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

Abstract

Hollow probe (311) for crushing body stones (341) for a lithotripsy device (101), wherein the hollow probe (311) has a shell 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), wherein 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) in the opposite direction (115), characterized in that the at least one crushing element (351, 353, 355) is formed directly by shaping the shell surface of the hollow probe (311). is.

Description

[0001] The invention relates to a hollow probe for fragmenting body stones for a lithotripsy device. 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 for fragmenting body stones in a distal direction. Furthermore, the invention relates to a lithotripsy device, a retrofit kit for retrofitting an existing lithotripsy device, and a method for manufacturing a hollow probe from a hollow tube.

[0002] Lithotripsy is a well-known procedure for breaking up stones, which form in body organs such as the bladder or kidneys through the condensation and / or crystallization of salts and proteins, forming so-called calculi. If the stones are too large to pass naturally and cause discomfort, they must be broken up with a lithotripter so that the crushed stones can be removed through natural excretion and / or by means of a suction and irrigation pump.

[0003] 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 further to its distal end to fragment the body stone. Regardless of the generation of shock waves or deformation waves, for example, using lasers, pneumatic energy sources, and / or ultrasound, resulting stone fragments should be removed as soon as possible during fragmentation to prevent them from circulating uncontrollably within the organ and potentially becoming irretrievable.

[0004] In order to remove stone fragments directly from the organ during fragmentation, hollow probes are typically used in lithotripsy devices to discharge and / or suction stone fragments through the hollow probe's cavity. However, hollow probes can have cross-sectional constrictions along their length due to roughness, manufacturing tolerances, and / or mechanical deformation, in which stone fragments and / or cores can become trapped and / or jammed. Such blockages inside a hollow probe cause a disadvantageous loss of time due to the necessary unblocking measures and thus potentially prolong 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 from the cavity, for example using a wire, the hollow probe must be laboriously reinstalled.

[0005] In addition, existing lithotripsy probes can, due to incorrect operation, for example, if the hollow probe tip is used for too long and without interruption on a body stone, result in excessively long core samples being collected inside the hollow probe, which can subsequently lead to blockages at more proximal points of the suction line. These excessively long core samples, resulting from continuous, uninterrupted operation, often become trapped in narrow bends in the irrigation channel and clog it. For design reasons, narrow bends in the suction channel are usually unavoidable.

[0006] With conventional hollow probes, there is a risk of excessively long core samples forming, especially in the distal end section of the cavity. Due to friction on the inner surface of the hollow probe and proximal deflections, these core samples can only be removed very slowly and with difficulty in the proximal direction. Excessively long core samples often get stuck in a cross-hole to the suction line in the probe head and clog the suction path.

[0007] DE 195 00 893 A1 discloses a device for fragmenting calculi using a hollow probe. The hollow probe consists of a tube, a probe base, and a hollow probe tip. 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, a narrowing of the inlet opening is made possible, thus preventing clogging of the probe tube. Furthermore, the hollow probe has an outlet opening outside the housing of the lithotripter for suctioning out fragmented calculi. The disadvantage here is that a connection device for receiving a suction hose is attached to the distal side of the housing, thus restricting the working area, and that, due to the rotatable connection device, there is an increased risk of clogging if the bores do not align.Furthermore, there is a risk that the soldered connection will come loose due to the high load and that the hollow probe tip will remain in the body being treated when used.

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

[0009] 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 counter to the distal direction.

[0010] Thus, a hollow probe for fragmenting calculi is provided, in which, when fragmenting a calculus with the hollow probe tip, a calculus core entering the cavity of the hollow probe can be further fragmented directly by means of the at least one fragmentation element on the inner surface before the calculus core reaches the proximal cavity and / or a proximal transverse bore to a suction line and thereby causes a blockage. Because particularly excessively long calculus cores are fragmented directly within the cavity of the hollow probe by means of the at least one fragmentation 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 cavity of the hollow probe and / or on the proximal side at the transition to a transverse bore to the suction line is significantly reduced.

[0011] Consequently, crushed body stones and / or resulting core samples 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 even long core stones are crushed by the at least one crushing element on the inner surface of the hollow probe and can be removed proximally through the cavity as stone fragments, time-saving, uninterrupted operation of the hollow probe on a large body stone is possible. Consequently, long-lasting, continuous, and time-saving stone crushing using the hollow probe is possible without having to put the hollow probe down, thus interrupting the crushing of the body stones in the body.

[0012] Because the comminution element is arranged on the inner surface of the hollow probe and projects into the cavity, the comminution element exerts a transverse force obliquely or substantially perpendicular to the longitudinal center axis of the hollow probe and to the transport direction of the stone cores and / or fragments to the proximal end of the hollow probe. Due to the stationary arrangement of at least one comminution element on and / or in the inner surface of the hollow probe, a continuous comminution of long stone cores entering the cavity of the hollow probe one after the other takes place during the fragmentation of a stone. Due to the transverse force exerted by the at least one comminution element on the stone core, the stone preferably breaks off from the remaining stone at the base due to the acting torque and / or material load. However, the stone core can also break at other locations.A stone core can also break centrally within the cavity or into two or more fragments of different lengths along the longitudinal center axis. The design of the at least one comminution element allows the effective transverse force and the maximum remaining fracture length of the stone fragment and / or stone fragments to be specified and / or adjusted. For this purpose, the at least one comminution element is designed such that the crushed stone fragments can be safely transported away in the proximal direction and that more proximal locations in the drainage channel can be easily passed.

