LITHOTRIPSIEVORRICHTUNG

Description

Status of Technology

[0001] The invention relates to a lithotripsy device according to claim 1. Further embodiments are listed in the subclaims. No surgical methods are claimed. Furthermore, the invention may relate to a lithotripsy device comprising at least one such lithotripsy device, a kit for at least one such lithotripsy device, a lithotripsy system comprising at least one such lithotripsy device, and a method for manufacturing and / or operating at least one such lithotripsy device.

[0002] EP 1 163 883 B2 already discloses a lithotripter configured to apply ultrasonic waves to concretions and comprising an ultrasonic horn configured at least for focusing and / or transmitting the ultrasonic waves to the sonotrode. The lithotripter also has a cap surrounding the sonotrode. Furthermore, the lithotripsy device has an irrigation channel extending through the entire sonotrode and ultrasonic horn, which is configured to conduct an irrigant. The irrigation channel is fluidically connected to at least one discharge channel within the ultrasonic horn for discharging the irrigant.

[0003] EP 1 380 265 A1 discloses a lithotripsy device with a combination of an ultrasonic unit for generating ultrasonic vibrations and a mechanical unit for generating mechanical shock waves by magnetic force, in which a sonotrode is firmly connected to the distal end of the horn and an outer cap surrounds the horn, holds and fixes it in position at its proximal end and elastically supports it at its distal end section.

[0004] US Pat. No. 6,558,397 B2 describes a combined lithotripsy device with an ultrasonic transducer, a horn, and pneumatic impact excitation via a projectile. The projectile acts on a mass body to generate the impact excitation. The mass body is connected to the horn via a screw section with a screw connection. The screw section also has a screw connection with a screw cap, which in turn is connected to the sonotrode via a damping element, so that the sonotrode is connected internally within the horn via the screw section.

[0005] The object of the invention is, in particular, to provide a generic device with improved properties regarding assembly. This object is achieved according to the invention by the features of patent claim 1, while advantageous embodiments and further developments of the invention can be found in the subclaims. Advantages of the invention

[0006] The invention is based on a lithotripsy device, in particular an intracorporeal lithotripsy device, with at least one sonotrode which is designed to apply at least ultrasonic waves to concretions, with at least one ultrasonic horn which is designed at least to focus and / or transmit ultrasonic waves to the sonotrode, with at least one fastening means which is designed to fasten the sonotrode to the ultrasonic horn and with at least one cap which, in an assembled state, is arranged to at least partially surround the sonotrode and / or the ultrasonic horn.

[0007] It is proposed that the cap is configured for mounting the sonotrode on the ultrasonic horn by means of the fastening means.

[0008] This advantageously simplifies assembly. Furthermore, operational reliability can be increased by ensuring that the sonotrode is mounted to the ultrasonic horn as intended. Hygiene can also be improved by preventing the user from having to touch the sonotrode during installation.

[0009] A "lithotripsy device" is understood to mean, in particular, a preferably functional component, in particular a subassembly and / or a structural and / or functional component of a lithotripter. Preferably, the lithotripsy device can form the lithotripter at least partially, preferably at least to a large extent, and particularly preferably completely. The lithotripsy device is configured to fragment calculi. "Calculi" is understood to mean, in particular, solid structures formed in the body by deposition, which consist at least partially, preferably at least to a large extent, and particularly preferably completely, of salts, such as kidney stones, gallstones, urinary stones, salivary stones, or the like. "Configured" is understood to mean, in particular, specially programmed, provided, designed, and / or equipped.The fact that an object is configured for a specific function should be understood in particular to mean that the object fulfills and / or performs this specific function in at least one application and / or operating state. The lithotripsy device is preferably designed as an intracorporeal lithotripsy device, which is designed to be inserted at least partially and preferably at least to a large extent into a particularly artificial and / or natural opening, in particular a body orifice, in order to fragment and / or remove calculus accumulated there. The expression "at least to a large extent" should be understood in particular to mean at least 55%, preferably at least 65%, preferably at least 75%, particularly preferably at least 85%, and most preferably at least 95%, and advantageously completely, in particular with reference to a volume and / or mass of an object.To fragment calculi, the lithotripsy device uses at least ultrasonic waves. "Ultrasonic waves" are understood to mean, in particular, sound waves above the human hearing frequency range. In the present case, the ultrasonic waves have, in particular, an ultrasonic frequency of at least 10 kHz, preferably at least 15 kHz, and particularly preferably at least 20 kHz, and / or of at most 100 kHz, preferably of at most 80 kHz, and particularly preferably of at most 56 kHz. The ultrasonic frequency is most preferably between 22 kHz and 55 kHz. To provide ultrasonic waves, the lithotripsy device has at least one ultrasonic generator. The ultrasonic generator is particularly configured to generate ultrasonic waves and preferably to provide additional components.The ultrasonic generator has in particular at least one, preferably at least two, more preferably at least three, and most preferably a plurality of ultrasonic actuators, which is / are in particular designed as a piezo actuator. In particular, if the ultrasonic generator comprises at least two ultrasonic actuators, these are at least indirectly in contact with one another in order to advantageously increase the intensity of the generated ultrasound. The ultrasonic generator is in particular connected to the ultrasonic horn. The lithotripsy device can also have the ultrasonic horn. The ultrasonic horn in particular has a preferably concavely tapered cylindrical shape. The ultrasonic horn can, for example, be formed at least partially, preferably at least largely, and more preferably entirely from metal, such as iron, titanium, steel, or a metal alloy.

[0010] The sonotrode is designed to contact the calculus at least directly or indirectly during a lithotripsy procedure. Furthermore, the sonotrode is designed to be inserted into a body orifice. A "sonotrode" is understood, in particular, to be an elongated component of the lithotripsy device. An "elongated component" is understood, in particular, to be a component whose main extension is at least five times larger, preferably at least ten times larger, and particularly preferably at least twenty times larger than an extension of the component perpendicular to the main extension direction, i.e., in particular, a diameter of the component. The sonotrode has, in particular, a diameter of at least 1 mm, preferably at least 2 mm, and particularly preferably at least 4 mm. Furthermore, the shaft has a diameter of at most 20 mm, preferably at most 18 mm, and particularly preferably at most 16 mm."At least substantially" is understood to mean, in particular, a maximum deviation of a value of at most 10%, preferably at most 5%, and particularly preferably at most 2%. The sonotrode defines, in particular, a distal section of the lithotripsy device. "Distal" is understood to mean, in particular, facing a patient and / or facing away from an operator during operation. Furthermore, distal can be understood to be the opposite of proximal. "Proximal" is understood to mean, in particular, facing away from a patient and / or facing away from an operator during operation.

[0011] In the assembled state, the sonotrode is operatively connected, in particular, to the ultrasonic horn. For example, the ultrasonic horn and the sonotrode are connected to one another in a force-locking and / or form-locking manner. A "force-locking and / or form-locking connection" is understood, in particular, to mean a connection that can preferably be released without tools and / or non-destructively, whereby a holding force between two objects is created via such a connection of connected objects, for example, via a geometric engagement with one another and / or via a frictional force that preferably acts between the objects. The connection is preferably a flange connection. Most preferably, the connection is a screw connection using a thread.

[0012] The fastening means is in particular designed for fastening and thus connecting the sonotrode to the ultrasonic horn. The fastening means is in particular arranged on the sonotrode. It is conceivable that the fastening means is connected and / or formed integrally with the sonotrode. For example, the fastening means can be a screw, bolt or the like. For fastening, the lithotripsy device has a further fastening means designed to correspond to the fastening means. The further fastening means is arranged on the ultrasonic horn. Likewise, the further fastening means can be connected and / or formed integrally with the ultrasonic horn. For example, the further fastening means can be a socket, thread or the like.

[0013] Alternatively or additionally, the connection between the sonotrode and the ultrasonic horn could be integral. A "integral connection" is understood in particular to mean that the objects are held together by atomic or molecular forces, such as during soldering, welding, gluing, and / or vulcanization. Furthermore, the connection between the sonotrode and the ultrasonic horn could be at least partially integrally formed / connected. The term "an object and another object are at least partially integrally formed / connected" is understood in particular to mean that at least one element and / or part of the object and at least one element and / or part of the other object are integrally formed / connected."Integral" should be understood in particular as being at least materially connected, for example by a welding process, an adhesive process, an injection molding process, and / or another process deemed appropriate by a person skilled in the art, and / or advantageously formed in one piece, such as by production from a single casting and / or by production using a single- or multi-component injection molding process, and advantageously from a single blank. Alternatively or additionally, the sonotrode and / or the ultrasonic horn could be manufactured by a generative process, such as 3D printing, in particular by laser welding and / or laser sintering. The sonotrode is, for example, tubular. The sonotrode is in particular at least partially, preferably at least largely, and particularly preferably entirely made of metal, such as iron, titanium, steel, or a metal alloy.

