The present invention relates to a shock wave therapy apparatus having an integrated x-ray device.
Shock waves, i.e. mechanical waves sometimes also named “acoustic”, are presently used in different ways for therapeutic treatment. Shock wave lithotripsy is especially important and has been the starting point of the development in a historical sense, namely the disintegration of concrements in the body, especially stones, using focused shock waves of high amplitude and steep rising edges. Here, single pulses are directed to the concrement, wherein the first “half wave” corresponding to a compression dominates as regards edge steepness and amplitude whereas already the next succeeding half wave, corresponding to an expansion, is substantially less pronounced. Such pulses are used in a regularly repeated manner.
Comparable methods using shock waves are also known for other indications, e.g. for treating badly healing bone fractures.
Besides that, the invention also relates to shock wave therapies using proper waves, i.e. continuously oscillating waves. They can be used in a focused manner for heating body tissue, e.g. for the so-called thermal ablation of tumors.
Although therapies using non-focused shock waves are known, the present invention is related to applications of focused waves (including pulses, compare above). Although the delimitation between focused and non-focused waves can be problematic, in the following, only such therapies shall be meant in which the shock waves are intentionally concentrated to a body region which is more or less extended in order to increase intensities, pressures or edge steepnesses.
Since in these focusing therapies the localization to the body region to be treated is essential, naturally, the adjustment of the respective apparatus for a correct positioning of the focus region in the body is of essential importance. Naturally, this relates to a preliminary adjustment to the region to be treated, e.g. a stone, on the one hand. In case of too large tolerances, healthy tissue is damaged or unnecessarily much of healthy tissue is detrimented and, further, the success of therapy in the region to be treated is diminished or endangered. The term “navigation” is used here.
As a complication, further, the navigation needs not necessarily be a static operation, i.e. changes during treatment may occur. Movements of the patient or displacements of organs, especially due to respiration, are an essential cause.
Image producing methods can be used for navigation that render the region to be treated distinguishable from surrounding regions and produce navigation information, i.e. coordinates, for the shock wave apparatus. Especially known is a running x-ray monitoring during shock wave lithotripsy. If, for example, the patient is to be positioned on a patient berth, it has to be determind precisely where the region to be treated is located, at first. Hereto, conventionally a vertical x-ray radiography is performed first. Usually, the region to be treated, for example the stone, appears in the x-ray image but is not centered. Then, a horizontal shift can be performed (either of the berth or of the stand carrying the x-ray device) until the stone is centered.
For three-dimensionally locating a region to be treated, principally two different x-ray images in different directions are necessary, for example in an angle of 30°. Thus, a second x-ray radiography in a second direction is performed in order to be able to adjust to the correct height for example of the stone, e.g. to adjust to the correct isocenter. Hereto, for example the patient berth can be adjusted in its height. Only after the stone has been centered three-dimensionally and thus is located in the shock wave focus, it can be disintegrated.
Basically, an x-ray image in one direction only can be combined with other imaging methods or other non-imaging locating technologies. There are also cases in which a two-dimensional locating by one x-ray imaging direction is sufficient for anatomical reasons.
Anyhow, frequently a combined use of x-ray diagnosis and shock wave therapy is desired. Hereto, combined apparatus are known combining x-ray apparatus, also x-ray apparatus adjustable as regards the imaging direction, with shock wave therapy devices, in particular shock wave lithotripters.
The present invention has the object to provide an apparatus of this type being improved as regards its practical properties.
An apparatus for shock wave therapy of a human or animal body comprising a focusing shock wave therapy device an integrated X-ray device having an X-ray source and an image capturing device, said X-ray source and said image capturing device being mounted to a stand by carrying arms, and a patient berth beside said stand, said X-ray device and said shock wave therapy device being adapted to be applied to an abdominal region of a patient on said patient berth, said X-ray device being adapted to vertically radiograph said abdominal region, and said apparatus being adapted to that said stand on the one hand and said X-ray source and said image capturing device of said X-ray device on the other hand, in case of a vertical radiography of said abdominal region, have a connection line in a vertical projection in an angle of at most 75° to a longitudinal axis of said patient berth, and to that a region of said patient berth corresponding to said abdominal region of said patient is kept free on both sides of that patient berth for accessibility by persons. Further, the invention is directed to advantageous uses of this apparatus and preferred embodiments according to the dependent claims. In the description hereunder, there is no explicit difference between the apparatus category and the use category so that the description is relevant for both, principally.