[0013] An essential idea of ​​the invention is based on partially and specifically narrowing the cross-section of the hollow space of the hollow probe obliquely 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, due to the transverse forces and / or clamping forces thereby acting by means of the at least one comminution element, specifically comminuting a body stone that has entered the cavity during its transport in the proximal direction, whereby shorter and / or smaller body stone fragments are created, which are removed from the hollow probe, the probe head and / or the lithotripsy device without the risk of clogging during further transport through the cavity and the suction channel.Thus, a targeted, temporary local blockage is induced by a drill core entering the hollow probe cavity at at least one comminution element extending into the cavity, in order to crush the core using the resulting forces. This improves both the service life of the hollow probe and the uninterrupted, efficient removal performance of the hollow probe when crushing calculi.

[0014] The following terminology is explained: A “hollow probe” is, in particular, an elongated component which has a hollow space at least partially or completely continuous in its interior in the longitudinal direction. The hollow probe has, in particular, a distal opening at its distal end which is connected to the internal hollow space. A hollow probe is, for example, tubular and / or hose-shaped. The hollow probe can itself be set into vibration, resonant 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 is a component of a sonotrode. The hollow probe is, in particular, formed in one piece. The hollow probe has, in particular, 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 is, in particular, made of steel, titanium, aluminum and / or carbon.A hollow probe can be either a reusable probe or a disposable probe.

[0015] In a pneumatic lithotripsy device, a specifically shaped deformation wave is imparted by means of impact energy when a projectile strikes a distal stop element, in particular the hollow probe. The deformation wave causes, in particular, a translational movement of the hollow probe, which, due to the deflection, causes stone fragmentation. In addition to the mechanical impact, the hollow probe can also be excited into vibration, in particular a longitudinal vibration, in particular by means of a vibration excitation device, for example, an ultrasonic vibration exciter. Thus, the hollow probe is designed in particular as a waveguide for the vibration waves generated by a vibration excitation device and / or for the deformation waves of the projectile.

[0016] The proximal end of the hollow probe can in particular rest directly or indirectly on the distal stop element. Preferably, the hollow probe is 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 the insertion part is held in particular in a receiving unit in the thicker head piece. The receiving unit is, for example, a bore in the head piece into which the proximal end and / or the proximal end section of the hollow probe is firmly and / or permanently fitted, e.g., soldered. Preferably, the head piece of the hollow probe is movably mounted. The hollow probe is in particular shaped such 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 fragmented.The hollow probe (also called probe tube), the receiving unit and the base body / head piece form a sonotrode.

[0017] A “surface surface” is understood to mean in particular the surface of the hollow probe and / or the probe tube without the two opposite end-side annular surfaces at the distal end and the proximal end of the hollow probe and / or the probe tube.

[0018] An “outer surface” of the hollow probe is in particular the surface on the outside of the hollow probe oriented towards the environment. The “inner surface” of the hollow probe is in particular the inner surface of the hollow probe oriented towards 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.

[0019] "Distal" and "distal" refer to an arrangement close to the patient's body and thus far from the user, and / or a corresponding end or section. Accordingly, "proximal" or "proximal" refers to an arrangement close to the user and thus far from the patient's body, or a corresponding end or section.

[0020] A “comminution element” is, in particular, any type of element that crushes stone cores entering the cavity of the hollow probe. The comminution element is, in particular, arranged on and / or in the inner surface of the hollow probe. The comminution element can be a component that is connected to and / or to the inner surface of the hollow probe. If the comminution element is designed as a separate component, it can be connected to the inner surface of the hollow probe, for example, by means of a material connection. The comminution element is preferably formed directly by deforming the outer surface of the hollow probe, for example by pressing and / or embossing. The comminution element, in particular, protrudes at least partially into the cavity of the hollow probe and thereby at least partially restricts the cross-section of the cavity of the hollow probe.The cross-section of the comminution element can also be arranged essentially entirely 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 stone core moving in the proximal direction and thus along the longitudinal center axis.For comminuting body stone cores, the comminution element can be designed and / or shaped in particular such that the body stone core is comminuted by breaking and / or cutting. The breaking can occur, for example, at a section of the comminution element that projects furthest into the cavity of the hollow probe. For cutting, the comminution element can, for example, have a sharp cutting edge oriented in the distal direction. The comminution of body stone cores by means of the comminution element can be amplified 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 comminution element can be designed to be closed and thus form a barrier between the cavity of the hollow probe and the external environment.However, the comminution element can also be designed to be open and thus have one or more openings which allow passage into the cavity of the hollow probe from the environment.

[0021] A "lithotripsy device" (also called a "lithotripter") is, in particular, a device for fragmenting body stones through impacts, shock waves, and / or deformation waves. A lithotripsy device is understood to mean, in particular, various components, structural and / or functional components of a lithotripter. The lithotripsy device can form a lithotripter completely or partially. A lithotripsy device can, in particular, be an intracorporeal or extracorporeal lithotripsy device. In the case of an intracorporeal lithotripsy device, it can additionally have a rinsing / suction pump. The lithotripsy device can be designed as a handheld device and / or have an endoscope or be inserted into an endoscope. The lithotripsy device is, in particular, autoclavable and comprises, for example, instrument steel and / or plastic.The lithotripsy device may include additional components, such as a control and / or supply unit, or these may be associated with the lithotripsy device. A lithotripsy device is, in particular, a pneumatic lithotripsy device.