[0014] Furthermore, the lithotripsy device comprises, in particular, a housing, which is preferably hollow-cylindrical in shape. The housing defines a proximal portion of the lithotripsy device. Further components of the lithotripsy device can be arranged in the housing. Furthermore, in particular, the ultrasonic horn is arranged at least partially in the housing.

[0015] It is conceivable that the cap is at least partially arranged in / on the housing. Alternatively, the cap could also be formed integrally with the housing. The cap in particular surrounds the sonotrode at least partially, preferably at least to a large extent, preferably along a circumference of the sonotrode. The cap in particular surrounds the ultrasonic horn at least partially, preferably at least to a large extent, preferably along a circumference of the ultrasonic horn. The cap in particular surrounds the housing at least partially, preferably at least to a large extent, preferably along a circumference of the housing. The cap can be formed, for example, from a plastic and / or a metal. The cap is preferably formed integrally. The cap is in particular at least partially tubular, hollow conical and / or funnel-shaped.The cap has, in particular, a distal portion that is tubular. Furthermore, the cap has, in particular, a proximal portion that is tubular. Furthermore, the cap has, in particular, at least one central portion that is funnel-shaped. The central portion is located, in particular, between the proximal portion and the distal portion.

[0016] The lithotripsy device can further comprise at least one projectile configured to impinge on the ultrasonic horn and / or the sonotrode with impacts in addition to the ultrasonic waves. In particular, the projectile is configured to impinge on the sonotrode during movement with an impact frequency that is significantly lower than the ultrasonic frequency of the ultrasonic waves. "Significantly lower" should be understood to mean at least a factor of 10, preferably at least a factor of 100, and particularly preferably at least a factor of 1000 lower. The projectile is in particular shaped like a ring, a cylinder, or a hollow cylinder. The projectile is preferably made at least partially of metal, such as steel, particularly hardened steel or spring steel.The projectile particularly preferably has a coating, such as in particular a hardening coating, sliding coating, a non-stick coating, a corrosion coating or the like. The non-stick, sliding and / or corrosion coating is preferably arranged on surface sections that rub against other surfaces in an operating state, such as a lateral surface of the projectile. The non-stick, sliding and / or corrosion coating can be, for example, a PTFE, ceramic, carbon coating or the like. The hardening coating is preferably arranged on surface sections that abut other surfaces in an operating state, such as a cover surface of the projectile. The hardening coating can be, for example, a metal alloy, in particular a titanium alloy.

[0017] The projectile could be movably mounted along a guide channel of the lithotripsy device. The guide channel is in particular arranged at least partially within the housing. The projectile or a guide channel guiding the projectile can be arranged at least partially coaxially within a volume enclosed by the ultrasonic horn. The guide channel forms in particular a bearing, preferably a linear bearing, for the projectile, wherein the bearing can in particular be a plain bearing. The guide channel preferably has a non-stick, anti-friction, and / or anti-corrosion coating on surfaces which, in an operating state, rub against other surfaces of the projectile, such as a lateral surface of the guide channel. The non-stick, anti-friction, and / or anti-corrosion coating can, for example, be a PTFE, ceramic, carbon coating, or the like.The guide channel is designed in particular as an elongated channel.

[0018] To accelerate the projectile, a drive device can be provided for the projectile. The drive device is, for example, an electromagnetic, a mechanical, a hydraulic and / or a pneumatic drive device. The drive device could be part of the lithotripsy device, in particular if it is, for example, an electromagnetic drive device. For this purpose, the drive device can be arranged at least partially, preferably at least for the most part, within the housing. Alternatively, the drive device can be formed separately from the lithotripsy device. For example, the drive device can be part of a lithotripsy system which also has a lithotripter comprising the lithotripsy device. The drive device could also be integrated into a control unit of such a lithotripsy system.The drive device can be a linear actuator or motor, in particular a linear electric motor. Alternatively, the drive device can be a pneumatic actuator. The pneumatic actuator has at least one pressure generator connected to the guide channel of the lithotripsy device. To accelerate the projectile using the pressure generator, the pressure generated by the pressure generator can be suddenly applied to the guide channel, thereby accelerating the projectile.

[0019] It is also proposed that the cap comprise at least one tool which is designed to correspond to the fastening means and which is configured to actuate the fastening means when the sonotrode is mounted on the ultrasonic horn. This can further simplify assembly, in particular, since the provision of a separate tool can be dispensed with. Furthermore, safety can be improved, since it can be avoided that the fastening means is actuated with a tool not intended for actuating the fastening means. The tool is in particular designed in one piece with a base body of the cap. The tool can be designed as a nut, a bit or the like and is in particular designed to correspond to a profile of the actuating means.For example, the nut can be a hexagon nut, which is configured to correspond to a screw head, in particular a hexagon screw head, of the further actuating element. The tool and the fastening means are arranged with play relative to each other, particularly when the sonotrode is mounted, so that vibrations from the sonotrode are prevented from being transmitted to the cap.

[0020] Furthermore, it is proposed that the cap comprise at least one handle, which is configured for manual actuation of the cap during assembly of the sonotrode to the ultrasonic horn. This can advantageously further improve assembly. Advantageously, the handle is designed in the form of a recess or a projection. Particularly preferably, the handle functions as a type of lever, which ensures that the fastening means can be tightened with a predetermined torque. Alternatively or additionally, it is conceivable for a lever to be mounted on the cap, by means of which a torque for tightening the actuating element can be increased.

[0021] Advantageously, assembly and / or cooling can be further improved if the cap is arranged coaxially surrounding the sonotrode and / or the ultrasonic horn, as a more homogeneous heat transfer to a large area of ​​the sonotrode and / or the ultrasonic horn can be achieved. In particular, the cap is arranged such that a rotational symmetry axis and / or a central axis of the cap is identical to a rotational symmetry axis and / or a central axis of the sonotrode and / or the ultrasonic horn. The rotational symmetry axis is preferably identical to a central axis of the irrigation channel.

[0022] It is further proposed that the cap be configured to correspond to the sonotrode and / or the ultrasonic horn. This advantageously allows a design to be further improved, allowing a compact, efficient installation space while simultaneously ensuring a sufficient size of the discharge channel and thus adequate fluid transport. In particular, the opposing walls of the cap and the sonotrode and / or the ultrasonic horn that define the space are configured to correspond to one another. For example, if one wall of the sonotrode is concave, the opposite wall of the cap is also concave. "Corresponding" is intended, in particular, to be related, just as puzzle pieces can be configured to correspond to one another in order to be connected to one another. Furthermore, "corresponding" should also be understood to mean "matching."

[0023] To advantageously simplify assembly, replacement, and / or cleaning of the cap, it is proposed that the cap have at least one axial opening through which the sonotrode extends. This advantageously allows the cap to be easily pushed onto or pulled off the sonotrode. The axial opening, in particular, has an inner diameter that at least substantially corresponds to an outer diameter of the sonotrode. The axial opening is, in particular, a distal opening of the cap.The axial opening is arranged in particular at a position within a region, wherein the region, measured along the main extension direction of the sonotrode, corresponds to a length of at most one quarter, preferably at most one eighth and particularly preferably at most one sixteenth of a wavelength of the ultrasound, around a vibration node of the ultrasonic waves or at the location of a vibration node of the ultrasonic waves themselves.

[0024] In order to advantageously simplify assembly, replacement and / or cleaning of the cap, it is proposed that the cap have at least one further axial opening through which the ultrasonic horn extends. Furthermore, in particular the housing extends at least partially through the further axial opening. The further axial opening in particular has an inner diameter which corresponds to an outer diameter of the ultrasonic horn and / or the housing. The further axial opening is in particular arranged around a node of oscillation of the ultrasonic waves or at the location of a node of oscillation of the ultrasonic waves themselves, wherein the region, measured along the main direction of extension of the sonotrode, corresponds to a length of at most one quarter, preferably at most one eighth and particularly preferably at most one sixteenth of a wavelength of the ultrasound.The opening is, in particular, a proximal opening of the cap. The further axial opening is, in particular, opposite the axial opening. The further axial opening is, in particular, arranged at a position within a region, wherein the region, measured along the main extension direction of the sonotrode, corresponds to a length of at most one-quarter, preferably at most one-eighth, and particularly preferably at most one-sixteenth of an ultrasound wavelength, around a vibration node of the ultrasonic waves or at the location of a vibration node of the ultrasonic waves themselves.

