Medical system

The present invention relates to a medical system for performing examination and / or treatment.

One of the most frequent illnesses is myocardial infarction, especially in industrialized countries. It is caused by a disease of the coronary arteries (arteriosclerosis). In this case, the diameter of the vessel decreases as individual or multiple coronary vessels are blocked by deposits (arteriosclerotic plaque) on the vessel wall. It has now been recognized that the risk of suffering a myocardial infarction is not primarily related to reduced vessel diameter. Rather, the question is whether the protective membrane that covers the arteriosclerotic deposits will withstand. That is, when it tears, platelets in particular accumulate at the site of collapse, which completely occludes the blood vessels within a short period of time, thereby causing myocardial infarction.

Traditionally, catheters have been used for examination or treatment, and catheters are used for coronary vessels at risk under simultaneous x-ray monitoring for catheter position detection and for examination and / or treatment. Inserted within range. Such catheters are manually inserted into the vascular system by a physician and moved there. Although the catheter is flexible, problems arise with manual guidance, especially in areas such as bends. Therefore, catheter movement and positioning is a problem. If the tip of the catheter is pushed too strongly against the vessel wall, it is likely to cause perforation of the vessel wall, which can occur with a small possibility of course effect.

Another problem is that the simultaneous x-ray surveillance merely provides image information about the free, ie, additive-free vessel volume, and does not provide any information about the vessel wall and thus plaque deposition itself. Therefore, known testing and / or treatment systems provide doctors with very important information, but all the information needed in the best case for an accurate diagnosis. It cannot be said that it supplies.

<p> An object of the present invention is to provide a medical system for performing improved examination and / or treatment for it.</p>