A basic idea of the invention is to improve the spacial conditions in the application of a combined apparatus for shock wave therapy and X-ray. Therein, predominantly the access to the patient is of interest, namely to the abdominal region in this invention, that is to the belly and underside. Conventional apparatus have a stand directly beside the patient berth, which carries the X-ray apparatus by means of carrying arms. This stand stands on one side beside the patient berth's middle and thus inhibits the access to the abdominal region from the side. In many cases, however, an access from both sides is advantageous. Not only the improved accessibility by a multiplicity of persons such as medical doctor and nurse but also the necessity of a treatment of regions on both sides of the patient, for example of both kidneys, can be relevant. In these cases, the medical doctor prefers to stand directly at the side just treated, in particular when being supported by an external excess to a kidney. Therefor, the patient is changed in position when using conventional apparatus and changing the side treated.
According to the invention, an eccentric arrangement of the stand can be achieved, i.e. beside the patient berth and at one of its longitudinal sides as well, but not beside the abdominal region. Thus, an arrangement beside the head region or the foot region is considered.
More precisely, this can be expressed by the angle between two characteristic lines. The first line is a connection line to be imagined horizontally, i.e. in a vertical projection, between the stand and the X-ray source and the X-ray image receiving means in case of a vertical radiographing direction of the X-ray device. This line represents the longitudinal extension of the X-ray device construction on the stand. The other line is the longitudinal extension of the patient berth, i.e. from the head region to the foot region or vice versa. Between both lines, an angle of at most 75° should exist according to the invention whereas the prior art has an angle of 90° here. Since a vertical position of the X-ray device during radiographing the abdominal region is used as a basis, this angle definition means a quantification of the eccentric arrangement according to the invention. Especially preferred are angles of at most 70°, 65°, or at most 60°.
Consequently, the staff can access the abdominal region during treatment from both sides. In case of an arrangement of the stand beside the head region, the foot side of the treatment berth and the opposite side of the treatment berth in the head region remain free, in particular for anaesthesia, which needs a head access. In case of an arrangement beside the foot region being even more preferred, the X-ray source region remains free from three sides, at least as regards the X-ray device.
It is to be noted that the arrangement of the combined apparatus according to the invention is to be understood in terms of a suitability for use only. The apparatus can also be adapted to be arranged and used in a different manner. On the other hand, conventional devices are not suitable for the arrangement according to the invention. Preferably, the invention is also directed to a use of the apparatus according to the invention in which the above mentioned arrangement is present.
In the apparatus according to the invention, the patient berth and/or the stand may be displaceable in order to find an optimal geometry for an individual situation. In particular, these elements can also be displaceable in order to move them for example from one room to another. As an example, a multiplicity of patient berths can be used wherein the patients are prepared on patient berths arranged outside of the area of the X-ray device and the shock wave therapy device, and can be moved thereon to the treatment as soon as other patients on other patient berths have been completely treated. Further, the stand together with the X-ray device and the shock wave therapy device can be moved from one room to another in order to be used in different rooms or also in different hospital wards or even, in case of a transport by a vehicle, in different hospitals or medical practices.
In a preferred embodiment, the X-ray device is adjustable as regards its imaging direction, namely by tilting an arc consisting of the arms on which the X-ray source and the X-ray image capturing device are mounted. Thus, as seen in a vertical projection, either the X-ray source or the image capturing device is moved nearer to the stand and the other element farther therefrom. A rotating movement around a horizontal axis is preferred herein, which axis is thus orthogonal to the connection line described between the X-ray source and the image capturing device on the one hand and the stand on the other hand in the vertical projection. However, the tilting movement can also be implemented in an other manner, i.e. not around a fixed rotation axis. In the preferred implementations having a temporarily constant rotation axis, this axis is preferably directed through the focus region of the shock wave device.
In this embodiment, the X-ray imaging direction can be tilted out of the precisely vertical position, thus. By means of the adjustment described, a region in the abdominal region relevant for the shock wave therapy can be located. Consequently the invention enables a mere X-ray locating and X-ray navigation in this embodiment.
