DE102008058497B3 - Medical device - Google Patents

Abstract

The invention relates to a medical device, comprising a patient support table (1) with patient support plate (2) and an electromagnetic locating and navigation device with a field generator (15), wherein the field generator (15) in the patient support plate (2) of the patient support table (1) integrated is, wherein the field generator (15) in the patient support plate (2) with respect to the patient support plate (2) is arranged longitudinally and transversely adjustable.

Description

The The invention relates to a medical device, in particular for one Minimally invasive procedure under navigation of a medical object in the body a patient.

Minimally invasive Medical interventions are becoming increasingly important. So are for example, in the treatment of coronary heart disease the Surgical bypass surgery on the heart clearly in favor of Balloon Dilatation (PTCA = Percutaneous Transluminal Coronary Angioplasty) and the insertion of a stent decreased. Also in the area biopsies, spine therapies and tumor ablation increase with minimally invasive procedures.

at a minimally invasive procedure z. B. one or more medical instruments in the body of a patient for therapy or diagnostics. After the introduction a medical instrument into the patient's body is this for one performing the procedure Doctor no longer directly visible. For navigation of the instrument in the body The patient must therefore do this appropriately for the doctor visualized in image information. For position determination of the instrument in the body the patient in minimally invasive medical interventions, which for the Visualization of the instrument, in particular the tip of the instrument, in image information from inside the body the patient is required, are nowadays more diverse Systems and procedures available.

progress in 3D X-ray imaging now allow 3D images of organs as well as instruments, which is in the body of a Living being. However, it is still difficult in the X-ray distinguish between instruments, organs and bones and at the same time as little as possible X-ray radiation for imaging and to use for positioning of instruments.

In this context is in the DE 10 2005 028 746 A1 a method for determining the position and orientation of an object, in particular a catheter, described in a patient from two-dimensional X-ray images by means of so-called template matching. In doing so, a three-dimensional template of the catheter is generated on the basis of the known structural properties of the catheter. To determine the position and the orientation of the catheter in the body of a living being, the three-dimensional pattern is projected onto a two-dimensional plane and the generated projection image is compared with an X-ray image in which the catheter is imaged. Subsequently, initially set parameters for the position and orientation of the pattern in space are iteratively changed and a similarity measure is determined which is used to determine the position and orientation of the catheter.

In "Needle C-arm CT interventions ", Markus Nagel, Martin Hoheisel, Ralf Petzold, Willi A. Kalender and Ulrich H.W. Krause, Medical Imaging 2007: Visualization and Image-Guided Procedures, edited by Kevin R. Cleary, Michael I. Miga, Proc. of SPIE Volume 6509, 65090J, (2007) · 1605-7422 / 07 / $ 18 · doi: 10.1117 / 12.709435 is an electromagnetic navigation system AURORA of the company NDI, Waterloo, Ontario, Canada. The electromagnetic navigation system comprises a field generator for generating an electromagnetic Field to positions and orientations of medical instruments to determine which in their tip each small induction coils exhibit. Based on the induced voltages, the AURORA system determine the position and orientation of the respective instrument.

to Improving the accuracy of locating instruments and for Improving the determination of coordinate transformations between one Image coordinate system and a navigation system associated Coordinate system, which is also referred to as registration point on X-rays based and / or electromagnetic wave based navigation systems often an x-ray marker and / or electromagnetic marker comprising plate, which is placed under a patient to whom the minimally invasive Intervention performed becomes. This is what the "Needle and catheter navigation using electromagnetic tracking for computer-assisted C-arm CT interventions ", Markus Nagel, Martin Hoheisel, Ralf Petzold, Willi A. Kalender and Ulrich H.W. Krause, Medical Imaging 2007: Visualization and Image-Guided Procedures, edited by Kevin R. Cleary, Michael I. Miga, Proc. of SPIE volume 6509, 65090J, (2007) · 1605-7422 / 07 / $ 18 · doi: 10.1117 / 12.709435 System a so-called "registration panel" with five x-ray markers, which automatically in X-ray images can be detected and with an electromagnetic sensor connected to the AURORA System is detectable. The "registration panel " not only for registration, but also as a reference system while the navigation of instruments used.