<p> To solve this problem, the medical system according to the present invention has an X-ray source and an X-ray detector and an image generator to perform an examination and / or a treatment. It has an X-ray imaging system that includes a control and processing device to control, and an imaging system for optical interference tomography that includes a catheter with an optical fiber, and the light is guided through the optical fiber within the inspection range. With a catheter system that is radiated in the range of the inserted catheter tip and the reflected light from the illuminated inspection range is guided via an optical fiber to a control and processing device having an image generator of the imaging system for image generation. It is equipped with at least one monitor for displaying X-ray images and optical interference tomographic images.</p><p> The medical system according to the present invention utilizes, in part, the ability to monitor catheter movement and vascular volume using an X-ray imaging system. Here, for example, a simple C-arm or a biplan C-arm can be used. Further, in the case of the medical system according to the present invention, a catheter system including an imaging system is used. The imaging system is optical coherence tomography (OCT) It is configured to perform Tomography) or is useful for performing optical coherence tomography. In such a system, also called an OCT system, light is introduced through an optical guide fiber placed inside the OCT catheter, and the light is emitted within the end range of the OCT catheter within the inserted blood vessel to surround it. Illuminate. That is, the blood vessels to be inspected are illuminated from the inside. The light reflected by the blood vessel wall or the like is returned via the optical guide fiber, and is processed by the image generator of the imaging system to obtain an image of the inside of the blood vessel or the like. The imaging system can visualize blood vessel walls, possible deposits, and the like. When a large number of images are generated one after another, continuous image observation inside the inspection range is performed in color display based on the mode of camera photography. This allows the treating physician to obtain accurate information about the appearance of the vessel wall, which the physician can process in conjunction with information from a parallel x-ray examination.</p><p> Therefore, the medical system according to the invention has a series of advantages: taking various images in the form of X-ray images showing free vascular volume and OCT images showing detailed vascular lining and vascular structure. provide. That is, the doctor is provided with important image information that should be combined with each other for diagnosis and is essential for correct treatment. X-ray images provide information on possible vascular stenosis and thus information on the diameter of the vessel available for blood flow in very good quality, whereas OCT images provide possible deposits or deposits on the lining of the vessel and the lining of the vessel. Provides information on arteriosclerotic plaques and plaque surfaces. Of course, the use of the medical system according to the present invention is also suitable, for example, for examination of the ventricles (atria and ventricles).</p><p> In the development of the idea of the present invention, an X-ray image and an OCT image can be displayed in common, especially on a common monitor at the same time. That is, the doctor can immediately combine or compare both figures showing the same examination range with each other, and can perform image processing processing to the extent necessary. A very favorable superposition of X-ray and OCT images is also possible, which allows the vessel to be examined to be displayed almost entirely, which is examined by the doctor by visually combining the information in both figures. Allows you to.</p><p> Further, it is desirable to provide a common image generator for generating X-ray images and optical coherence tomographic images so that the equipment cost can be reduced.</p><p> According to a preferred development of the idea of the present invention, at least one magnetic field generating element is provided in the tip of the catheter, and an external magnetic field generating device for generating an external magnetic field useful for moving the catheter inserted in the patient is provided. There is. In the case of the system according to the invention, the catheter is guided by a magnetic field generated externally to the patient rather than manually. For this purpose, a magnetic field generating element that generates a magnetic field on the catheter side is provided in the tip of the catheter. This magnetic field generated within the patient interacts with an external navigation or guidance magnetic field that can be repositioned with respect to the patient due to catheter movement. In this way, inevitably, the catheter tip is actively and correctly controlled within the range of the catheter tip that should be guided around some kind of vascular curved portion, so that the catheter can be moved extremely easily, and positioning is also possible. It is possible very accurately.</p><p> For easy operation of the treatment system with various components, the control of the X-ray system, the control of the imaging system and the control of the external magnetic field generator, the operation of these systems is the only central It is desirable that it be incorporated within a common controller so that it can be done by the control unit.</p><p> It is desirable that the magnetic field of the catheter generated at the tip of the catheter via the magnetic field generating element can be changed when the catheter is inserted into the patient, i.e. the strength and / or direction of the magnetic field is variable. In this way, the interaction between the generated catheter-side magnetic field and the external magnetic field can be changed. It is desirable to use an electromagnet with a core and a coil as the magnetic field generating element, in which case the lead wire of the coil is guided inside the catheter sheath and is controlled and fed from outside the patient via a catheter control device. The magnetic field can be easily changed by appropriately controlling the coil current. The magnetic field strength is increased by increasing the current, and the magnetic field direction and the like can be changed by switching the current direction. This control is easily performed, for example, via a catheter controller configured as a portable, separate device, which allows the catheter controller to be placed relatively close to the patient, at least a long lead to the coil. You can eliminate the line. However, of course, it is conceivable to incorporate the catheter control device into a common control device as well.</p><p> It is desirable to provide two or more electromagnets in order to gain more freedom in changing the magnetic field by superimposing individual magnetic fields on the individually driveable electromagnets. However, it is also conceivable to control a plurality of electromagnets in common.</p><p> In the developed form of the idea of the present invention, at least one electromagnet is arranged so that the magnetic field that can be generated is substantially parallel to the longitudinal axis of the catheter. Alternatively, at least one electromagnet is arranged, on the other hand, so that the magnetic field is approximately perpendicular to the longitudinal axis of the catheter. Depending on which direction the magnetic field is, the interaction with the external magnetic field (in the case of the same assumed magnetic field direction of the external magnetic field) occurs. That is, the forces generated by this and acting on the catheter tip are directed in different directions.</p><p> In that case, in a particularly desirable embodiment, at least two electromagnets are provided, the magnetic field generated by one electromagnet is substantially parallel to the longitudinal axis of the catheter, and the magnetic field generated by the other electromagnet is relative to the longitudinal axis of the catheter. It is almost vertical, so both magnetic fields can be utilized. In addition, there is at least one permanent magnet element in the area of the catheter tip. Therefore, if the magnetic field of the permanent magnet element is sufficient for movement, the operation of the electromagnet can be at least temporarily eliminated.</p><p> According to an advantageous development of the idea of the present invention, the catheter control device communicates with the control device of the external magnetic field generator, and the control of the electromagnet is performed depending on the control information of the magnetic field control device. That is, the catheter control device responds to changes in the current set parameters of the magnetic field generator, or these are considered within the control of the coil current, so that the coil is always fed according to the desired interaction. Can be done.</p><p> For good illumination inside the vessel, it is desirable that light can be radiated laterally from the fiber and / or anteriorly from the tip. The magnets, which are sometimes provided to help automatic guidance, are located slightly behind the tip, especially in the case of forward-directed exits. In order to maximize the illumination range, capture as much reflected light as possible, and enable internal imaging of a large area, it is best to radiate in all directions as much as possible.</p>

Hereinafter, other advantages, features, and details of the present invention will be described with reference to the drawings. FIG. 1 is a principle diagram of a medical system for performing an examination and / or treatment according to the present invention, and FIG. 2 is a principle diagram of a catheter equipped with a catheter control device.

