling for transport and positioning an occluder located "retracted" stop position in the forward direction from the outer catheter sheath to move out, thereby keeping at constant catheter sleeve define a variably positionable observation point from which the further ahead areas are inspected can. For this purpose, the imaging sensor, for example at a relative to the outer catheter sheath displaceable and arranged in the cavity inner catheter or be arranged on an inner part.

Preferably is the imaging sensor as an (acoustic) ultrasonic sensor, realized as a magnetic resonance sensor or as an optical image sensor.

The Ultrasound imaging (sonography) is performed after the so-called Echo pulse method. An electrical pulse of a high frequency generator is in the transducer of an ultrasonic transducer (usually a piezo-crystal, possible is also a silicon-based sensor) in one Sound pulse implemented and sent out. The sound wave is on the inhomogeneities of the tissue structure partially or completely scattered or reflected. A returning echo will converted into an electrical signal in the transducer and then in a connected electronic evaluation and display unit visualized, using a mechanical or electronic panning the sensor is a 2D or 3D scan of the examination area done can. Intervascular ultrasound imaging (IVUS) is especially for imaging deep tissue layers and Vascular structures suitable.

In a second advantageous variant is in the imaging Sensor around a so-called IVMRI sensor for intervascular Magnetic Resonance Imaging (IVMRI = Intra Vascular Magnetic Resonance Imaging). In magnetic (nuclear) resonance tomography are the magnetic moments (nuclear spins) of the nuclei of the investigated Tissue aligned in an external magnetic field and by radiated radio waves to a gyroscope movement (precession) stimulated, whereby as a result of relaxation processes in one associated receiving coil an electrical magnetic resonance signal that is the basis for the image calculation represents.

Recently, it has been possible to miniaturize the magnetic field generating elements and the transmitting and receiving coils and to integrate in an imaging IVMRI sensor that an intracorporeal or intervascular application of the MRI method (MRI = Magnetic Resonance Imaging) is possible, advantageously the required static magnetic field is generated or applied within the patient's body. Such a concept is z. B. in the US 6,600,319 described.

To For this purpose are in the IVMRI sensor, a permanent magnet or a Electromagnet for generating a static magnetic field and a equally integrated as transmitting and receiving coil effective coil. The magnet generates field gradients of preferably 2 T / m up to 150 T / m near the vessel to be examined or organ. Nearby means up to 20 mm removed from the magnet. About the coil can be dependent from the strength of the magnetic field radio waves in the frequency domain from 2 MHz to 250 MHz for stimulation of the surrounding body tissue be decoupled. Higher static magnetic field strengths require higher frequencies at the excitation field. The sink advantageously also serves to receive the associated "response field" the body tissue. In an alternative embodiment can be provided separate transmit and receive coils.

in the Unlike conventional MRI systems are the IVMRI sensor and the electronic signal processing and evaluation provided Circuits and digital evaluation advantageously designed so that they are synonymous with a comparatively inhomogeneous Working magnetic field with high local field gradients and generate corresponding magnetic resonance images. Since under these conditions the received echo signals in characteristic Way through the microscopic diffusion of water molecules is influenced in the examined tissue is usually an excellent representation and differentiation between different Soft tissues, z. Between lipid layers and fibrous tissue, allows. This is just what is now planned Application of minimally invasive interventions of special interest.

alternative to the concept described here, the static magnetic field also be generated by external magnets. Unlike the conventional one MRI becomes the dynamic fields, i. H. the radio waves, as well in this embodiment expediently intervascular, d. H. by a number of on the catheter device arranged transmitting and receiving units generated.

Of Further, in alternative or additional embodiment an optical imaging element in the region of the catheter tip the catheter device may be provided. For example, comes on the well-known CMOS technology (CMOS = Complementary Metal Oxide Semiconductor-based optical semiconductor detector for detection of incident light into consideration. One such as "Active Pixel Sensor "known CMOS sensor is similar as well as the well-known from the field of digital photography CCD sensors (CCD = Charge-Coupled Device) on the inner photoelectric Effect and, in addition to low power consumption, has the advantage that it is particularly inexpensive to produce. For illumination the examination and treatment region, especially the walls of cardiovascular, is in this variant of imaging a suitable light source, e.g. B. an LED (LED = light emitting Diode) in the region of the catheter tip provide over a guided through the catheter cavity electrical line can be supplied with electrical power.

