DE102022126992A1 - Hollow probe for crushing body stones for a lithotripsy device with a crushing element, lithotripsy device, retrofit kit and method for manufacturing a hollow probe - Google Patents

Abstract

The invention relates to a hollow probe for crushing body stones for a lithotripsy device, wherein the hollow probe has a lateral surface with an outer surface and an inner surface, a cavity along its longitudinal central axis and a distal end in a distal direction for crushing body stones, wherein the hollow probe has at least one crushing element on its inner surface for crushing a body stone core entering the cavity of the hollow probe in the opposite direction to the distal direction. The invention further relates to a lithotripsy device for crushing body stones, a retrofit kit for retrofitting an existing lithotripsy device and a method for manufacturing a hollow probe.

Description

The invention relates to a hollow probe for breaking up body stones for a lithotripsy device, wherein the hollow probe has a lateral surface with an outer surface and an inner surface, a cavity along its longitudinal central axis and a distal end in a distal direction for breaking up body stones. Furthermore, the invention relates to a lithotripsy device, a retrofit kit for retrofitting an existing lithotripsy device and a method for producing a hollow probe from a hollow tube.

Lithotripsy is a well-known method for breaking up body stones, which form as so-called concretions in body organs such as the bladder or kidneys through condensation and/or crystallization of salts and proteins. 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 up stones can be removed through natural excretion and/or by means of a suction-irrigation pump.

For example, pneumatic lithotripters are based on the percussion hammer principle, in which a projectile is accelerated within an acceleration tube and the kinetic energy of the projectile is transferred via an elastic impact to the proximal end of a probe and/or sonotrode and then to its distal end to fragment the body stone. Regardless of the generation of the shock waves or deformation waves, for example by means of lasers, pneumatic energy sources and/or ultrasound, stone fragments that arise during crushing should be removed as soon as possible after they are formed so that these fragments do not circulate uncontrollably in the organ and may not be able to be found again.

In order to remove stone fragments directly from the organ during crushing, hollow probes are usually used in lithotripsy devices to remove and/or suck out stone fragments through the hollow space of the respective hollow probe. However, hollow probes can have cross-sectional constrictions in their inner cavity along their length due to roughness, production tolerance and/or mechanical deformation, in which stone fragments and/or drill cores can get caught and/or jammed. Such blockages inside a hollow probe cause a disadvantageous loss of time due to the necessary unblocking measures and thus possibly extend the duration of the operation. Furthermore, conventional hollow probes are usually not secured against rotation, so that after the laborious disassembly and manual poking of fragments in the cavity, for example using a wire, the hollow probe has to be laboriously reinstalled.

In addition, existing lithotripsy probes can, due to incorrect operation, for example if the hollow probe tip is used for too long without stopping on a body stone, result in overly long core samples inside the hollow probe, which can then lead to blockages at more proximal points of the suction line. These overly long core samples, due to uninterrupted, non-stop operation, get stuck in narrow bends in the irrigation channel and block it. For design reasons, narrow bends in the suction channel are usually unavoidable.

With known hollow probes, there is a risk that overly long cores will form, especially in the distal end section of the cavity, which can only be removed in the proximal direction very slowly and with difficulty due to friction on the inner surface of the hollow probe and proximal-side deflections. Overly long cores get stuck in a cross hole to the suction line in the probe head and block the suction path.

From the DE 195 00 893 A1 A device for breaking up concretions using a hollow probe is known, whereby the hollow probe consists of a tube, a probe base and a hollow probe tip, whereby these three components can be plugged into one another and are secured to one another via a soldered connection. By plugging and joining the hollow probe tip into the probe tube, the inlet opening is narrowed and clogging of the probe tube can be avoided. The hollow probe also has an outlet opening outside the housing of the lithotripter for suctioning out crushed concretions. The disadvantage here is that a connection device for receiving a suction hose is attached to the distal side of the housing, thus limiting the working area, and that there is an increased risk of clogging if the holes do not match up due to the rotatable connection device. There is also a risk that the soldered connection will come loose due to the high load and the hollow probe tip will remain behind when used in a body to be treated.

The object of the invention is to improve the state of the art.

The object is achieved by a hollow probe for crushing body stones for a lithotripsy device, wherein the hollow probe has a lateral surface with an outer surface and an inner surface, a cavity along its longitudinal central axis and, in a distal direction, a distal end for crushing body stones, wherein the hollow probe has at least one crushing element on its inner surface for crushing a body stone core entering the cavity of the hollow probe against the distal direction.

Thus, a hollow probe is provided for crushing body stones, in which, when a body stone is crushed with the hollow probe tip, a body stone core entering the hollow space of the hollow probe can be further crushed directly by means of the at least one crushing element on the inner surface before the body stone core reaches the proximal cavity and/or a proximal cross-bore to a suction line and thereby causes a blockage. Because particularly overly long body stone cores are crushed directly within the hollow space of the hollow probe by means of the at least one crushing element and thus broken into stone fragments, their removal in the proximal direction is facilitated and accelerated and the risk of a blockage in the hollow space of the hollow probe and/or on the proximal side at the transition to a cross-bore to the suction line is significantly reduced.

As a result, broken stones and/or drill cores that have been created in the body can be removed safely and without clogging via the hollow probe's cavity, without the risk of stone fragments remaining in the body and migrating into the organ. Because long drill cores are broken up and removed as stone fragments through the cavity in a proximal direction due to the at least one crushing element on the inner surface of the hollow probe, time-saving, uninterrupted operation of the hollow probe on a large stone is possible. As a result, long-lasting, continuous and time-saving stone crushing can be achieved using the hollow probe without the hollow probe having to be set down and the crushing of the stones in the body having to be interrupted.

Because the crushing element is arranged on the inner surface of the hollow probe and protrudes into the cavity, the crushing element causes a transverse force at an angle or essentially perpendicular to the longitudinal central axis of the hollow probe and to the transport direction of the body stone cores and/or fragments to the proximal end of the hollow probe. Due to the fixed arrangement of the at least one crushing element on and/or in the inner surface of the hollow probe, a continuous crushing of long body cores entering the cavity of the hollow probe one after the other takes place during the crushing of a body stone. Due to the transverse force of the at least one crushing element on the body stone core, it preferably breaks off at the base of the remaining body stone due to the acting torque and/or the material load. However, the body stone core can also break in other places. A body stone core can also break in the middle within the cavity or into two or more fragments with different lengths along the longitudinal central axis. By designing the at least one crushing element, the effective transverse force and the maximum remaining fracture length of the body stone fragment and/or the body stone fragments can be specified and/or adjusted. For this purpose, the at least one crushing element is designed in such a way that the crushed stone fragments can be safely transported away in the proximal direction and more proximal locations in the drainage channel can be passed without any problem.

A key idea of the invention is to partially narrow the cross-section of the hollow space of the hollow probe at an angle or transversely to the longitudinal center axis of the hollow probe by means of at least one comminution element on the inner surface of the hollow probe and to specifically crush a body stone that has entered the hollow space during its transport in the proximal direction due to the transverse forces and/or clamping forces acting by means of the at least one comminution element, thereby creating shorter and/or smaller body stone fragments which are removed from the hollow probe, the probe head and/or the lithotripsy device without the risk of blockage during further transport through the hollow space and the suction channel. In this way, a local, short-term blockage is deliberately caused by a drill core that has entered the hollow space of the hollow probe on the at least one comminution element protruding into the cavity in order to crush it with the forces acting in this process. This improves both the service life of the hollow probe and the uninterrupted, efficient removal performance of the hollow probe when breaking up body stones.

• Eine „Hohlsonde“ ist insbesondere ein längliches Bauteil, welches in seinem Inneren in Längsrichtung zumindest teilweise oder vollständig durchgehend einen Hohlraum aufweist. Die Hohlsonde weist an ihrem distalen Ende insbesondere eine distale Öffnung auf, welche mit dem innenliegenden Hohlraum verbunden ist. Eine Hohlsonde ist beispielsweise röhren- und/oder schlauchförmig ausgebildet. Die Hohlsonde ist insbesondere durch Einwirken und/oder Einleiten von mechanischen Schwingungen selbst in Schwingung, Resonanzschwingung und/oder Verformungsschwingungen versetzbar. Bei einer Hohlsonde kann es sich auch um eine Sonotrode handeln oder die Hohlsonde ist Bestandteil einer Sonotrode. Die Hohlsonde ist insbesondere einstückig ausgebildet. Die Hohlsonde weist insbesondere einen Durchmesser in einem Bereich von 0,5 mm bis 4,5 mm, insbesondere von 0,8 mm bis 3,8 mm, auf. Die Hohlsonde weist insbesondere Stahl, Titan, Aluminium und/oder Carbon auf. Bei einer Hohlsonde kann es sich insbesondere um eine Mehrwegsonde oder eine Einwegsonde handeln.