[0022] "Body stones" (also called "concrements") are understood to mean, in particular, all stones in the human or animal body that form, for example, from salts and proteins through crystallization and / or condensation. Body stones can be, for example, gallstones, urinary stones, kidney stones, and / or salivary stones. The action of the sonotrode and / or hollow probe on the body stone results in the formation of body stone cores (also called drill cores) and / or body stone fragments.

[0023] A "projectile" is, in particular, a body that 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 be in the shape of a bolt or a ball. The projectile, in particular, comprises hard steel and / or magnetic properties. To ensure free mobility, the projectile, in particular, has a slightly smaller outer diameter than the diameter of the cavity of the acceleration tube, 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 continuously moved back and forth between the proximal stop element and the distal stop element, and thus along an acceleration path, for example, by means of a pressure medium of the drive device. Preferably, the projectile is continuously moved back and forth between the proximal stop element and the distal stop element in an intermittent and / or oscillating manner.

[0024] A "carrier unit" is, in particular, a hand-held and / or holding part of the lithotripsy device. The carrier unit can, in particular, be a handle for manual and / or automated operation and / or connection of the lithotripsy device. The carrier unit can also be arranged, connected, and / or guided automatically at a distal end of a robot arm. The carrier unit, in particular, has a housing.

[0025] A "drive device" can, in principle, be any type of device that exerts a force on the projectile and thus causes it to move. The drive device can, for example, be a device that accelerates the projectile using a laser, a pressure medium, for example pneumatically using compressed air, an electromagnetic field, and / or a mechanical device. A drive device can, in particular, exert a force on the projectile and thus cause it to move by supplying and / or removing a pressure medium.The drive device enables, in particular, a continuous and uniform inflow of the pressure medium through proximal and distal through-openings of the guide tube and proximal and distal openings of the control sleeve and an acceleration of the projectile within the cavity of the control sleeve and / or the guide tube.

[0026] A "vibration excitation device" is, in particular, a component of an ultrasonic transducer and / or a lithotripsy device that converts an applied alternating voltage at a specific frequency into a mechanical vibration frequency. The vibration excitation device is, in particular, an electromechanical transducer utilizing 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, comprises one or more piezoelements. Preferably, the vibration excitation device comprises at least two piezoelements, with an electrical conductor, for example, a copper disc, arranged between the piezoelements.In the case of ultrasonic excitation, the sonotrode operates particularly in the ultrasonic range with a frequency range of 20 kHz to 90 kHz, preferably from 20 kHz to 34 kHz.

[0027] 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.

[0028] Thus, two or more comminution elements can be arranged at a distance along the inner surface along the cross-section and / or at a distance along the longitudinal central axis. By arranging two or more comminution elements along the longitudinal central axis, the comminution of body stone cores and the resulting fragments can be carried out step by step, and each resulting fragment can be further comminuted in a proximal direction by the next comminution element.

[0029] The second, third, fourth, and optionally further shredding elements are, in particular, functionally equivalent to the shredding elements described above. However, the two or more shredding elements may have different shapes and / or properties, such as different material thicknesses and / or dimensions.

[0030] 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 to prevent further transport of the excessively 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.

[0031] 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 comminution element, so that clogging of the cavity is prevented already 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 comminution element are arranged relative to one another in the proximal direction such that maximum fragment lengths of <30 mm, in particular <20 mm, preferably 10 mm, are produced due to the crushing by the first comminution element.

[0032] For optimal comminution with moderate friction between the entering stone core and the first comminution element, the distal opening through which the stone core enters the cavity of the hollow probe and the first subsequent comminution element can be offset and / or coordinated with each other in the proximal direction relative to the longitudinal central axis. Because the first comminution element is positioned directly after the distal opening of the hollow probe and thus directly after the site of origin of crushed stone in the body and / or a drill core, their targeted comminution by the first comminution element in the cavity is enabled spatially and temporally before a proximal blockage can even occur.At the same time, the counterpressure of the body stone against the comminution element causes an early advance in the proximal direction, which presses the body stone core against, along and / or through the comminution element and whereby body stones and / or fragments located in the cavity on the proximal side are pushed further in the direction of the suction line.

[0033] 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.

[0034] A staggered and / or alternating arrangement of the comminution elements on and / or in the inner surface of the hollow probe achieves further comminution and / or shortening of calculus cores and / or fragments. Furthermore, two comminution elements can be arranged on opposite sides of the inner surface of the hollow probe, so that a calculus core is simultaneously cut and / or pressed in from two sides as it passes through the two opposing comminution elements, thus being comminuted. The staggered arrangement also allows forces to be exerted on the calculus core or fragment from different directions using the comminution elements.For example, the first comminution element can have a triangular cross-section with a downward-facing cutting edge at its lower corner, so that as it passes through the comminution element, the calculus is cut in the direction of the longitudinal central axis. The next comminution element can then, for example, exert a breaking action on the calculus core that has already been cut longitudinally in the direction of the transverse axis perpendicular to the longitudinal central axis, and in doing so engage in the incision. The breaking force and / or cutting depth in the proximal direction can also be continuously or gradually increased by means of several comminution elements spaced apart from one another in the longitudinal direction and extending to different depths into the cavity, thus also capturing the increasingly further crushed fragments.

[0035] In order to use a wedge effect and / or notch effect to split body stones in the body by means of an external taper, and at the same time to 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 align the incoming body stone core spatially 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.