In In a further embodiment variant, the catheter device also with a sensor for optical coherence tomography (OCT = Optical Coherence Tomography).

The Optical coherence tomography imaging provides high-resolution Pictures, in particular, the structures near the Vessel surface comparatively accurate play. The principle of this method is based on that of the catheter device supplied via a light guide Light, preferably infrared light, radiated into the vessel is, where the light reflected there again in the light guide coupled and guided to an evaluation. In the evaluation unit is - similar to a Michelson interferometer - the interference of the reflected Light with the reference light for image generation evaluated.

While conventional interferometric apparatus preferred with Laser light of a defined wavelength work, which a comparatively large optical coherence length owns, come with the so-called LCI (LCI = Low Coherence Interferometry) Light sources with broadband radiation characteristics ("white Light ") and with a comparatively short coherence length the emitted light is used.

Corresponding image sensors, which are now provided according to an advantageous embodiment of the invention for use in the catheter device, are for example in the US 2006/0103850 described.

In an advantageous modification, it is also possible to provide an image sensor which is based on the so-called OFDI principle (OFDI = Optical Frequency Domain Imaging). The method is related to OCT, but uses a wider frequency band. The operating principle is z. B. in the publication "Optical frequency domain imaging with a rapidly swept laser in the 815-870 nm range", H. Lim et al., Optics Express 5937, Vol. 13 described in more detail.

After all the catheter device can also have an imaging sensor, the so-called "near-infrared (NIR) Diffuse Reflectance Spectroscopy "is based.

Further can also be combinations of at least two optical Sensors of the above type be present.

A tabular overview summarizes the strengths and weaknesses of the respective optical imaging techniques (from ++ = particularly good or suitable to - = poor or unsuitable): Comparison of the image sensors Close-resolution Remote-resolution Penetration of blood Optical (CMOS) + + - OCT ++ - - LCI + + + NIR - - +/- OFDI ++ - +

There the detectable or to be surveyed with the respective image sensor Solid angle is usually limited, it is particular in the already mentioned configuration with radial viewing direction (with respect to the central axis of the catheter device), when the imaging sensor is over in the catheter cavity guided drive shaft relative to the catheter sheath is rotatable. This makes it possible without the catheter sheath even turn against the vessel path to have a 360 ° view.

alternative It is also conceivable, a plurality of imaging sensors via the circumference of the catheter sheath distributed and opposite to arrange this fixed and a cyclic data reading to provide from the sensors. Thus, with this configuration only a single signal line within the catheter sheath required, over which the image data of the different Sensors in the manner of a serial interface sequentially sent or queried. A small number of signal lines, preferably only one, limits the space requirement within the catheter sheath and is therefore for the usability of mechanical flexibility and flexibility of the catheter sheath beneficial.

Of Further is for a cyclic data reading of the Sensors preferably provided a multiplexer.

By the (mechanical or electronic) rotation of the image sensor can with simultaneous withdrawal or advance by appropriate, in principle known from the prior art methods of signal processing and image calculation advantageously 3D images or volume data sets be generated.

In An advantageous development is in the region of the catheter tip a number of position sensors or position sensors are arranged, by means of which the current position and preferably also the Orientation of the catheter tip can be determined. Preferably these are several, in particular three electromagnetic Transmit coils that are connected to a number of externally, d. H. outside the patient arranged receiving coils or signal detectors interact. In an alternative embodiment, the role the transmitting and receiving units also be reversed, d. h., the Reception coils are fixed on the catheter side, while the Transmitting coils are preferably arranged stationary in the room. The position information thus obtained on the one hand facilitate the safe Inserting the catheter device and navigating to Target area, on the other hand, they support in an advantageous manner Make the construction of three-dimensional images from one Plurality of two-dimensional cross-sectional images. Furthermore, let the position data advantageous in the computational correction of motion artifacts and the like.