The following terminology is explained:

• A “hollow probe” is in particular an elongated component which has a hollow space in its interior which is at least partially or completely continuous in the longitudinal direction. The hollow probe points at its distal end into the in particular a distal opening which is connected to the internal cavity. A hollow probe is, for example, tubular and/or hose-shaped. The hollow probe can itself be set into vibration, resonance vibration and/or deformation vibration, in particular by the action and/or introduction of mechanical vibrations. A hollow probe can also be a sonotrode or the hollow probe can be a component of a sonotrode. The hollow probe is in particular formed in one piece. The hollow probe in particular has a diameter in a range from 0.5 mm to 4.5 mm, in particular from 0.8 mm to 3.8 mm. The hollow probe in particular comprises steel, titanium, aluminum and/or carbon. A hollow probe can in particular be a reusable probe or a disposable probe.

In a pneumatic lithotripsy device, a specifically shaped deformation wave is impressed by means of impact energy when a projectile strikes a distal-side stop element, in particular the hollow probe. The deformation wave causes in particular a translational movement of the hollow probe, which causes stone fragmentation due to the deflection. In addition to the mechanical impact, the hollow probe can also be excited into an oscillation, in particular a longitudinal oscillation, in particular by means of an oscillation excitation device, for example with an ultrasonic oscillation exciter. The hollow probe is thus designed in particular as a waveguide for the oscillation waves generated by an oscillation excitation device and/or for the deformation waves of the projectile.

The proximal end of the hollow probe can in particular rest directly or indirectly on the distal stop element. The hollow probe is preferably fitted on the proximal side in a holding nipple that is thicker than its diameter. The corresponding nipple can also be a head piece or base body. The hollow probe as an insertion part is in particular accommodated in a receiving unit in the thicker head piece. The receiving unit is, for example, a hole in the head piece in which the proximal end and/or the proximal end sections of the hollow probe are firmly and/or permanently fitted, for example soldered. The head piece of the hollow probe is preferably movably mounted. The hollow probe is in particular shaped in such a way that it optimally introduces the vibration waves, deformation waves and/or the ultrasonic vibrations at its distal end into the body, the body region to be treated and/or directly onto the body stone to be broken up. The hollow probe (also called probe tube), the receiving unit and the base body/head piece form a sonotrode.

A “surface surface” is understood to mean in particular the surface of the hollow probe and/or the probe tube without the two opposite frontal annular surfaces at the distal end and the proximal end of the hollow probe and/or the probe tube.

An “outer surface” of the hollow probe is in particular the surface on the outside of the hollow probe aligned with the environment. The “inner surface” of the hollow probe is in particular the inner surface of the hollow probe aligned with the cavity. A “cavity” (also called probe lumen) is in particular a hollow space inside the hollow probe. The cavity extends in particular from a distal opening of the hollow probe partially or completely to the proximal end of the hollow probe along its longitudinal direction and/or longitudinal central axis. A “longitudinal central axis” is in particular the axis of the hollow probe and/or the probe tube, which corresponds to the direction of the greatest extension and/or dimension of the hollow probe and/or the probe tube. The longitudinal central axis can also be the axis of symmetry of the hollow probe and/or the probe tube.

The terms “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, the terms “proximal” and “proximal” refer to an arrangement close to the user and thus far from the patient’s body or a corresponding end or section.

A “crushing element” is in particular any type of element that causes a crushing of body stone cores entering the hollow space of the hollow probe. The crushing element is in particular arranged on and/or in the inner surface of the hollow probe. The crushing element can be a component that is connected to and/or to the inner surface of the hollow probe. If the crushing element is designed as a separate component, it can be connected to the inner surface of the hollow probe by means of a material connection, for example. The crushing element is preferably formed directly by reshaping the outer surface of the hollow probe, for example by pressing and/or embossing. The crushing element in particular protrudes at least partially into the hollow space of the hollow probe and thereby at least partially restricts the cross section of the hollow space of the hollow probe. The cross section of the crushing element can also be in the Essentially completely arranged within the cavity of the hollow probe. In principle, the comminution element can have any shape in cross-section and in the longitudinal direction. For example, the comminution element can have a triangular, round, oval and/or polygonal shape in cross-section. The cross-sectional shape of the comminution element can change in particular in the direction along the longitudinal center axis of the hollow probe. Thus, for example, the comminution element can have a triangular shape at its distal end and a round shape in cross-section at its proximal end. The comminution element is in particular shaped such that a transverse force acts obliquely or essentially transversely to the longitudinal center axis of the hollow probe on a body stone core moving in the proximal direction and thus along the longitudinal center axis. For comminution of body stone cores, the comminution element can in particular be designed and/or shaped such that the body stone core is comminuted by breaking and/or cutting. The breaking can, for example, take place at a section of the crushing element that extends furthest into the hollow space of the hollow probe. For cutting, the crushing element can, for example, have a sharp cutting edge directed in the distal direction. The crushing of body stone cores using the crushing element can be enhanced and used in a targeted manner, in particular by impact excitation and/or vibration excitation of the hollow probe when the hollow probe is used in a lithotripsy device. The crushing element can be designed to be closed and thus form a barrier between the hollow space of the hollow probe and the external environment. The crushing element can also be designed to be open and thus have one or more openings that allow passage into the hollow space of the hollow probe from the environment.

A "lithotripsy device" (also called a "lithotripter") is in particular a device for breaking up body stones by means of 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, this can additionally have a flushing/suction pump. The lithotripsy device can be designed as a hand-held device and/or have an endoscope or can be inserted into an endoscope. The lithotripsy device is in particular autoclavable and has, for example, instrument steel and/or plastic. The lithotripsy device can have further components, such as a control and/or supply device, or these are assigned to the lithotripsy device. A lithotripsy device is in particular a pneumatic lithotripsy device.

“Body stones” (also called “concrements”) are understood to mean all stones in a human or animal body that are formed from salts and proteins through crystallization and/or condensation. Body stones can be, for example, gallstones, urinary stones, kidney stones and/or salivary stones. When the sonotrode and/or hollow probe acts on the body stone, body stone cores (also called drill cores) and/or body stone fragments are created.

A "projectile" is in particular a body which is freely movable along an acceleration path within a cavity of an acceleration tube and/or guide tube of a lithotripsy device. The projectile is in particular movable back and forth between a proximal stop element and a distal stop element within the cavity of the acceleration tube and/or guide tube arranged therebetween. The projectile can also be surrounded by a control sleeve within the guide tube. In principle, the projectile can have any shape. For example, the projectile can have the shape of a bolt or a ball. The projectile in particular has hard steel and/or magnetic properties. For free mobility, the projectile in particular has a slightly smaller outer diameter than the diameter of the cavity of the acceleration tube, guide tube and/or control sleeve. For example, the projectile can have an outer diameter of 8 mm, preferably 6 mm. The projectile can be moved back and forth in particular between the proximal-side stop element and the distal-side stop element and thus along an acceleration path continuously, for example by means of a pressure medium of the drive device. Preferably, the projectile is moved back and forth continuously intermittently and/or oscillatingly between the proximal-side stop element and the distal-side stop element.

A “carrier unit” is in particular a hand 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. tripsy device. The carrier unit can also be arranged, connected and/or guided automatically at a distal end of a robot arm. The carrier unit has in particular a housing.

