Patent Description:
Lithotripters which generate high energy pulses to disintegrate concrements in a human body may have shock wave and/or ultrasound sources within a reflector filled with water. A cushion may be provided to enclose the water and to adapt to a separation film, also called patient film or the body of a patient. There may be small air bubbles within a coupling medium, e.g., an ultrasound gel, at an exterior surface of the cushion between the cushion and a patient film or the body of the patient. Such air bubbles may cause reflection and/or refraction of the high energy pulses and therefore may reduce the efficiency of treatment.

<CIT> discloses a device for detecting such bubbles with a camera system. <CIT> discloses an illumination device, which detects reflected light at the cushion to indicate air bubbles. <CIT> discloses a breast biopsy device. <CIT> discloses a shockwave therapy system with 3D control.

The problem to be solved by the invention is to provide an ultrasound and/or shock wave device, which can avoid and/or remove air bubbles at the exterior surface of a cushion of a lithotripsy device covering an ultrasound and/or shock-wave source. A further aspect relates to a method of removing remove air bubbles at the exterior surface of the cushion.

Solutions of the problem are described in the independent claims which define the system and methods according to the invention. The dependent claims relate to further improvements of the invention.

In an embodiment, a shock wave and/or ultrasound device, which may be a lithotripter includes an ultrasound and/or shockwave source within a reflector and covered by a cushion. The interior of the reflector and the cushion may be filled with a liquid, which may be water. The cushion may have an exit section through which ultrasound and/or shockwaves pass to the exterior. This exit section may be directly coupled to a patient or indirectly via a separation film, also called patient film to the patient. The patient film may include a plastic material. There may be a layer of coupling gel, also known as ultrasound gel or acoustic gel at the top of the exit section to allow further coupling of the ultrasound and/or shock-wave energy via the patient film or directly to the patient.

The ultrasound and/or shockwave source is suspended on a hexapod drive, such that it can be displaced and tilted. Displacement may be in at least one and up to three degrees of freedom. Tilt or rotation may be in at least one and up to three degrees of freedom. As the hexapod drive allows a free orientation of the source in space, it can basically adjust the ultrasound and/or shockwave source to any required position and orientation.

The hexapod drive may be configured to move the ultrasound and/or shockwave source towards the patient until the exit section of the cushion touches the patient film or the patient. Such a movement helps to remove small bubbles of air within a coupling medium, e.g., an ultrasound gel or another immersion media, in the space between the top of the cushion and the patient and specifically air bubbles which may be between the top of the cushion and the patient film and/or between the patient film and the patient body. This movement is done before an ultrasound and/or shockwave treatment is started. The hexapod drive may further be configured to perform additional lateral and/or rotational movements which may help further to wipe out or remove air bubbles from the coupling gel at the top of the exit section of the cushion. If, for example, the main movement direction is along the positive z-axis, the additional movement may be in the x-y-plane defined by the x-axis and y-axis. There may also be a rotation about the z-axis.

According to the invention, the hexapod drive is configured to perform at least one lateral and/or rotational movement. Such a movement may be relative to the center axis of the ultrasound and/or shockwave source. This movement helps to wipe out or remove air bubbles from the coupling gel at the top of the exit section of the cushion. If, for example, the center axis of the ultrasound and/or shockwave source is along the positive z-axis, the movement may be in the x-y-plane defined by the x-axis and y-axis. There may also be a rotation about the z-axis.

A slight off axis component of the lateral and/or rotational movement which may result in a wobble, may improve removal of bubbles.

Further, there may be movements in alternating directions, and even reversal of direction. Also, rotations and lateral displacements may be combined at the same time or alternating.

In an embodiment, a spiral movement in an X-Y plane may be combined with a translation in Z direction towards the patient. The movement may start centered close to the center axis making circles with continuously increasing radius and moving at the same time towards the patient. The movement may start with an axial offset to the center axis. The spiral may have only one or two turns. A higher number of turns is also possible. The X-Y plane may be a plane of the patient table and the Z direction may be orthogonal thereto.