[0036] 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 stone core is limited to the inner diameter at the distal opening of the hollow probe. As a result, the incoming stone core lies with its distal end essentially flush with the inner surface in the region 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 obliquely to the longitudinal central axis of the hollow probe. As a result, the stone core is clamped at its distal end and its proximal end against the inner surface and the comminution element, respectively, which promotes the breakup of the stone core during further transport.Due to the conical widening of the cavity from the tapered hollow probe tip in the distal direction towards the comminution element, the 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, whereby a breakage at the base of the stone to be crushed and / or a central breakage of the stone core is promoted by the clamping on both sides.

[0037] A “taper” is, in particular, a thinning of the hollow probe. The taper is, in particular, arranged at a distal end section of the hollow probe, i.e., at 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 “inner 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 up to the distal end and / or the distal opening of the hollow probe. Thus, with the inner taper, the cross-sectional area with respect to the inner surface and / or the diameter of the cavity decreases. The “outer 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 of ​​the outer surface of the hollow probe decreases in the tapered distal end section toward the distal opening and / or the distal end. However, the taper does not have to be uniform in cross-section toward the distal end of the hollow probe; rather, 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.

[0038] In a further embodiment, the hollow probe is formed in one piece.

[0039] 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 comminution of the incoming body stone cores within their cavity.

[0040] "Integral" (also called "single-piece") means, in particular, that the hollow probe is made from a single piece. Likewise, "one-piece" means, in particular, that the hollow probe consists of a single part. In particular, the hollow probe does not consist of two or more components connected to one another by a form-fitting, force-fitting, and / or material-fitting connection. The hollow probe and / or probe tube is, in particular, made from a single hollow tube.

[0041] 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 are each formed with a friction surface directed inwards into the cavity by deforming the lateral surface of the hollow probe, in particular by embossing and / or pressing.

[0042] Because the comminution 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 comminution element. Because the hollow tube typically has a thin wall for manufacturing the probe tube and / or the hollow probe, the desired shape and function of the comminution element, such as cutting or breaking properties, can be easily formed by deforming the outer surface.

[0043] 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 calculus core or a calculus fragment moving in the proximal direction within the cavity comes into contact, in particular, with the friction surface of the comminution element during transport in the proximal direction, and corresponding frictional forces arise between the calculus core or calculus 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 transmit transverse forces, acting in particular obliquely and / or substantially transversely to the longitudinal direction of the hollow probe, to the calculus core or calculus fragment.Depending on its design and shape, a comminution element can have several friction surfaces which act on a core or fragment with forces from different directions.

[0044] “Forming” is understood in particular to be a process in which a blank made of plastic material, in particular metal, is deliberately given a different shape without material being removed from or added to the blank. The blank is in particular a hollow tube for producing the hollow probe or the hollow probe itself. Thus, the hollow tube and / or the hollow probe retains its mass and cohesion during forming. Forming is also understood in particular to mean pressure forming. “Imprinting” is understood in particular to be a mechanical operation 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.Embossing also refers to countersinking, in which a countersinking punch is pressed into the outer surface of the hollow tube or hollow probe to form the comminution element. "Imprinting" refers in particular to the reshaping of the outer surface of the hollow tube or hollow probe with a forming tool, such as a punch, particularly at a low feed rate and high pressure. Imprinting can be performed with a movement, thus involving sliding, or without a movement, thus involving sliding of the tool over the surface of the workpiece.

[0045] In a further embodiment, the friction surface of the comminution element, the respective comminution element or the comminution elements is or are designed to be cutting and / or displacing in the distal direction.

[0046] As a result, the calculus core or stone fragment moving in the proximal direction can be specifically incised by means of a cutting friction surface or a cutting section of the friction surface, for example a cutting edge. Likewise, the friction surface or a section of the friction surface can be designed to displace the calculus core or stone fragment, so that the calculus core or stone fragment is displaced from its direction of movement and / or moved away from its alignment along the longitudinal center axis of the hollow probe and, preferably by changing the direction of movement, is optimally aligned with the section of the comminution element that protrudes furthest into the cavity of the hollow probe and thus exerts the greatest comminution force.Of course, the friction surface can also be designed to be both cutting and displacing, which allows the maximum remaining fracture length and / or size of the stone fragments to be adjusted very precisely.

[0047] In order to enable and / or increase a rinsing flow, the hollow probe has an opening for supplying a rinsing liquid in its lateral surface on the distal side and / or proximal side of a comminution element, the respective comminution element or the comminution elements.

[0048] Thus, one or more wall openings near the comminution element(s), particularly in the distal end section of the hollow probe, can enable rapid removal of the broken and / or cut core fragments and supply the friction points with friction-reducing irrigating fluid. One or more openings in the outer surface of the hollow probe can enable a permanent irrigating flow, thus preventing 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 thus closed or temporarily blocked.Thus, one or more openings in the outer surface enable a constant flow of rinsing agent and the constant removal of stone material, independent of the distal opening of the hollow probe, and / or prevent a build-up of stone material. The constant flow of rinsing agent improves 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 solely or in combination with ultrasound. High temperatures occur at the antinodes of the standing ultrasonic wave, particularly at high ultrasonic oscillation amplitudes.By cooling the stress bellies along a hollow probe designed as a sonotrode by means of a constant flow of rinsing agent, on the one hand, a material change with possible consequence of a fatigue fracture is prevented and on the other hand, the risk of burns for the patient and the doctor is reduced.

[0049] An "opening" (also called a wall opening) is, in particular, a continuous opening through the outer surface of the hollow tube or hollow probe outside the area of ​​the respective comminution element. The opening can, for example, be a through-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.

[0050] In a further embodiment, the comminution element, the respective comminution element or the comminution elements each have an opening passing through a wall thickness, in particular the deformed lateral surface, so that a rinsing liquid can flow through the respective opening.