A “drive device” can in principle be any type of device that exerts a force on the projectile and thus causes the projectile to move. The drive device can, for example, be a device that accelerates the projectile by means of a laser, a pressure medium, for example pneumatically using compressed air, by means of an electromagnetic field and/or by means of a mechanical device. A drive device can, in particular, exert a force on the projectile and thus cause the projectile to move by supplying and/or removing a pressure medium. The drive device in particular enables the pressure medium to flow continuously and evenly through proximal and distal through-openings in the guide tube and proximal and distal openings in the control sleeve and accelerates the projectile within the cavity of the control sleeve and/or the guide tube.

A "vibration excitation device" is in particular a component of an ultrasonic transducer and/or a lithotripsy device, which converts a supplied alternating voltage with a specific frequency into a mechanical vibration frequency. The vibration excitation device is in particular an electromechanical transducer using the piezoelectric effect. By applying the electrical alternating voltage generated by an ultrasonic generator, a mechanical vibration is generated due to a deformation of the vibration excitation device. The vibration excitation device in particular has one or more piezo elements. The vibration excitation device preferably has at least two piezo elements, with an electrical conductor, for example a copper disk, arranged between the piezo elements. In the case of ultrasonic excitation, the sonotrode works in particular in the ultrasonic range with a frequency range of 20 kHz to 90 kHz, preferably from 20 kHz to 34 kHz.

In a further embodiment, the hollow probe has a second comminution element, a third comminution element, a fourth comminution element and/or further comminution elements on its inner surface.

Thus, two or more crushing elements can be arranged at a distance on the inner surface along the cross section and/or at a distance along the longitudinal center axis. By arranging two or more crushing elements along the longitudinal center axis, the crushing of body stone cores and the resulting fragments can be carried out step by step and each resulting fragment can be further crushed by the next crushing element in the proximal direction.

The second, third, fourth and optionally further shredding elements are, in particular in terms of function, a shredding element as described above. However, the two or more shredding elements can have different shapes and/or properties, such as different material thicknesses and/or dimensions.

In order to crush a body stone core entering the cavity of the hollow probe in the opposite direction to the distal direction at an early stage and thus prevent further transport of the overly long body stone even in the proximal direction, the at least one crushing element or the crushing elements are arranged at a distal end section in the distal direction in front of the distal end.

Consequently, a body stone entering through the distal opening at the distal end of the hollow probe is crushed as soon as possible after entry during further transport in the proximal direction by the first crushing element, so that clogging of the cavity is prevented in the distal end section of the hollow probe by crushing the body stone core into two or more fragments and further transport of the resulting fragments in the proximal direction is facilitated. Preferably, the distal end of the hollow probe and the first crushing element are arranged in relation to one another in the proximal direction in such a way that maximum fragment lengths of < 30 mm, in particular < 20 mm, preferably 10 mm, are created due to the crushing by means of the first crushing element.

For an optimal crushing effect with moderate friction between the entering body stone core and the first crushing element, the distal opening through which the body stone core enters the cavity of the hollow probe and the first subsequent crushing element can be arranged offset from one another in the proximal direction with respect to the longitudinal central axis and/or coordinated with one another. Because the first crushing element is arranged directly after the distal opening of the hollow probe and thus directly after the location of the formation of crushed body stones in the body and/or a drill core, their targeted crushing by means of the first The crushing element enables the stone to be pushed forward in the cavity in terms of time and place before a blockage on the proximal side can occur. At the same time, the counterpressure of the body stone against the crushing element causes an early advance in the proximal direction, which presses the body stone core against, along and/or through the crushing element and as a result body stones and/or fragments located in the cavity on the proximal side are pushed further in the direction of the suction line.

In a further embodiment of the hollow probe, the comminution elements are arranged radially circumferentially and/or offset in the distal direction on the inner surface.

By arranging the crushing elements offset and/or alternately on and/or in the inner surface of the hollow probe, further crushing and/or shortening of body stone cores and/or fragments is achieved. In addition, two crushing elements can be arranged on opposite sides on the inner surface of the hollow probe, so that a body stone core is cut and/or pressed in from two sides at the same time when it passes through the two opposing crushing elements and is thus crushed. The offset arrangement also allows forces to be exerted on the body stone core or fragment from different directions using the crushing elements. For example, the first crushing element can have a triangular shape in cross-section with a downward-facing cutting edge at its lower corner, so that the body stone is cut in the direction of the longitudinal center axis when it passes through the crushing element. The next crushing element can then, for example, exert a breaking effect on the body stone core that has already been cut in the longitudinal direction in the direction of the transverse axis perpendicular to the longitudinal center axis, and can thereby engage in the incision. The crushing force and/or the cutting depth in the proximal direction can also be increased continuously or stepwise by means of several crushing elements spaced apart in the longitudinal direction and extending into the cavity to different depths, thus also capturing the increasingly further crushed fragments.

In order to use a wedge effect and/or notch effect to split body stones in the body by means of an external taper, to simultaneously limit a diameter of a body stone core entering the cavity of the hollow probe in the proximal direction by means of an internal taper in the distal direction and/or to optimally spatially align the incoming body stone core with the comminution element arranged in the proximal direction, the hollow probe has a taper in the distal direction at its distal end and/or at the distal end section.

Due to the tapering of the distal hollow probe tip in the distal direction and thus an expansion of the cross-section of the cavity in the proximal direction, the diameter of the incoming body stone core is limited to the inner diameter at the distal opening of the hollow probe. As a result, the incoming body stone core lies with its distal end essentially flush with the inner surface in the area of the distal opening and is pressed with its proximal end and/or proximal end section by the first comminution element in the proximal direction in the direction of the transverse axis transversely or diagonally to the longitudinal center axis of the hollow probe. As a result, the body stone core is clamped at its distal end and its proximal end on the inner surface and the comminution element, which promotes the breaking up of the body stone core during further transport. Due to the conical expansion of the cavity from the tapered hollow probe tip in the distal direction towards the crushing element, the body stone core is not transported concentrically to the longitudinal central axis of the cavity of the hollow probe, but tilts away from this longitudinal central axis, which promotes breaking at the base of the body stone to be crushed and/or central breaking of the body stone core by clamping on both sides.

A “taper” is in particular a thinning of the hollow probe. The taper is in particular arranged on a distal end section of the hollow probe, that is to say on a section of the hollow probe at and/or proximal to the distal end of the hollow probe. A taper is in particular continuous and/or discontinuous in the distal direction. An “internal taper” is in particular a decrease in the inner diameter and thus the diameter of the cavity in the distal direction along the distal end section to the distal end and/or the distal opening of the hollow probe. Thus, with the internal taper, the cross-sectional area with respect to the inner surface and/or the diameter of the cavity decreases. The “external taper” is in particular a decrease in the outer diameter of the hollow probe in the distal direction along the distal end section. Thus, the cross-sectional area with respect to the outer surface of the hollow probe decreases in the tapered distal end section to the distal opening and/or the distal end. However, the taper does not have to be uniform in cross-section towards the distal end of the hollow probe, but for example, in the longitudinal section, part of the inner surface can be straight and an opposite part can be tapered. Consequently, the hollow probe does not necessarily have to have a circular cross-section in the area of the taper.

In a further embodiment, the hollow probe is formed in one piece.

Because the hollow probe is designed as a single piece, it can be easily manufactured from a hollow tube and enables both optimal fragmentation of body stones in the body and optimal crushing of the incoming body stone cores within their hollow space.

The term "one-piece" (also called "single-piece") is understood to mean in particular that the hollow probe is made from one piece. Likewise, the term "one-piece" is understood to mean in particular that the hollow probe consists of one part. In particular, the hollow probe does not consist of two or more components that are connected to one another by a positive, non-positive and/or material connection. The hollow probe and/or the probe tube is in particular made from a single hollow tube.

In order to introduce the comminution element or comminution elements into the wall of the hollow probe in a simple and cost-effective manner, the comminution element or comminution elements is or are each formed with a friction surface directed inwards into the cavity by deforming the outer surface of the hollow probe, in particular by embossing and/or pressing.

Because the crushing element is formed and shaped directly from the outer surface of the hollow probe, neither additional components nor connecting elements are required to manufacture the crushing element. Because the hollow tube used to manufacture the probe tube and/or the hollow probe is usually thin-walled, the crushing element can be given a desired shape and function, such as cutting or breaking properties, by simply deforming the outer surface.

