Lithotripsy apparatus for breaking up calculi, having a lever element, and retrofit kit for retrofitting an existing lithotripsy apparatus

Abstract

The invention relates to a lithotripsy apparatus, in particular an intracorporeal lithotripsy apparatus, for breaking up calculi, wherein the lithotripsy apparatus comprises: a support unit; a proximal end; a distal end; at least one force generation device for generating a force, having a force generation axis; and a holding unit, having a longitudinal central axis, for holding a probe at the distal end, wherein the probe can be assigned to the lithotripsy apparatus. The longitudinal central axis of the holding unit for holding the probe and the force generation axis are arranged spatially differently, and the lithotripsy apparatus comprises a rotatably mounted lever element having an axis of rotation such that, if the probe is held by means of the holding unit, a force generated by means of the force generation device, said force having a direction of force, directly or indirectly causes a rotational movement of the rotatably mounted lever element and the probe can be set into vibration by a mechanical impact of the rotating lever element onto the holding unit and / or the probe in a main direction of impact that is substantially different from a distal direction. The invention further relates to a retrofit kit for retrofitting an existing lithotripsy apparatus.

Description

[0001] Lithotripsy device for crushing body stones with a lever element and retrofit kit for retrofitting an existing lithotripsy device

[0002] The invention relates to a lithotripsy device, in particular an intracorporeal lithotripsy device, for fragmenting body stones. The lithotripsy device comprises a support unit, a proximal end, a distal end, at least one force-generating device for generating a force with a force-generating axis, and a holding unit with a longitudinal central axis for holding a probe at the distal end. The probe can be assigned to the lithotripsy device. Furthermore, the invention relates to a retrofit kit for retrofitting an existing lithotripsy device.

[0003] Lithotripsy is a well-known procedure for breaking up body stones, which form, for example, through the condensation and / or crystallization of salts and proteins as so-called concretions in body organs such as the bladder or kidneys. If the body stones are too large to pass naturally and cause discomfort, they must be broken up with a lithotripter so that the broken stones can be removed through natural excretion and / or by means of a suction-irrigation pump. The body stones to be broken up are often inhomogeneous, with different components and / or strengths.

[0004] For these reasons, purely ultrasound-based lithotripters have been further developed in recent years to improve stone fragmentation performance. For this purpose, intermittent, ballistic shock wave energy is often applied in addition to the constant ultrasound energy. This can be achieved, for example, using a ballistic drive with electromagnets, in which an impact body is accelerated by the electromagnets and impacts a horn and / or the sonotrode head. It is also known to arrange an oscillating mass in a ring shape around a sonotrode and press it against an axial stop of the sonotrode by means of a spring. The ultrasonic vibration accelerates the mass away from the stop, compressing the spring and accelerating the mass back towards the stop. The disadvantage of this spring-mass system, which acts longitudinally along the sonotrode, is that it only allows for a limited impact force.Another disadvantage of ballistic drives using electromagnets is that they have to be actively cooled above a certain electrical power consumption, otherwise the surface temperature will be too high.

[0005] A major disadvantage of known combined lithotripsy devices is that the ballistic impact excitation is always coaxial with the ultrasound probe. Regardless of whether the shock waves or deformation waves are generated by impact excitation, for example, using pneumatic energy sources and / or electromagnets, the acceleration path for the impactor is usually at least partially surrounded concentrically by the ultrasound transducer, which significantly limits the installation space and the arrangement of the components. As a result, in existing lithotripters, only one additional form of excitation can be implemented besides ultrasound excitation.

[0006] WO 96 / 33661 A1 discloses an intracorporeal treatment system for fragmenting calculi, in which an impact unit comprises a housing in which an acceleration section for a projectile is arranged. A lever is hinged to the inner wall of the distal end section of the housing, the free end of which extends into the acceleration section of the projectile. Upon pneumatic acceleration of the projectile in a distal direction, it impacts the lever, which transmits the projectile's impact via a return spring to a shock transmitter designed as a probe, also in a distal direction. The longitudinal center axis of the acceleration section and the longitudinal center axis of the probe are arranged parallel but offset from one another in the longitudinal direction, with the lever being arranged transversely to the two longitudinal center axes upon impact. With this system, impact frequencies between 10 Hz and > 30 Hz can be achieved.The disadvantage of this system is that the lever limits the installation space within the housing of the impact unit due to its transverse orientation.

[0007] A disadvantage of all known combined lithotripsy devices is their lack of modularity, which means that only complete systems can be produced. Flexible production and arrangement of two or more different impact and / or vibration excitation units is not possible with existing systems. This increases the initial investment costs, and in the event of a failure, there is the disadvantage that the entire device always has to be replaced and / or repaired.

[0008] The object of the invention is to improve the state of the art.

[0009] The object is achieved by a lithotripsy device, in particular an intracorporeal lithotripsy device, for fragmenting body stones, wherein the lithotripsy device has a carrier unit, a proximal end, a distal end, at least one force generating device for generating a force with a force generating axis and a holding unit with a longitudinal central axis for holding a sonotrode at the distal end, and the probe can be assigned to the lithotripsy device, wherein the longitudinal central axis of the holding unit for holding the probe and the force generating axis are arranged spatially differently and the lithotripsy device has a rotatably mounted lever element with a rotation axis such thatthat in the case of holding the probe by means of the holding unit, a force generated by the force generating device with a force acting direction directly or indirectly causes a rotational movement of the rotatably mounted lever element and the probe can be excited to vibrate by a mechanical impact of the rotating lever element on the holding unit and / or the probe with a main impact direction substantially different from a distal direction.

[0010] Thus, a lithotripsy device is provided in which sole or combined impact stimulation occurs by means of the rotatably mounted lever element. By coupling the force generated by the force-generating device into the holding unit and / or the probe by means of the lever element, the force-generating device and the holding unit and / or probe can be arranged spatially separated from one another and / or spaced apart from one another. Thus, the installation space within the lithotripsy device can be used more flexibly and is not restricted by the fact that the force-generating axis and the longitudinal center axis of the holding unit of the probe spatially coincide. Consequently, additional impact stimulation can be positioned more flexibly within a lithotripsy device.Since the lever element represents a transmission link between the force-generating device and the probe holding unit, these two components of the lithotripsy device can be designed and / or arranged independently of one another. This allows, for example, an existing pneumatic unit serving as a force-generating device and an existing head device for a sonotrode to be used and combined in a newly designed lithotripsy device. Thus, a lever unit with the lever element serving as a connecting piece and / or connecting housing can be arranged between an existing force-generating device and a head device serving as a sonotrode holding unit and / or an ultrasound excitation device. Consequently, the lever element, as a force-coupling element, enables a variable, modular design of the components of a lithotripsy device for impact and / or vibration excitation of the probe.

[0011] While in state-of-the-art lithotripters, impact stimulation typically occurs in the distal direction by striking the head of the probe, thus moving the probe tip in an axial motion into the stone to be crushed, the different spatial arrangement of the force generation axis relative to the longitudinal center axis of the holding unit and / or the probe, and the rotational movement of the lever element about its axis of rotation, allow a mechanical impact of the rotating lever element on the holding unit and / or the probe with an impact direction essentially different from a distal direction. Thus, by arranging the lever element and its design, a freely selectable main impact direction can be specifically and flexibly set.This significantly increases the removal rate during stone fragmentation compared to conventional lithotripters with impact excitation in the distal direction, as well as compared to ultrasound-based systems. Depending on the selected main impact direction of the lever element on the holding unit and / or probe, forces are applied at an angle and / or perpendicular to the longitudinal center axis of the holding unit and / or probe. This causes the probe to vibrate in specific transverse directions, causing the probe tip to not only drill axially into the stone to be fragmented, but also fragment it laterally. This not only increases the removal rate and area, but also prevents the probe tip from becoming stuck in the stone when the probe tip is removed from the stone to be fragmented.In addition to the usual axial deflection and movement of the probe, a radial deflection and movement of the probe is also possible by specifically setting a main impact direction using the rotatably mounted lever element.

[0012] A key idea of ​​the invention is to provide a lithotripsy device for sole impact excitation and / or impact and vibration excitation of a probe, in which a flexible spatial design is realized due to the arrangement of the force generation axis of the force generation device for generating a force for impact excitation, which is spatially independent of and thus not coincident with the longitudinal center axis of the holding unit for the probe, in that the force for impact excitation can be flexibly and adjustably spatially and mechanically transmitted to the holding unit and / or the probe via the rotatably mounted lever element. Due to the design of the lever element for the indirect force transmission to the holding unit and / or probe, a distance between the force generation axis and the longitudinal center axis of the holding unit and / or the probe, a main impact direction and an impact excitation force can be specifically adjusted and / or changed.