[0025] It is further proposed that the cap be at least partially, preferably at least largely, and particularly preferably completely, transparent. The cap can advantageously make the drainage channel and the irrigant conveyed through the drainage channel visible, whereby fragments of concretions carried away by the irrigant can also be identified, so that the functionality of the lithotripsy device can be checked during operation. It is also advantageous to easily determine whether the drainage channel is blocked or clogged. Alternatively or additionally, the cap could be provided with an indicator, such as a pH indicator, which changes the color of the cap as soon as an irrigant is transported through the cap.

[0026] The cap can be a cap designed as a reusable component. The cap is, in particular, made of a plastic that can withstand an autoclaving process, such as PEEK, PPS, PVDF, PEO, PPSU, PSU, or a mixture thereof. To advantageously improve the hygiene of the lithotripsy device, for example, to avoid contamination due to incorrect use of an autoclaving process, it is proposed that the cap be designed as a disposable component. A "disposable component" is to be understood, in particular, as a component that can only be used once and is preferably not designed for an autoclaving process. This is the case, for example, if the cap is at least partially made of a plastic that is preferably deliberately deformed or damaged at temperatures of an autoclaving process known to a person skilled in the art.The cap is in particular made of a plastic that does not resist an autoclaving process, such as POM-C, PETP or a mixture thereof.

[0027] The cap is in particular firmly connected and / or connectable to other components of the lithotripsy device, such as the sonotrode, the ultrasonic horn and / or a housing of the lithotripsy device. If the cap is connectable in this way, cleanability can be improved since the cap can then be individually removed and cleaned. Furthermore, the discharge channel can advantageously be disassembled and cleaned in this way. In order to achieve simple cleaning and to facilitate the associated disassembly and assembly, it is particularly proposed that the lithotripsy device have at least one quick connector, such as a bayonet connector, a quick-action connector, a screw connector or the like, which is at least partially formed by the cap and is designed to arrange the cap so as to at least partially surround the sonotrode and / or the ultrasonic horn.The quick connector is particularly designed to create a tool-free and non-destructively releasable connection, such as in particular a force-locking and / or form-fitting connection. The quick connector is particularly designed to connect the cap to the housing. The cap in particular has at least one connecting part which at least partially forms the quick connector. It is conceivable for the cap to have at least two or more connecting parts which can be arranged offset from one another in particular along a circumference of the cap. The connecting part can be, for example, a bayonet connector guide which is particularly composed of a longitudinal slot and a transverse slot extending at a right angle to its end. Alternatively, the connecting part can also be a locking tab or hook, a thread or the like.In particular, the housing at least partially forms the quick connector. The housing preferably has a corresponding connecting part that is designed to correspond to the connecting part and that at least partially forms the quick connector. It is conceivable for the housing to have at least two or more corresponding connecting parts, which can in particular be arranged offset from one another along a circumference of the housing. The corresponding connecting part can, for example, be a bayonet connector head, which can in particular be inserted into the transverse slot of the connecting element and, by twisting in the longitudinal slot, creates a secure connection. Alternatively, the corresponding connecting part can also be a locking lug, a counter thread, or the like.It is also conceivable that the cap has at least one corresponding connecting part instead of the housing, and the housing has the connecting part instead of the cap. If multiple connecting parts and corresponding connecting parts are present, it is conceivable that the cap has both connecting parts and corresponding connecting parts, and the housing has multiple corresponding connecting parts and connecting parts.

[0028] It is further proposed that the cap has at least one stop for an arrangement that at least partially surrounds the sonotrode and / or the ultrasonic horn. This can advantageously achieve a compact arrangement of the cap, wherein in particular the hold of the cap can be improved and at the same time the cap can be prevented from being damaged by ultrasonic waves, becoming leaky or becoming detached. The stop is in particular formed integrally with a wall of the cap that delimits the space between the cap and the ultrasonic horn and / or sonotrode. The stop is preferably formed as a step that extends annularly along the entire circumference of this wall. On the proximal side, the cap bears in particular against the ultrasonic horn and / or the housing.The ultrasonic horn and / or the housing can have a corresponding stop configured to correspond to the stop, against which the stop rests in an assembled state. The corresponding stop is in particular formed integrally with a wall of the ultrasonic horn delimiting the space between the cap and the ultrasonic horn and / or sonotrode and / or a housing wall of the housing. The stop and / or the corresponding stop is particularly preferably arranged around a vibration node of the ultrasonic waves or arranged at the location of a vibration node of the ultrasonic waves themselves, wherein the region, measured along the main extension direction of the sonotrode, corresponds to a length of at most one quarter, preferably at most one eighth, and particularly preferably at most one sixteenth of a wavelength of the ultrasound.Furthermore, transmission of ultrasonic waves to the cap can be avoided, which can reduce energy loss during transmission of ultrasonic waves or shocks.

[0029] It is further proposed that the lithotripsy device comprises at least one irrigation channel which is configured to conduct an irrigant and which extends at least partially through the sonotrode and / or the ultrasonic horn, and at least one discharge channel which is fluidically connected to the irrigation channel for discharging the irrigant, wherein the discharge channel is formed at least partially by a gap enclosed between the cap and the sonotrode and / or the ultrasonic horn and is configured to cool the sonotrode and / or the ultrasonic horn by means of the discharged irrigant.Ultrasonic waves propagating along the sonotrode and the ultrasonic horn can cause heating of the lithotripsy device in an operating state compared to a resting state. This heating can be reduced by the present embodiment, since the sonotrode and / or the ultrasonic horn can be cooled by the irrigant. Furthermore, the design of the lithotripsy device can be simplified, since, for example, the design and / or arrangement of the ultrasonic generator for providing the ultrasonic waves is not restricted by the presence of a discharge channel. Furthermore, the safety of the lithotripsy device can be increased, since, in particular, the irrigant can be structurally separated from electrical components, such as the ultrasonic generator.This advantageously prevents current from being transmitted to a patient in the event of a short circuit between such components and the irrigator.

[0030] The irrigation channel is particularly designed as a tubular channel. A "channel," such as the irrigation channel or the drainage channel, is understood to mean, in particular, an object that is at least partially intended to guide a fluid flow and that, in particular, delimits the fluid flow, in particular at least substantially perpendicular to a main fluid flow direction, and / or directly completely encloses it, preferably on at least three sides, particularly preferably completely, advantageously from exactly four sides, and particularly preferably at least along a circumferential direction. A "main fluid flow direction" is understood to mean, in particular, an effective flow direction of a fluid, preferably a flow direction of a fluid averaged over a region."At least substantially perpendicular" is understood here to mean, in particular, an alignment of a direction relative to a reference direction, in particular in a plane, wherein the direction and the reference direction form an angle of 90°, in particular taking into account a maximum deviation of less than 8°, advantageously less than 5°, and particularly advantageously less than 2°. The irrigation channel extends, in particular, at least for a large part through the sonotrode and / or the ultrasonic horn. Preferably, the irrigation channel does not extend completely through the entire sonotrode and / or the ultrasonic horn. A main extension direction of the irrigation channel is, in particular, at least substantially parallel to a main extension direction of the sonotrode and / or the ultrasonic horn."At least substantially parallel" is understood here to mean, in particular, an alignment of a direction relative to a reference direction, in particular in a plane, wherein the direction and the reference direction form an angle of 0°, particularly taking into account a maximum deviation of less than 8°, advantageously less than 5°, and particularly advantageously less than 2°. A "main extension direction" of an object is understood to mean, in particular, a direction that runs parallel to a longest edge of a smallest imaginary cuboid that just completely encloses the object. The irrigation channel runs at least partially, and preferably at least largely, coaxially in the sonotrode and / or the ultrasonic horn. In order to exchange irrigant with the irrigation channel, the sonotrode has, in particular, at least one distal-side opening that is fluidically connected to the irrigation channel.Cooling can be advantageously improved.

[0031] The discharge channel is configured such that an irrigate flowing through it at least partially surrounds the sonotrode and / or the ultrasonic horn, in particular directly or indirectly, wherein the irrigate preferably comes into contact with the sonotrode and / or the ultrasonic horn. The discharge channel or the enclosed volume of the discharge channel is at least partially tubular and / or funnel-shaped. The discharge channel is in particular configured at least to discharge the irrigate of the irrigation channel. The discharge channel surrounds the sonotrode and / or the ultrasonic horn, in particular along a circumference, at least partially, preferably at least to a large extent, and particularly preferably completely. The cap and the sonotrode and / or the ultrasonic horn preferably form the discharge channel at least partially, preferably at least to a large extent.A conveying device, such as a pump, can be provided to convey the irrigated fluid, particularly along the irrigation channel and / or a drainage channel. The conveying device is advantageously designed separately from the lithotripsy device. For example, the conveying device can be part of a common lithotripsy system with a lithotripter comprising the lithotripsy device. The conveying device could also be integrated into a control unit of the lithotripsy system.