A “friction surface” is understood to mean in particular a surface or a section of a surface of the comminution element which is oriented inwards into the cavity of the hollow probe. A stone core or stone fragment moving in the proximal direction in the cavity comes into contact with the friction surface of the comminution element during transport in the proximal direction, and corresponding friction forces occur between the stone core or fragment and the friction surface of the comminution element. In addition to the friction along the longitudinal direction of the friction surface, the comminution element uses the friction surface to transfer transverse forces acting in particular at an angle and/or essentially transversely to the longitudinal direction of the hollow probe to the stone core or stone fragment. Depending on the design and shape, a comminution element can have several friction surfaces which act on a core or fragment with forces from different directions.

“Forming” is understood in particular to mean a process in which a blank made of plastic material, in particular metal, is deliberately given a different shape without removing or adding material to the blank. The blank is in particular a hollow tube for producing the hollow probe or the hollow probe. The hollow tube and/or the hollow probe thus retain their mass and cohesion during forming. Forming is also understood in particular to mean pressure forming. “Imprinting” is understood in particular to mean a mechanical process in a manufacturing process in which a forming tool is used to apply pressure to the essentially flat outer surface of the hollow tube or the hollow probe to deform it into the comminution element. Imprinting is also understood to mean countersinking in which a countersinking stamp is pressed as a tool into the outer surface of the hollow tube or the hollow probe in order to form the comminution element. "Indentation" is understood to mean, in particular, the forming of the outer surface of the hollow tube or the hollow probe using a forming tool, such as a stamp, in particular with a low feed rate and high pressure. Indentation can be carried out in particular with a movement and thus a sliding or without a movement and thus without sliding of the tool over the surface of the workpiece.

In a further embodiment, the friction surface of the comminution element, the respective comminution element or comminution elements is or are designed to cut and/or displace in the distal direction.

As a result, the stone core or stone fragment moving in the proximal direction can be cut in a targeted manner using a cutting friction surface or a cutting section of the friction surface, for example a cutting edge. The friction surface or a section of the friction surface can also be designed to displace the stone core or stone fragment, so that the stone core or stone fragment is displaced from its direction of movement and/or from its Alignment along the longitudinal center axis of the hollow probe and preferably by changing the direction of movement is optimally aligned to the section of the crushing element that extends furthest into the hollow space of the hollow probe and thus exerts the greatest crushing force. Of course, the friction surface can also be designed to be both cutting and displacing, which means that the maximum remaining fracture length and/or size of the stone fragments can be set very precisely.

In order to enable and/or increase a rinsing flow, the hollow probe has an opening for supplying a rinsing liquid in its outer surface on the distal side and/or proximal side of a comminution element, the respective comminution element or the comminution elements.

Thus, a wall opening or several wall openings close to the comminution element or comminution elements, particularly in the distal end section of the hollow probe, can be used to quickly remove the broken and/or cut core fragments and supply the friction points with friction-reducing rinsing fluid. An opening or several openings in the outer surface of the hollow probe can enable a permanent rinsing flow and thus also prevent blockage by stone fragments and/or cores along the suction channel, even if the distal opening at the distal end of the hollow probe is pressed against a body stone and is thus closed or temporarily blocked. Thus, an opening or several openings in the outer surface enable a constant flow of rinsing agent and a constant removal of stone material independently of the distal opening of the hollow probe and/or prevent a build-up of stone material. The constant flow of rinsing agent improves the internal lubrication of both the inner surface of the hollow probe around the cavity and the friction surface and/or the surface of the respective comminution element. In addition, an opening in the outer surface of the hollow probe also serves to cool the hollow probe when the hollow probe is excited using ultrasound alone or in combination. High temperatures occur at the load antinodes of the standing ultrasound wave, particularly at high ultrasound oscillation amplitudes. By cooling the load antinodes along a hollow probe designed as a sonotrode using a constant flow of rinsing agent, a change in the material with the possible consequence of fatigue fracture is prevented on the one hand, and the risk of burns for the patient and the doctor is reduced on the other.

An "opening" (also called a wall opening) is in particular a continuous breakthrough through the outer surface of the hollow tube or the hollow probe outside the area of the respective comminution element. The opening can, for example, be a continuous bore through the tube wall of the hollow probe. Of course, the opening does not have to be exactly perpendicular to the outer wall of the hollow probe or to the longitudinal direction of the hollow probe, but can also be arranged with its longitudinal center axis at an angle to the longitudinal direction, for example at an angle of 5° to 90° to the longitudinal direction.

In a further embodiment, the comminution element, the respective comminution element or the comminution elements each have an opening through a wall thickness, in particular the deformed lateral surface, so that a rinsing liquid can flow through the respective through opening.

Thus, the respective through opening is part of the comminution element and passes through a wall thickness and/or the deformed shell surface, whereby rinsing liquid from outside the hollow probe can enter the cavity of the hollow probe through the through opening of the comminution element.

For example, the through opening can be designed as an eye adjacent to a cutting and/or displacing section of the friction surface.

In the event that small stone fragments escape from the cavity of the hollow probe through the through-opening of the comminution element despite the rinsing liquid being sucked in from the outside, these can be sucked out again through the same through-opening and/or a subsequent through-opening. Likewise, after the distal end of the hollow probe has been removed from the stone to be crushed in the body, a crushed fragment that previously escaped through a through-opening can be sucked out again through this distal opening at the distal end of the hollow probe and conveyed through the cavity towards the suction line. It is particularly advantageous here that cutting and displacing friction surfaces and/or comminution elements can be arranged in any combination both in the cross-section and in the direction of the longitudinal central axis and that the respective through-opening always ensures a reliable flushing flow with optimal comminution of the drill core and/or the core fragments.

In order to produce the hollow probe in a simple and cost-effective manner, the respective through opening is formed by punching out and simultaneously forming the outer surface into the respective comminution element.

This means that when the shell surface is being formed, a continuous opening can be created in the crushing element and/or a transverse opening in the side wall of the hollow probe by means of punching. A part of the punched-out side wall of the crushing element adjacent to the continuous opening can also be designed as a cutting edge. The punched-out continuous opening (also called an eye) can therefore be aligned in a cutting or displacing manner with respect to the drill core.

In a further embodiment of the hollow probe, the inner surface and/or the friction surface of the comminution element, the respective comminution element and/or the comminution elements has or have a friction-reducing material.

By applying a friction-reducing material to the inner surface, the crushing element and/or the friction surface, the removal speed of the stone cores and/or fragments is accelerated and thus the removal performance of the hollow probe is improved.

A "friction-reducing material" is any material that reduces the friction between the outer surface of a body stone, fragment and/or core compared to an uncoated surface of the hollow probe. The friction-reducing material reduces in particular the frictional force between the inner surface of the hollow probe and/or the friction surface and a body stone, fragment and/or core. The hollow tube and/or probe tube can have the friction-reducing material or be made entirely of the friction-reducing material. The friction-reducing material can also be a friction-reducing coating on the inner surface of the hollow probe, the friction surface or the entire surface of the comminution element. A friction-reducing coating can, for example, be DLC (diamond-like carbon), titanium nitrite, titanium boron nitrite, molybdenum sulfate, FEP (fluoroethylene propylene), PTFE (polytetrafluoroethylene) and/or a galvanic and/or chemical nickel-PTFE compound.

In a further aspect, the object is achieved by a lithotripsy device, in particular an intracorporeal lithotripsy device, for crushing body stones, wherein the lithotripsy device has a carrier unit and a sonotrode, and a drive device for impressing a deformation wave and/or an oscillation wave on the sonotrode can be assigned to the lithotripsy device, wherein the sonotrode is directly or indirectly connected to the carrier unit at its proximal end, and the sonotrode is a hollow probe as described above, so that a body stone entering the cavity of the hollow probe in the opposite direction to the distal direction can be crushed in combination by means of the deformation wave and/or oscillation wave impressed on the sonotrode and by means of the crushing element or elements.

Thus, the deformation wave and/or vibration wave that can be impressed by the drive device, which also acts on the crushing element in the hollow space of the hollow probe and thus induces its movement, can be used specifically to crush stone cores. Since the sonotrode usually moves in both the distal and proximal directions when excited, this back and forth movement can also be used specifically to crush stone fragments clamped between two crushing elements or the hollow probe tip and a crushing element in the direction of the longitudinal center axis of the sonotrode, whereby forces are present from different directions and the crushing performance can be increased through synergistic effects.