[0013] The following terminology is explained:

[0014] A "lithotripsy device" (also called a "lithotripter") is, in particular, a device for fragmenting body stones through impacts, shock waves, and / or deformation waves. A lithotripsy device is understood to mean, in particular, various components, structural and / or functional components of a lithotripter. The lithotripsy device can form a lithotripter completely or partially. A lithotripsy device can, in particular, be an intracorporeal or extracorporeal lithotripsy device. In the case of an intracorporeal lithotripsy device, it can additionally have a rinsing / suction pump. The lithotripsy device can be designed as a handheld device and / or have an endoscope or be inserted into an endoscope. The lithotripsy device is, in particular, autoclavable and comprises, for example, instrument steel and / or plastic.The lithotripsy device may include additional components, such as a control and / or supply unit, or these may be associated with the lithotripsy device. A lithotripsy device is, in particular, a ballistic, pneumatic, and / or combined lithotripsy device. In the case of a pneumatic lithotripsy device, a specifically shaped deformation wave is imparted to the holding unit and / or probe by means of impact energy when a projectile strikes the lever element, particularly due to the angular momentum of the rotating lever element. Due to the radial and / or tangential movement of the lever element, the deformation wave causes, in particular, a transverse oscillation of the probe, which, due to the lateral deflection, results in improved stone fragmentation.In addition to the mechanical shock transmitted by the lever element, the probe can also be excited into vibration, particularly longitudinal vibration, by means of a vibration excitation device, for example, an ultrasonic vibration exciter. Thus, the probe is designed as a waveguide for the vibration waves generated by a vibration excitation device and / or for the deformation waves of the lever element.

[0015] "Body stones" (also called "concrements") are understood to mean all stones in the human or animal body that form, for example, from salts and proteins through crystallization and / or condensation. Body stones can be, for example, gallstones, urinary stones, kidney stones, and / or salivary stones. The action of the sonotrode and / or hollow probe on the body stone results in the formation of body stone cores (also called drill cores) and / or body stone fragments.

[0016] A “carrier unit” is, in particular, a hand-held and / or holding part of the lithotripsy device. The carrier unit can, in particular, be a handle for manual and / or automated operation and / or connection of the lithotripsy device. The carrier unit can also be arranged, connected, and / or guided automatically at a distal end of a robot arm. The carrier unit, in particular, has a housing. The carrier unit can also be constructed in two or more parts. For example, the carrier unit can have a separate housing for the force-generating unit and / or a pneumatic unit and a separate housing for the ultrasound excitation unit. If the carrier unit is constructed in the form of two or more separate housings, the carrier unit can also have a separate housing for a lever unit with the lever element.

[0017] "Distal" and "distal" refer to an arrangement close to the patient's body and thus far from the user, and / or a corresponding end or section. Accordingly, "proximal" or "proximal" refers to an arrangement close to the user and thus far from the patient's body, or a corresponding end or section.

[0018] "Apical" refers in particular to a layer located "at the tip" or top of the support unit and / or lithotripsy device. "Basal" refers in particular to a layer located at the base and thus at the bottom of the support unit and / or lithotripsy device. Thus, basal is specifically the opposite of apical.

[0019] A "force generating device" can, in principle, be any type of device that generates a force that can act directly or indirectly on the lever element and thus causes a rotational movement of the lever element. The force generating device can, for example, be a device that induces the rotational movement of the lever element by means of a pressure medium, for example pneumatically using compressed air, by means of an electromagnetic field and / or by means of a mechanical device, such as a spring force, and / or a component. The force generating device can, for example, also be a spring element, such as a torsion spring, which only generates a torque on the lever element.In the case of a pneumatic lithotripsy device, a force generating device can, in particular by supplying and / or discharging a pressure medium, exert a force on an accelerable projectile and thus cause a movement of the projectile, which strikes directly or indirectly against the lever element.

[0020] A "probe" (also called a "sonotrode") is, in particular, a component that is itself set into vibration, resonant vibration, and / or deformation vibration by the action and / or introduction of mechanical vibrations. A probe and / or sonotrode has, in particular, a head piece (also called a "nipple," "retaining nipple," and / or "base body") and an elongated insertion part, for example, a probe tube or probe rod. The insertion part is, in particular, received in a receiving unit in the thicker head piece. The receiving unit is, for example, a bore in the head piece, into which the proximal end and / or the proximal end section of the insertion part is firmly and / or permanently joined, for example, soldered. A sonotrode is, in particular, an elongated component. A sonotrode is, for example, at least partially rod-, tube-, and / or hose-shaped. The sonotrode can be a hollow probe.The sonotrode can be constructed in one piece or in multiple parts. The sonotrode has a diameter in the probe tube, in particular, ranging from 0.5 mm to 4.5 mm, in particular from 0.8 mm to 3.8 mm. The sonotrode comprises, in particular, steel, iron, cobalt, chromium, nickel, molybdenum, titanium, magnesium, and / or aluminum alloys and / or carbon or glass composite materials. The sonotrode is designed, in particular, as a waveguide for the oscillation waves generated by a vibration excitation device and / or for the shock waves and / or deformation waves of the lever element.

[0021] A “holding unit” is, in particular, a holding device that at least partially encloses and / or holds the sonotrode. The holding unit can, in particular, be a head device. The holding unit and / or the head device is, in particular, arranged within a carrier unit and / or the handpiece of the lithotripsy device. The holding unit can, in particular, also be just the receiving unit and / or the head piece of the probe. The holding unit and / or the head piece of the probe tube or probe rod is, in particular, movably mounted within a head device. A holding unit can also be a horn of an ultrasound transducer. A “longitudinal central axis” is, in particular, the axis of the respective body or component that corresponds to the direction of its greatest extension and / or dimension.The longitudinal central axis can also be the axis of symmetry of the respective body and / or component. The probe is preferably held concentrically in the holding unit so that the longitudinal central axis of the holding unit and the longitudinal central axis of the probe coincide. A "force generation axis" is in particular the central axis along which the generated force acts on the lever element. The force generation axis can be, for example, the longitudinal central axis of a spring element or the longitudinal central axis of an acceleration tube for a projectile. The force generation axis can be shorter or longer at its distal end, and thus at the point of force transfer to the lever element, than the distal end of the longitudinal central axis of the holding unit. Thus, the distal end of a force generation unit and a head device of the probe do not have to be spatially arranged flush with one another.

[0022] "Spatially differently arranged" is understood in particular to mean that the longitudinal center axis of the holding unit and / or the probe and the force generation axis are arranged and / or aligned differently in space. The longitudinal center axis of the holding unit and / or the probe and the force generation axis are, in particular, spaced apart from each other at least vertically. The longitudinal center axis of the holding unit and / or probe and the force generation axis can also be spaced apart from each other horizontally. Likewise, the longitudinal center axis of the holding unit and / or probe and the force generation axis can intersect.Spatially differently arranged also means, in particular, that the longitudinal central axis of the holding unit and / or the probe and / or the holding unit itself are arranged in a different part of the carrier unit, a different housing, and / or a different housing part than the force-generating axis and the force-generating device. In the lithotripsy device, in particular, the force-generating device can be arranged apically with its force-generating axis, and the holding unit and / or the sonotrode and / or a vibration excitation device can be arranged basally with their longitudinal central axes.

[0023] A “lever element” is understood in particular to be a mechanical component for force conversion, which has at least a partially rigid body and can rotate about a pivot point. A lever element can be a one-sided, two-sided, or bent lever. The pivot point and thus the axis of rotation can be located at one end of the lever arm or at any position along the lever arm. The axis of rotation can be rotatably mounted or fixed. In the case of a one-sided lever with the pivot point at one end, the load arm and the force arm of the lever element are on the same side but have different lengths. In a two-sided lever element, in particular the length of the force arm and the length of the load arm can be specifically adjusted for the desired impact excitation. In principle, the lever element can be designed differently in terms of its properties and / or its material.The lever element can, in particular, be designed to be rigid or flexible. Likewise, the lever element can, in particular, have different shapes and dimensions. The lever element can, in particular, have a different shape in the region of the force arm than in the region of the load arm. The force arm of the lever element can, in particular, have a specially shaped surface for the action of the force generated by the force generating device. Likewise, the lever element on the load arm can have a specially designed impact transmission surface for transmitting the force to the holding unit and / or the probe. In its longitudinal dimension, the lever element has, in particular, a sufficient length to act as a transmission element between the force generating axis of the force generating device and the longitudinal center axis of the holding unit and / or the sonotrode.The lever element can, for example, be rod-shaped or club-shaped, or in the form of a circular disc cutout. The shape of the circular disc cutout, in particular, provides stiffening and optimal torque transmission. A special apical head shape and / or an inclined force-acting surface of the lever element can, in particular, reduce the angle of attack of the lever element from the vertical, thereby shortening the running time of the lever element during rotation and minimizing a radial component compared to a tangential component of the speed during the rotational movement of the lever element. This enables an increase in the impact frequency and a higher impact speed.