The hexapod drive may be configured to provide a spiral movement in a plane orthogonal to the center axis of the ultrasound and/or shockwave source combined with a translation in a direction of the center axis. This translation may be in a direction to a patient film and/or a patient.

A patient film may be part of the patient table.

In an embodiment, a movement along the center axis of the ultrasound and/or shockwave source, in z-direction may be done with the ultrasound and/or shock-wave source tilted slightly around an axis in the x-y-plane such that the top of the exit section of the cushion approaches the patient film or patient under an angle. When a first edge of the cushion touches or approaches the patient film or patient closer than a minimum distance, the ultrasound and/or shockwave source may be tilted, such, that it is parallel to the patient film or patient.

The hexapod drive bearing the ultrasound and/or shockwave source is also known as a hexapod platform. Such a hexapod platform also is called a Stewart platform. Basically, it is a type of parallel manipulator or parallel robot that has six linear actuators, which may be hydraulic or pneumatic jacks or electric linear actuators. Examples of electric linear actors are motors coupled to a belt or a spindle to perform a linear movement. These linear actuators are connected in pairs to three mounting positions at a base, crossing over to three mounting positions at the ultrasound and/or shockwave source. Each connection of a linear actuator to either the base or the ultrasound and/or shockwave source may include a universal joint, also called a cardan joint or a ball joint. By variation of the length of the linear actuators, the ultrasound and/or shockwave source can be moved in six degrees of freedom with respect to the base. There are three degrees of translation and three degrees of rotation. Although the use of six linear actuators is preferred, a lower number of actuators may be used, e.g., like in a delta robot with three actuators.

The hexapod drive allows to adjust the position of an ultrasound and/or shock-wave source relative to a patient's body and/or the X-ray system. Positioning of the ultrasound and/or shockwave source may be done automatically or by manual control. An automatic control may allow quick adjustment and it may also allow to store and retrieve preconfigured settings.

Such a hexapod drive is a very robust and mechanical stiff support or suspension of the ultrasound and/or shockwave source. Therefore, it can withstand high forces from the patient body, the weight of the ultrasound and/or shockwave source and dynamic loads which occur when shockwave pulses are generated. Further, a hexapod drive can be moved quickly. Therefore, a stable positioning of the ultrasound and/or shockwave source is achieved providing the additional ability to quickly correct deviations and movements by the patient.

A hexapod drive may allow movement in all <NUM> degrees of freedom. This allows for a precise adjustment of the position of the focal volume of the ultrasound and/or shockwave source and/or the path of the ultrasound and/or shockwave though the body of the patient.

The ultrasound and/or shockwave source is oriented in a cartesian coordinate system as follows: a y-axis may be a longitudinal axis through the center of a patient table. An x-axis may be orthogonal to the y-axis and in the plane of the table surface. A z-axis is orthogonal to the plane of the table surface and therefore orthogonal to the x-axis and the y-axis and in a direction upward from the table. There may also be a first rotation around the x-axis, a second rotation and a third rotation around the z-axis. A positive rotation may be a clockwise rotation in a direction of a positive axis.

The shock wave or ultrasound therapy system may include a system controller which may control at least the hexapod drive of the ultrasound and/or shock-wave source.

The ultrasound and/or shockwave source may be of any type suitable for generating shock waves. It may include a shock wave generator and/or transducer, which may include at least one of a coil, a spark gap or a Piezo transducer. The shock wave generator/transducer may be partially enclosed by a reflector. Depending on the type of transducer, the reflector may have a parabolic or half-elliptic shape. In case of a piezo transducer, the transducer may itself have a spherical shape, such that a reflector may not be needed. The ultrasound and/or shockwave source may have a focal volume which is distant from the ultrasound and/or shockwave source and normally around a center axis of the ultrasound and/or shockwave source. The focal volume may be defined as a volume, where the maximum shock wave intensity is maintained with a deviation of maximal -<NUM> dB or -<NUM> dB. If the focal volume is defined with a <NUM> dB deviation, the pressure at the limit of the zone is half of the maximum pressure inside the zone. The focal volume may have an elliptical shape with a length in an axial direction (defined by the center axis) of the ultrasound and/or shockwave source axis of <NUM> to <NUM> and a diameter between <NUM> and <NUM>. The focal volume normally is spaced from the shock wave generator and/or transducer.