In further expedient embodiment can in the area the catheter tip at least one magnetic element for guidance the catheter device provided by means of an external magnetic field be. In this so-called magnetic navigation becomes the catheter device So controlled and driven by an external magnetic field. at the respective magnetic element may be a permanent magnet or act around an electromagnet.

alternative for guiding the catheter device by an external Magnetic field can be provided mechanical navigation. For this are conveniently in the catheter device suitable mechanical elements, eg. B. in the form of Zugdrähten and the like, integrated by external Tensile and compressive forces a temporary mechanical Deformation, stretching and / or bending of the catheter or individual, selectable Allow catheter sections, in particular the catheter tip. Preferably takes place the mechanical and / or Magneti cal leadership of Catheter device automatically using a computerized Control and drive device.

Of Furthermore, it can be provided, the actual catheter device through an outer guide catheter through to the organ to be treated. For example can then, if advantageous for diagnostic purposes or useful, a catheter device with IVMRI imaging exchanged for a catheter device with optical imaging without the patient being re-invaded, say by a change or a movement or other manipulation of the outer guide catheter, loaded becomes. The replaced inner catheter does not have to be laborious navigated to the target area and adjusted there again. Much more it is enough to him up to a stop position in the cavity of the outer catheter to be inserted during the procedure in its previously reached or ingested position remains in the vessel or in the heart.

• 1. Positionierung des Patienten auf dem Behandlungstisch,
• 2. evtl. vorbereitende Röntgenuntersuchung und/oder extrakorporale Ultraschalluntersuchung,
• 3. Einführung der Kathetervorrichtung über venösen Zugang
• 4. Führung der Kathetervorrichtung basierend auf der integrierten Bildgebung bis zu der zu behandelnden Scheidewand des Herzens unter Mitführung eines Occluders an der Kupplungseinrichtung,
• 5. Beobachtung der zu behandelnden Lücke in der Scheidewand mit der integrierten Bildgebung der Kathetervorrichtung,
• 6. Positionierung der Kathetervorrichtung mit Unterstützung der integrierten Bildgebung,
• 7. Einführung des Occluders in die Lücke in der Scheidewand und Positionierung des Occluders unter Echtzeitbeobachtung mittels der integrierten Bildgebung,
• 8. Auskopplung des Occluders aus der Kupplungseinrichtung unter Echtzeitbeobachtung der Entfaltung des Occluders mittels der integrierten Bildgebung,
• 9. abschließende Nachkontrolle der Position und der Konfiguration des entfalteten Occluders mit Hilfe der integrierten Bildgebung,
• 10. evtl. ergänzende abschließende Röntgenkontrolluntersuchung und/oder extrakorporale Ultraschalluntersuchung,
• 11. Verlegung des Patienten.

For example, a convenient workflow for using the integrated imaging catheter device in the treatment of septal defects is as follows:

• 1. positioning the patient on the treatment table,
• 2. possibly preparatory X-ray examination and / or extracorporeal ultrasound examination,
• 3. Introduction of the catheter device via venous access
• 4. Guiding the catheter device based on the integrated imaging up to the septum of the heart to be treated while carrying an occluder on the coupling device,
• 5. Observation of the gap to be treated in the septum with the integrated imaging of the catheter device,
• 6. positioning the catheter device with integrated imaging support,
• 7. Introduction of the occluder into the gap in the septum and positioning of the occluder under real-time observation using integrated imaging,
• 8. decoupling the occluder from the coupling device with real-time observation of the deployment of the occluder by means of the integrated imaging,
• 9. Final follow-up of the position and configuration of the deployed occluder using integrated imaging,
• 10. possibly supplementary final X-ray examination and / or extracorporeal ultrasound examination,
• 11. Transfer of the patient.

ever on the type of imaging and their ability to "penetrate" Blood may make sense during steps # 5 through # 9 be to the observed area with a physiological saline solution rinse, pulsed once for a short or short time in periodic repetition cycles to displace the blood and thus (optically) to dilute. Furthermore it can be useful to apply a contrast agent at the place of observation, in the case of IVMRI imaging, for example based on gadolinium, or in an ultrasound imaging based on sulfur hexane fluoride. The injection is advantageously carried out via a catheter in the hollow space moved, in the region of the catheter tip an outlet opening having injection line or the like.