[0032] It is further proposed that the lithotripsy device comprise at least one seal which fluid-tightly seals off a gap, which at least partially forms the discharge channel, between the cap and the housing and which is arranged to at least partially surround the sonotrode and / or the ultrasonic horn, from the environment. This advantageously makes it possible to achieve a compact arrangement of the cap, wherein in particular the hold of the cap is improved and at the same time the discharge channel can be prevented from becoming leaky. The seal is designed in particular as a sealing ring and / or a sealing sleeve. It is further conceivable for the seal to be integrally connected to the cap. The seal can in particular be arranged in the proximal section of the cap. The seal can for example be embedded in the wall of the housing of the cap, the housing and / or the ultrasonic horn.The seal is particularly preferably arranged at a position within a region, wherein the region, measured along the main extension direction of the sonotrode, corresponds to a length of at most one-quarter, preferably at most one-eighth, and particularly preferably at most one-sixteenth of an ultrasound wavelength, around a vibration node of the ultrasonic waves or at the location of a vibration node of the ultrasonic waves themselves. A seal can also be arranged on the distal section. Furthermore, transmission of ultrasonic waves to the cap can be advantageously avoided, thereby reducing energy loss during the transmission of ultrasonic waves or shocks.

[0033] It is further proposed that the cap have at least one connection fluidically connected to the discharge channel. A particularly compact design can be achieved because the irrigant can flow out of the discharge channel outside the lithotripsy device, thereby allowing the irrigant to pass through the lithotripsy device and in particular through components of the lithotripsy device that are connected downstream of the sonotrode and / or the ultrasonic horn, such as the guide channel, the ultrasonic generator and / or a drive for the projectile. It can also be prevented that electrical components of the lithotripsy device, such as the ultrasonic generator or the like, come into contact with the irrigant, thereby improving the safety of the lithotripsy device. The wall of the cap that delimits the discharge channel has, in particular, at least one recess that forms an opening towards the connection.The connection is in particular connected to a conveying device, such as a pump, which is particularly designed to convey the irrigate. Furthermore, it is conceivable for the cap to have at least two or more such connections, which could be arranged offset from one another along the cap and / or along a circumference of the cap. The wall of the cap delimiting the discharge channel can in particular have at least two or more such recesses, which could be arranged offset from one another along the cap and / or along a circumference of the cap.

[0034] It is further proposed that the discharge channel surround the sonotrode and / or the ultrasonic horn at least partially, preferably at least to a large extent, and particularly preferably completely, along its periphery. This can advantageously further improve cooling, since the sonotrode and / or the ultrasonic horn can thus be flushed over a large area by the irrigant used for cooling.

[0035] It is further proposed that the discharge channel be funnel-shaped, at least in sections. This can advantageously improve cooling, as the sonotrode and / or the ultrasonic horn can be flushed over a particularly large area by the irrigant used for cooling. Furthermore, the discharge channel can be at least partially tubular.

[0036] It is further proposed that the irrigation channel have a main extension, and that the sonotrode and the ultrasonic horn have a total main extension, wherein the main extension of the irrigation channel is smaller than the total main extension of the sonotrode and the ultrasonic horn. This advantageously simplifies the design of the lithotripsy device, as it is possible to avoid having to extend the irrigation channel completely through the entire sonotrode and / or ultrasonic horn. In particular, the main extension of the irrigation channel is smaller than the main extension of the sonotrode. A "main extension" of an object is to be understood, in particular, as an extension of the object along its main extension direction.

[0037] It is also proposed that the sonotrode and / or the ultrasonic horn have at least one radial opening for fluidically connecting the irrigation channel to the discharge channel. Particularly preferably, the radial opening is arranged at a position within a region, the region, measured along the main extension direction of the sonotrode, corresponding to a length of at most one quarter, preferably at most one eighth, and particularly preferably at most one sixteenth of an ultrasound wavelength, around an antinode of the ultrasonic waves or at the location of an antinode of the ultrasonic waves themselves. Advantageously, a connection between the irrigation channel and the discharge channel can be created in a simple manner, wherein, in particular, damage to the sonotrode caused by a discharge channel created by the opening becomes leaky.The radial opening is arranged in particular at a proximal end portion of the sonotrode and / or the ultrasonic horn. The radial opening is arranged, for example, in a wall of the sonotrode and / or the ultrasonic horn that delimits the discharge channel. Furthermore, it is conceivable for the sonotrode to comprise at least two or more such radial openings, which could be arranged offset from one another longitudinally and / or along a circumference of the sonotrode and / or the ultrasonic horn. Furthermore, the sonotrode can have additional radial openings arranged at a distal end portion of the sonotrode, for example to convey an irrigant into the irrigation channel.An "end section" of an object is to be understood in particular as a section which extends from one end of the object in the direction of the object by at most 10%, preferably at most 5% and particularly preferably by at most 1% of a main extension of the object in the direction of a center of the object.

[0038] To achieve a simple and fluid-tight design, it is proposed, in particular, that the cap be arranged so as to cover the radial opening of the sonotrode and / or the ultrasonic horn. Thus, the cap encloses both the radial opening and the discharge channel, thereby creating a fluid-tight and, in particular, replaceable module.

[0039] It is also proposed that the irrigation channel within the sonotrode and / or the ultrasonic horn have at least one bend extending toward the radial opening of the sonotrode and / or the ultrasonic horn. This can advantageously achieve particularly targeted cooling and / or removal of the irrigated fluid. A "bend" is understood in particular to mean a channel section of the irrigation channel that connects at least two other channel sections of the irrigation channel at an angle. "Angled" is understood in particular to mean different from at least substantially parallel. Preferably, an angle between the two channel sections connected by the bend corresponds to at least 0° and at most 90°.

[0040] Furthermore, a lithotripter with at least one such lithotripsy device is claimed. This advantageously improves cooling. Furthermore, the design of the lithotripsy device can be simplified.

[0041] Furthermore, a cap for at least one such lithotripsy device is claimed. This advantageously improves cooling. Furthermore, the design of the lithotripsy device can be simplified.

[0042] Additionally claimed is a kit for a lithotripter comprising at least one such lithotripsy device and at least one further cap. This advantageously allows cooling to be improved. Further advantageously, a design of the lithotripsy device can be simplified. Furthermore, hygiene and cleaning can be improved. In particular, such a kit can comprise at least two or more such further caps. The caps could be designed to differ from one another, at least in part. For example, the caps could differ from one another in an assembled state by a gap enclosed by the caps and the sonotrode and / or the ultrasonic horn, so that discharge channels of different sizes can advantageously be realized depending on the combination of the caps used.Furthermore, it is conceivable that the caps, which are preferably designed differently from one another, differ from one another by a coding, such as a color coding, an RFID chip coding, or the like.

[0043] In addition, a lithotripsy system with at least one such lithotripter and at least one control unit which is configured to control the lithotripter is claimed. This can advantageously improve cooling. Furthermore, a design of the lithotripsy system can advantageously be simplified. The control unit comprises in particular at least one processor which is configured to execute a program for controlling the lithotripter. The program can be, for example, a program for executing a method for operating the lithotripsy device. Furthermore, the control unit can have at least one memory on which at least the program configured for execution in the processor can be stored.

[0044] Furthermore, a method for test operation outside the body and / or for producing at least one such lithotripsy device is claimed. This can advantageously improve cooling of the lithotripsy device. Further advantageously, assembly and disassembly of the lithotripsy device can be simplified. The method can, for example, be a test method which is designed in particular for extracorporeal test operation of the lithotripsy device. The extracorporeal test operation can be different from surgical or therapeutic operation of the lithotripsy device, since in this case concretions cannot be destroyed inside a body for test purposes, for example in order to test the application duration of the lithotripsy device. Drawings

[0045] Further advantages will become apparent from the following description of the drawings. The drawings illustrate an exemplary embodiment of the invention. The drawings, the description, and the claims contain numerous features in combination. Those skilled in the art will expediently consider the features individually and combine them into further meaningful combinations.

[0046] They show: Fig. 1 shows a schematic representation of a lithotripsy system with a lithotripsy device forming a lithotripter in a perspective view. Fig. 2 shows a schematic representation of a part of the lithotripsy device in a sectional view. Fig. 3 shows a schematic representation of a part of the lithotripsy device with a cap in a sectional view. Fig. 4 shows a schematic flow chart of an exemplary method for producing a lithotripsy device. Fig. 5 shows a schematic representation of a kit for a lithotripter with a lithotripsy device and at least one additional cap. Fig. 6 shows a schematic flow chart of an exemplary method for testing a lithotripsy device outside the body. Fig. 7 is a schematic representation of a further lithotripsy device in a sectional view, Fig. 8 is a schematic representation of an additional lithotripsy device in a sectional view and Fig. 9 is a schematic representation of a part of the additional lithotripsy device in a sectional view. Description of the embodiments

[0047] Fig. 1 shows a schematic representation of a lithotripsy system 50a in a perspective view. The lithotripsy system 50a has at least one lithotripter 46a. In this case, the lithotripter 46a is designed as an intracorporeal lithotripter. Alternatively, a lithotripter could also be designed as an extracorporeal lithotripter.