[0024] The "force acting direction" (also called "force generation direction") is, in particular, the direction from which the force generated by the force generation device acts on the lever element. For example, a projectile can impact a force acting surface (also called impact surface) of the lever element from the distal or proximal direction in the corresponding force acting direction. Likewise, a different type of force can be applied in the force acting direction, accelerating the lever element.

[0025] The “main direction of impact” is in particular the direction in which the lever element primarily impacts the holding unit and / or sonotrode as it accelerates and / or rotates about the axis of rotation. Since the lever element is still accelerated and / or rotating during mechanical impact with the holding unit and / or probe, the main direction of impact can still change until the maximum possible stop of the lever element on and / or the holding unit and / or the sonotrode is reached. Accordingly, the main direction of impact is also understood to mean that the main direction of impact is substantially different from a distal direction and / or that the main direction of impact does not occur solely or not exactly from the distal direction. The main direction of impact can also occur substantially from the distal direction and thus in the proximal direction.The main direction of impact can also be precisely in the proximal direction upon impact, so that a stroke of the lever element is coupled precisely in the proximal direction and thus opposite to the usual distal direction, and a vibration of the probe is excited. Due to the tilting of the lever element in the case of a one-sided lever element and the rotation in the case of a two-sided lever element, the movement of the lever element always has velocity components with different directions and accordingly a changing main direction of impact up to the maximum stop. In addition to the design of the lever element with different mass and / or lever ratios, the center of gravity of the lever element can also be arranged outside the pivot point and / or the axis of rotation or within the pivot point and / or the axis of rotation.

[0026] In a further embodiment, the lithotripsy device comprises the probe, wherein the force generation axis has a smallest angle in a range of 1° to 89° or is arranged parallel to a longitudinal center axis of the probe and / or the longitudinal center axis of the holding unit.

[0027] Thus, the force generation axis and the longitudinal center axis of the probe and / or the holding unit can be arranged at a largely arbitrary angle to each other. In the case of a parallel arrangement of the force generation axis to the longitudinal center axis of the probe and / or the holding unit, the parallel arrangement can, for example, be arranged side by side in a horizontal plane or vertically one above the other in two horizontal planes. For example, the force generation axis can be arranged apically and the longitudinal center axis of the holding unit basally, or vice versa.

[0028] In order to specifically adjust the main impact direction of the lever element and to achieve optimal impact excitation of the holding unit and / or the probe, the lever element has one or more impact transmission surfaces aligned with the holding unit and / or the probe.

[0029] Through a specific design of the respective impact transmission surface, the impact of the respective impact transmission surface can be realized orthogonally or obliquely to the longitudinal center axis of the holding unit and / or the sonotrode. In addition, by shaping the impact transmission surface and / or a section of the lever element with the impact transmission surface, an eccentric or centric force introduction can be specifically set upon impact with the holding unit and / or sonotrode. The “impact transmission surface” is in particular a specially shaped surface and / or a shaped section of the lever element which impacts the holding unit and / or the probe during the rotational and / or tilting movement of the lever element. The impact transmission surface can be an outer surface and / or an inner surface of the lever element.The orientation of the impact transmission surface may also change due to its shape when approaching the holding unit and / or the probe, which also changes the main direction of impact accordingly.

[0030] In a further embodiment of the lithotripsy device, the lever element has a continuous cavity for the passage of the probe, so that an inner wall around the continuous cavity is formed as an impact transmission surface.

[0031] This initiates an early and large-area impact transmission via the impact transmission surface to the holding unit and / or the probe as soon as it is approached.

[0032] Thus, with an already connected probe, it can be arranged in the continuous hollow space of the lever element. When the lever element is moved, the continuous hollow space moves around the probe in the direction of the main impact direction. The continuous hollow space can be aligned in such a way that there is sufficient space so that only an outer impact transmission surface of the lever element impacts the holding unit and / or an inner wall around the continuous hollow space acts as an impact transmission surface early on when the lever element is moved because it surrounds the probe. When the lever element is moved, the inner wall can act as an impact transmission surface by continuously approaching the surface of the probe, making contact and acting on the outer surface of the probe with an increasing force until maximum impact is reached.

[0033] The “cavity” is in particular an empty and / or hollow space within the lever element or on the lever element. The cavity in particular passes completely through a material thickness of the lever element, in particular in the main impact direction, so that the cavity has two opposite openings and a probe can be arranged in the cavity or passed through the cavity. The cavity is in particular delimited by two side walls and in particular by an upper wall. In addition, the cavity can be delimited by a lower wall. However, a cavity can also be a recess which, for example, is formed only in one side wall of the lever element. Thus, the lever element is open in the region of the recess and the inner cavity of the recess is delimited by an upper wall and a lateral inner wall and optionally a lower wall.

[0034] In order to optimally utilize the available installation space of the lithotripsy device and to achieve a targeted force and / or impact transmission by means of the lever element to the holding unit and / or the sonotrode, the main impact direction of the lever element can be the same or different from the direction of force action.

[0035] In a further embodiment of the lithotripsy device, the rotation axis of the lever element is arranged between the longitudinal center axis of the holding unit and / or the longitudinal center axis of the probe and the force generation axis.

[0036] Because the rotational axis of the lever element lies between the longitudinal center axis of the holding unit, the sonotrode, and / or an ultrasonic vibration excitation device, and the force-generating axis of the force-generating device, the force and / or impact in the direction of force action is converted into an impact with the main direction of impact and thus in the direction of the longitudinal center axis of the sonotrode. If the direction of force action is oriented distally, this arrangement of the rotational axis between the force-generating axis and the longitudinal center axis of the probe transmits the transmitted force and thus the impact to the holding unit and / or the probe in a main direction of impact essentially in the opposite proximal direction.Thus, with a two-sided lever element, the targeted arrangement of the rotation axis between the force generation axis and the longitudinal center axis of the holding unit and / or the sonotrode allows the direction of the generated and transmitted force to be freely changed from the direction of force action to the main impact direction. This enables an independent spatial arrangement of the force generation device and the holding unit, the sonotrode, and / or an ultra-vibration device.

[0037] In order to achieve an advantageous translation of the lever element and to achieve a higher removal rate of crushed body stones, the rotation axis of the lever element is arranged closer to the longitudinal center axis of the holding unit and / or to the longitudinal center axis of the probe than to the force generation axis, so that a shorter lever arm of the lever element is aligned with the probe.

[0038] By modifying the lever ratios of the two lever arms of the lever element, the reduced masses in the force transmission and impact chain can be influenced. Due to the shorter, particularly basal, lever arm, the lever element has a highly reduced mass when striking the holding unit and / or probe. In this case, the axis of rotation must be shifted in relation to the longitudinal center axis of the probe and / or basally far enough that the opposite, particularly apical, lever arm still has the best possible mass ratio for energy and momentum transmission. Thus, by adjusting the length of the load arm and the length of the force arm, the best possible force transmission of the lever element can be achieved. In the event of an impact excitation using the force generation device on the lever element, optimal mass ratios for force and impact transmission can be achieved.In particular, if a heavy ultrasonic transducer is also arranged along the longitudinal center axis of the holding unit, a maximum energy transfer with a mass ratio of 1:1 between all force transmission and / or impact elements can be achieved by an optimal ratio of the lengths of the two lever arms.

[0039] In principle, in a ballistic lithotripsy device, in which a mass, for example a projectile, is accelerated by the force-generating device, energy is subsequently transferred via one or more partially elastic impacts. The energy transfer between all impact partners should be maximized so that a stone is destroyed maximally and efficiently by the probe tip. To achieve an optimal mass ratio for each impact, ideally 1:1, the impact, which is converted into a rotational movement by the lever element, must be calculated accordingly with angular momentum as a rotational impact in analogy to a linear impact. For this purpose, a "reduced mass" is understood to mean that the mass of the rotating lever element is replaced by this reduced mass, which includes both the moment of inertia J and the distance b of the mass from the axis of rotation: m re d=J / b 2

[0040] It has surprisingly been shown that with a short lever arm with the distance b between the rotation axis and the longitudinal center axis of the probe and a longer lever arm to the impact point of the ballistic force generating device, an advantageous mass transmission can be achieved, which is not possible with linear ballistic systems.