Summarized is above all one with the catheter device described here Optimization of medical workflows at one minimally invasive intervention in the heart of a living being. such Interventions can be made with a higher degree Patient safety and faster than previously completed become.

Various Embodiments of the invention will be described with reference to a Drawing explained in more detail. In it show in each case highly simplified and schematic representation:

1 a medical examination and treatment device with a catheter device shown in longitudinal section,

2 to 5 alternative embodiments of a catheter device,

6 a detailed view of an integrated in a catheter device optical sensor with lateral / radial observation direction,

7 a detailed view of an integrated in a catheter device optical sensor with forward viewing direction,

8th a detailed view of a sensor head integrated in a catheter device for OCT or LCI imaging with lateral / radial observation direction,

9 a detailed view of a sensor head integrated in a catheter device for OCT or LCI imaging with a forward-looking observation direction,

10 a detailed view of an integrated sensor for IVMRI imaging with lateral / radial observation direction, and

11 a detailed view of an integrated sensor for IVMRI imaging with forward viewing direction.

Same Parts are provided with the same reference numerals in all figures.

In the 1 illustrated catheter device 2 is designed for a minimally invasive surgical procedure on the septum of a heart. It includes a flexible catheter sheath 4 for introduction into a blood vessel, not shown. For therapy, the catheter device 2 advanced into a ventricle of the heart (not shown). The catheter sheath 4 surrounds a cylindrical catheter cavity 6 (also referred to as lumen), in which a control line indicated only schematically 8th for controlling a coupling device 14 runs. The coupling device 14 comprises a holding device, not shown, for the transport and for the exact positioning of an occluder to be implanted 16 which is biased in a transport configuration for transportation. In 1 For example, the existing from a Nitinol wire mesh occluder is already shown unfolded. After deployment and decoupling from the coupling device 14 the occluder remains in an opening of the cardiac septum and closes it permanently.

For optimal and lasting healing success and to minimize any risk of intervention, it is important that the Occluder 16 positioned as accurately as possible in the gap in the septum of the heart is what was usually done by angiographic X-ray control. For improved monitoring of catheter advancement and more accurate occluder placement 16 even without the use of ionizing X-radiation is the catheter device 2 according to 1 with an imaging sensor 18 in the area of the catheter tip 12 fitted. Depending on the sensor type and other details of the embodiment, its "field of vision" is preferably radially outward (to the surrounding vessel wall or to the wall of the ventricle, not shown here) and / or in the proximal direction to the front (ie in the direction of advance of the catheter device 2 ), as symbolically by the arrows 20 is indicated.

The imaging sensor 18 For example, it can be an optical, an acoustic (ultrasound) or a sensor based on the principle of magnetic resonance. The signal and supply lines required for its operation and transmission of the recorded image data 22 are inside the catheter sheath 4 to a body distal (distal) end of the catheter device 2 arranged connection coupling 24 guided. About the connection coupling 24 on the one hand, the pressure and / or fluid-carrying lines within the catheter sheath 4 mechanically connectable to external storage containers and the like. On the other hand are the connection coupling 24 the imaging electronic components of the catheter device 2 electrically with a signal interface indicated only schematically 26 connectable, which in turn with an external image editing and playback device 28 connected is. A non-illustrated monitor is used to reproduce the imaging sensor 18 intervascular and / or intra-corporeal recorded and optionally subsequently computationally prepared "live images" from the treatment site.

To the imaging sensor 18 within the fixed catheter sheath 4 In order to rotate about its own axis, can also be a rotatable drive shaft in the catheter cavity 6 be arranged, however, in 1 not shown in detail. The imaging sensor 18 , the signal lines 22 and optionally the drive shaft may be in the nature of one within the outer catheter sheath 4 arranged Innenka theters combined into a compact unit and of an (inner) protective cover 30 be surrounded. In particular, when using interferometric imaging methods, optical fibers can also be laid in the inner catheter, via the incoming and outgoing light bundles to an externally mounted, via the connection coupling 24 connectable interferometer unit or the like. In the area of the imaging sensor 18 has the inner protective cover 30 , optionally also the outer catheter sheath 4 , Expediently a transparent window for the respective imaging process 32 , optionally also an optical lens.