[0048] The lithotripter 46a has at least one lithotripsy device. In the present case, the lithotripsy device completely forms the lithotripter 46a. Alternatively, the lithotripsy device could form only part of a lithotripter.

[0049] The lithotripsy system 50a has at least one control unit 52a. The control unit 52a is configured at least to control the lithotripsy device. The lithotripsy device is connected to the control unit 52a. The control unit 52a has at least one control electronics unit (not shown). To control the lithotripsy device, the control electronics unit is electrically and / or electronically connected to it. The control electronics unit contains at least one processor. Furthermore, the control electronics unit contains at least one memory unit. An operating program is stored in the memory unit. The operating program can be executed by the processor.

[0050] The lithotripsy system 50a has at least one actuating means 58a. The actuating means 58a is designed to activate and / or deactivate the lithotripsy device. The actuating means 58a is connected to the control unit 52a, in particular to the control electronics of the control unit 52a. In the present case, the actuating means 58a is designed as a foot switch. Alternatively, an actuating means could also be designed as another electrical and / or electronic switch, such as a push button, a toggle switch, or the like, which could in particular be part of a lithotripsy device. The lithotripsy device could also be operated via an external device, in particular a handheld device, such as a tablet, a smartphone, a smartwatch, or the like.

[0051] The lithotripsy system 50a further comprises a conveying device 60a. In this case, the conveying device 60a is configured as a pump. The conveying device 60a is configured to convey an irrigant. For this purpose, the conveying device 60a is fluidically connected to the lithotripsy device. The conveying device 60a serves to suction out an irrigant and / or to flush the irrigant during a lithotripsy procedure.

[0052] The irrigant can be a liquid, such as saline solution. For example, it can be used to remove fragments of a calculus destroyed during a lithotripsy procedure.

[0053] To generate shock pulses, for example by means of a projectile 62a, the lithotripsy device is provided with at least one drive device 64a (cf. Fig. 2). In the present case, the drive device 64a is designed separately from the lithotripsy device. The drive device 64a is part of the lithotripsy system 50a. The drive device 64a is part of the control unit 52a. In the present case, the drive device 64a is designed as a pneumatic drive device 64a. The drive device 64a is designed as a compressed air generator. Alternatively, the drive device could be a mechanical, electromagnetic, or hydraulic drive device. Alternatively, such a drive device could also be part of such a lithotripsy device, for example, if this drive device is designed as an electromagnetic drive unit, such as a linear actuator. A drive device could also form a drive device separate from a control unit.

[0054] The lithotripsy device has a proximal portion 66a. The proximal portion 66a faces an operator of the lithotripsy device during operation. The proximal portion 66a faces away from a patient during operation. The proximal portion 66a lies outside the patient during treatment.

[0055] Furthermore, the lithotripsy device has a distal portion 68a. During operation, the distal portion 68a faces away from an operator of the lithotripsy device. During operation, the distal portion 68a faces a patient. During treatment, the distal portion 68a lies at least partially within the patient.

[0056] The lithotripsy device has a housing 70a. The housing 70a is hollow-cylindrical in shape. The housing 70a at least partially forms the proximal portion 66a of the lithotripsy device. The housing 70a serves to accommodate additional components of the lithotripsy device.

[0057] Furthermore, the lithotripsy device has a handle 72a. The handle 72a is designed for manual operation of the lithotripsy device. The handle 72a is formed by the housing 70a. The handle 72a at least partially forms the proximal section 66a. Alternatively, particularly in the case of robotic control of such a lithotripsy device, a handle 72a could be omitted or used for connection to a robotic arm.

[0058] Fig. 2 shows a schematic representation of a part of the lithotripsy device in a sectional view.

[0059] The lithotripsy device has at least one ultrasound generator 74a. The ultrasound generator 74a is designed to provide ultrasound waves. For control, the ultrasound generator 74a is connected to the control unit 52, specifically to the control electronics. The ultrasound generator 74a is at least partially arranged in the housing 70a. In the present case, the ultrasound generator 74a is arranged entirely in the housing 70a. The ultrasound generator 74a at least partially forms the proximal section 66a of the lithotripsy device.

[0060] The ultrasonic generator 74a contains at least one ultrasonic actuator c. In the present case, the ultrasonic generator 74a has several ultrasonic actuators 78a. For the sake of clarity, any connection and / or contacting means and / or insulation of the ultrasonic actuators 78a are not shown in the Fig. 2 shown.

[0061] The ultrasonic generator 74a has two ultrasonic actuators 78a. The ultrasonic actuators 78a are arranged stacked adjacent to one another. For the sake of clarity, only one ultrasonic actuator 78a is provided with a reference symbol in the drawings. The ultrasonic actuators 78a are at least substantially identical to one another. Only one ultrasonic actuator 78a is described in more detail below. This description also applies to the other ultrasonic actuators 78a. In the present case, the ultrasonic actuator 78a is designed as a piezo actuator. The ultrasonic actuator 78a is cylindrical plate-shaped.

[0062] The lithotripsy device further comprises at least one ultrasonic horn 12a. The ultrasonic horn 12a is configured to transmit ultrasonic waves. The ultrasonic horn 12a is positioned adjacent to the ultrasonic actuator 78a. The ultrasonic horn 12a is further configured to focus ultrasonic waves.

[0063] The ultrasonic horn 12a is at least partially arranged within the housing 70a. The ultrasonic horn 12a at least partially forms the proximal section 66a of the lithotripsy device. The ultrasonic horn 12a is arranged at least partially outside the housing 70a. The ultrasonic horn 12a has the shape of a rotating body. In the present case, the ultrasonic horn 12a has a hollow cylindrical shape. The ultrasonic horn 12a is formed at least partially from metal, in particular steel or titanium. The ultrasonic generator 74a lies against the ultrasonic horn 12a.

[0064] The ultrasonic horn 12a has a taper. The taper is located outside the housing 70a. The taper is free of steps. The taper has a continuous profile. The taper profile is concave. The taper profile is exponential. Alternatively or additionally, the taper could also be step-shaped or catenoidal. The ultrasonic horn 12a has a recess 80a. The recess 80a runs coaxially along a rotation axis of the ultrasonic horn 12a.

[0065] The lithotripsy device comprises at least one projectile 62a. The projectile 62a is mounted for linear movement. The projectile 62a is arranged in a movable manner in the region of the ultrasonic horn 12a. In at least one operating state, the projectile 62a is designed to at least indirectly impact the sonotrode 10a and / or the ultrasonic horn 12a. In the present case, the projectile 62a indirectly impacts the sonotrode 10a. To do this, the projectile 62a impacts the connecting sleeve 84a in one operating state.

[0066] For supporting the projectile 62a, the lithotripsy device has at least one guide channel 88a. The lithotripsy device has a guide tube 86a. The guide tube 86a is at least partially arranged in the recess 80a of the ultrasonic horn 12a. The guide tube 86a defines the guide channel 88a. Alternatively, the guide channel could also be formed by the recess of the ultrasonic horn. The guide tube could be closed in the area of ​​the ultrasonic horn, which advantageously prevents compressed air from possibly reaching a patient during pneumatic operation.

[0067] The drive device 64a is pneumatically connected to the guide channel 88a. A connecting piece is arranged on the guide tube 86a. The drive device 64a is connected to the connecting piece via a hose. The drive device 64a transmits compressed air pulses to the guide channel 88a, thereby accelerating the projectile 62a arranged in the guide channel 88a. The drive device 64a accelerates the projectile 62a within the guide channel 88a.

[0068] The lithotripsy device has at least one sonotrode 10a. The sonotrode 10a has a main extension 82a. The main extension 82a of the sonotrode 10a corresponds to the main extension 36a of the irrigation channel 14a. The sonotrode 10 is arranged at least partially outside the housing 70a. In the present case, the sonotrode 10 is arranged entirely outside the housing 70a. The sonotrode 10a forms at least a large part of the distal section 68a of the lithotripsy device. The sonotrode 10a is tubular. The sonotrode 10a is rigid. The sonotrode 10a is made at least partially of metal, in particular steel.

[0069] The sonotrode 10a is at least partially arranged in / on the ultrasonic horn 12a. In an operating state, the ultrasonic horn 12a transmits ultrasonic waves from the ultrasonic generator 74a to the sonotrode 10a. For this purpose, the sonotrode 10a is connected to the ultrasonic horn 12a. In the present case, the sonotrode 10a and the ultrasonic horn 12a are screwed together. For this purpose, the lithotripsy device has a connecting sleeve 84a. The connecting sleeve 84a encloses a proximal end portion of the sonotrode 10a. The sonotrode 10a is pressed into the connecting sleeve 84a. Alternatively or additionally, the sonotrode can be glued to the connecting sleeve. Furthermore, it is conceivable that such a sonotrode could be formed integrally with such a connecting sleeve.