FIG. 1 shows a medical system 1 for performing an examination and / or treatment according to the present invention in the form of a principle diagram. The medical system 1 for testing and / or treating can test and / or treat an unspecified patient on the patient bed 2. This medical system 1 includes an X-ray imaging system 3. This X-ray imaging system 3 includes an X-ray source 4 for generating X-rays, an X-ray detector for capturing an X-ray image, for example, a planar image detector 5, and an X-ray source 4 and X. It includes a control and processing device 6 that controls the operation of the line detector 5, spatial movement, positioning, and the like.

In addition, the catheter system 7 includes an OCT catheter 8 that is inserted into the patient with a magnetic field generator located at the tip (which is described in more detail in FIG. 2) and to move the catheter through the patient's blood vessels. It includes an external magnetic field generator 9 for generating a magnetic field outside the patient that interacts with the magnetic field generated at the tip of the catheter. In addition, the catheter system 7 includes a control and processing device 10 that controls the operation of the external magnetic field generator 9.

In addition, the catheter system 7 includes a catheter control device 11. The catheter control device 11 is, on the one hand, connected to at least one coil of an electromagnet located at the tip of the catheter and generating a magnetic field on the catheter side via at least one lead wire 12, and the coil is connected through this lead wire. Is powered. Further, the catheter control device 11 is, on the other hand, communicatively connected to the control and processing device 10 via a communication line 13, where wireless communication can be performed.

In addition, an imaging system 14 belonging to the catheter system is provided, which includes a light generator and light receiver 16 which is not shown in detail. The light generating and light receiving device 16 causes the light to enter the light guide fiber on the catheter side and receives the reflected light returned from the light guide fiber. The optical guide fiber connection 15 leads to the catheter 8.

The image signal acquired by the X-ray detector 5 and given to the control and processing device 6 and the reflected image signal or reflected light received by the light generating and light receiving device 16 are common in the digital image processing device 30. It is processed. Further, a monitor 17 for displaying the X-ray image and the OCT image formed by the image processing device 30 in common is provided.

FIG. 2 shows the catheter 8 in detail. In the illustrated example, the catheter tip 18 is provided with two electromagnets 19 each consisting of a core 20 and a coil 21. The coil 20 can be fed separately via both leads 12, so that the two electromagnets 19 can operate separately.

The catheter control device 11 incorporates a power supply module 31 for power supply. Further, an interface 22 is provided, through which control for the external magnetic field generator 9 and communication with the processing device 10 are performed. That is, the catheter control device 11 always has instantaneous control information, generates an external magnetic field based on this control information, and detects the strength and direction of the external magnetic field and other related information based on the control information. can do. The power supply of the coil 20 can be controlled depending on this information.

By arranging the two electromagnets 19, the magnetic field generated by the electromagnets 19 is always directed in the direction of the longitudinal axis. The direction of the magnetic field can be reversed depending on the direction of the coil current, and thus the polarities can be exchanged. Various interactions are possible, depending on how the external magnetic field is directed with respect to the internal magnetic field. When the external magnetic field is parallel to the internal magnetic field, the movement of the external magnetic field causes forward movement or backward movement depending on the direction of the magnetic field. The catheter follows the movement of an external magnetic field based on magnetic interaction. That is, when both magnetic fields are in the same direction, so to speak, sliding movement in the vertical direction is performed.

If the external magnetic field is perpendicular to the internal magnetic field, the internal magnetic field tends to rotate in the direction of the external magnetic field. That is, in this regard, it is possible to cause a swinging motion or a bending motion, and whether it is bent left or right or bent up or down is related to the external magnetic field and the internal magnetic field or their directions. The internal magnetic field always tries to rotate in the same direction as the external magnetic field.