The patient table may have a basically planar surface defining a longitudinal axis. It is configured for accommodating a patient. The ultrasound and/or shockwave source may be mounted below the patient table. In general, a shockwave source may be mounted in alternative ways, e.g., on a stand or support.

The base may be standing on a floor directly or by a stand or it may be attached to a floor. The base may also hold the table.

A method of operating an ultrasound and/or shockwave source before an ultrasound and/or shockwave treatment is started, wherein the ultrasound and/or shockwave source is suspended on a hexapod drive, includes moving the ultrasound and/or shockwave source by the hexapod drive towards a patient film or patient while at the same time performing at least one lateral and/or rotational movement.

The method may be performed with a lateral and/or rotational movement with respect to the center axis of the ultrasound and/or shockwave source.

In an embodiment, there may be an off-axis movement resulting in a wobble.

In <FIG>, a first embodiment of a lithotripsy system is shown. The invention works with any ultrasound and/or shockwave treatment system.

An extra-corporal ultrasound and/or shockwave lithotripsy system for non-invasive treatment of stones <NUM> comprises a patient table <NUM>, an ultra-sound and/or shockwave source <NUM>. The ultrasound and/or shockwave source <NUM> is mounted to a hexapod drive <NUM>. The hexapod drive <NUM> may further be held by a stand <NUM>. The hexapod drive <NUM> allows fine positioning of the ultrasound and/or shockwave source <NUM> in multiple axes relative to the patient table <NUM> and therefore relative to the patient (not shown in this figure). The ultrasound and/or shockwave source <NUM> has a focal volume which moves together with the source. In an embodiment the distance of the focal volume to the source may be modified.

The patient table <NUM> is based on a stand <NUM> which may stand on a floor. The table <NUM> may be held by a positioning device <NUM> to move the table relative to the ultrasound and/or shockwave source <NUM> together with the hexapod drive <NUM>. A movement of the patient table may be coarse positioning which may be limited to a displacement in <NUM> axes.

The table <NUM> may have a flat surface for accommodating a patient who is not shown here.

An X-ray device <NUM>, acting a targeting device, may be provided. It may have an X-ray tube <NUM> opposing an X-ray detector <NUM>, both mounted tiltable at a C-arm <NUM>. There is a common center axis <NUM> on which the X-ray device and the ultra-sound and/or shockwave source are aligned.

To describe the relative movement of the table <NUM>, the X-ray device <NUM> and the ultrasound and/or shockwave source <NUM>, a cartesian coordinate system <NUM> may be used. There is a y-axis <NUM>, which may be a longitudinal axis through the center of the table. Furthermore, there is an x-axis <NUM> orthogonal to the y-axis and in the plane of the table surface. A z-axis <NUM> is orthogonal to the plane of the table surface and therefore orthogonal to the x-axis and the y-axis. There may also be a first rotation <NUM> around the x-axis, a second rotation <NUM> and a third rotation <NUM> around the z-axis. A positive rotation may be a clockwise rotation in a view along a positive axis.

A hexapod drive <NUM> may allow movement in all these <NUM> degrees of freedom. This allows for a precise adjustment of the position of the focal volume of the ultra-sound and/or shockwave source <NUM>. The patient table may be positioned for a slow and coarse adjustment in <NUM> degrees of translation for larger distances, but normally no rotation, whereas the hexapod drive provides a comparatively quick adjustment in <NUM> degrees of translation and <NUM> degrees of rotation. The movement distances of the table may be larger than the movement distances of the hexapod drive. The X-ray device may at least be tiltable to perform a second rotation <NUM> around an axis parallel to the y-axis <NUM>. It may also be tiltable around an axis parallel to the Y axis. It may further be translated in a plane defined by the X and Y axis. This means, it may be moved on the floor which is also in the X-Y plane.

For control of the movement of the ultrasound and/or shockwave source <NUM> relative to the patient table <NUM>, a control panel <NUM> may be provided.