[0041] In a further embodiment of the lithotripsy device, the rotation axis of the lever element is arranged at one end of the lever element and the longitudinal axis of the holding unit and / or the longitudinal central axis of the probe is arranged between the rotation axis and the force generation axis.

[0042] Due to the single-sided lever element, the force-generating device can be formed solely by a spring element, for example, a tension spring, and thus the spring element and the lever element form a spring-mass pendulum. Due to the single-sided lever element with the force-generating axis and the longitudinal center axis of the probe on the same side of the plane of the rotation axis, the force-generating direction is not deflected into an opposite main impact direction, and the force-generating device and / or the spring element are arranged distally of the lever element, the distal end of the holding unit, and / or the lithotripter.

[0043] In a further embodiment of the lithotripsy device, wherein the probe is a sonotrode, the lithotripsy device comprises an ultrasonic vibration exciter and a horn, wherein the ultrasonic vibration exciter comprises at least one piezo element and a counter bearing, and the at least one piezo element is arranged and mechanically coupled between the counter bearing and the horn, wherein the horn is connectable to the holding unit and / or the sonotrode and the at least one piezo element is electrically connectable to an assignable ultrasonic generator, so that a combined vibration excitation of the sonotrode can be realized by means of the at least one piezo element and a rotational movement of the lever element induced by the ultrasonic vibration exciter.

[0044] Through the combined vibration excitation of the sonotrode, the ultrasonic vibration exciter can be used simultaneously to directly impart vibrations and thus deformation waves to the sonotrode and to induce the rotational movement of the lever element. With sole ultrasonic vibration excitation, the force-generating device, such as a spring system, can also be activated using the generated ultrasonic vibrations, or a second impact excitation can be applied to the sonotrode using an additional force-generating device. The combined vibration excitation of the sonotrode significantly increases the removal rate of the fragmented body stones, in particular by a factor of 2 to 10 compared to sole vibration excitation of the sonotrode using the ultrasonic vibration exciter without the lever element.In addition, the two combined, different types of vibration excitation can simultaneously break up both soft and hard body stones more effectively.

[0045] Due to the fundamental possibility of impact excitation from the distal direction to the proximal direction, the horn of the ultrasonic transducer can not only be designed to taper towards the distal tip of the sonotrode in the usual way, but the horn, with its larger diameter, can also be arranged proximal to the lever element and taper in the proximal direction. The ultrasonic vibration induced by the ultrasonic transducer, as well as a substantially proximal impact of the lever element and / or the ballistic excitation unit on the distal extended end of the horn, is first reflected at the proximal tapered end of the horn before being introduced into the sonotrode in the opposite distal direction.In such a backward-facing horn tapering in the proximal direction, the proximal end of the sonotrode can be directly received, for example, screwed, into the distal end of the horn. The sonotrode can also be arranged at least partially or completely within the horn up to the tapered proximal end of the backward-facing horn.

[0046] An "ultrasonic vibration exciter" (also called a "vibration exciter") is, in particular, a component of an ultrasonic transducer and / or handpiece of a lithotripsy device, which converts an applied alternating voltage at a specific frequency into a mechanical vibration frequency. The ultrasonic vibration exciter is, in particular, an electromechanical transducer utilizing the piezoelectric effect. By applying an electrical alternating voltage generated by an ultrasonic generator, a mechanical vibration is generated, in particular, due to a deformation of the ultrasonic vibration exciter. The ultrasonic vibration exciter has, in particular, one or more piezoelements. The ultrasonic vibration exciter preferably has at least two piezoelements, wherein an electrical conductor, for example, a copper disc, can be arranged between the piezoelements.The ultrasonic vibration exciter and / or the ultrasonic transducer may in particular comprise a horn.

[0047] A "horn" is, in particular, a component arranged between the vibration exciter and / or a piezo element and the sonotrode. The horn serves, in particular, to transmit, forward, and / or align the ultrasonic waves generated by the vibration exciter to the sonotrode. For this purpose, the horn can taper in one transmission direction and directly or indirectly transmit the ultrasonic waves to a sonotrode head. The horn can also be used to mount the sonotrode. At the same time, the horn, particularly in conjunction with a counterbearing, serves to mechanically mount the piezo element(s) on both sides.

[0048] In order to form a spring-mass oscillator with the lever element as an oscillating mass and / or to keep the lever element in its initial position regardless of the spatial position of the lithotripsy device and yet still allow an impact on the sonotrode, a spring element can be arranged on and / or adjacent to the rotatably mounted lever element.

[0049] The spring element can be arranged in particular on the proximal side or distal side of the rotatably mounted lever element or around the axis of rotation of the lever element.

[0050] A “spring element” is, in particular, any element and / or component that can be sufficiently elastically deformed to overcome a brief counterpressure when the lever element is turned back. The spring element imparts a preload, in particular to the lever element. A spring element can, for example, be a helical spring and thus a wire wound in a helical shape. The spring element can also be a leaf spring, spiral spring, leg spring, or torsion spring. The spring element is, in particular, made of metal and / or plastic. The spring element can be held on the proximal or distal side in a holder that is open to the lever element on one side. The spring element can also be arranged at the distal end of an acceleration tube or within the acceleration tube in front of its distal end. Likewise, a spring element can be arranged around the distal end of a billiard projectile of the acceleration tube.A spring element is, in particular, also a return spring for a projectile and / or billiard projectile. In the case of a torsion spring, the torsion spring can be arranged on the axis of rotation and / or around the axis of rotation of the lever element. In this case, the torsion spring can press against the lever element with part of its spring wire, thereby generating a contact force. Likewise, the torsion spring can act on the lever element in such a way that the torsion spring directly generates a torque. For this purpose, the lever element is, in particular, firmly connected to the axis of rotation and the torsion spring is, in particular, fixed to the stationary shaft / axis of rotation, and one end of the torsion spring presses against the housing, thereby generating a torque that acts on the lever element. In the case of a leg spring, this can be arranged around the rotatable axis of rotation of the lever element and can be fastened with its two leg ends at different spatial positions in and / or on the housing.

[0051] In order to form a compact spring-mass oscillator and / or to provide an impact surface for a projectile of a ballistic force generating device, the spring element is held by means of a holder so that the lever element is designed as an oscillatable mass.

[0052] In a further embodiment of the lithotripsy device, the at least one force generating device comprises an electromagnet and the rotatably mounted lever element comprises a magnetic and / or magnetizable material.

[0053] In order to integrate a ballistic impact excitation, the lithotripsy device can comprise an acceleration tube with a cavity, a proximal end, a distal end and a longitudinal central axis, a movable projectile within the cavity, a proximal-side stop element at the proximal end of the acceleration tube and the force generating device for moving the projectile back and forth along an acceleration path between the proximal-side stop element and the distal-side stop element, wherein the rotatably mounted lever element is arranged distally of the distal end of the acceleration tube,such that upon mechanical impact of the projectile at the distal end with a distal impact direction, an impact of the projectile can be transmitted by means of the rotatably mounted lever element to the holding unit and / or the probe or the sonotrode in a main impact direction different from the distal impact direction and / or the force generation direction for oscillation excitation of the probe or sonotrode.

[0054] Thus, a modular, flexibly designed lithotripsy device is provided, which can have a ballistic force generating device, for example by means of a pneumatically or electromagnetically accelerated projectile, and / or a force generating device based on a spring-mass oscillator and / or ultrasonic vibration excitation, wherein in all embodiments of the lithotripsy device, the at least one force generating device and / or further force generating devices can be arranged and / or are arranged spatially differently from the longitudinal center axis of the probe and / or sonotrode.

[0055] An "acceleration tube" is, in particular, an elongated hollow body whose length is greater than its diameter. The acceleration tube has, in particular, a hollow space inside it in which a projectile can move freely in the longitudinal direction. Furthermore, the acceleration tube has, in particular, a proximal end and a distal end, which spatially define the maximum acceleration distance.

[0056] A "stop element" is, in particular, a desired end point of the projectile's movement along the acceleration path, at which the accelerated projectile strikes the stop element, is decelerated, and / or moved in the opposite direction. A distal-side stop element is, in particular, arranged at and / or in the distal end of the acceleration tube and / or within the cavity in a region of the distal section of the acceleration tube. The distal-side stop element, in particular, directly or indirectly transfers the impact of the projectile to the lever element. The distal-side stop element can, for example, be the proximal wall of a spring element holder, a distal wall of a spring element holder, or a billiard projectile in the acceleration tube.The proximal-side stop element is arranged in particular at and / or in the proximal end of the acceleration tube or within the cavity in a proximal section of the acceleration tube.