[0051] Thus, the respective through opening is part of the comminution element and passes through a wall thickness and / or the formed shell surface, whereby rinsing liquid can enter the cavity of the hollow probe from outside the hollow probe through the through opening of the comminution element.

[0052] For example, the through opening can be designed as an eye adjacent to a cutting and / or displacing section of the friction surface.

[0053] If, despite externally aspirated rinsing fluid, small stone fragments escape from the hollow probe cavity through the through-opening of the comminution element, they can be suctioned out again through the same through-opening and / or a subsequent through-opening. Likewise, after the distal end of the hollow probe is removed from the stone to be crushed in the body, a crushed fragment that previously escaped through a through-opening can be suctioned out again through this distal opening at the distal end of the hollow probe and conveyed through the cavity toward the suction line.It is particularly advantageous 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 center axis and that a reliable flushing flow is always realized by means of the respective through opening with optimal comminution of the drill core and / or the core fragments.

[0054] 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.

[0055] This allows a continuous opening to be created in the comminution element and / or a transverse opening in the side wall of the hollow probe by punching during the forming of the shell surface. A portion of the punched-out side wall of the comminution element, adjacent to the continuous opening, can also be designed as a cutting edge. Thus, the punched-out continuous opening (also called the eye) can be oriented to cut or displace the drill core.

[0056] 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 comprise or comprise a friction-reducing material.

[0057] A friction-reducing material on the inner surface, the crushing element and / or the friction surface accelerates the removal speed of the stone cores and / or fragments and thus improves the removal performance of the hollow probe.

[0058] A "friction-reducing material" is any material that reduces the friction between the outer surface of a calculus, fragment, and / or core compared to an uncoated surface of the hollow probe. The friction-reducing material specifically reduces the frictional force between the inner surface of the hollow probe and / or the friction surface and a calculus, fragment, and / or core. The hollow tube and / or probe tube can comprise the friction-reducing material or be formed entirely from 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.

[0059] In a further aspect, the object is achieved by a lithotripsy device, in particular an intracorporeal lithotripsy device, for fragmenting body stones, wherein the lithotripsy device has a carrier unit and a sonotrode, and a drive device for imposing a deformation wave and / or an oscillation wave on the sonotrode can be assigned to the lithotripsy device, wherein the sonotrode is connected directly or indirectly 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 fragmented in a combined manner by means of the deformation wave and / or oscillation wave imposed on the sonotrode and by means of the fragmentation element or fragmentation elements.

[0060] Thus, the deformation wave and / or vibration wave imparted by the drive device, which also acts on the comminution element in the hollow probe cavity and thus induces its movement, can be used specifically for comminution of stone cores. Since the sonotrode typically moves in both distal and proximal directions when excited, this back-and-forth movement can also be used specifically for comminution of stone fragments clamped between two comminution elements or the hollow probe tip and a comminution element in the direction of the longitudinal center axis of the sonotrode. Forces are applied from different directions, and synergistic effects can increase the comminution performance.

[0061] 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.

[0062] In order to make the lithotripsy device compact, the lithotripsy device has the drive device.

[0063] In a further embodiment, the lithotripsy device comprises 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.

[0064] This allows, on the one hand, the hollow probe to be stimulated by impact excitation through the imposition of a deformation wave. On the other hand, the mechanical impact of the projectile on the distal stop element transmits the impact in a distal direction and thus essentially transversely to the comminution element protruding into the cavity of the sonotrode, causing the comminution element to deform and press against a distally located stone core and / or fragment, further shattering it. The impact effect of the projectile, and thus the deformation of the sonotrode and the comminution element, is in a distal direction and thus directly opposite to the proximal removal direction of the stone. As a result, the stone cores and / or fragments in the cavity are also subject to a back-and-forth movement, further increasing the comminution performance.

[0065] In a further embodiment, the lithotripsy device and / or the drive device has or have a vibration excitation device for ultrasonic vibration excitation of the sonotrode.

[0066] Thus, the sonotrode can be excited by a constant vibration excitation using an ultrasonic 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 the vibration excitation device can supply the sonotrode with essentially constant ultrasonic energy simultaneously or alternately, while the drive device can transmit a repetitive, intermittent, yet very uniform ballistic deformation wave energy to the sonotrode.

[0067] 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.

[0068] Using the retrofit kit, an existing lithotripsy device can be equipped with the hollow probe for the first time, or an existing hollow probe can be replaced with a hollow probe with different properties, in particular with a different length and / or a different comminution element. Of course, the two or more hollow probes can also have other different properties, such as 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 comminution elements, for example comminution elements that extend to different distances into the hollow probe cavity, in order to achieve a high comminution 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.

[0069] 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 reshaping the outer surface of the hollow tube, so that a friction surface of each of the at least one comminution element or comminution elements protrudes into the cavity of the hollow probe, and / or - Punching out one or more openings through the lateral surface, so that a hollow probe as described above is present.

[0070] Thus, by means of the method, a hollow probe with at least one comminution element and optionally at least one opening in the lateral 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.

[0071] 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.

[0072] By using a mandrel with a lower die surface and a punch with an upper die surface as tools, with the punch pressing down on the wall of the hollow tube with its upper die surface, the comminution element is indented during the stamping process in a manner characteristic of the die, leaving marks characteristic of the die on the inner surface of the hollow probe and / or the comminution element, which, particularly due to their microstructure, can also be used specifically for comminution. At the same time, the hollow probe manufactured in this way differs from other conventionally manufactured hollow probes.