<FIG> shows an embodiment in a schematic view of an embodiment with an ultrasound and/or shockwave source <NUM> mounted to a hexapod drive <NUM>.

A shock wave or ultrasound device, which may be a lithotripter <NUM> may include a patient table <NUM> and an ultrasound and/or shockwave source <NUM>. The ultra-sound and/or shockwave source <NUM> may be arranged below the patient table <NUM>, such that a patient <NUM> may be accommodated on top of the patient table. The patient may have a kidney <NUM> with a kidney stone <NUM>. The patient table may have a longitudinal axis. There may be a hole or cutout in the patient table at the position of the ultrasound and/or shockwave source.

Below the table <NUM>, the ultrasound and/or shockwave source <NUM> is shown in a sectional view. It may have a shock wave generator <NUM> which may be a coil as shown herein and which is at least partially enclosed by a reflector <NUM>. Further, the center axis <NUM> is marked as a dashed line. Normally, the interior of the reflector and the space between the source and the patient is filled with a liquid <NUM> like water or another shockwave conducting medium. To contain the water within the volume, a coupling cushion <NUM> may be provided. There may be small bubbles of air <NUM> within a coupling medium, e.g., an ultrasound gel, water, or another immersion media, in the space between the top of the cushion and the patient. Specifically, the air bubbles may be between the top of the cushion and the patient film and/or between the patient film and the patient body.

The ultrasound and/or shockwave source <NUM> which may have a center axis <NUM> is supported by and/or suspended on a hexapod drive <NUM>. Basically, it is a type of parallel manipulator or parallel robot that has six linear actuators <NUM> - <NUM>, which may be hydraulic or pneumatic jacks or electric linear actuators. These linear actuators are connected in pairs to three mounting positions <NUM>, <NUM>, <NUM> at a base <NUM>, crossing over to three mounting positions <NUM>, <NUM>, <NUM> at the ultra-sound and/or shockwave source <NUM>. Each connection of a linear actuator to either the base or the ultrasound and/or shockwave source may include a universal joint, also called a cardan joint or a ball joint. By variation of the length of the linear actuators, the ultrasound and/or shockwave source can be moved in six degrees of freedom with respect to the base. There are three degrees of translation, parallel to at least one X-axis <NUM>, Y-axis <NUM>, Z-axis <NUM> and three degrees of tilt or rotation including a first tilt <NUM> around an axis parallel to X-axis <NUM>, a second tilt <NUM> around an axis parallel to Y-axis <NUM>, a third tilt <NUM> around an axis parallel to Z-axis <NUM>.

A system controller controls at least operation of the hexapod drive <NUM> by means of a hexapod control <NUM>.

<FIG> shows a more detailed view of the coupling between ultrasound and/or shockwave source and patient. A cushion <NUM> covers the interior of an ultrasound and/or shockwave source filled with a liquid <NUM> which may include water.

The cushion <NUM> may include an at least partially flexible polymer material and may have an exit section <NUM> through which ultrasound and/or shockwaves pass to the exterior. This exit section <NUM> may be directly coupled to a patient <NUM> or indirectly via a patient film <NUM> to the patient. There may be a layer of coupling gel <NUM>, also known as ultrasound gel or acoustic gel at the top of the exit section <NUM> to allow coupling of the ultrasound and/or shock-wave energy. There may be another layer of coupling gel <NUM> or another immersion media, e.g., an ultra-sound gel, water between the patient film <NUM> and the patient <NUM>. There may be a plurality of small air bubbles <NUM> enclosed in the coupling gel <NUM>.

Claim 1:
A shock wave and/or ultrasound therapy system (<NUM>) comprising an ultra-sound and/or shockwave source (<NUM>),
characterized in that
the ultrasound and/or shockwave source (<NUM>) is suspended on a hexapod drive (<NUM>), wherein the hexapod drive (<NUM>) is configured to provide a first movement in a direction of a center axis (<NUM>) of the ultrasound and/or shockwave source (<NUM>) and at the same time a second movement laterally and or rotationally to avoid and/or remove air bubbles at the exterior surface of a cushion covering the ultrasound and/or shockwave source.