Thus, a lithotripsy device is provided in which, due to the design of the hollow probe with at least one comminution element, an optimal removal performance of body stones and a blockage-free discharge of stone fragments and/or drill cores by means of the hollow probe in the proximal direction are possible.

In order to make the lithotripsy device compact, the lithotripsy device has the drive device.

In a further embodiment, the lithotripsy device has an elongated cavity with an acceleration path, a proximal end and a distal end, a movable projectile within the elongated cavity and a distal-side stop element and a proximal-side stop element for the movable projectile, wherein the projectile can be moved back and forth along the acceleration path between the proximal end and the distal end by means of the drive device, so that a deformation wave of the sonotrode can be impressed by mechanical impact of the projectile on the distal-side stop element.

This means that, on the one hand, the hollow probe can be excited by means of impact stimulation by imposing a deformation wave, and, on the other hand, the mechanical impact of the projectile on the distal stop element transmits the impact in the distal direction and thus essentially transversely to the crushing element protruding into the cavity of the sonotrode, whereby the crushing element also deforms and presses against a body stone core and/or fragment arranged on the distal side and further shatters it. The impact effect of the projectile and thus the deformation of the sonotrode and the crushing element is in the distal direction and thus directly opposite to the direction in which the body stones are transported away in the proximal direction. As a result, the body stone cores and/or fragments in the cavity are also subject to a back and forth movement, which further increases the crushing performance.

In a further embodiment, the lithotripsy device and/or the drive device has/have a vibration excitation device for ultrasonic vibration excitation of the sonotrode.

The sonotrode can thus be excited by a constant vibration excitation using an ultrasound generator or simultaneously by a combined excitation using a constant vibration excitation and a repetitive impact excitation by imposing deformation waves. It is particularly advantageous that a substantially constant ultrasound energy can be supplied to the sonotrode simultaneously or alternately using the vibration excitation device, while a repetitive, intermittent, but very uniform ballistic deformation wave energy can be transferred to the sonotrode using the drive device.

In an additional aspect of the invention, the object is achieved by a retrofit kit for retrofitting an existing lithotripsy device, wherein the retrofit kit has at least one previously described hollow probe or two or more previously described hollow probes, wherein the two or more hollow probes have different lengths and/or different comminution elements.

Using the retrofit kit, an existing lithotripsy device can be equipped with the hollow probe for the first time, and an existing hollow probe can be replaced with a hollow probe with different properties, in particular with a different length and/or a different crushing element. Of course, the two or more hollow probes can also have other different properties, for example a different diameter, a straight hollow probe tip or a conically tapered hollow probe tip, a different material and/or friction-reducing material. Thus, depending on the application, a hollow probe can advantageously have optimal properties and differently designed crushing elements, for example crushing elements that extend into the hollow probe cavity to different extents, in order to achieve a high crushing performance depending on the type and composition of body stones within the hollow probe cavity and thus a high discharge performance of incoming drill cores and/or stone fragments in the proximal direction.

• - Ausbilden von mindestens einem Zerkleinerungselement oder mehrerer Zerkleinerungselemente mittels Umformen der Mantelfläche des Hohlrohres, sodass jeweils eine Reibfläche des mindestens einen Zerkleinerungselementes oder der Zerkleinerungselemente in den Hohlraum der Hohlsonde ragt, und/oder
• - Ausstanzen einer Öffnung oder mehrerer Öffnungen durch die Mantelfläche,

sodass eine zuvor beschriebene Hohlsonde vorliegt.In a further aspect of the invention, the object is achieved by a method for manufacturing a hollow probe from a hollow tube with a lateral surface, an outer surface and an inner surface, a distal end and a proximal end, with the following steps:

• - forming at least one comminution element or several comminution elements by deforming the outer surface of the hollow tube so that a friction surface of the at least one comminution element or the comminution elements protrudes into the cavity of the hollow probe, and/or
• - Punching one or more openings through the shell surface,

so that a hollow probe as described above is present.

Thus, by means of the method, a hollow probe with at least one comminution element and optionally at least one opening in the outer surface for a flushing agent flow can be manufactured in a simple and cost-effective manner, which ensures a high comminution performance in its inner cavity and thus a high removal performance of body stone cores and/or fragments.

In a further embodiment of the method, a mandrel with a lower die surface and a punch with an upper die surface are used when forming the outer surface of the hollow tube, wherein the punch presses on the outer surface of the hollow tube.

Because a mandrel with a lower die surface and a punch with an upper die surface are used as tools, whereby the punch with the upper die surface presses down the pipe wall of the hollow pipe, the crushing element is pressed in during embossing in a die-like manner and is pressed onto the inner surface of the hollow probe and/or the crushing element, characteristic traces are left behind, which can also be used specifically for crushing due to their microstructure. At the same time, the hollow probe manufactured in this way differs from other conventionally manufactured hollow probes.

• 1 eine stark schematische dreidimensionale Darstellung einer Lithotripsievorrichtung,
• 2 eine schematische Darstellung der Lithotripsievorrichtung mit einem Führungsrohr und einer Steuerhülse im Längsschnitt bei einer Bewegung eines Projektils in distaler Richtung und mit einer Sonotrode ausgebildet als Hohlsonde,
• 3 eine stark schematische Darstellung des distalen Bereiches der Lithotripsievorrichtung mit der Hohlsonde während einer Steinzertrümmerung,
• 4 eine stark schematische Darstellung eines distalen Bereichs einer Alternative der Hohlsonde während einer Steinzertrümmerung,
• 5 eine stark schematische Darstellung eines distalen Bereichs einer weiteren Alternative der Hohlsonde während einer Steinzertrümmerung,
• 6 eine stark schematische Darstellung eines Zerkleinerungselementes mit einer verdrängenden Seite und einer Öffnung,
• 7 eine stark schematische Darstellung einer Alternative des Zerkleinerungselementes mit einer Öffnung und einer schneidenden Seite, und
• 8 eine stark schematische Darstellung von Verfahrensschritten eines Verfahrens zum Fertigen einer Hohlsonde.

The invention is explained in more detail below using exemplary embodiments.

• 1 a highly schematic three-dimensional representation of a lithotripsy device,
• 2 a schematic representation of the lithotripsy device with a guide tube and a control sleeve in longitudinal section during a movement of a projectile in the distal direction and with a sonotrode designed as a hollow probe,
• 3 a highly schematic representation of the distal area of the lithotripsy device with the hollow probe during stone fragmentation,
• 4 a highly schematic representation of a distal region of an alternative hollow probe during stone fragmentation,
• 5 a highly schematic representation of a distal area of another alternative of the hollow probe during stone fragmentation,
• 6 a highly schematic representation of a crushing element with a displacing side and an opening,
• 7 a highly schematic representation of an alternative of the crushing element with an opening and a cutting side, and
• 8th a highly schematic representation of process steps of a process for manufacturing a hollow probe.

A lithotripsy device 101 has a carrier unit 103 with a central housing tube 105. At a proximal end of the housing tube 105, a proximal end cap 107 is screwed onto the housing tube 105 by means of a proximal lock nut 109. Likewise, at the distal end of the housing tube 105, a distal end cap 111 is screwed onto the housing tube 105 by means of a distal lock nut 113 (see 1 and 2 ). At the proximal end of the proximal end cap 107, a first exhaust port 151 and a 1 A second exhaust air connection 153 is arranged on the proximal side of the proximal end cap 107. Furthermore, a first supply air connection 155 and a not shown 1 visible second air supply connection 156 is arranged. A suction line 119 for suctioning body stone fragments is led from the distal end section of the distal end cap 111 in a direction opposite to a distal direction 115 to the proximal end of the lithotripsy device 101. The suction line 119 is in the 1 only symbolically shown and does not have practical narrow bending radii. Likewise, in the 1 an operating element 117 at the proximal end of the carrier unit 103 is only shown symbolically, whereby the operating element 117 is arranged in an alternative embodiment in an optimally ergonomic manner on the housing tube 105. The operating element 117 is designed with a control sleeve 131 arranged inside the housing tube 105 for starting and switching off as well as for single and/or continuous firing by means of the ballistic lithotripsy device 101. An elongated sonotrode 211 designed as a hollow probe 311 with a sonotrode tip 213 is arranged at the distal end of the carrier unit 103.