An additional preferred embodiment provides an additional axis of the X-ray device implemented in that the arc is rotatably mounted at the stand. According to the invention, this axis is preferably not horizontal but inclined. Preferred is a range of the angle between this rotation access and the horizontal direction between 30° and 60°, in particular between 40° and 50°. Since rotations around the X-ray imaging axis itself do not make sense, principally arbitrary angle positions can be adjusted by means of these two rotatory degrees of freedom, at least as long as the mounting environment, in particular the space above and below the patient berth and the dimensions of the X-ray source and the X-ray image capturing device enable this. In particular, lateral inclinations of the X-ray radiation axis, i.e. around the patient's longitudinal axis, cranio-caudal tilts, i.e. around a horizontal access transverse to the patient, and radiation direction inversions can be implemented. The cranio-caudal position is usually only approximated, but named so never the less.
In further preferred embodiments also the shock wave therapy device is movable. Preferably, it is mounted on the arc and is displaceable along the arc, preferably isocentrically. The center of the displacement path of the shock wave therapy device, the section of all possible X-ray radiation axes and the focus region of the shock wave therapy device are preferably coincident, thus.
Further, the shock wave therapy device can advantageously be in a parking position and in an operation position. In the operation position, the focus region is in the X-ray radiation path. In the parking position, the shock wave therapy device is completely outside of the X-ray radiation path as far at it is used for imaging, in order not to interfere therewith. Ideally, the movement mechanism for the movements between these two positions is moveable along the arc as well and works in the different tilting positions of the shock wave therapy device. Thus, the shock wave therapy device can be moved out of the berth region during a tilting operation and can be moveable into a respective operation position in certain therapeutically relevant positions such as below the berth with a vertical upward working direction, laterally beside the patient short above the berth with a horizontal working direction and above the berth with a vertical downward working direction.
Still further, lateral displacement means are advantageous for bringing the region of interest in the abdominal region into the region accessible by the X-ray device and the shock wave therapy device, in particular in case of the preferred isocentrical embodiment. Therein, two horizontal adjustment directions can be provided. Effectively, the relative arrangement of the stand and the patient berth is important so that the patient berth and/or the stand can be adjusted. An adjustment of the stand is preferred because it does not shatter the patient and there is no need to pay attention to conducts in connection with catheters, with anaesthesia or other items, if any. An adjustment of the stand does not necessarily mean to move the stand as a whole relative to the floor. It may be sufficient to move the common construction of the shock wave therapy device and the X-ray device, i.e. in particular the arc. This adjustment is preferably also vertically possible.
If the shock wave therapy device is already focused (at least) in the plane of the X-ray image to a location fixed in relation to the X-ray images such as the middle of the X-ray image, the relative adjustment between the stand and the patient berth described can adjust the shock wave therapy device onto the region to be treated in this respect. Normally, a further adjustment in the direction of the X-ray imaging device is necessary, then. For defining the height adjustment of the therapy region, in case of a pure X-ray locating, a further direction of radiography shall be achievable by adjustment, for example different from the vertical direction, preferably by 30° relative to the vertical direction. This can be achieved by a rotation of the arc, a so called C arc. The adjustment itself can also be made by adjusting the shock wave therapy device (including the X-ray device) or by a corresponding further adjustment of the patient berth, such as a height adjustment, as well. A height adjustment of the berth is preferred because an advantageous height for the entering of the patient can be achieved therewith as well.
Finally, a hollow implementation of the shock wave therapy device is preferred. This applies in particular to shock wave lithotripters. The shock wave source can be a hollow coil. In any case, a penetration of the X-rays through the shock wave therapy device shall be enabled, preferably at least axially. Thereby, the X-ray device and the shock wave therapy device can be used simultaneously and having a vertical working direction, respectively. Herein, it is advantageous, by the way, to arrange the shock wave therapy device in the above mentioned adjustment near to the X-ray source because the limitation of the image diagonal of the X-ray device that can possibly not be avoided by the hollow geometry is less than in an arrangement near to the image capturing device, for example the image amplifier.