[0070] The connecting sleeve 84a has an external thread 96a. Furthermore, the ultrasonic horn 12a has an internal thread 98a. The internal thread 98a is located at a distal end of the ultrasonic horn 12a. The internal thread 98a is located on a wall delimiting the recess 80a. The internal thread 98a and the external thread 96a engage with each other to connect the sonotrode 10a and the ultrasonic horn 12a.

[0071] The lithotripsy device has at least one irrigation channel 14a. The irrigation channel 14a is configured to conduct an irrigant. In the present case, the irrigation channel 14a is configured to suction an irrigant. Furthermore, the irrigation channel 14a is configured to suction calculi and / or fragments of calculi transported by the irrigant. Alternatively, such an irrigation channel could also be used to deliver an irrigant. The irrigation channel 14a is at least partially formed by the sonotrode 10a. In the present case, the irrigation channel 14a is formed entirely by the sonotrode 10a. In the present case, the irrigation channel 14a extends only through the sonotrode 10a.A main extension 36a of the irrigation channel 14a is smaller than a total main extension 38a, which is composed of a main extension 82a of the sonotrode 10a and a main extension 100a of the ultrasonic horn 12a. In the present embodiment, the ultrasonic horn 12a is free of an irrigation channel 14a.

[0072] Furthermore, the irrigation channel 14a is arranged entirely outside the housing 70a. No irrigation channel 14a is arranged within the housing 70a. Alternatively, an irrigation channel can also extend at least partially through an ultrasonic horn or be at least partially formed by an ultrasonic horn. In this case, a main extension 36a of the irrigation channel 14a is selected to be smaller than a total main extension 38a, which is composed of the main extension 82a of the sonotrode 10a and the main extension 100a of the ultrasonic horn 12a.

[0073] The sonotrode 10a has at least one radial opening 40a. The radial opening 40a is designed to connect the irrigation channel 14a to further channels carrying irrigant. The radial opening 40a is arranged at a proximal end portion of the sonotrode 10a. The radial opening 40a is arranged at a position at which an antinode of the ultrasonic waves forms in an operating state. The radial opening 40a is formed by a radial recess 80a in a wall of the sonotrode 10a, which wall delimits the irrigation channel 14a. Furthermore, the sonotrode 10a has a further radial opening 42a. The further radial opening 42a is identical to the radial opening 40a. The further radial opening 42a is arranged offset from the radial opening 40a along a circumference of the sonotrode 10a.In the present case, the radial opening 40a and the further radial opening 42a are offset from each other by 180° along the circumference of the sonotrode 10a. The radial opening 40a and the further radial opening 42a are arranged mirror-symmetrically to each other. One axis of mirror symmetry corresponds to a central axis of the sonotrode 10a.

[0074] Within the sonotrode 10a, the irrigation channel 14a has at least one bend 108a. The bend 108a extends toward the radial opening 40a of the sonotrode 10a. In the present case, the irrigation channel 14a has at least one further bend 110a within the sonotrode 10a. The further bend 110a extends toward the further radial opening 424a of the sonotrode 10a. The further bend 110a is mirror-symmetrically opposite the bend 108a. A mirror-symmetrical axis of symmetry in this regard corresponds to a central axis or a main extension 82a of the sonotrode 10a.

[0075] The sonotrode 10a further has at least one axial opening 22a. The axial opening 22a is arranged at a distal end portion of the sonotrode 10a. The axial opening 22a is configured to exchange irrigate with the environment during operation. In addition, the sonotrode 10a has at least one additional radial opening 114a. The additional radial opening 114a is arranged at a distal end portion of the sonotrode 10a. The additional radial opening 114a is configured to exchange irrigate with the environment during operation.

[0076] The connecting sleeve 84a has at least one congruent opening 104a arranged and / or formed congruently with the radial opening 40a of the sonotrode 10a. Furthermore, the connecting sleeve 84a has a further congruent opening 106a arranged and / or formed congruently with the further radial opening 42a of the sonotrode 10a. The further congruent opening 106a is arranged and / or formed congruently with the further radial opening 42a of the sonotrode 10a.

[0077] Fig. 3 shows a schematic representation of a part of the lithotripsy device with a cap 16a in a sectional view. The lithotripsy device has at least one such cap 16a. The cap 16a encloses a gap 20a between itself, the sonotrode 10a, and the ultrasonic horn 12a (cf. Fig. 2 ).

[0078] The cap 16a is formed as a hollow rotational body. The cap 16a is at least partially funnel-shaped. Furthermore, the cap 16a is at least partially hollow-cylindrical. The cap 16a has a distal section 90a. The distal section 90a is hollow-cylindrical. Furthermore, the cap 16a has a proximal section 94a. The proximal section 94a is hollow-cylindrical. The cap 16a has a central section 92a. The central section 92a is funnel-shaped.

[0079] The cap 16a has a main extension 116a. The main extension 116a of the cap 16a is smaller than a main extension 82a of the sonotrode 10a. Furthermore, the main extension 116a of the cap 16a is smaller than a main extension 100a of the ultrasonic horn 12a. In an assembled state, the cap 16a is arranged such that it at least partially encloses the ultrasonic horn 12a and the sonotrode 10a.

[0080] The cap 16a surrounds a distal end portion of the ultrasonic horn 12a. In the present case, the cap 16a coaxially surrounds the distal end portion of the ultrasonic horn 12a.

[0081] The cap 16a coaxially surrounds the distal end portion of the housing 70a. The cap 16a is configured to correspond, at least in sections, to a wall of the ultrasonic horn 12a. Corresponding to a concave wall of the ultrasonic horn 12a, the cap 16a is also concave in the central portion 92a. The cap 16a is configured to correspond, at least in sections, to a wall of the ultrasonic horn 12a.

[0082] The cap 16a is arranged to at least partially coaxially surround the sonotrode 10a. The cap 16a surrounds at least one proximal end portion of the sonotrode 10a. The cap 16a is arranged to cover at least the radial opening 40a of the sonotrode 10a. Furthermore, the cap 16a is arranged to surround the further radial opening 42a of the sonotrode 10a. In addition, the cap 16a surrounds the congruent opening 104a of the connecting sleeve 84a. Furthermore, the cap 16a surrounds the further congruent opening 106a of the connecting sleeve 84a.

[0083] The cap 16a has an axial opening 22a. The axial opening 22a is arranged in the proximal section 94a. An inner diameter of the axial opening 22a corresponds to an outer diameter of the housing 70a. The sonotrode 10a and the ultrasonic horn 12a can be inserted into the cap 16a via the axial opening 22a. Alternatively, an inner diameter of the proximal opening could also correspond to an outer diameter of an ultrasonic horn.

[0084] The cap 16a has a further opening 24a. The further opening 24a is arranged in the distal section 90a. The further opening 24a is formed as an axial opening 22a. An inner diameter of the further axial opening 24a corresponds to an outer diameter of the sonotrode 10a. The sonotrode 10a can be passed through the cap 16a via the further axial opening 24a.

[0085] In an assembled state, the cap 16a rests directly against the housing 70a. Furthermore, the cap 16a can rest against the ultrasonic horn 12a. Alternatively or additionally, however, it is also conceivable for a cap to be arranged directly against an ultrasonic horn.

[0086] The cap 16a has at least one stop 26a. The stop 26a is formed as a step that extends annularly along the entire circumference of an inner wall of the cap 16a. By means of the stop 26a, the cap 16a is supported axially on the housing 70a. Furthermore, the cap 16a can be supported on the ultrasonic horn 12a by means of the stop 26a. The stop 26a is arranged at a position at which a vibration node of the ultrasonic waves forms in an operating state. The ultrasonic horn 12a and / or the housing 70a can have a corresponding stop 120a configured to correspond to the stop 26a, against which the stop 26a rests in an assembled state.

[0087] The lithotripsy device has at least one seal 28a. The seal 28a fluid-tightly seals the enclosed gap 20a between the cap 16a, the sonotrode 10a, and the ultrasonic horn 12a from the environment. The seal 28a is arranged directly between the cap 16a and the housing 70a. In the present case, the seal 28a is designed as an O-ring. An inner wall of the cap 16a has a groove 122a in which the seal 28a is at least partially arranged. The groove 122a is annular. Alternatively, however, a seal could also be arranged between such a cap and an ultrasonic horn. The seal 28a is arranged at a position at which a vibration node of the ultrasonic waves forms in an operating state. In the present case, the seal 28a contacts the housing 70a at the position at which a vibration node of the ultrasonic waves forms in the operating state.