Inside the housing tube 105 of the carrier unit 103, a guide tube 121 is arranged at a distance from the housing tube 105, wherein between an inner wall of the housing tube 105 and an outer wall of the guide tube 121, two supply air chambers 157 and exhaust air chambers 159 are arranged symmetrically across the cross section, which are connected via holes in the proximal end cap 107 to the crosswise arranged first exhaust air connection 151 and the second exhaust air connection 153 as well as the first supply air connection 155 and the second supply air connection 156 (in 2 one supply air chamber 157 is located behind a fifth through hole 127 and is only visible through this, while the second supply air chamber is located in front of the viewing plane. The supply air chambers 157 and the exhaust air chambers 159 extend over the entire length of the guide tube 121. The two exhaust air connections 151, 153 and the two supply air connections 155, 156 are each connected via a Y-connector (not shown) to an exhaust air hose and a supply air hose of a drive device (not shown).

The guide tube 121 has a first through-hole 123 and a fourth through-hole 126 on the proximal side, which are each connected to one of the two exhaust air chambers 159. On the distal side, the guide tube 121 has a second through-hole 124 and a third through-hole 125, which are each connected to one of the two exhaust air chambers 159. Furthermore, the guide tube 121 has the fifth through-hole 127 on the proximal side and an opposite and therefore in 2 not visible further through-holes, each of which is connected to one of the two supply air chambers 157 (the two corresponding distal-side through-holes connected to the supply air chambers 157 are in 2 Not shown). All through holes 123, 124, 125, 126, 127 pass transversely through the outer surface of the guide tube 121 and each have a diameter of 3 mm.

The control sleeve 131 is arranged inside the guide tube 121 and has a first valve bore 133 and a fourth valve bore 136 on the proximal side corresponding to the proximal through-bores 123, 126 of the guide tube 121. Accordingly, a second valve bore 134 and a third valve bore 135 are introduced into the control sleeve 131 on the distal side. The control sleeve 131 is arranged in a rotationally secure manner inside the guide tube 121 so that the corresponding through-bores of the guide tube 121 and the valve bores of the control sleeve 131 are freely passable in a respective valve opening position. The control sleeve 131 has a cavity 141 on the inside which simultaneously forms an acceleration path for a projectile 143. The projectile 143 has a driver ring 145 on its outer surface, which rests on the outside against an inner surface of the control sleeve 131. The control sleeve 131 is 4 mm shorter than the guide tube 121.

On the proximal side of the control sleeve 131, a return spring 171 is arranged in a sheath tube, which is held in the proximal end cap 107 by means of a holder 173. At the distal end of the control sleeve 131, a tempering spring 181 is arranged for imparting a defined deformation wave to the sonotrode 211 due to the mechanical impact of the projectile 143. The tempering spring 181 has a plurality of stacked polymer disks 191 in the distal direction 115, which are surrounded on the outside by a sheath tube 185. The sheath tube 185 is held in the distal end cap 111 by means of a holder 183. At the proximal end of the sheath tube 185, a proximal end cap 187 is arranged, which has an O-ring 193 on the inside and is movably captured and held by means of a welding ring 195 which is welded to the sheath tube 185. On the distal side, a distal end cap 189 is arranged, which is also movably held by means of a flange on the sheath tube 185 and also has an O-ring 193 on the inside.

Thus, the distal end of the return spring 171 represents a proximal stop element and the proximal end cap 187 of the temping spring 181 represents a distal stop element for the projectile 143. The 2 shows the state in which the control sleeve 131 is struck in a distal direction 115 against the distal stop element formed by the proximal end cap 187 of the tempering spring 181. Since the control sleeve 131 is 4 mm shorter than the guide tube 121, the cavity of the guide tube 121 in the area of the proximal fifth through-opening 127 is free of the control sleeve 131. After repulsation of the projectile 143 on the end cap 187 of the tempering spring 181, the projectile 143 moves back against the distal direction 115 and takes the control sleeve 131 with it by means of the driver ring 145. This return movement causes the 2 not shown opposite distal-side through-openings of the guide tube 121 and the associated valve openings for the entry of supply air into the cavity 141 of the control sleeve 131 are freely passable and the incoming supply air pushes the projectile 143 further in the proximal direction. Due to this backward movement of the projectile 143 and the movement of the control sleeve 131, the first valve bore 133 of the control sleeve 131 is pushed onto the first through-bore 123 of the guide tube 121 and the fourth valve bore 136 of the control sleeve 131 is pushed onto the fourth through-bore 126 of the guide tube 121 over a distance of 4 mm, with the proximal end of the control sleeve 131 coming to a defined stop against the distal end wall of the casing tube of the return spring 171, whereby the respective through-bore and valve bore are open for the exit of exhaust air into the exhaust air chambers 159. At the same time, the fifth through-bore 127 and the other through-bore opposite (not visible) are closed for the passage of supply air. After repulsion of the projectile 143 at the proximal stop by means of the return spring 171 and followed by renewed movement in the distal direction 115, the control sleeve 131 is again taken along by the projectile 143 by means of the driver ring 145 and thereby the fifth through hole 127 and the opposite, invisible further through hole are opened. Supply air enters the cavity 141 of the control sleeve 131 through this and moves the projectile 143 further in the distal direction 115 until the 2 shown state is reached again.

Distal to the temperature control spring 181 is a head piece 215 of the sonotrode 211, the head piece 215 being movably mounted in a guide part 216 at its proximal end and its distal end by means of O-rings 217. The head piece 215 has a transverse bore 221 in which a plunger 223 loosely engages with an actuating handle 225 as an anti-twist device and for removing body stone fragments. The plunger 223 is actuated by means of a non-included 2 shown spring in position. By pressing the plunger 223 into the transverse bore 221 using the actuating handle 225, fragments of body stones can be removed from the head piece 215. A braking element 219 for limiting an amplitude of the sonotrode 211 is arranged on the distal side of the head piece 215.

Relief bores 203 to the head piece 215 of the sonotrode 211 and to the holder 183 of the tempering spring 181 are provided in the distal end cap 111, which together with a respective elastomer ring 205 form a pressure relief valve 201 to the holder 183 of the tempering spring 181 and to the head piece 215 of the sonotrode 211 in order to prevent the effect of excess pressure in the patient when using the lithotripsy device 101 in the event of an error occurring.

The sonotrode 211 designed as a hollow probe 311 of the lithotripsy device 101 has a probe tube 312, an outer surface 313, an inner surface 315 and an inner probe lumen 317 as a hollow space along its longitudinal central axis 149. At its distal end, the hollow probe 311 has a distal opening 318 which is connected to the probe lumen 317. Distal to the distal opening 318, the hollow probe 311 has a conical collar 319 with an outer taper 321 and an inner taper 323. The conical collar 319 at the distal end section of the hollow probe 311 has an inner cone angle 325 of 13° (see 3 ).

In the area of the conical collar 319, the hollow probe 311 has a first comminution element 351. In the transition area between the conical collar 319 and the probe tube 312 with a constant cross-section, a second comminution element 353 is arranged opposite to the distal direction 115, and then a third comminution element 355 is arranged diagonally opposite. The first, second and third comminution elements 351, 353, 355 each have a friction surface 357 for contact with a drill core 343. The first comminution element 351 is formed closed from the tube wall of the probe tube 312 and protrudes in an arc shape into the probe lumen 317. A distal transverse opening 327 is arranged in the tube wall of the probe tube 312 on the proximal side of the first comminution element 351. The second comminution element 353 is also curved, but extends even further into the probe lumen 317 and is open with a central opening 365. Likewise, the third comminution element 355 extends curved into the probe lumen 317 and is formed with an opening 365, wherein the opening 365 is arranged at the proximal end of the third comminution element 355.