[0057] An "acceleration distance" is, in particular, a section of a longitudinal dimension of the cavity of the acceleration tube, which is defined by a distal-side stop surface of the proximal-side stop element and a proximal-side stop surface of the distal-side stop element. The maximum acceleration distance corresponds, in particular, to the maximum longitudinal dimension of the cavity when the proximal-side stop element is arranged flush with the proximal end of the acceleration tube and the distal-side stop element is arranged flush with the distal end of the acceleration tube, minus the length of the projectile and / or the length of the billiard projectile in the cavity of the acceleration tube.

[0058] A "projectile" is, in particular, a body that is freely movable along the acceleration path within the cavity of the acceleration tube. The projectile is, in particular, movable back and forth between the proximal stop element and the distal stop element within the cavity of the acceleration tube arranged therebetween. In principle, the projectile can have any shape. For example, the projectile can have the shape of a bolt or a sphere. The projectile, in particular, has hard steel and / or weakly magnetic properties. To ensure free mobility, the projectile, in particular, has a slightly smaller outer diameter than the diameter of the cavity of the acceleration tube. For example, the projectile can have an outer diameter of 8 mm, in particular 6 mm, or 4 mm.

[0059] The projectile can be moved back and forth continuously or discontinuously along the acceleration path by means of the force-generating device. Preferably, the projectile is moved back and forth intermittently and / or oscillatingly between the proximal stop element and the distal stop element.

[0060] In a further embodiment of the lithotripsy device, a billiard projectile can be arranged between the projectile and the lever element as a distal-side stop element at the distal end of the acceleration tube, so that the impact of the projectile can be transferred to the lever element by means of the billiard projectile.

[0061] By means of the billiard projectile at and / or in the distal end or end section of the acceleration tube, a recoil and thus a backward movement of the projectile in the proximal direction can be induced after the distal end of the projectile impacts the proximal end of the billiard projectile. Above all, the billiard projectile transfers the projectile's impact to the lever element. Thus, a billiard projectile is essentially a projectile as defined above; however, the billiard projectile has two impact partners formed by the projectile and the lever element. The billiard projectile can have different properties than the projectile, for example a different material and / or a different shape. The billiard projectile can have a smaller diameter at its distal end section than at its proximal end section.Thus, for example, the billiard projectile can have a smaller diameter impact pin at its distal end, which protrudes distally through the distal end of the acceleration tube and whose distal end surface can impact the lever element. Thus, upon distal impact, the impact pin of the billiard projectile transitions from the acceleration tube into the housing around the lever element. A spring element can be arranged around the impact pin of the billiard projectile. This spring element can serve as a return spring for the billiard projectile itself, returning it to its original position and assisting in returning the projectile in the proximal direction after impacting the billiard projectile. The billiard projectile can also have a sealing ring around its impact pin, which simultaneously serves as a self-reinforcing seal and as a return spring for the billiard projectile.

[0062] As explained above, a mass ratio of 1:1 between two impact partners is considered optimal with regard to energy and momentum transfer. However, if a recoil of one impact partner is to occur during and / or after the impact, an increased mass ratio of 1:1.2 should be used, with the impacted partner being heavier, thereby inducing recoil on the first impact partner. In order to achieve repulsion of the projectile when it impacts the billiard projectile, the billiard projectile has a slightly increased mass compared to the projectile. The mass ratio between the projectile and the billiard projectile should in particular be in a range of 0.8 to 1.4. The ratio of the mass of the billiard projectile to the reduced mass of the lever element is in particular in a range of 0.8 to 1.4.The reduced mass of the lever element takes the distance from the point of force application to the axis of rotation into account and enables a transmission. This advantageously allows a relatively light projectile to transfer its entire energy to the billiard projectile and / or a heavier lever element, while the lever element itself can in turn enable a transmission to the significantly heavier ultrasonic transducer, which, due to its design, is significantly heavier, thus maximizing energy transfer.

[0063] In a further embodiment of the lithotripsy device, the rotatably mounted lever element can have an impact surface for absorbing the impact of the projectile or the billiard projectile.

[0064] Thus, the lever element can have a specifically shaped and / or apical impact surface in the area of ​​the force generation axis, onto which the impact of the projectile or billiard projectile impinges. Ideally, the impact acts tangentially to the circle described by the lever element during its rotational movement.

[0065] In order to achieve a surface contact between the projectile or the billiard projectile when it hits the impact surface of the lever element, the impact surface can be aligned obliquely to a longitudinal center axis of the lever element, the force generation axis and / or the longitudinal center axis of the acceleration tube.

[0066] To provide an inclined impact surface, the apical end of the lever element is particularly beveled and tapers obliquely in the apical direction, aligned on one side with the projectile or billiard projectile. The inclined impact surface improves force transmission into the lever element, as the inclined impact surface is parallel to the impact surface of the projectile or billiard projectile, resulting in lower friction losses. This results in a higher impact speed of the lever element on the holding unit and / or the sonotrode. Furthermore, the angle of attack of the lever element from the vertical can be reduced. The angle of attack of the lever element from the vertical is in particular in a range of 2° to 15°, preferably from 4° to 6°.

[0067] In order to combine a spring-mass oscillator as a force generating device with a ballistic force generating device, the holder of the spring element can be designed as a distal-side stop element or, in the case of a mechanical impact of the projectile or the billiard projectile with a proximal impact direction, as a proximal stop.

[0068] This allows a ballistic impact unit to be additionally integrated into such a lithotripsy device with a first force-generating device configured as a spring-mass pendulum. A further ballistic force-generating unit is arranged distally of the holder of the spring element and impacts the holder and / or the spring element in a proximal direction. Thus, two different impact types and / or directions can be transmitted to the holding unit and / or the probe by means of the spring and the ballistic excitation unit. This allows two different impact excitations to be easily integrated into one lithotripsy device. Additionally, ultrasonic vibration excitation can also be applied at the level of the longitudinal center axis of the holding unit and / or probe.In principle, it should be emphasized that an additional ballistic impact can be applied not only to the distal side or proximal side but also to an apical side and thus to an upper side of the holder.

[0069] In the case of additional ballistic impact excitation on one side of the spring element holder, a combination of strong, low-frequency impacts down to 20 Hz, especially up to 40 Hz, preferably up to 60 Hz, and higher-frequency impacts from the mass oscillator in a range of 300 Hz to 500 Hz is achieved, thus enabling a very high removal rate of body stones. In the case of a spring-mass system, an indefinable rattling noise occurs across a broad frequency spectrum, which cannot be assigned to a specific frequency. This rattling noise causes chaotic excitation of the probe.

[0070] In a further aspect of the invention, the object is achieved by a retrofit kit for retrofitting an existing lithotripsy device, wherein the existing lithotripsy device has a probe and / or a sonotrode and a force generating device, and the retrofit kit has at least one rotatably mounted lever element or two or more rotatably mounted lever elements, wherein the lever elements are designed differently, and optionally has a spring element and a holder, so that a previously described lithotripsy device can be formed.

[0071] Using the retrofit kit, an existing lithotripsy device can be equipped for the first time with a lever element as a transmission element, and an existing lever element can be replaced with a lever element with different properties, in particular with different lengths, differently shaped impact and / or impact transmission surfaces, and / or a differently sized and / or shaped cavity. Of course, the two or more lever elements can also have other different properties, such as different dimensions, shapes, materials, and / or degrees of hardening or coatings. Advantageously, when replacing a probe and / or sonotrode in the lithotripsy device, the optimal lever element for impact excitation of this probe and / or sonotrode can be selected from the retrofit kit and used in the lithotripsy device at the same time.

[0072] It is particularly advantageous that the retrofit kit also allows existing force-generating devices, such as a pneumatic unit of a commercially available lithotripter, and a commercially available ultrasonic vibration excitation unit and / or holding unit of the probe and / or sonotrode, to be connected at their distal ends via a housing of a lever unit in which the lever element is replaceably and rotatably mounted. Thus, a lithotripsy device can be assembled in a modular manner, and individual force-generating devices and / or ultrasonic vibration units can be offered, used, and flexibly combined separately. Due to this modularity, in the event of damage and / or failure, only this subunit can be repaired or replaced.The retrofit kit thus offers a lever unit with interchangeable lever elements, which can be modularly mounted on existing ultrasonic vibration units and force generation units.

[0073] For this purpose, for example, a distal lever unit connects a basal ultrasound transducer unit to the lever element by means of a positive and / or non-positive connection with an apical pneumatic unit. The drawings, the description, and the claims contain numerous features in combination. It is understood that the features mentioned above and those to be explained below can be used not only in the respective combinations specified, but also in other combinations or on their own, without departing from the scope of the present invention. The invention is explained in more detail below using exemplary embodiments.