Furthermore, (optionally) one or more lines 34 be provided for a rinsing liquid or a contrast agent, which via one in the vicinity of the coupling device 14 arranged outlet opening 36 injectable into the vascular or cardiac region to be examined / treated.

Finally, in the area of the catheter tip 12 , here in 1 in the immediate vicinity of the imaging sensor 18 , Position sensors 38 be provided, which in conjunction with a position outside the patient body position detection unit 40 according to the transmitter-receiver principle accurate location / localization of the catheter tip 12 by identifying the coordinates of the catheter tip. The position data obtained in this way can be used, for example, by the image processing and reproduction device 28 and be taken into account in the image reconstruction, especially in the artifact correction. The necessary signal lines 42 for the position sensors 38 can also inside the (inner) protective cover 30 essentially parallel to the signal lines 22 of the imaging sensor 18 be guided.

In 2 to 5 are each constructive modifications of the catheter device 2 shown.

For example, in 2 that the imaging sensor 18 supporting inner part 44 opposite the catheter sheath 4 forward (in the proximal direction) from an unspecified, the position in 1 corresponding retraction position displaceable in an upstream position and vice versa (indicated by the double arrow 46 ). That is, the imaging sensor 18 If required, it can be passed over the area of the catheter tip 12 with the transparent window 32 Push forward and has a completely unrestricted view. If necessary, it is then possible to completely dispense with a transparent window, as in FIG 3 is shown.

The embodiment according to 4 is essentially the same as 1 but the position sensor (s) is / are 38 in this variant now on the outer catheter sheath 4 arranged. In the variant according to 5 Finally, the displacement path of the imaging sensor 18 in longitudinal direction tion and accordingly is a transparent window 32 provided with a larger spatial extent. The position sensors 38 are here also further to the body remote end of the catheter device 2 towards the rear end of the coupling device 14 appropriate.

In the detail view according to 6 is the area of the catheter tip 12 with the imaging sensor 18 lifted out, wherein in the variant shown here, a CMOS-based optical sensor is used. A light source 48 here a high-power micro-LED, which illuminates the catheter device approximately in a ring shape 2 and especially the imaging sensor 18 surrounding vessel wall 50 (emitted light 51 ). At the vessel wall 50 reflected light 53 falls through a lens 52 on a reflection mirror 54 (Or, for example, on a prism with analog operation or beam guidance) and from there to the actual CMOS image detector 56 , The arrangement according to 6 So is for a radial line of sight (relative to the central axis 58 the catheter device 2 ). Through one with the help of the drive shaft 59 accomplished rotational movement about the central axis 58 , indicated by the arrow 60 , the full 360 ° side-view field can be covered.

Alternatively, in 7 an example of a light source configuration 48 , Lens 52 and CMOS detector 56 shown, with the forward viewing is enabled, the feed of the catheter device 2 through the blood vessels to the heart chambers and through the heart valves is particularly useful. An obstacle lying in the forward direction, possibly obstructing the further feed 61 can be recognized this way. The two variants after 6 and 7 If desired, they can also be combined with one another in order to provide a particularly comprehensive field of vision in virtually all directions.

The observation directions mentioned, namely radially / laterally and forwards, can also be realized with other sensor types. For example, in 8th a configuration of an OCT or LCI sensor head 62 for radial radiation and reception and in 9 represents a forward-looking radiation and reception. More specifically, the reference numeral designates 62 only for the Lichtaus- and coupling into the light guide 64 responsible sensor part or sensor head; the actual interferometric evaluation and imaging takes place outside the catheter device 2 , Shown in each case by the reflection mirror 66 and the lens 68 influenced beam path outcoupled and reflected light beams.