[0073] The invention will be explained in more detail below using exemplary embodiments. Fig. 1 a highly schematic three-dimensional representation of a lithotripsy device, Fig. 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, Fig. 3 a highly schematic representation of the distal area of ​​the lithotripsy device with the hollow probe during stone fragmentation, Fig. 4 a highly schematic representation of a distal region of an alternative hollow probe during stone fragmentation, Fig. 5 a highly schematic representation of a distal region of another alternative of the hollow probe during stone fragmentation, Fig. 6 a highly schematic representation of a comminution element with a displacing side and an opening, Fig. 7 a highly schematic representation of an alternative of the crushing element with an opening and a cutting side, and Fig. 8 a highly schematic representation of process steps of a process for manufacturing a hollow probe.

[0074] A lithotripsy device 101 comprises 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 Fig. 1 and Fig. 2). At the proximal end of the proximal end cap 107, a first exhaust port 151 and a Fig. 1 not visible second exhaust air connection 153 is arranged. Furthermore, on the proximal side of the proximal end cap 107, a first supply air connection 155 and a not shown Fig. 1 visible second air supply connection 156 is arranged. From the distal end section of the distal end cap 111, a suction line 119 for suctioning body stone fragments is led 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 Fig. 1 is only shown symbolically and does not have practical tight bending radii. Likewise, Fig. 1, an operating element 117 at the proximal end of the carrier unit 103 is shown only symbolically. In an alternative embodiment, the operating element 117 is arranged for optimal ergonomics 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 stopping, 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.

[0075] 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 bores 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 to the first supply air connection 155 and the second supply air connection 156 (in Fig. 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).

[0076] The guide tube 121 has on the proximal side a first through-bore 123 and a fourth through-bore 126, 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-bore 124 and a third through-bore 125, which are each connected to one of the two exhaust air chambers 159. Furthermore, the guide tube 121 has on the proximal side the fifth through-bore 127 and an opposite and therefore Fig. 2 additional through-holes (not visible), 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 shown in Fig. 2 not shown). All through holes 123, 124, 125, 126, 127 each pass transversely through the outer surface of the guide tube 121 and each have a diameter of 3 mm.

[0077] The control sleeve 131 is arranged internally within the guide tube 121. On the proximal side, the control sleeve has a first valve bore 133 and a fourth valve bore 136, corresponding to the proximal through-bores 123, 126 of the guide tube 121. Accordingly, on the distal side, a second valve bore 134 and a third valve bore 135 are formed in the control sleeve 131. The control sleeve 131 is arranged within the guide tube 121 in a rotationally secure manner, 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 inside, which simultaneously forms an acceleration path for a projectile 143. The projectile 143 has on its outer surface a driver ring 145, which rests externally on an inner surface of the control sleeve 131.The control sleeve 131 is 4 mm shorter than the guide tube 121.

[0078] Proximal to the control sleeve 131, a return spring 171 is arranged in a sheath tube, which is held in the proximal end cap 107 by a holder 173. At the distal end of the control sleeve 131, a tempating spring 181 is arranged for imparting a defined deformation wave to the sonotrode 211 due to the mechanical impact of the projectile 143. The temping spring 181 has a plurality of stacked polymer discs 191 in the distal direction 115, which are externally surrounded by a sheath tube 185. The sheath tube 185 is held in the distal end cap 111 by a holder 183. At the proximal end of the cladding 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 cladding tube 185.On the distal side, a distal end cap 189 is arranged, which is also movably held by means of a flanging of the sheath tube 185 and also has an O-ring 193 on the inside.

[0079] Thus, the distal end of the return spring 171 represents a proximal stop element and the proximal end cap 187 of the tempating spring 181 represents a distal stop element for the projectile 143. The Fig. Figure 2 shows the state in which the control sleeve 131 is abutted in a distal direction 115 against the distal-side stop element formed by the proximal end cap 187 of the tempating 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 region of the proximal fifth through-opening 127 is free of the control sleeve 131. After repulsation of the projectile 143 at the end cap 187 of the tempating 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. Through this return movement, the Fig. 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 entrainment 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 a defined stop of the proximal end of the control sleeve 131 against the distal end wall of the cladding tube of the return spring 171, whereby the respective through-bore and valve bore are continuous for the outlet of exhaust air into the exhaust air chambers 159.At the same time, the fifth through-bore 127 and the opposite, non-visible, further through-bore are closed to allow 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 carried by the projectile 143 by means of the driver ring 145, thereby opening the fifth through-bore 127 and the opposite, non-visible, further through-bore. 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... Fig. 2 shown state is reached again.

[0080] Distal to the temperature control spring 181 is a head piece 215 of the sonotrode 211, wherein the head piece 215 is movably mounted at its proximal end and its distal end in a guide part 216 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 Fig. 2. By pressing the plunger 223 into the transverse bore 221 using the actuating handle 225, fragments of body stones can be removed from the headpiece 215. A braking element 219 is arranged distally on the headpiece 215 to limit the amplitude of the sonotrode 211.

[0081] Relief bores 203 to the head piece 215 of the sonotrode 211 and to the holder 183 of the tempating 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 tempating 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.

[0082] 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 center 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 portion of the hollow probe 311 has an inner cone angle 325 of 13° (see Fig. 3).

[0083] In the region of the conical collar 319, the hollow probe 311 has a first comminution element 351. A second comminution element 353 is arranged opposite the distal direction 115 in the transition region between the conical collar 319 and the probe tube 312 with a constant cross-section, followed by a third comminution element 355 diagonally opposite it. 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 as a closed portion of the tube wall of the probe tube 312 and projects in an arcuate manner into the probe lumen 317. A distal transverse opening 327 is arranged in the tube wall of the probe tube 312 proximal to 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 projects arcuately 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.