[0074] Figure 1 is a highly schematic representation of a section of a lithotripsy device with an apical force generating device with a billiard projectile and a basal ultrasonic vibration exciter with a sonotrode and a lever element arranged therebetween,

[0075] Figure 2 is a highly schematic representation of an alternative lithotripsy device with a pneumatic force generating device with an acceleration tube, a projectile and a billiard projectile and a basal ultrasonic vibration exciter with a lever element arranged distally in the form of a circular disc,

[0076] Figure 3 is a highly schematic representation of an alternative of the lithotripsy device of Figure 2 with a spring around a butt pin of the billiard projectile,

[0077] Figure 4 is a highly schematic representation of a further alternative of the lithotripsy device with a basal force generating device designed as a spring-mass system and a basal ultrasonic vibration exciter with a sonotrode and a distally arranged lever element in the form of a circular disc section and an optional additional or alternative electromagnetic force excitation device, and

[0078] Figure 5 shows a further alternative of the lithotripsy device with a basal ultrasonic vibration exciter and a spring arranged apically distally from a one-sided lever element with a distal-side holder.

[0079] A lithotripsy device 101 has an ultrasonic vibration exciter 231 on a basal side 173 with a distally arranged horn 237, which merges into a headpiece 115. A threaded nipple 117 of a sonotrode 121 is inserted into the headpiece 115. The ultrasonic vibration exciter 231, the horn 237, the headpiece 115, the threaded nipple 117, and the sonotrode 121 all have the same longitudinal center axis 127 of the sonotrode 121 and the threaded nipple 117. A ballistic force generating device 151 arranged on an apical side 171 has an acceleration tube 105 with an internal cavity 107. In the acceleration tube 105, a projectile not shown in Figure 1 is arranged proximal to a billiard projectile 211. A longitudinal central axis 153 of the acceleration tube 105 simultaneously forms the force generation axis.The billiard projectile 211 is arranged at a distal end of the acceleration tube 105 toward a distal side 163. The billiard projectile 211 is partially received within the cavity 107 of the acceleration tube 105. The billiard projectile has an O-ring 213 followed by a thrust pin 215 at its distal end portion. A distal end face of the thrust pin 215 simultaneously represents the distal end 110 of the force-generating device 151 in the initial position shown in Figure 1. A lever element 131 is arranged distally of this distal end 110 and thus of the thrust pin 215 and distally of the threaded nipple 117.

[0080] The lever element 131 is arranged longitudinally and thus along its longitudinal central axis 132 in the initial position shown in Figure 1, transversely to the longitudinal central axis 153 of the acceleration tube 105 and thus to the force generation axis, as well as transversely to the longitudinal central axis 127 of the sonotrode 121 and the threaded nipple 117. The lever element 131 has an apical lever arm 135 with an inclined impact surface 149 for the billiard projectile 211. Opposite, the lever element has a basal lever arm 137 with an outer impact transmission surface 143 for impacting the threaded nipple 117. The apical lever arm 135 is longer than the basal lever arm 137 and thus a rotation axis 133 of the lever element 131 is closer to the longitudinal center axis 127 of the sonotrode 121 and the threaded nipple 117 than to the longitudinal center axis 153 of the acceleration tube 105 and thus to the force generation axis.

[0081] The following operations are carried out using this lithotripsy device 101 shown in Figure 1.

[0082] The magnetic projectile, located further on a proximal side 161 and therefore not visible in Figure 1, is accelerated in a distal direction 165 in the cavity 107 of the acceleration tube 105 by means of electromagnets (not shown) toward the proximal end of the billiard projectile 211. When the distal end of the projectile (not shown) impacts the proximal end of the billiard projectile 211, the impact of the projectile is transferred via the billiard projectile 211 to the inclined impact surface 149. As a result, the lever element 131 rotates about its axis of rotation 133 in a clockwise direction of rotation 139, and the impact is transferred to the distal side of the threaded nipple 117 by means of the outer impact transmission surface 143 on the proximal side of the basal lever arm 137.Thus, in this embodiment, a force acting direction 155 of the force generating device 151 and its apical impact direction 175 coincide and are both oriented in the distal direction 165. The basal impact direction of the lever element 131 is oriented in the exact opposite direction in the proximal direction 167. The basal impact of the basal lever arm 137 with the outer impact transmission surface 143 induces a body wave in the threaded nipple 117 and the head piece 115, which is reflected proximally, runs in the distal direction 165 through the probe 121, and thereby contributes to stone fragmentation.

[0083] When the outer impact transmission surface 143 of the lever element 131 strikes the distal side of the threaded nipple 117, the lever element 131 is moved back in an opposite direction of rotation 139, counterclockwise, due to its speed, so that the impact pin 215 is pushed back into the acceleration tube 105 by the inclined impact surface 149, and the lever element 131 returns to its unloaded initial position. While the ultrasonic vibration exciter 231 imparts a constant ultrasonic vibration to the sonotrode 121 via the horn 237, by repeating the above-described process, the force generation device 151 and the lever element 131 impart a repetitive impact excitation to the threaded nipple 117 and thus to the sonotrode 121 connected to it.Thus, when crushing body stones with a distal tip of the sonotrode 121, both mechanisms of action are optimally used and a high removal rate of body stones is achieved.

[0084] In an alternative version of the lithotripsy device 101 shown in Figure 2, the lithotripsy device 101 comprises an apical force generating device 151 and a basal ultrasound unit 230 in a carrier unit 103. Within the carrier unit 103, the force generating unit 151 in turn comprises an acceleration tube 105 with an internal cavity 107 and a longitudinal central axis 153 of the acceleration tube 105. As shown in Figure 2, a projectile 111 bears against a proximal stop element 113. At the opposite distal end 110, partially within the cavity 107 of the acceleration tube 105, a billiard projectile 211 is arranged. The projectile projects with its abutment pin 215 into a carrier housing 150, in which a lever element 131 in the shape of a circular disk cutout is arranged.The force generating device 151 has a compressed air connection 175 at its proximal end 109 for supplying compressed air and accelerating the projectile 111. The basal ultrasound unit 230 has a hose connector 181 on a proximal side 161 and a supply connection 183 on a basal side 153. Furthermore, the ultrasound unit 230 in turn has an ultrasonic vibration exciter 231, a horn 237 arranged on the proximal side with a subsequent head piece 115, and a threaded nipple 117, wherein the sonotrode 121 is received in the threaded nipple 117.The lever element 131 in the form of a circular disc section in turn has a longer apical lever arm 135 than a basal lever arm 137, so that the axis of rotation 133 of the lever element 131 and a plane 179 of the axis of rotation 133 are arranged closer to the longitudinal central axis 127 of the sonotrode 121 and the threaded nipple 117 than to the longitudinal central axis 153 of the acceleration tube 105 and thus to the force generation axis.

[0085] In its basal lever arm 137, the lever element 131 has a through-bore 141 with an inner wall 147 and an inner impact transmission surface 145. The sonotrode 121 is guided through the through-bore 141. On the outside, the basal lever arm 137 has an outer impact transmission surface 143. Thus, in the alternative version of the lithotripsy device 101 shown in Figure 2, the force application direction 155 and the apical impact direction 175 are both oriented in the distal direction 165, and the basal impact direction 177 is oriented in the proximal direction 167.When operating the lithotripsy device 101 shown in Figure 2, compressed air is introduced from the proximal side 109 into the acceleration tube 105 via the compressed air connection 157, thereby pushing the projectile 111 in the distal direction 165 and, as described above, impacting the billiard projectile 211, which in turn transmits the impact to the proximal side of the apical lever arm 135 of the lever element 131 with its impact pin 215, whereby the lever element 131 rotates clockwise in its direction of rotation 139 about its axis of rotation 133 towards the threaded nipple 117.

[0086] By guiding the sonotrode 121 through the through-bore 141 in the basal lever arm 137, an impact is directly transmitted to the sonotrode 121 as the outer impact transmission surface 143 approaches the threaded nipple 117 by the inner impact transmission surface 145 on the inner wall 147 of the through-bore 141, which successively impacts the outer surface of the sonotrode 121. In addition, the outer impact transmission surface 143 impacts the threaded nipple 117 as described above. The ultrasonic vibration exciter 231 is operated as described above to continuously impart ultrasonic vibrations to the sonotrode 121. By simultaneously using the inner impact transmission surface 145 and the outer impact transmission surface 143 by means of the lever element 131 in the form of a circular disc cutout, an increased impact excitation of the sonotrode 121 is achieved.