[0088] The lithotripsy device has at least one further seal 29a. The further seal 29a fluid-tightly seals the gap 20a between the cap 16a and the sonotrode 10a. The further seal 29a contacts the sonotrode 10a. The further seal 29a seals the further axial opening 24a of the cap 16a. The further seal 29a is arranged at the distal end of the cap 16a. The further seal 29a is designed as a sealing sleeve. The further seal 29a is slipped onto the cap 16a at the distal end. The cap 16a has a further groove 124a. The further seal 29a is held in the further groove 124a. The further seal 29a is arranged at a position at which an oscillation node of the ultrasonic waves forms in an operating state. At this position, the seal 28a contacts the sonotrode 10a.

[0089] The lithotripsy device has at least one quick connector 34a. The quick connector 34a is configured to arrange the cap 16a on the sonotrode 10a and / or the ultrasonic horn 12a. The quick connector 34a is configured to establish a connection that can be released without the use of tools and without causing damage. In the present case, the connection is a force-locking and / or positive-locking connection. The quick connector 34a is configured, in particular, to connect the cap 16a to the housing 70a. The cap 16a at least partially forms the quick connector 34a. The cap 16a has at least one connecting part. The connecting part at least partially forms the quick connector 34a. The connecting part is a bayonet connector guide. The quick connector 34a can, for example, be a bayonet lock, a quick-action lock, a screw lock, or the like.

[0090] The connecting part has a longitudinal slot. Furthermore, the connecting part has a transverse slot extending at a right angle to the end of the longitudinal slot. Alternatively, the connecting part can also be a locking tab or hook, a thread, or the like. It is conceivable for the cap to have at least two or more connecting parts, which can be arranged offset from one another, in particular, along a circumference of the cap.

[0091] Furthermore, the housing 70a at least partially forms the quick connector 34a. The housing 70a has a corresponding connecting part designed to correspond to the connecting part. The corresponding connecting part at least partially forms the quick connector 34a. In the present case, the corresponding connecting part is a bayonet connector head. The corresponding connecting part can be inserted into the transverse slot of the connecting element. Furthermore, the corresponding connecting part can be firmly connected to the connecting element by twisting it in the longitudinal slot of the connecting element. It is conceivable for the housing to have at least two or more corresponding connecting parts, which can be arranged offset from one another, in particular along a circumference of the housing. Alternatively, the corresponding connecting part can also be a locking lug, a counter thread, or the like.It is also conceivable that the cap has at least one corresponding connecting part instead of the housing, and the housing has the connecting part instead of the cap. If multiple connecting parts and corresponding connecting parts are present, it is conceivable that the cap has both connecting parts and corresponding connecting parts, and the housing has multiple corresponding connecting parts and connecting parts.

[0092] The lithotripsy device has at least one discharge channel 18a. The discharge channel 18a is at least partially formed by the gap 20a enclosed between the cap 16a, the sonotrode 10a, and the ultrasonic horn 12a. The discharge channel 18a is configured to cool the sonotrode 10a and / or the ultrasonic horn 12a. Furthermore, the discharge channel 18a is configured to discharge the irrigated fluid from the irrigation channel 14a. The discharge channel 18a is fluidically connected at least to the irrigation channel 14a. The discharge channel 18a is connected to the irrigation channel 14a at least via the radial opening 40a. In the present case, the discharge channel 18a is fluidically connected to the irrigation channel 14a via the radial openings 40a, 44a and the congruent openings 104a, 106a of the connecting sleeve 84a.

[0093] The discharge channel 18a extends at least partially along the sonotrode 10a and / or the ultrasonic horn 12a. The discharge channel 18a extends at least partially transversely of the sonotrode 10a and / or the ultrasonic horn 12a. The discharge channel 18a at least partially surrounds a casing of the sonotrode 10a and / or the ultrasonic horn 12a. The discharge channel 18a is at least partially tubular. The discharge channel 18a is at least partially funnel-shaped. In the region of the distal section 90a of the cap 16a, the discharge channel 18a is tubular. In the region of the central section 92a of the cap 16a, the discharge channel 18a is funnel-shaped.

[0094] The discharge channel 18a is fluidically connected to the conveying device 60a. The cap 16a has at least one connection 30a. The discharge channel 18a opens toward the connection 30a. The discharge channel 18a is fluidically connected to the conveying device 60a via the connection 30a. In the present case, the connection 30a is designed as a nozzle. The connection 30a is formed separately from a wall of the cap 16a. Alternatively, however, the connection could also be formed integrally with the wall of the cap.

[0095] Fig. 4 shows a schematic flow chart of an exemplary method for manufacturing the lithotripsy device.

[0096] The method comprises at least one method step 150a. In method step 150a, the cap 16a is arranged on the sonotrode 10a or the ultrasonic horn 12a. Alternatively, instead of the cap 16a, the additional cap 48a of a kit of a lithotripter with a lithotripsy device, such as in Fig. 5 shown. The sonotrode 10a is inserted into an axial opening 22a of the cap 16a. The cap 16a is pushed proximally onto the sonotrode 10a. The cap 16a is pushed until the stop 26a of the cap 16a rests against the ultrasonic horn 12a. Furthermore, the cap 16a is pushed until its stop 26a rests against the housing 70a.

[0097] The method comprises at least one further method step 152a. In method step 152a, the cap 16a is fastened. The quick connector 34a is used for this purpose. The connecting part and the corresponding connecting part of the quick connector 34a are firmly connected to one another. For this purpose, the corresponding connecting part is inserted into the transverse slot of the connecting element. Furthermore, the corresponding connecting part is rotated in the longitudinal slot of the connecting element.

[0098] Following this procedure, the lithotripsy device can be connected to other components of the lithotripsy system. For example, the drive device can be connected to the guide channel. Furthermore, the conveyor unit can be connected to the discharge channel. To disassemble the lithotripsy device, especially for cleaning, the above process steps are performed in reverse order.

[0099] Fig. 6 shows a schematic flowchart of an exemplary method for testing the lithotripsy device outside the body. This method is a test procedure for testing, for example, the sequence or duration of a surgical procedure.

[0100] The method comprises at least one method step 154a. In method step 154a, the lithotripsy device is activated. Activation occurs by operating the actuating means 58a. The control electronics of the control unit 52a start the drive unit. The control electronics of the control unit 52a start the conveyor device 60a. The control electronics of the control unit 52a start the ultrasound generator 74a.

[0101] The method comprises a further method step 156a. In the further method step 156a, the sonotrode 10a is brought into contact with a calculus. The calculus can be a test specimen whose properties are similar to kidney stones or other body stones. The ultrasonic waves provided by the ultrasonic generator 74a are transmitted by the ultrasonic horn 12a to the sonotrode 10a. Furthermore, the ultrasonic waves are focused by the ultrasonic horn 12a. The sonotrode 10a in turn transmits the ultrasonic waves to the calculus. Furthermore, the drive device 64a accelerates the projectile 62a in the guide channel 88a. The projectile 62a transmits its impact pulse to the sonotrode 10a. The sonotrode 10a emits the impact pulse to the calculus.

[0102] The method comprises a further method step 158a. In the further method step 158a, an irrigant with which the calculus is rinsed is suctioned off by means of the conveying device 60a. The conveying device 60a generates a negative pressure, whereby the irrigant is conveyed into the irrigation channel 14a. The irrigant flows through the axial opening 22a of the sonotrode 10a into the irrigation channel 14a. Furthermore, the irrigant flows through the additional radial opening 114a into the irrigation channel 14a. For example, a larger portion of the irrigant flows through the additional radial opening 114a if the axial opening 22a is blocked by the calculus axially adjacent to the sonotrode 10a. The irrigant transports away fragments of the calculus treated with ultrasound and / or shock pulses. The irrigant is discharged via the discharge channel 18a.The irrigate is transported from the irrigation channel 14a to the discharge channel 18a by means of the conveying device 60a. The irrigate flows through radial openings 40a, 42a of the irrigation channel 14a into a gap 20a between the cap 16a, the sonotrode 10a, and the ultrasonic horn 12a. This gap 20a forms the discharge channel 18a during operation. Furthermore, the irrigate is transported from the discharge channel 18a. The irrigate is transported from the discharge channel 18a via the connection 30a of the cap 16a.

[0103] In the Fig. 7 A further embodiment according to the disclosure is shown. The following descriptions and the drawings are essentially limited to the differences between the embodiments, whereby with regard to components with the same designation, in particular with regard to components with the same reference numerals, reference is also made to the drawings and / or the description of the other embodiments, in particular to the Figures 1 to 6 All combinations of the embodiments mentioned here are also to be considered as disclosed. To distinguish the embodiments, the letter a is added to the reference numerals of the embodiment in the Figures 1 to 6 In the example of the Figure 7 the letter a is replaced by the letters b.