Preferably, there is even a further possible direction of penetration by the X-rays through the shock wave therapy device being somewhat inclined to the axial direction, preferably for a laterally tilted second X-ray imaging in an arrangement of the shock wave therapy device in its working position.
The lateral arrangement of the shock wave therapy device does usually not disturb X-ray imaging, by the way, at least not if this is performed near to the vertical imaging axis or even in a cranio-caudal position.
The stand can comprise a foot having a somewhat larger extension in the direction of the connection line between the X-ray source and the image capturing device on the one hand and the stand on the other hand, in order to support the center of mass of the overall construction. This foot together with its covering can inhibit a movement near to the patient berth because of a collision with the supporting construction of the patient berth, or can at least limit the space under the patient needed for other purposes. In this context, the stand is preferably formed in an oblique manner in the relevant region, that is the region towards the X-ray source and the X-ray image capturing device. Thereby, a reasonable support can be combined with a manner of construction as slim as possible in the problematic region. The oblique form of the covering shall comprise at least half of the side to the X-ray source and the X-ray image capturing device, i.e. the region not oblique shall comprise a half at maximum. Preferably, a not oblique rest is provided in the middle and there are two oblique portions on both sides thereof. The oblique portions need not have straight side faces but should correspond to oblique angles in the range between 10° and 60°, preferably at least 15° and preferably at most 45°. At a side of a not oblique portion of at most half of the covering front considered, respective angles shall be given, thus. Thereby, the stand having the inclined orientation according to the invention can be moved quite near to the patient berth without essentially or at all projecting below the patient berth and without inhibiting the freedom of movement (in particular in the foot region) of the therapist standing beside the berth. In case of a double-sided oblique structure, this applies to different arrangements, namely on the right or on the left side of the patient berth and beside the head region or the food region, respectively. For illustration, reference is made to the embodiment.
A further preferred embodiment of the stand comprises an apparatus rack for further medical-technological apparatus such as endoscopy apparatus or control and evaluation apparatus, an ultrasonic diagnosis unit and the like. This apparatus rack is arranged in an “upper” region in that sense that it is at least in part mounted higher than the patient berth, i.e. the patient plane. Thus, it can be kept out of the foot region which is possibly needed for other purposes and easier to be operated and to be cleaned. Finally, this arrangement is economically preferred for operating the apparatus compared to an arrangement below the height of the hips. In a particularly preferred embodiment, the apparatus rack is arranged on the stand as such as shown by the embodiment.
The patient berth preferably comprises an eccentric column in order to keep the region below the abdominal region of the patient free. Thereby, for example a part of the X-ray device can be moved under the abdominal region. Additionally, the patient berth comprises a support foot extending from the eccentric column and relatively flat on the bottom until at least into the abdominal region in order to guarantee a sufficient stability of the patient berth. This embodiment is particularly adequate also for moveable berths that are not permanently fixed to the floor by screws. Also here, reference is made to the embodiment for illustration.
The invention will be explained in further detail with reference to an embodiment wherein the individual features can also be relevant for the invention in other combinations and relate both to the apparatus category and the method category.
In the drawings:
a+b show two top views onto an apparatus according to the invention in various arrangements,
a-c elevational views as in
In
Column 3 is supported by two longitudinal feet 4 essentially parallel to the longitudinal direction of the berth (in
Beside patient berth 1-4, a stand 5 rests on the floor and carries an essentially semi-circular C arc 6. At the ends of C arc 6, as can be seen in
a and b show clearly that stand 5 is positioned eccentrically beside patient berth 1, namely beside the foot region in
Carrying rod 10 penetrates apparatus rack 9 and projects therefrom upwardly and carries two large flat screens operable by touching on a lever arm for displaying X-ray images or images of the video camera, also of the endoscopy, of data essential for the user, of ultrasonic images etc.
It can be seen in
As can be seen in
A linearly working lift device is provided within column 3 shown in
The arrangement of
Further,
In comparising thereto,
In this position, the shock wave treatment is performed from the upside and the X-ray imaging direction is inverted compared to
Both in the position of C arc 6 in
In relation thereto, in
The same applies to
Number | Date | Country | Kind |
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EP08005803 | Mar 2008 | EP | regional |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP09/02068 | 3/20/2009 | WO | 00 | 9/27/2010 |