[0087] In a further alternative of the lithotripsy device 101, it is constructed in principle as shown in Figure 2, however, a spring 251 is additionally arranged around the butt pin 215 of the billiard projectile 211 within the support housing 150 of the lever element 131. Furthermore, Figure 3 shows the ultrasonic vibration exciter 231 in more detail, including a counterbearing 233, two distally arranged piezo elements 235, and the downstream horn 237. As shown in Figure 3, a proximal end 123 of the sonotrode 121 is received in the headpiece 115 through the threaded nipple 117.

[0088] The spring 251, which is designed as a compression spring, serves to pretension the lever element 131 relative to the billiard projectile 211. The projectile 111, accelerated by means of compressed air, strikes the proximal side of the billiard projectile 211 and accelerates it in the apical impact direction 175 and thus in the distal direction 165 onto the proximal side of the apical lever arm 135. Due to the recoil, the backflow of compressed air from a distal-side compensation container (not shown), and a further impact by the spring 251 itself, which simultaneously serves as a return spring for the billiard projectile 211, the projectile 111 is returned to its starting position on the proximal-side stop element 113. Thus, the spring 251 serves both to preload the lever element 131 against the billiard projectile 211 and to reset the billiard projectile 211 itself and the projectile 111.

[0089] The lever element 131 is repelled by the recoil upon impacting the sonotrode 121 by means of the inner impact transmission surface 145 and the threaded nipple 117 by means of the outer impact transmission surface 143, and is returned to its original position by means of the spring 251. The additional spring 251 in this alternative of the lithotripsy device 101 enables dual impact excitation with strong, low-frequency impacts at a frequency of up to 60 Hz and higher-frequency impacts in the range of 300 to 500 Hz due to the lever element 131 acting as a mass oscillator. This results in a higher removal rate of fragmented calculi and simultaneous fragmentation of soft and hard calculi. Otherwise, the lithotripsy device 101 shown in Figure 3 and the lever element 131 with the circular disc cutout shape are designed as previously described and are operated as previously described.

[0090] In a further alternative, a lithotripsy device 201 in a support unit 103 comprises an ultrasound unit 230 on a basal side 173 and a force-generating device 151 with a spring 251 in a holder 253 within the support unit 103. The ultrasound unit 230 is further configured as described above. The holder 253 with the internal spring 251 has a proximal side wall 255. The longitudinal center axis of the holder 253 and the spring 251 coincide with the force-generating axis 153.

[0091] The lever element 131 is arranged with its apical lever arm 135 directly on the distal side of the spring 251. Otherwise, the lever element 131, as described above, has a through-bore 141 with an apical inner impact transmission surface 145 on its inner wall 147. Here, the spring 251, together with the lever element 131, again designed in the shape of a circular disc cutout, forms a mass-spring oscillator, with the lever 131 itself representing the mass.The ultrasonic vibration continuously generated by the ultrasonic vibration exciter 231 causes this mass-spring oscillator composed of the spring 251 and the lever element 131 to vibrate, thus alternately pressing the lever element 131 with its apical inner impact transmission surface 143 against the outer surface of the sonotrode 121 in the clockwise direction of rotation 139, transmitting an impact directly to the sonotrode 121. Subsequently, due to the recoil and the vibration system, the apical lever arm 135 is pressed against the distal end of the spring 251 in the counterclockwise direction of rotation 139. These processes are continuously repeated due to the vibration excitation by the ultrasonic vibration exciter 231 with intermittent impact excitation by the lever element 131.

[0092] In a further alternative, a second or sole force-generating device 151 in the form of an electromagnet 261 is arranged in the effective range of the lever element 131. The electromagnet 161 has a coil 263 and an iron core 265 with a force-generating axis 153. Accordingly, the lever element 131 comprises a magnetic material. Due to the arrangement of the electromagnet 161 on the basal side 173, when the coil 263 is energized, the lever element 131 is attracted, and the lever element 131 moves in the clockwise direction of rotation 139, so that the apical inner impact transmission surface 145 strikes the outer surface of the sonotrode 121 and directly transmits an impact to the sonotrode. Here, the force acting direction 155 of the electromagnet 161 as force generating device 151 is oblique to a plane of the rotation axis 179, the longitudinal center axis 127 of the sonotrode 121 and the force generating axis 153 of the spring 251.

[0093] Due to the recoil and the deactivation of the electromagnet 161, the lever element 131 is again moved in the opposite direction of rotation 139 toward the distal end of the spring 251. Thus, in this lithotripsy device 201, in a combined design, there is an apical force generating device 151 due to the spring-mass oscillator of the spring 251 and the lever 131, and a second basal force generating device 151 due to the electromagnet 161. Thus, a dual percussion excitation with different percussion strengths and frequencies can be realized in addition to the continuous ultrasonic vibration excitation.

[0094] In addition to this dual impact excitation, a third impact excitation can also be applied (not shown in Figure 4) by arranging an apical force generating device 151 with an acceleration tube 105 on the proximal side of the proximal side wall 255 of the holder 253 of the spring 251, as shown above in Figure 3, wherein a billiard projectile 211 or directly a projectile 111 then impacts with its respective distal end directly onto the proximal outer side of the proximal side wall 255 and transmits an impact to the lever element 131 via the holder 253 and the internal spring 251.

[0095] In a further alternative of the lithotripsy device 201, it comprises a support unit 103 with an ultrasound unit 230. The ultrasound unit 230 comprises, as described above, an ultrasonic vibration exciter 231, a horn 273, and a headpiece 115 in which a proximal end 123 of a sonotrode 221 is received. A lever element 131 is designed as a rod and is mounted on one side at its basal end. A plane 179 of its rotation axis 133 is accordingly arranged on the basal side 173 and lies below the longitudinal central axis 127 of the sonotrode 121, which in turn is arranged below the force generation axis 153, the latter lying on an apical side 171. At the apical end of the rod-shaped lever element 131, a spring 251 is arranged on its distal side, which is attached to the carrier unit 103 on the distal side by means of a holder 253.Here, the spring 251 and the lever 131 are again designed as spring-mass oscillators and are set into vibration by the continuous ultrasonic vibration applied by the ultrasonic vibration exciter 231. This compresses the spring 251 in the distal direction 165, causing the end of the rod-shaped lever element 131 adjacent to the spring 251 to also move in the distal direction 165 until, due to the spring force, it is moved back in the proximal direction 176 and strikes the distal end of the head device 115. Thus, in this embodiment, the apical impact direction 175 and the basal impact direction 177 are both aligned in the proximal direction 167.

[0096] In a further alternative not shown in Figure 5, the holder 253 can be displaceably mounted on the carrier unit 103, so that by displacing the holder 253 by means of a manual or automatic actuating element, the spring 251 is compressed in the proximal direction 167 and the lever 131 is pressed against the distal side of the head device 115. Additionally and additionally, a ballistic force generating device 151 can be arranged on the distal side of the holder 253, wherein a projectile and / or a billiard projectile is then accelerated in the proximal direction 167 against the distal wall of the holder 253 and, upon impact with the holder 253, induces a movement via the spring 251 and the lever element 131 to excite the impact on the distal side of the head device 151, wherein the body wave induced in the head device 115 is reflected on the proximal side and introduced into the sonotrode 121 for stone fragmentation.

[0097] Thus, a modular lithotripsy device 101, 201 is provided in which, through a modular and flexible arrangement of at least one force generating device 151 and optionally further force generating devices 151, 261, different impact excitations of a sonotrode 121 with different impact strength and / or orientation can be realized in addition to a continuous ultrasonic vibration excitation of the sonotrode 121, wherein, due to the spatially different arrangement of the ultrasound unit 230 and the respective force generating device 151, 251, 261, optimal utilization of the installation space of the lithotripsy device 101, 201 and easy interchangeability of its components is ensured.

[0098] The drawings, the description, and the claims contain numerous features in combination. It is understood that the aforementioned features can be used not only in the respective combination specified, but also in other combinations or alone, without departing from the scope of the present invention. The invention relates to a lithotripsy device, in particular an intracorporeal lithotripsy device, for fragmenting body stones. The lithotripsy device has a carrier unit, a proximal end, a distal end, at least one force-generating device for generating a force with a force-generating axis, and a holding unit with a longitudinal central axis for holding a probe at the distal end. The probe can be assigned to the lithotripsy device.The longitudinal central axis of the holding unit for holding the probe and the force generation axis are arranged spatially differently, and the lithotripsy device comprises a rotatably mounted lever element with a rotational axis such that, when the probe is held by the holding unit, a force generated by the force generation device with a force-acting direction directly or indirectly causes a rotational movement of the rotatably mounted lever element, and the probe can be excited to vibrate by a mechanical impact of the rotating lever element on the holding unit and / or the probe with a main impact direction substantially different from a distal direction. Furthermore, the invention relates to a retrofit kit for retrofitting an existing lithotripsy device.