[0084] The hollow probe 311 was manufactured from a one-piece hollow tube in a process 301 for its production, wherein the first comminution element 351 formed 303 the outer surface and thus the tube wall of the hollow tube in the region of the conical collar 319, forming 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. Subsequently, the distal transverse opening 327 was drilled into the tube wall of the hollow tube on the proximal side.During the production 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 simultaneously, so that a one-piece hollow probe 311 with the three comminution elements 351, 353 and 355 described above is present (. Fig. 8).

[0085] The hollow probe 311 manufactured in this way is used to crush a body stone 341, whereby a regular shock excitation of the hollow probe 311 is carried out by the impact of the projectile 143 on the tempating spring 181 as a distal stop element to excite a deformation wave of the hollow probe 311 as described above. As in Fig. 3, the conical collar 319 thereby enters the body stone 341 and splits it due to its outer 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 inner 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 strikes the friction surface 357 of the first comminution element 351 with its proximal end section in the region of the conical collar 319 and is thereby pressed downwards onto the pipe wall opposite the first comminution element 351 in a direction of movement deviating from the longitudinal center axis 149 of the hollow probe 311.Due to this transverse force exerted by the first comminution element 351 with its friction surface 357 and continuous suction via the transverse bore 221, the drill core 343 is moved further in the proximal direction, whereby the transverse force of the first comminution element 351 on the drill core 343 increases and the core breaks. In addition, the impact excitation by the projectile 143 causes a deformation wave of the hollow probe 311 in the distal direction 115, whereby the drill core 343 is moved in the distal direction 315 and pressed with its distal end against the inner surface 315 of the inner taper 323, which narrows in the distal direction 115, and after the impact effect has subsided, again against the friction surface 357 of the first comminution element 351.Thus, due to the impact excitation by the projectile 143, the drill core 343, as well as the hollow probe 311, is subject to a constant back-and-forth deformation in the distal direction 115 and in the opposite direction in the proximal direction, which further promotes the fragmentation of the drill core 343. The resulting fragments from the drill core 343 strike the distal friction surface 357 of the second comminution element 353 after the first comminution element 351 and are thereby deflected upwards. During further transport in the proximal direction, they strike the subsequent, diagonally opposite, third comminution element 355, so that the fragments are pushed between the proximal friction surface 357 of the second comminution element 353 and the distal friction surface 357 of the third comminution element 355 and are thereby further comminuted.These fragments from the drill core 343 are then, like the stone fragments 345 which have already passed through, carried in a proximal direction through the probe lumen 317 to the transverse bore 221 and, due to a . Fig. 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 thus the distal opening 318 itself is closed to a flow of rinsing agent.In addition, during transport of the fragments from the drill core 343 and the stone fragments 345 in the proximal direction to the transverse bore 221, the impact of the projectile 143 on the headpiece 215 and the associated hollow probe 311 can further break them up in the probe lumen 317. Furthermore, and / or in the event of blockage of the transverse bore 221 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 removed in the removal direction 347 by manually pressing the actuating handle 225 in the actuating direction 226 against a spring force of the spring 227, 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.

[0086] 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 ( Fig. 4). Opposite a proximal end of the first comminution element 351 is a distal end of a second comminution element 353 with a central opening 365. Otherwise, the hollow probe 311 is configured as described above.A drill core 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 during the fragmentation of a body stone 341 with the hollow probe 311 in the probe lumen 317 by impacting the friction surface 357 of the first comminution element 351 and, as it continues to move counter to the distal direction 115, impacts 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 drill core 343 is pressed between the upper inner surface 315 and the proximal-side friction surface 357 of the second comminution element 353 and is crushed.In addition, as described above, when a projectile 143 impacts the probe head of the hollow probe 311, a deformation wave is imparted to 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. This further promotes comminution of the drill core 343 and, in addition to the transverse forces 379 directed in different directions, corresponding forces along the longitudinal central axis 149 interact synergistically. The stone fragments 345 resulting from the drill core 343 are transported away in the proximal direction, as described above. The rinsing agent flows from the area around the body stone 341 only through the central opening 365 in the second comminution element 353.

[0087] In another, in Fig. In the alternative shown in Figure 5, the hollow probe 311 does not have a circumferential conical collar 319. Instead, the hollow probe tip is formed with a straight tube wall 375 in the upper region and an inclined tube wall 377 in the lower region, so that this region does not have a circular cross-section. Furthermore, the second comminution element 353 has a terminal proximal opening 365 instead of a central opening.As a result, the entering core sample 343 is deflected directly downwards in the cavity 317 in the region of the hollow probe tip, deviating from the longitudinal center axis 149, so that the core sample 343 impacts the friction surface 357 of the first comminution element 351 with its side surface and not its proximal end face, and also impacts the lower inner surface 315 of the probe tube 312 with its underlying side surface. By clamping the side surfaces of the core sample 343, the transverse force 379 is increased and the breaking up of the core sample 343 is improved. Otherwise, the operation of the hollow probe 311 with the two comminution elements 351, 353 is as described above.