A disadvantage of this solution is that the plate or the "registration panel" comprising the x-ray markers and the electromagnetic marker is uncomfortable for the patient and, for longer interventions, pressure points or pressure injuries on the patient ducks can occur.

Of Further must be the field generator of the electromagnetic navigation system on a patient support device receiving the patient attached or on a separately executed tripod next to the patient support device be arranged to the electromagnetic field for navigation in the desired room area to disposal to deliver. However, this structure affects access to the Patients and elevated In addition, the risk of collisions, for example, with an imaging medical device that used in the intervention for interoperative imaging.

In the US 2006/0025668 A1 a medical device is described with a patient table, in the table top, a sensor array is integrated, which includes a plurality of sensors. Each sensor may include one or more coils for generating one or more magnetic dipole fields for navigating a medical instrument. The sensors are arranged at fixed positions in the array.

From the US 2004/0199072 A1 a patient positioning device is known for placement on an operating table, in which a transmitter coil array of a navigation system for navigation of a medical instrument is integrated. However, the patient positioning device may also be integrated in the operating table. The transmitter coil array is fixedly disposed with respect to the patient positioning device and the operating table.

One Electromagnetic navigation system usually also has one on a cart or a rack arranged PC (personal computer) with display device for operating the electromagnetic navigation system on. The cart or rack also takes up space around the Patient support device.

Also patient administration as well as the documentation of navigation-guided interventions included the retention of consumables in such a medical Intervention is due to the different equipment used and individual components are not consistent, what the best possible medical Workflow is disadvantageous. Because a medical procedure concerned Data, e.g. Eg patient data both on the electromagnetic navigation system and on manages the imaging device used, entered, modified, supplied to a patient record, etc. become.

Of the The invention is therefore based on the object, a device of specify the type mentioned above such that in a medical procedure using the device the requirements for an improvement of the workflow.

To the invention, this object is achieved by a medical technology Device comprising a patient table with patient support plate and an electromagnetic location and navigation device with a field generator, which field generator into the patient support plate of the patient table is integrated and with respect to this Flatten along and is arranged transversely adjustable.

It So it is proposed, the electromagnetic positioning and navigation device at least partially integrate into the patient table, which means that components of the positioning and navigation device, as a field generator integrated into the patient support plate are included in the sense of and therefore no separate room claim. This measure creates the prerequisites that the workflow or the workflow in a medical, especially a minimally invasive Engaging a patient using the medical device to improve, because free space can be created around the patient table.

Of the Field generator for generating a variable electromagnetic Field of the electromagnetic locating and navigation device, the is an integral part of the patient table is included adjustably arranged with respect to the patient support plate. For example, this can be done Rails or a rail system for moving the field generator transverse and longitudinal relative be provided to the patient support plate.

To an embodiment the invention is the field generator in an adjustable tray the patient support plate, comparable to an X-ray cassette In a Bucky table, arranged, which load in the patient support plate is arranged and relative to the patient support plate or a patient in a desired Position can be brought or adjusted.

According to a variant of the invention, preferably at least one X-ray positive and / or at least one electromagnetic marker and sensor of the electromagnetic positioning and navigation device is permanently or adjustably integrated into the patient support plate, ie received therein, which is generally not directly recognizable from the outside, if not appropriate optical mark ments are present. In this way can be dispensed with a marker plate or the "registration panel" described above.

The medical device is in particular for use in a biopsy, a tumor ablation or for diagnostic or therapeutic interventions on the lungs or provided at the heart of a patient.

embodiments The invention are in the attached schematic drawings shown. Show it:

1 a medical device,

2 a patient table of the medical device with adjustable field generator, integrated X-ray markers and integrated electromagnetic marker,

3 a side view of a patient support plate of the medical device with integrated into the patient support plate field generator and

4 a patient table of the medical device with integrated field coils, X-ray markers and electromagnetic marker.

In 1 is a medical device for performing a medical procedure, in particular a minimally invasive medical intervention on a not explicitly shown patient shown. For example, the procedure may include biopsy, catheter navigation, tumor ablation, or generally diagnostic or therapeutic interventions on the heart or lungs of a patient.