[0099] List of reference symbols

[0100] 101 Lithotripsy device

[0101] 103 carrier unit

[0102] 105 Acceleration tube

[0103] 107 Cavity

[0104] 109 proximal end

[0105] 110 distal end

[0106] 111 Projectile

[0107] 113 proximal stop element

[0108] 115 headpiece

[0109] 117 threaded nipples

[0110] 121 Sonotrode

[0111] 123 proximal end of the sonotrode

[0112] 127 Longitudinal center axis of the sonotrode / threaded nipple

[0113] 131 Lever element

[0114] 132 Longitudinal center axis of the lever element

[0115] 133 axis of rotation

[0116] 135 apical lever arm

[0117] 137 basal lever arm

[0118] 139 Direction of rotation

[0119] 141 Through hole

[0120] 143 outer impact transmission surface

[0121] 145 inner impact transmission surface

[0122] 147 interior wall

[0123] 149 inclined impact surface

[0124] 150 Carrier housing of the lever element

[0125] 151 Power generating device

[0126] 153 Force generation axis / longitudinal center axis of the acceleration tube

[0127] 155 Direction of force

[0128] 157 Compressed air connection

[0129] 161 proximal side

[0130] 163 distal side

[0131] 165 distal direction

[0132] 167 proximal direction

[0133] 171 apical side

[0134] 173 basal side

[0135] 175 apical direction basal direction

[0136] plane of the axis of rotation

[0137] hose connector

[0138] Supply connection

[0139] Lithotripsy device

[0140] Billiard projectile

[0141] O-ring

[0142] butt pin

[0143] Ultrasound unit

[0144] Ultrasonic vibration exciter

[0145] Counter bearing

[0146] Piezo element

[0147] horn

[0148] Feather

[0149] Holder proximal side wall of the holder

[0150] electromagnet

[0151] Sink

[0152] iron core

Claims

Claims 1. Lithotripsy device (101, 201), in particular an intracorporeal lithotripsy device, for fragmenting body stones, wherein the lithotripsy device (101, 201) comprises a carrier unit (103), a proximal end (109), a distal end (110), at least one force generating device (151) for generating a force with a force generating axis (153) and a holding unit (117, 115) with a longitudinal central axis (127) for holding a probe (121) at the distal end (110), and the probe (121) can be assigned to the lithotripsy device (101, 201), characterized in that the longitudinal central axis (127) of the holding unit (117, 115) for holding the probe (121) and the force generating axis (153) are spatially different are arranged and the lithotripsy device (101, 201) has a rotatably mounted lever element (131) with a rotation axis such that in the case of holding the probe (121) by means of the holding unit (117,115) a force generated by means of the force generating device (151) with a force acting direction (155) directly or indirectly causes a rotational movement of the rotatably mounted lever element (131), and the probe (121) can be excited to vibrate by a mechanical impact of the rotating lever element (131) on the holding unit (117, 115) and / or the probe (121) with a main impact direction (177) substantially different from a distal direction.

2. Lithotripsy device (101, 201) according to claim 1, characterized in that the lithotripsy device (101, 201) has the probe (121), wherein the force generation axis (153) has a smallest angle in a range of 1° to 89° or is arranged parallel to a longitudinal center axis (127) of the probe (121) and / or the longitudinal center axis (127) of the holding unit.

3. Lithotripsy device (101, 201) according to claim 1 or 2, characterized in that the lever element (151) has one or more impact transmission surfaces (143, 145) aligned with the holding unit (117, 115) and / or the probe (121).

4. Lithotripsy device (101, 201) according to one of the preceding claims, characterized in that the lever element (131) has a continuous cavity (141) for the passage of the probe (121), so that an inner wall (147) around the continuous cavity (141) is formed as an impact transmission surface (145). Lithotripsy device (101, 201) according to one of the preceding claims, characterized in that the main direction of impact (177) of the lever element (131) is the same as or different from the direction of force action (155). Lithotripsy device (101, 201) according to one of the preceding claims, characterized in that the rotational axis (133) of the lever element (131) is arranged between the longitudinal central axis (127) of the holding unit (117, 115) and / or the longitudinal central axis (127) of the probe (121) and the force generation axis (153). Lithotripsy device (101, 201) according to one of the preceding claims, characterized in that the rotational axis (133) of the lever element (131) is arranged closer to the longitudinal central axis (127) of the holding unit (117, 115) and / or to the longitudinal central axis (127) of the probe (121) than to the force generation axis (153), so that a shorter lever arm (137) of the lever element (131) is aligned with the probe (121).Lithotripsy device (101, 201) according to one of claims 1 to 5, characterized in that the axis of rotation (133) of the lever element (131) is arranged at one end of the lever element (131) and the longitudinal center axis (127) of the holding unit (117, 115) and / or the longitudinal center axis (127) of the probe (121) is arranged between the axis of rotation (131) and the force generation axis (153).Lithotripsy device (101, 201) according to one of the preceding claims, wherein the probe is a sonotrode (121), characterized in that the lithotripsy device (101, 201) has an ultrasonic vibration exciter (231) and a horn (237), wherein the ultrasonic vibration exciter (231) has at least one piezo element (235) and a counter bearing (233), and the at least one piezo element (235) is arranged and mechanically coupled between the counter bearing (233) and the horn (237), wherein the horn (237) is connectable to the holding unit (117, 115) and / or the sonotrode (121), and the at least one piezo element (235) is electrically connectable to an assignable ultrasonic generator, so that a combined vibration excitation of the sonotrode (121) by means of the at least a piezo element (235) and a rotary movement of the lever element (131) induced by means of the ultrasonic vibration exciter (231). Lithotripsy device (101, 201) according to one of the preceding claims, characterized in that a spring element (251) is arranged on and / or adjacent to the rotatably mounted lever element (131). Lithotripsy device (101, 201) according to claim 10, characterized in that the spring element (251) is held by means of a holder (253), so that the lever element (131) can be designed as an oscillatable mass. Lithotripsy device (101, 201) according to one of the preceding claims, characterized in that the at least one force-generating device (151) comprises an electromagnet (261), and the rotatably mounted lever element (131) comprises a magnetic and / or magnetizable material. Lithotripsy device (101, 201) according to one of the preceding claims, wherein the lithotripsy device (101, 201) comprises an acceleration tube (105) with a cavity (107), a proximal end, a distal end and with a longitudinal central axis (153),a movable projectile (111) within the cavity (107), a proximal-side stop element (113) at the proximal end of the acceleration tube (105) and the force generating device (151) for moving the projectile (111) back and forth along an acceleration path between the proximal-side stop element (113) and the distal end, characterized in that the rotatably mounted lever element (131) is arranged distally of the distal end of the acceleration tube (105), so that upon a mechanical impact of the projectile (111) at the distal end with a distal impact direction (165), an impact of the projectile (111) by means of the rotatably mounted lever element (131) on the holding unit (117,115) and / or the probe or the sonotrode (121) in a main impact direction (177) different from the distal impact direction (165) and / or the force generation direction (155) for oscillating the probe or sonotrode (121). Lithotripsy device (101, 201) according to claim 13, characterized in that a billiard projectile (211) is arranged between the projectile (111) and the lever element (131) as a distal-side stop element at the distal end of the acceleration tube (105), so that the impact of the projectile (111) can be transmitted to the lever element (131) by means of the billiard projectile (211). Lithotripsy device (101, 201) according to one of the preceding claims, characterized in that the rotatably mounted lever element (131) has an impact surface (149) for absorbing the impact of the projectile (111) or the billiard projectile (211). Lithotripsy device (101, 201) according to claim 15, characterized in that the impact surface (149) is oriented obliquely to a longitudinal central axis (132) of the lever element (131), the force generation axis (153), and / or the longitudinal central axis (153) of the acceleration tube (105). Lithotripsy device (101, 201) according to one of claims 11 to 16, characterized in that the holder (253) of the spring element (251) is designed as a distal-side stop element or, in the case of a mechanical impact of the projectile (111) or the billiard projectile (211) with a proximal impact direction (167), as a proximal stop.Retrofit kit for retrofitting an existing lithotripsy device (101, 201), wherein the existing lithotripsy device (101, 201) has a probe and / or a sonotrode (121) and a force generating device (151), characterized in that the retrofit kit has at least one rotatably mounted lever element (131) or two or more rotatably mounted lever elements (131), wherein the lever elements (131) are designed differently, and optionally has a spring element (251) and a holder (253), so that a lithotripsy device (101, 201) according to one of claims 1 to 17 can be designed.

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