[0088] In an alternative of the first comminution element 351, this comprises, 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 Fig. Figure 6 shows an internal view of the inner surface 315 of the hollow probe 311. When a stone fragments, the displacing side 363 initially exerts a transverse force on the stone as described above upon entry of a core sample in the direction opposite to the distal direction 115. When the core sample breaks into stone fragments due to the transverse force 379, the stone fragments are pressed against the cutting side 361 in the distal direction 115 upon impact by a projectile 143, and are cut and / or dissected before the remaining fragments are then suctioned away further in the proximal direction, as described above.Because the opening 365 is directly adjacent to 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.

[0089] In a further alternative of the first crushing element 351, this is compared to the Fig. 6 is formed in reverse 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 ( Fig.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, where it is cut 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.

[0090] 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, optimal comminution of drill cores 343 entering the probe lumen 317, 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 holders 185 cladding tube 187 Proximal end cap 189 Distal end cap 191 polymer discs 193 O-ring 195 welding ring 201 pressure relief valve 203 relief well 205 Elastomer ring 211 Sonotrode 213 Sonotrode tip 215 headpiece 216 guide part 217 O-ring 219 Brake element 221 cross hole 223 plungers 225 operating handle 226 Actuating direction 227 spring 229 Tappet holder 301 Method for manufacturing a hollow probe 303 Forming the outer 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 lumens 318 distal opening 319 Conical collar 321 external rejuvenation 323 inner rejuvenation 325 cone angle 327 distal transverse opening 341 body stone 343 drill core 345 Stone fragment 347 Discharge direction 351 first crushing element 353 second crushing element 355 third crushing element 357 Friction surface 361 cutting side 363 displacing page 365 Opening of the shredding element 367 friction-reducing coating 371 distal end of the comminution element 373 proximal end of the comminution element 375 straight pipe wall 377 sloping pipe wall 379 Shear force QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] DE 19500893 A1

[0007]

Claims

[1] 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 in a distal direction (115) a distal end for crushing body stones (341), characterized by that the hollow probe (311) has on its inner surface (315) at least one comminution element (351, 353, 355) for comminuting a body stone core (343) entering the cavity (317) of the hollow probe (311) opposite to the distal direction (115). [2] Hollow probe (311) according to claim 1, characterized by 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. [3] Hollow probe (311) according to claim 1 or 2, characterized bythat 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. [4] Hollow probe (311) according to one of claims 2 to 3, characterized by that the comminution elements (351, 353, 355) are arranged radially circumferentially and / or offset in the distal direction (115) on the inner surface (315). [5] Hollow probe (311) according to one of the preceding claims, characterized by 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. [6] Hollow probe (311) according to one of the preceding claims, characterized by that the hollow probe (311) is formed in one piece. [7] Hollow probe (311) according to one of the preceding claims, characterized bythat 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 lateral surface of the hollow probe (311), in particular by means of embossing and / or pressing. [8] Hollow probe (311) according to one of the preceding claims, characterized by 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). [9] Hollow probe (311) according to one of the preceding claims, characterized by that the hollow probe (311) has an opening (327) for supplying a rinsing liquid in its lateral surface on the distal side and / or proximal side of a comminution element, the respective comminution element or the comminution elements (351, 353, 355). [10] Hollow probe (311) according to one of the preceding claims, characterized by that the comminution element, the respective comminution element or the comminution elements (351, 353, 355) each have or have an opening (365) passing through a wall thickness, in particular the deformed lateral surface, so that the respective opening (365) can be flowed through by a rinsing liquid. [11] Hollow probe (311) according to claim 10, characterized by that the respective through opening (365) is formed by punching out with simultaneous deformation of the lateral surface into the respective comminution element (351, 353, 355). [12] Hollow probe (311) according to one of the preceding claims, characterized by 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). [13] Lithotripsy device (101), in particular an intracorporeal lithotripsy device, for fragmenting body stones (341), wherein the lithotripsy device (101) comprises a carrier unit (103) and a sonotrode (211), and a drive device for imposing a deformation wave and / or an oscillation wave on the sonotrode (211) can be assigned to the lithotripsy device (101), wherein the sonotrode (211) is connected directly or indirectly to the carrier unit (103) at its proximal end, characterized by that the sonotrode (211) is a hollow probe (311) according to one of claims 1 to 12, so that by means of the impressed deformation wave and / or oscillation wave on the sonotrode (211) and by means of the comminution element or comminution elements (351, 353, 355) a body stone core (343) entering the cavity (3179) of the hollow probe (311) opposite to the distal direction (115) can be combinedly crushed. [14] Lithotripsy device (101) according to claim 13, characterized by that the lithotripsy device (101) has the drive device. [15] Lithotripsy device (101) according to claim 13 or 14, characterized by 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. [16] Lithotripsy device (101) according to one of the preceding claims, characterized by 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). [17] Retrofit kit for retrofitting an existing lithotripsy device, characterized by that the retrofit kit has at least one hollow probe (311) according to one of claims 1 to 12 or two or more hollow probes (311) according to one of claims 1 to 12, wherein the two or more hollow probes (311) have different lengths and / or different comminution elements (351, 353, 355). [18] Method (301) for manufacturing a hollow probe (311) from a hollow tube having a lateral surface, an outer surface (313) and an inner surface (315), a distal end and a proximal end, comprising the following steps: - forming at least one comminution element or several comminution elements (351, 353, 355) by forming (303) the outer surface of the hollow tube, so that a friction surface (357) of each of the at least one comminution element or comminution elements (351, 353, 355) projects into the cavity (317) of the hollow probe (311), and / or - punching (305) one or more openings (327, 365) through the lateral surface, so that a hollow probe (311) according to one of claims 1 to 12 is present. [19] Method (301) according to claim 18, characterized by 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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