Similarly, an IVMRI sensor or IVUS sensor may be configured for either radial or forward radiation / reception, as in FIG 10 and 11 schematically for an IVMRI sensor 69 with permanent magnets 70 for the static magnetic field and transmitting / receiving coils 72 is shown.

at lateral radiation / reception may be particularly in the case of Ultrasonic sensors instead of a single rotating sensor be advantageous to provide an array of ultrasonic sensor elements with different "viewing directions", which, for example, is activated cyclically via a multiplexer, d. H. be excited and queried.

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• US 2003/0144694 [0009]
• WO 2004/103223 [0009]
• US 6600319 [0022]
• US 2006/0103850 [0030]

Cited non-patent literature

• - Dr. Ewert, "Interventional Closure of Atrial Defects: Special Indications and New Therapeutic Strategies", Humbold-Universität Berlin (2002) [0008]
• "Optical frequency domain imaging with a rapidly swept laser in the 815-870 nm range", H. Lim et al., Optics Express 5937, Vol. 13 [0031]

Claims (13)

Catheter device ( 2 ) for the treatment of the septal wall of a heart which has a catheter cavity ( 6 ) surrounding flexible catheter sheath ( 4 ) and one at the proximal end ( 10 ) near the catheter tip ( 12 ) arranged coupling device ( 14 ) for the transport and positioning of an Occluder designed to close a defect of the septum ( 16 ), characterized in that in the region of the catheter tip ( 12 ) at least one sensor ( 18 ) is provided for imaging. Catheter device ( 2 ) according to claim 1, wherein the sensor ( 18 ) is configured and oriented in such a way that its field of vision extends one to the coupling device ( 14 ) coupled Occluder ( 16 ) covers around space area. Catheter device ( 2 ) according to claim 1 or 2, wherein the sensor ( 18 ) is configured and oriented so that its field of vision is one in front of the catheter tip ( 12 ) covering the area of space. Catheter device ( 2 ) according to one of claims 1 to 3, wherein the sensor ( 18 ) opposite the catheter sheath ( 4 ) is mounted longitudinally displaceable. Catheter device ( 2 ) according to one of claims 1 to 4, wherein as an imaging sensor ( 18 ) An ultrasonic element is provided. Catheter device ( 2 ) according to one of claims 1 to 4, wherein as an imaging sensor ( 18 ) A magnetic resonance element is provided. Catheter device ( 2 ) according to one of claims 1 to 4, wherein as an imaging sensor ( 18 ) An optical image sensor is provided. Catheter device ( 2 ) according to one of claims 1 to 7, wherein the imaging sensor ( 18 ) over one in the catheter cavity ( 6 ) guided drive shaft ( 59 ) opposite the catheter sheath ( 4 ) is rotatably mounted. Catheter device ( 2 ) according to one of claims 1 to 7, wherein a plurality of imaging sensors ( 18 ) over the circumference of the catheter sheath ( 4 ) and with respect to the catheter sheath ( 4 ) is fixed. Catheter device ( 2 ) according to claim 9, wherein a cyclical data readout from the imaging sensors ( 18 ) is provided via a multiplexer. Medical examination and treatment device with a catheter device ( 2 ) according to one of claims 1 to 10, wherein the imaging sensor ( 18 ) over one in the catheter cavity ( 6 ) guided signal line ( 22 ) with an outside of the catheter device ( 2 ) image processing and playback device ( 28 ) and to these in real time image information from the location of one using the catheter device ( 2 ) carried out intervention. Method for minimally invasive surgery on the septum of a heart, in which a catheter device ( 2 ) with a coupling device ( 14 ) for the transport and positioning of an Occluder designed to close a defect of the septum ( 16 ) and with one in the proximal end ( 10 ) of the catheter device ( 2 ) integrated imaging sensor ( 18 ) is guided through the blood vessels of a patient as far as the dividing wall of the heart to be treated, wherein real-time images transmitted by the reproduction unit to a patient outside of the patient body are recorded by the imaging sensor (FIG. 18 ), a monitoring of the catheter feed and a position check of the occluder ( 16 ) is made. Method according to Claim 12, in which, with the aid of the real-time images, monitoring by means of the catheter device ( 2 ) positioning of the occluder ( 16 ) is made.