The arrangement shown in FIG. 2 of the electromagnets may be arranged by twisting them by approximately 90 °. This results in the internal magnetic field being approximately perpendicular to the longitudinal axis of the catheter. If the external magnetic field is also perpendicular to the longitudinal axis of the catheter, but deviates, for example, 90 ° from the longitudinal axis of the catheter, it can cause rotational movement around the longitudinal axis of the catheter. This is because, in this case as well, the internal magnetic field follows the external magnetic field and tries to be in the same direction. This rotational motion is performed until the internal magnetic field is in the same direction as the external magnetic field. Using a principle known by electric motors, the catheter can be partially rotated in a stationary external magnetic field. In this case as well, rotation to the left or right can be considered depending on the direction in which the external magnetic field is oriented with respect to the internal magnetic field.

The catheter controller is provided with various operating elements, such as operating keys 23,24,25,26,27,28, in order to appropriately configure the internal magnetic field so that the movement of the catheter is as desired by the physician. There is. For example, key 23 is for "forward" and key 24 is for "backward". For example, when the key 23 is pressed, the direction of the coil current is selected so that an internal magnetic field in the same direction is generated in response to the external magnetic field. Moved to the right. If the catheter should be pulled back, on the one hand, the external magnetic field is converted accordingly, and the same is true for the internal magnetic field, which starts automatically by pressing the operating element 24. The catheter control device 11 obtains information on how to select the coil current based on the control information of the control and processing device 10 via the interface 22.

Similarly, a bending motion to the left or right is performed. This starts when you press operating element 25 or 26. For this reason, based on the knowledge of in which direction the external magnetic field is oriented perpendicular to the longitudinal axis of the catheter, the internal magnetic field is correspondingly generated by the selection of the current direction, so that the internal magnetic fields are mutually generated with respect to the external magnetic field. A corresponding bend to the right or left occurs based on the equidirectional action resulting from the action.

If rotation to the left or right around the longitudinal axis of the catheter should be initiated, the corresponding operating elements 27,8 should be manipulated. In this regard, another electromagnet, which is not shown in detail in the illustrated embodiment, is controlled. This other electromagnet is arranged perpendicular to the electromagnet 19 and generates a magnetic field perpendicular to the longitudinal axis of the catheter. In this case as well, the selection of the coil current direction is made based on the information regarding the external magnetic field or its direction.

In addition, the catheter is detailed with the optical guide fiber 29 described above. The optical guide fiber 29 terminates in the area of the catheter tip, where the light emitted from the catheter, which is correspondingly transparent in this area, illuminates the periphery. The required transparency can be obtained, for example, by the clear plastic material forming the catheter jacket or by a corresponding transparent fit into the catheter sheath. In that case, the light can be radiated laterally, forwardly, or laterally or forwardly by the arrangement of the free ends of the optical guide fiber 29. In the illustrated example, light is emitted laterally, i.e. the catheter jacket is transparent, at least in the lateral range. The use of numerous, and in some cases, differently terminated optical guide fibers is also conceivable. The optical guide fiber 29 migrates to the optical guide fiber connection portion 15 via a detachable plug-in connection in some cases.

For patient examination or treatment, the catheter is first inserted into the patient at the appropriate insertion point, followed by the catheter being guided through the external magnetic field in interaction with the internal magnetic field and accurately guided to the examination site. .. This is performed under continuous X-ray monitoring by the X-ray imaging system 3, and the X-ray image is displayed on the monitor 17. At the same time, during the entire movement of the catheter, OCT imaging is performed via the OCT imaging system 14 when introducing or deriving the catheter. That is, continuous knowledge about the concrete appearance of the inner wall of the blood vessel can be obtained. This OCT image is also displayed on the common monitor 17.

<figref num="1">Principles of a medical system for performing examinations and / or treatments according to the present invention</figref><figref num="2">Principle diagram of a catheter equipped with a catheter control device</figref>

Code description

1 Medical system for examination and / or treatment 2 Patient sleeper 3 X-ray imaging system 4 X-ray source 5 Planar image detector 6 Control and processing device 7 Catheter system 8 Catheter 9 Patient external magnetic field generator 10 Control and Processing device 11 Catheter control device 12 Lead wire 13 Communication line 14 Ultrasonic imaging system 15 Optical guide connection 16 Light generator and light receiver 17 Monitor 18 Catheter tip 19 Electromagnet 20 Core 21 Coil 22 Interface 23 Operation key 24 Operation key 25 Operation Key 26 Operation key 27 Operation key 28 Operation key 29 Optical guide fiber 30 Image processor 31 Power supply module