The device comprises a patient table 1 with a patient support plate 2 and an electromagnetic location and navigation device. In addition, in the case of the present embodiment, an imaging medical device in the form of a C-arm X-ray device 3 available.

The C-arm X-ray machine 3 points, as in the DE 10 2005 012 700 A1 described, an articulated robot 4 on, of which a C-arm 5 is guided, on which lying opposite to each other, an X-ray source 6 and an X-ray receiver 7 are arranged. The X-ray receiver 7 is in the case of the present embodiment, an X-ray image intensifier. The X-ray receiver 7 however, it can also be implemented as an aSi flat-panel detector.

The C-arm X-ray machine 3 has a controller 8th in the case of the present embodiment, the function of a system controller 8th complied with the medical device. The C-arm X-ray machine 3 are also an arithmetic unit 9 for pre-processing of X-ray images, a computing unit 10 for calibration or registration with the electromagnetic positioning and navigation device, a computing unit 11 for image correction and a computing unit 12 for the reconstruction of images, for image processing of x-ray images, in particular having soft tissue, as well as for image fusion, segmentation of images and auto-segmentation of images. In addition, a picture memory 13 available, which like the arithmetic units 8th to 12 on a data bus 14 connected.

With the C-arm X-ray machine 3 and possibly the associated computing units can in a conventional manner of a on the patient table 1 stored patients 2D X-ray projections or fluoroscopic images from unterschiedli chen projection directions are recorded and displayed. In addition, with the C-arm X-ray machine 3 3D images of the inside of a patient's body are reconstructed and displayed from 2D X-ray projections recorded from different projection directions.

The electromagnetic location and navigation device is controlled by the system controller 8th controlled and therefore has no own control. The electromagnetic location and navigation device comprises in the case of the present, in 1 shown embodiment, a field generator 15 for generating a variable electromagnetic field, not explicitly shown, in or at the tips or distal ends of medical intervention instruments, such as biopsy needles, catheter, etc. defined electromagnetic sensors or coils, a drive unit 16 for the field generator 15 , a computing unit 17 for preprocessing the signals with a signal interface originating from the electromagnetic sensors or coils of the intervention device or instruments 18 for the signals as well as a computing unit 19 for image processing based on the signals of the electromagnetic sensors or coils. The drive unit 16 , the preprocessing unit 17 and the arithmetic unit 19 for image processing are also on the data bus 14 connected. The arranged in the intervention instruments not shown coils or coils having sensors are wired or by radio with the signal interface 18 the arithmetic unit 17 connected for preprocessing of the signals. But it can also be a connection interface 36 for coils or coils having electromagnetic Sen soren, which are arranged in or on a medical instrument, on the patient table 1 be provided. The interface 36 is in a manner not shown with the signal interface 18 connected.

When using the medical device induces the electromagnetic field of the field generator 15 Tensions in the small coils of the intervention instruments, with the arithmetic unit 17 be measured for preprocessing and then preferably used to determine the position and orientation of the tip of the respective intervention instrument in one of the locating and navigation device associated coordinate system. With the arithmetic unit 19 However, images based on the signals can also be generated in the manner of a mapping system.

At the patient table 1 It may, moreover, be a patient table, as used in the DE 199 20 008 B4 is described. Settings or adjustments of the patient table 1 or the patient support plate 2 take place in the case of the present embodiment with the system control 8th ,

The system control 8th not only features the operating software for the C-arm X-ray machine 3 on and controls the C-arm X-ray machine 3 associated computing units 9 to 12 but also includes the operating software of the patient support table 1 and in particular the operating software of the electromagnetic positioning and navigation device and controls the computing units associated with the electromagnetic positioning and navigation device 16 . 17 and 19 at. The operating software of the electromagnetic location and navigation device is as a software module or as a plug-in in the operating software of the C-arm X-ray machine 3 integrated. The operating software of the electromagnetic positioning and navigation device is via a menu in the operating software of the C-arm X-ray machine 3 selectable, callable and operable. In particular, can be via a menu in the operating software of the C-arm X-ray machine 3 call and operate a functional map for the electromagnetic location and navigation device.