The hollow probe 311 was manufactured from a one-piece hollow tube in a process 301 for its manufacture, wherein the first comminution element 351 was used to reshape 303 the outer surface and thus the tube wall of the hollow tube in the region of the conical collar 319 to form the closed, curved shape of the first comminution element 351, whereby the first comminution element 351 protrudes into the probe lumen 317 in the region of the conical collar 319. The distal transverse opening 327 was then drilled into the tube wall of the hollow tube on the proximal side. During the manufacture of the second comminution element 353 and the third comminution element 355, a forming 303 of the outer surface of the hollow tube and a punching 305 of an opening through the outer surface within the respective comminution element 353, 355 are carried out at the same time, so that a one-piece hollow probe 311 with the three comminution elements 351, 353 and 355 described above is present ( 8th ).

The hollow probe 311 manufactured in this way is used to break up a body stone 341, whereby a regular shock excitation of the hollow probe 311 takes place by impact of the projectile 143 on the tempering spring 181 as a distal stop element for exciting a deformation wave of the hollow probe 311 as described above. As in 3 As shown, the conical collar 319 enters the body stone 341 and splits it due to its external taper 321. Stone fragments 345 and a drill core 343 enter the probe lumen 317 through the distal opening 318 of the hollow probe 311. Due to the conical collar 319 with the internal taper 323, the outer diameters of the drill core 343 and the stone fragments 345 are limited to a diameter of the distal opening 318. The drill core 343 entering through the distal opening 318 hits the friction surface 357 of the first comminution element 351 in the area of the conical collar 319 with its proximal end section and is thereby pressed downwards in its direction of movement, deviating from the longitudinal center axis 149 of the hollow probe 311, onto the pipe wall opposite the first comminution element 351. Due to this transverse force exerted by the first comminution element 351 with its friction surface 357 and a continuous suction via the transverse bore 221, the core 343 is moved further in the proximal direction, whereby the transverse force of the first comminution element 351 on the core 343 increases and the core breaks. In addition, the impact excitation by means of the projectile 143 causes a deformation wave of the hollow probe 311 in the distal direction 115, whereby the core 343 is moved in the distal direction 315 and is pressed with its distal end against the inner surface 315 of the inner taper 323, which becomes narrower in the distal direction 115, and after the impact has subsided, again against the friction surface 357 of the first comminution element 351. The core 343 and the hollow probe 311 are thus subject to constant Back and forth deformation in the distal direction 115 and opposite in the proximal direction, whereby the fragmentation of the core 343 is further promoted. The resulting fragments from the core 343 hit the distal friction surface 357 of the second crushing element 353 after the first crushing element 351 and are thereby deflected upwards and, as they are transported further in the proximal direction, hit the third crushing element 355 which is diagonally opposite, so that the fragments are pressed through between the proximal friction surface 357 of the second crushing element 353 and the distal friction surface 357 of the third crushing element 355 and are thereby further crushed. These fragments from the core 343 are then carried in the proximal direction through the probe lumen 317 to the transverse bore 221, like the stone fragments 345 which have already passed through, and due to a 3 not shown suction in a discharge direction 347 from the transverse bore 221 and thus from the probe lumen 317. Due to this suction in the discharge direction 347 from the transverse bore 221, there is a constant flow of rinsing agent from a rinsed area around the stone fragmentation of the body stone 341 through the distal transverse opening 327 on the proximal side of the first comminution element 351 and through the respective opening 365 of the second and third comminution elements 353, 355, wherein the incoming and passing flow of rinsing agent lubricates the inner wall of the hollow probe 311 and the friction surfaces 357 of the comminution elements 351, 353 and 355, whereby the comminuted fragments are quickly transported away from the drill core 343, even if the distal opening 318 of the hollow probe 311 is pressed against the body stone 341 for fragmentation and the distal opening 318 itself is thus closed to a flow of rinsing agent. In addition, when the fragments from the core sample 343 and the stone fragments 345 are transported in the proximal direction to the transverse bore 221, the impact of the projectile 143 on the head piece 215 and the hollow probe 311 connected thereto can cause them to be broken further in the probe lumen 317. In addition, and/or when the transverse bore 221 is blocked by the stone fragments 345, the transverse bore 221 can be emptied by means of the plunger 323 and the stone fragments 345 can be discharged in the discharge direction 347 by manually pressing the actuating handle 225 in the actuating direction 226 against a spring force of the spring 227 and thereby pushing the free end of the plunger 223 further into the transverse bore 221. If stone fragments 345 become wedged in the transverse bore 221, the plunger 223 is repeatedly pressed until the transverse bore 221 is punched free again, whereby the spring 227 returns the plunger 223 to the unactuated starting position.

In an alternative of the hollow probe 311, the first comminution element 351 is formed in a closed form in the proximal direction after the conical collar 319 ( 4 ). A distal end of a second comminution element 353 with a central opening 365 is arranged opposite a proximal end of the first comminution element 351. Otherwise, the hollow probe 311 is designed as described above. A core sample 343 entering through the distal opening 318 is deflected downwards from the direction of movement along the longitudinal center axis 149 in the proximal direction due to the transverse force 379 acting through the friction surface 357 when a body stone 341 is crushed with the hollow probe 311 in the probe lumen 317 by hitting the friction surface 357 of the first comminution element 351 and, as it continues to move against the distal direction 115, hits the distal-side friction surface 357 of the second comminution element 353, whereby in turn an upward-directed transverse force 379 occurs and the proximal end of the core sample 343 is pressed and crushed between the upper inner surface 315 and the proximal-side friction surface 357 of the second comminution element 353. In addition, as described above, when a projectile 143 strikes the probe head of the hollow probe 311, a deformation wave is imposed on the hollow probe 311 and the first and second comminution elements 351, 353 with a corresponding movement in the distal direction 115 and vice versa in the proximal direction, whereby comminution of the drill core 343 is further promoted and, in addition to the transverse forces 379 directed in different directions, corresponding forces along the longitudinal central axis 149 work together synergistically. The stone fragments 345 arising from the drill core 343 are transported away in the proximal direction, as described above. The flushing agent flows from the area around the body stone 341 only through the central opening 365 in the second comminution element 353.

In another, in 5 In the alternative shown, the hollow probe 311 does not have a conical collar 319 running all the way around, but the hollow probe tip is formed in the upper area with a straight tube wall 375 and in the lower area with an inclined tube wall 377, so that there is no circular cross-section in this area. In addition, the second comminution element 353 has a terminal proximal opening 365 instead of a central opening. As a result, the entering core 343 in the cavity 317 in the area of the hollow probe tip is deflected directly downwards, deviating from the longitudinal central axis 149, so that the core 343 with its side surface and not with its proximal end face on the friction surface 357 of the first comminution element 351 and also with its lower side surface on the lower inner surface 315 of the probe tube 312, so that by clamping the side surfaces of the core 343 the transverse force 379 is increased and the breaking up of the core 343 is improved. Otherwise the functioning of the hollow probe 311 with the two comminution elements 351, 353 is as described above.

In an alternative of the first comminution element 351, this has from its distal end 371 to its proximal end 373 first a displacing side 363 with a friction surface 357 followed by a cutting side 361 and an opening 365, wherein the opening 365 ends at the proximal end 373 of the first comminution element 351. The 6 shows a view from the inside of the inner surface 315 of the hollow probe 311. When a stone is broken up, the displacing side 363 initially exerts a transverse force on the stone when a core enters the distal direction 115, as described above. When the core breaks into stone fragments due to the transverse force 379, the stone fragments are pressed against the cutting side 361 and cut and/or cut when struck by a projectile 143 in the distal direction 115, before the other fragments are then sucked out further in the proximal direction, as described above. Because the opening 365 is located directly on the cutting side 361, the rinsing agent enters from the outside through the opening 365 and flows along the inner surface 315 in the probe lumen 317 in the proximal direction, the fragments created on the displacing side 363 and the cutting side 361 are optimally transported further in the proximal direction, whereby the incoming rinsing agent provides lubrication on the inner surface 315.

In a further alternative of the first crushing element 351, this is compared to the 6 from its distal end to its proximal end 373. At the distal end 371, first the opening 365 is arranged, then the cutting side 361 and then the displacing side 363 with the friction surface 375, which ends at the proximal end 373 of the first comminution element 351 ( 7 ). The friction surface 357 of the displacing side 363 has a friction-reducing coating 367. Due to the flushing flow from the outside through the opening 365, a drill core transported in the proximal direction is moved at high speed against the cutting side 361 due to the lubrication on the inner surface 315 in the probe lumen 317 and is cut there into stone fragments, which are then efficiently further crushed by the friction surface 357 with the friction-reducing coating 367 and the acting transverse force 379 and transported away in the proximal direction.