[0104] Fig. 7 shows a schematic representation of a further embodiment of a lithotripsy device in a sectional view. The present lithotripsy device differs from the previous one essentially in the design of an irrigation channel 14b of the lithotripsy device. In the present case, the irrigation channel 14b extends through both a sonotrode 10b of the lithotripsy device and an ultrasonic horn 12b of the lithotripsy device.

[0105] Within the ultrasonic horn 12b, the irrigation channel 14b has at least one bend 108b. Along the bend 108b, the irrigation channel 14b bends. In the present case, the irrigation channel 14b bends by 90°. Furthermore, the irrigation channel could also bend by an angle of at least 0° and at most 90°. Furthermore, the irrigation channel could have a bend 108b within the sonotrode. Furthermore, the irrigation channel 14b has at least one further bend 110b. The further bend 110b is mirror-symmetrically opposite the bend 108b. In the present case, a mirror-symmetry axis is equal to a central axis of the sonotrode 10b.

[0106] The ultrasonic horn 12b has at least one radial opening 40b. The angled portion 108b extends toward the radial opening 40b. Thus, the irrigation channel 14b opens toward a discharge channel 18b of the lithotripsy device. Furthermore, the ultrasonic horn 12b has at least one further radial opening 42b. The further radial opening 42b is located mirror-symmetrically opposite the radial opening 40b. In the present case, a mirror-symmetrical axis of symmetry is equal to a central axis of the ultrasonic horn 12b.

[0107] Figs. 8 and 9 show a schematic representation of an additional embodiment of a lithotripsy device in a sectional view. The present lithotripsy device differs from the previous one essentially in a design of a cap 16c of the lithotripsy device.

[0108] In the present case, the cap 16c is configured for mounting a sonotrode 10c of the lithotripsy device. The lithotripsy device has a fastening means 160c. The fastening means 160c is arranged on the sonotrode 10c. In the present case, the fastening means is integrally connected to the sonotrode. The fastening means is welded to the sonotrode.

[0109] The fastening means 160c is designed as a screw. The fastening means 160c has a screw head 162c. The screw head 162c is integrally connected to the sonotrode 10c. The screw head 162c is welded to the sonotrode 10c. In this case, the screw head 162c is designed as a hexagon screw head. Furthermore, the fastening means 160c has a screw thread 166c. The screw thread 166c is integrally formed with the sonotrode 10c. The screw thread 166c is formed by a casing of the sonotrode 10c.

[0110] The lithotripsy device has a further fastening means 168c configured to correspond to the fastening means 160c. The further fastening means 168c is arranged on an ultrasonic horn 12c of the lithotripsy device. In the present case, the further actuating means 168c is integrally connected to the ultrasonic horn 12c. The further fastening means 168c has a threaded socket 170c. The threaded socket 170c is embedded in the ultrasonic horn 12c.

[0111] The fastening means 160c and the additional fastening means 168c are configured to connect the sonotrode 10c to the ultrasonic horn 16c. In this case, the connection is a screw connection.

[0112] To actuate the fastening means 160c during assembly, the cap 16c has at least one tool 172c. In this case, the tool 172c is firmly connected to a wall of the cap 18c, for example, by adhesive bonding. Alternatively, the tool can be formed integrally with the wall of the cap. For example, the wall and the tool can be made from a single cast.

[0113] The tool 172c is configured to correspond to the fastening means 160c. In the present case, the tool 172c is a socket. In this case, it is a hexagon socket. The tool 172c is formed integrally with an inner wall of the cap 16c. When the sonotrode is mounted, the tool 172c and the fastening means 160c are arranged with play relative to one another, thus preventing vibrations from being transmitted from the sonotrode to the cap.

[0114] Furthermore, the tool 172c or the wall of the cap 16c can have a predetermined breaking point, which releases the tool from the wall when the sonotrode 10c is attached and a predetermined force and / or torque is reached. The tool 172c can then be designed like a shear screw. This prevents damage to the sonotrode 10c. Furthermore, the tool 172c can subsequently be removed.

[0115] The cap 16c has at least one handle 174c. The handle 174c is configured for manual actuation of the cap 16c during assembly of the sonotrode 10c to the ultrasonic horn. The handle 174c is designed in the form of a projection. The handle 174c functions as a type of lever, ensuring that the fastening means 160c can be tightened with a specified torque.

[0116] The cap 16c and the sonotrode 10c together form an assembly module. During assembly, this assembly module can be arranged as a whole on the ultrasonic horn 12c. The tool 172c is arranged congruently with the fastening means 160c so that they engage with each other. Furthermore, the fastening means 160c is arranged congruently with the further fastening means 168 so that they engage with each other. By transmitting a force and / or a torque from the handle 174c to the tool 172c and from the latter to the fastening means 160c, the fastening means 160c and the further fastening means 168c can then be connected to each other. 10 Sonotrode 68 Distal section 12 Ultrasonic horn 70 Housing 14 Irrigation channel 72 Handle 16 cap 74 Ultrasonic generator 18 drainage channel 78 Ultrasonic actuator 20 gap 80 recess 22 Axial opening 82 Main extension of the sonotrode 24 Further axial opening 84 connecting sleeve 26 stop 86 guide tube 28 seal 88 guide channel 29 Further sealing 90 Distal section 30 Connection 92 Middle section 34 Quick connector 94 Proximal section 36 Main extension of the irrigation canal 96 external thread 98 internal thread 38 Total main extension 100 Main extension of the ultrasonic horn 40 Radial opening 42 Further radial opening 104 Congruent opening 46 Lithotripter 106 Further congruent opening 48 Additional cap 108 Bending 50 Lithotripsy system 110 Further bending 52 control unit 114 Additional radial opening 58 Actuating means 116 Main extension of the cap 60 conveyor system 120 Corresponding stop 62 projectile 122 Groove 64 drive device 124 Further groove 66 Proximal section 150 Process step 152 Process step 154 Process step 166 screw thread 156 Process step 168 Additional fastening material 158 Process step 170 threaded socket 160 Fasteners 172 Tool 162 screw head 174 Handle

Claims

1. A lithotripsy device, in particular intracorporeal lithotripsy device, having at least one sonotrode (10a, 10b, 10c) which is configured to apply at least ultrasonic waves to concretions, having at least one fastening means which is designed for fastening the sonotrode to an ultrasonic horn (12a, 12b, 12c) which is configured at least for focussing and / or transmitting ultrasonic waves to the sonotrode (10a, 10b, 10c), and having at least one cap (16a, 16c) which, in a mounted state, is arranged at least partially surrounding the sonotrode (10a, 10b, 10c) and / or the ultrasonic horn (12a, 12b, 16c), characterised in that the cap (16a, 16c) is configured for mounting the sonotrode (10a, 10b, 10c) on the ultrasonic horn by means of the fastening means.

2. The lithotripsy device according to claim 1, characterised in that the cap (16c) comprises at least one tool (172c) which is designed to correspond to the fastening means (160c) and which is configured to actuate the fastening means (160c) when the sonotrode (10c) is mounted on the ultrasonic horn (12c).

3. The lithotripsy device according to claim 1 or 2, characterised in that the cap (16c) comprises at least one handle (174c) which is configured for manual actuation of the cap (16c) when the sonotrode (10c) is mounted on the ultrasonic horn (12c).

4. The lithotripsy device according to one of the preceding claims, characterised in that the cap (16a) is arranged coaxially surrounding the sonotrode (10a, 10b) and / or the ultrasonic horn (12a, 12b).

5. The lithotripsy device according to one of the preceding claims, characterised in that the cap (16a) is designed to correspond to the sonotrode (10a, 10b) and / or the ultrasonic horn (12a, 12b).

6. The lithotripsy device according to one of the preceding claims, characterised in that the cap (16a) has at least one axial opening (22a) through which the sonotrode (10a, 10b) extends.

7. The lithotripsy device according to one of the preceding claims, characterised in that the cap (16a) has at least one further axial opening (24a) through which the ultrasonic horn (12a, 12b) extends.

8. The lithotripsy device according to one of the preceding claims, characterised in that the cap (16a) is designed to be at least partially transparent.

9. The lithotripsy device according to one of the preceding claims, characterised in that the cap (16a) is configured as a disposable component.

10. A lithotripter (46a) having at least one lithotripsy device according to one of the preceding claims.

11. A lithotripsy system (50a) having a lithotripter (46a) according to claim 10 and having at least one control unit (52a) which is configured at least for controlling at least the lithotripter (46a).

12. A method for creating and / or operating at least one lithotripsy device outside the body according to one of claims 1 to 9.