The operating software for the patient table is comparable in a similar way 1 into the operating software of the C-arm X-ray machine 3 integrated, so that these too via a menu in the operating software of the C-arm X-ray machine 3 selectable, callable and operable.

The operation of the medical device can via the not explicitly shown control devices or input means of the C-arm X-ray device 3 respectively. The operating devices or input means may comprise a keyboard, a computer mouse, a trackball, a touchscreen, etc. in a manner known per se. In addition, the medical device points to the data bus 15 connected controls 20 or input means 20 as well as on or in the area of the patient table 1 arranged on the data bus 14 connected patient-near operating devices 21 or input means 21 which may also include a keyboard, a computer mouse, a trackball, a touch screen, etc.

The display or presentation of menus of the operating software, data in general, patient data, with the C-arm X-ray machine 3 or the electromagnetic location and navigation device obtained image information, etc. takes place in the case of the present embodiment on a group of six vision devices 22 , In this case, a first viewing device 22 as a display device for the electromagnetic location and navigation device, a second viewing device 22 as a display device for the C-arm X-ray machine 3 , a third screen 22 as display device for the patient table, a fourth viewing device 22 be provided as a display device for X-ray images, superimposed images, etc.

Alternatively, instead of the group of viewing devices 22 Also, a large screen can be used, which can be divided into different display panels for corresponding displays of data and images of the various equipment.

There is a DICOM interface for patient administration 23 intended for patient and image data. That way, from the Control Panel 8th Patient and image data can be retrieved from an electronic patient record of a HIS (Hospital Information System). Likewise, data relating to medical intervention, be it image data, patient data, diagnostic or therapeutic data, findings, protocols, data on consumables, etc., can be retrieved using the DICOM interface 23 For example, with the help of DICOM MPPS (Modality Performed Procedure Step) a network of a hospital, an electronic medical record of a HIS or a billing system are supplied.

The field generator 15 the electromagnetic positioning and navigation device can, as in 1 shown on the patient support plate 2 to be ordered. The field generator 15 can, as in 2 shown transversely and / or longitudinally relative to the patient support plate 2 displaceable or adjustable below the patient support plate 2 be arranged. This can not, for example be provided rails on which the field generator is slidably mounted. The electrical contact of the field generator 15 via a connection 24 ,

In addition, in the case of the present embodiment, multiple radiopaque markers 25 and a six-degree-of-freedom electromagnetic marker 26 the electromagnetic location and navigation device defined in the patient support plate 2 integrated, so that can be dispensed with the above-mentioned marker plate or the "registration panel". The electromagnetic marker 26 is via an electrical connection 27 contactable.

The radiopaque markers 25 and the electromagnetic marker 26 Incidentally, like the marker plate mentioned above or the "registration panel", among other things, for the registration of the C-arm X-ray device 3 and the electromagnetic locating and navigation device used together, in which a coordinate transformation between a patient or image coordinate system and a coordinate system associated with the electromagnetic positioning and navigation device is determined. Only then can an image of at least one tip of an intervention instrument into one with the C-arm X-ray device 3 obtained image of the body interior of a patient position and correct position are displayed.

The five radiopaque markers 25 are preferably spherical and made of lead. The markers 25 have a diameter of about 3 to 15 mm and are clearly visible in X-ray images. The electromagnetic marker 26 or sensor 26 has in the case of the present embodiment, six, not explicitly shown, relative to each other spatially differently oriented receiving coils, so six degrees of freedom. The markers 25 and the marker 26 are defined relative to each other.

According to the invention, the field generator 15 in contrast to 2 but in the patient support plate 2 arranged as in 3 shown. The field generator 15 is in a fixed or adjustable drawer 28 arranged. Drawer 28 is in the patient support plate 2 integrated. Despite the integration, the loading 28 However, be spent in a position in which the field generator 15 is accessible from the outside.

Basically, the field generator 15 also on or on the patient support plate 2 attached articulated robot 29 be arranged. With the help of the articulated robot 29 can the field generator 15 in different positions relative to one on the patient support plate 2 placed patients are placed. The articulated robot 29 can do this from the Control Panel 8th be controlled.