Thus, a lithotripsy device 101 and a hollow probe 311 are provided in which, due to a comminution element 351 or several comminution elements 351, 353, 355 projecting into the probe lumen 317, an optimal comminution of drill cores 343 entering the probe lumen 317, a rapid removal of the stone fragments resulting from the drill core 343 in the proximal direction and thus a high removal performance of the hollow probe 311 are realized.

List of reference symbols

101

Lithotripsy device

103

Carrier unit

105

Housing tube

107

Proximal end cap

109

Proximal lock nut

111

Distal end cap

113

Distal counter nut

115

Distal direction

117

Control element

119

Suction line

121

Guide tube

123

First through hole for exhaust air

124

Second through hole for exhaust air

125

Third through hole for exhaust air

126

Fourth through hole for exhaust air

127

Fifth through hole for supply air

131

Control sleeve

133

First valve bore

134

Second valve bore

135

Third valve bore

136

Fourth valve bore

141

Cavity/Acceleration section

143

projectile

145

Driving ring

149

Longitudinal center axis

151

first exhaust air connection

153

second exhaust air connection

155

first supply air connection

156

second supply air connection

157

Supply air chamber

159

Exhaust air chamber

171

Return spring

173

bracket

181

Tempering spring

183

holder

185

Sheath tube

187

Proximal end cap

189

Distal end cap

191

Polymer discs

193

O-ring

195

Welding ring

201

Pressure relief valve

203

Relief bore

205

Elastomer ring

211

Sonotrode

213

Sonotrode tip

215

Headpiece

216

Guide part

217

O-ring

219

Brake element

221

Cross hole

223

Pestle

225

Operating handle

226

Actuation direction

227

Feather

229

Tappet holder

301

Method for manufacturing a hollow probe

303

Forming the surface of the hollow tube

305

Punching an opening through the shell surface

311

Hollow probe

312

Probe tube

313

Exterior surface

315

Inner surface

317

Probe lumen

318

distal opening

319

Conical collar

321

external rejuvenation

323

inner rejuvenation

325

Cone angle

327

distal transverse opening

341

Body stone

343

Core

345

Stone fragment

347

Discharge direction

351

first shredding element

353

second shredding element

355

third shredding element

357

Friction surface

361

cutting side

363

repressive side

365

Opening of the shredding element

367

friction-reducing coating

371

distal end of the crushing element

373

proximal end of the crushing element

375

straight pipe wall

377

sloping pipe wall

379

Shear force

QUOTES INCLUDED IN THE DESCRIPTION

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Cited patent literature

• DE 19500893 A1 [0007]

Claims (19)

Hollow probe (311) for crushing body stones (341) for a lithotripsy device (101), wherein the hollow probe (311) has a lateral surface with an outer surface (313) and an inner surface (315), a cavity (317) along its longitudinal central axis (149) and a distal end in a distal direction (115) for crushing body stones (341), characterized in that the hollow probe (311) has at least one crushing element (351, 353, 355) on its inner surface (315) for crushing a body stone core (343) entering the cavity (317) of the hollow probe (311) against the distal direction (115). Hollow probe (311) according to Claim 1 , characterized in that the hollow probe (311) has on its inner surface (315) a second comminution element (353), a third comminution element (355), a fourth comminution element and/or further comminution elements. Hollow probe (311) according to Claim 1 or 2 , characterized in that the at least one comminution element or the comminution elements (351, 353, 355) is or are arranged at a distal end portion in the distal direction (115) in front of the distal end. Hollow probe (311) according to one of the Claims 2 until 3 , characterized in that the comminution elements (351, 353, 355) are arranged radially circumferentially and/or offset in the distal direction (115) on the inner surface (315). Hollow probe (311) according to one of the preceding claims, characterized in that the hollow probe (311) has a taper (321, 323) in the distal direction (115) at its distal end and/or at the distal end portion. Hollow probe (311) according to one of the preceding claims, characterized in that the hollow probe (311) is formed in one piece. Hollow probe (311) according to one of the preceding claims, characterized in that the comminution element or the comminution elements (351, 353, 355) are each formed with a friction surface (357) directed inwards into the cavity (317) by means of deforming the outer surface of the hollow probe (311), in particular by means of embossing and/or pressing. Hollow probe (311) according to one of the preceding claims, characterized in that the friction surface (357) of the comminution element, of the respective comminution element or of the comminution elements (351, 353, 355) is or are designed to be cutting and/or displacing in the distal direction (115). Hollow probe (311) according to one of the preceding claims, characterized in that the hollow probe (311) has an opening (327) for supplying a rinsing liquid in its outer surface on the distal side and/or proximal side of a comminution element, the respective comminution element or the comminution elements (351, 353, 355). Hollow probe (311) according to one of the preceding claims, characterized in that the comminution element, the respective comminution element or the comminution elements (351, 353, 355) each have or have an opening (365) through a wall thickness, in particular the deformed lateral surface, so that the respective through opening (365) can be flowed through by a rinsing liquid. Hollow probe (311) according to Claim 10 , characterized in that the respective through opening (365) is formed by punching out with simultaneous deformation of the outer surface to form the respective comminution element (351, 353, 355). Hollow probe (311) according to one of the preceding claims, characterized in that the inner surface (315) and/or the friction surface (357) of the comminution element, the respective comminution element and/or the comminution elements (351, 353, 355) has or have a friction-reducing material (367). Lithotripsy device (101), in particular intracorporeal lithotripsy device, for breaking up body stones (341), wherein the lithotripsy device (101) has a carrier unit (103) and a sonotrode (211), and the lithotripsy device (101) can be assigned a drive device for impressing a deformation wave and/or an oscillation wave onto the sonotrode (211), wherein the sonotrode (211) is connected directly or indirectly to the carrier unit (103) at its proximal end, characterized in that the sonotrode (211) has a hollow probe (311) according to one of the Claims 1 until 12 is such that a body stone core (343) entering the cavity (3179) of the hollow probe (311) against the distal direction (115) can be broken up in combination by means of the deformation wave and/or vibration wave impressed on the sonotrode (211) and by means of the comminution element or comminution elements (351, 353, 355). Lithotripsy device (101) according to Claim 13 , characterized in that the lithotripsy device (101) has the drive device. Lithotripsy device (101) according to Claim 13 or 14 , characterized in that the lithotripsy device (101) has an elongated cavity (141) with an acceleration path, a proximal end and a distal end, a movable projectile (143) within the elongated cavity (141) and a distal-side stop element and a proximal-side stop element for the movable projectile (143), and by means of the drive device the projectile (143) can be moved back and forth along the acceleration path between the proximal end and the distal end, so that the deformation wave of the sonotrode (211) can be impressed by mechanical impact of the projectile (143) on the distal-side stop element. Lithotripsy device (101) according to one of the preceding claims, characterized in that the lithotripsy device (101) and/or the drive device has or have a vibration excitation device for ultrasonic vibration excitation of the sonotrode (211). Retrofit kit for retrofitting an existing lithotripsy device, characterized in that the retrofit kit comprises at least one hollow probe (311) according to one of the Claims 1 until 12 or two or more hollow probes (311) according to one of the Claims 1 until 12 wherein the two or more hollow probes (311) have different lengths and/or different comminution elements (351, 353, 355). Method (301) for producing a hollow probe (311) from a hollow tube with a jacket surface, an outer surface (313) and an inner surface (315), a distal end and a proximal end, with the following steps: - forming at least one comminution element or several comminution elements (351, 353, 355) by forming (303) the jacket surface of the hollow tube, so that a friction surface (357) of the at least one comminution element or the comminution elements (351, 353, 355) protrudes into the cavity (317) of the hollow probe (311), and/or - punching (305) one or several openings (327, 365) through the jacket surface, so that a hollow probe (311) according to one of the Claims 1 until 12 is present. Procedure (301) according to Claim 18 , characterized in that in the forming (303) of the outer surface of the hollow tube, a mandrel with a lower die surface and a punch with an upper die surface are used, wherein the punch presses on the outer surface of the hollow tube.

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