The field generator 15 can also be attached to a holder device 30 the patient support plate 2 be arranged, which is stationary or transversely and / or longitudinally relative to the Patientenla gerungsplatte 2 is adjustable. The holding device 30 is foldable and foldable. The field generator can thus if necessary by unfolding the holding device 30 be brought into a desired position relative to a patient. Otherwise, the holder device becomes 30 Folded with the field generator so that the field generator under the patient support plate 2 located in a parking position.

In principle, the field generator can also be in the C-arm X-ray machine 3 , z. B. in the C-arm 5 be integrated. In this case, in contrast to those in the WO 2007/029 139 A2 described magnetic field tracking system, wherein the field generators to an X-ray source and an X-ray detector are arranged, field shields, for example in the form of metallic plates, for the X-ray source 6 and the X-ray image intensifier 7 provided to negatively affect the image quality of the C-arm X-ray machine 3 to avoid generated images by the electromagnetic field of the field generator. As already mentioned, it is useful in this embodiment of the invention; aSi flat-panel detector as X-ray receiver.

Regardless of the selected arrangement alternative of the field generator 15 is the field generator 15 always assigned an electrical connection, so that the field generator 15 with its drive unit 16 can be connected.

An alternative to using a field generator involves the use of multiple field coils 31 for generating various electromagnetic fields. In 4 is the use of such field coils 31 illustrated. After the in 4 shown embodiment are five field coils 31 into the patient support plate 2 integrated and by means of connections 32 in this case with the drive unit 16 for the field coils 31 contactable.

In the case of the present embodiment, the medical device additionally comprises a collision detection unit 33 on. The collision detector unit 33 for example, a camera 34 and a computer evaluating the camera images 35 have, with which the space around the patient table 1 can be monitored for collisions. This is especially of Benefit if the field generator 15 for example, on the articulated robot 29 is arranged, so that in particular collisions with the C-arm X-ray machine 3 would be possible. The Control Panel 8th are thus based on the data of the collision detector unit 33 and the patient support table that you own 1 , the C-arm X-ray machine 3 and the articulated robot 29 control data concerned, the positions of the patient table 1 , the C-arm X-ray machine 3 and the articulated robot 29 known, so the collisions of the various equipment can be avoided with each other.

at the described medical imaging device it must By the way not necessarily an X-ray device or a C-arm X-ray device. The medical imaging device may also be an X-ray computer tomograph or an ultrasound device be.

Furthermore, the control computer 8th not necessarily be the control computer of the medical imaging device. Rather, the control computer can also be a separately executed computer or a computing unit.

at the electromagnetic positioning and navigation device can it is functionally for example the AURORA tracking system from Northern Digital Inc., Waterloo, Ontario, Canada it u. a. in "Needle C-arm CT interventions ", Markus Nagel, Martin Hoheisel, Ralf Petzold, Willi A. Kalender and Ulrich H.W. Krause, Medical Ima went 2007: Visualization and Image-Guided Procedures, edited by Kevin R. Cleary, Michael I. Miga, Proc. of SPIE Volume 6509, 65090J, (2007) · 1605-7422 / 07 / $ 18 · doi: 10.1117 / 12.709435 is described.

at The present invention is the electromagnetic locating and Navigation device in pendency from the embodiment partially, preferably completely integrated into the patient table, resulting in an improved Workflow or workflow is achievable.

Claims (3)

Medical device comprising - a patient table ( 1 ) with patient support plate ( 2 ) and - an electromagnetic positioning and navigation device with a field generator ( 15 ), - which field generator ( 15 ) into the patient support plate ( 2 ) of the patient table ( 1 ), and - which field generator ( 15 ) in the patient support plate ( 2 ) with respect to the patient support plate ( 2 ) is arranged longitudinally and transversely adjustable. Medical device according to Claim 1, in which the field generator ( 15 ) in relation to the patient support plate ( 2 ) adjustable charging ( 28 ) of the patient support plate ( 2 ) arranged in the patient support plate ( 1 ) is arranged. Medical device according to claim 1 or 2, wherein at least one X-ray positive ( 25 ) and / or at least one electromagnetic marker ( 26 ) of the electromagnetic positioning and navigation device fixed or adjustable in the patient support plate ( 2 ) is integrated.