DE102008059547A1 - Device for removing concrements in body vessels - Google Patents

Abstract

The invention relates to a device for removing concrements from body vessels with at least one compressible receiving element (20) for receiving concrements and a supply device (10) for guiding the compressed receiving element (20). The invention is characterized in that the receiving element (20) has a fluid-tight cover (21) which forms a closable by the concretion to be removed, in particular proximal cavity (30a), wherein the receiving element (20) associated with an actuating device (11) is, which at least in use with the cover (21) and / or the cavity (30a) is operatively connected in that in the cavity (30a) for moving, in particular for releasing the calculus to be removed, a different pressure is adjustable than outside the cavity (30a).

Description

The invention relates to a device for removing concrements from body vessels according to the preamble of claim 1. Such a device is for example from the WO 2006/031410 known.

The Formation of concrements in body vessels can cause the body vessel through the Concrete completely or at least partially closed will result in significant health restrictions. A particularly high risk is based on thrombi, d. H. from Blood clots that form intravascularly and the blood vessel partially or completely close. If the occlusion affects an artery, the downstream ones arranged tissue areas no longer or inadequate with Oxygen and other nutrients supplied what is called ischemia designated and has a Gewebesterben the possible consequence.

Currently Thrombi are common in human arteries treated by the drug thrombolysis, the Blood clots are dissolved with the help of medication. The condition for this therapy is that the treatment at the latest three hours after the onset of symptoms he follows. In addition to this narrow window of opportunity has the drug thrombolysis has the disadvantage that the treatment not only locally in the area of the thrombus, but also in others Regions, for example, in nearby brain areas acts. By the Inhibition of blood clotting there is a risk of bleeding complications, in particular the risk that the therapy triggers a brain hemorrhage becomes.

An alternative to drug therapy is the mechanical removal of thrombi from blood vessels, in which, for example, a device according to the aforementioned WO 2006/031410 A1 is used. The known device comprises a receiving basket with a stent-like lattice structure arranged for insertion into the blood vessel in a compressed state within a catheter. To remove the blood clot, the catheter is inserted into the blood vessel until the catheter tip is positioned near the thrombus. The receiving basket located in the catheter is released at the catheter tip and unfolds there to about the size of the blood vessel so that the thrombus can be received by the basket. The catheter is also designed as an aspiration catheter, which generates a negative pressure in the area in front of the thrombus, so that parts of the thrombus are detached and sucked into the catheter. The receiving basket additionally serves as a filter so that no larger particles are transported past the aspiration catheter into further blood vessels.

at The known device is characterized by the aspiration in the area the thrombus a relatively large area with a negative pressure applied. The pressure drops in a larger one Brain area under physiological pressure and there is a risk that the transmural pressure becomes negative. This can result that the blood vessel is narrowed before the thrombus or collapses, causing the blood flow in this area is limited or comes to a halt. Thereby On the one hand, an efficient detachment of the thrombus is prevented and on the other hand, risk that the vessel through the Effect of negative transmural pressure is violated. Especially when the negative pressure in vascular areas with branching Side vascular acts, there is a risk that the Collapse secondary vessels and thus previously well supplied with blood Tissue areas are under-supplied. Even with positive transmural Pressure causes aspiration-induced negative pressure, d. H. a pressure that is less than the physiological pressure, too a reduced blood flow to the affected areas, in particular in the brain.

A further problem when using the known device results in cases when the thrombus to be resolved is not closes the entire vessel cross-section, so that still a partial blood flow is possible. Such a situation can arise, for example, parts of the thrombus are already removed by the aspiration so that the vessel is partially recanalized, d. H. is reopened. There is a risk that now past the catheter and flowing through the receiving basket Blood on passage through the thrombus entrains particles, those in downstream, smaller blood vessels can lead to a re-closure. Around To counteract this process, it is known, the aspiration volume to increase, so that the entire, flowing through the blood vessel Blood is sucked off. This will give the patient a relatively short time Period, a large amount of blood volume taken, which significant health consequences for the patient can draw.

Particle detachment with subsequent closure of downstream vessels may occur, in particular, when a relatively large particle is released from the thrombus by aspiration, aspirated by the catheter, and the suction opening is thereby closed. In this case, the generation of the negative pressure is suddenly interrupted, so that the original pressure conditions in the blood vessel are restored. The re-forming blood flow can detach other particles and trans to downstream vessels trans port, which can lead to a renewed vascular occlusion.

Of the Invention is based on the object, a device for removing indicate concrements from body vessels, which ensures a simple and safe handling and function and reduces the health risks to the patient.

According to the invention this object is achieved by the subject matter of patent claim 1. Alternatively, this task is done by the subject of the sibling Patent claim 19 solved.

The The invention is based on the idea of a device for removal of concrements from body vessels with at least one compressible receiving element for receiving concrements and a supply means for guiding the kompri-optimized Specify receiving element, wherein the receiving element is a fluid-tight cover having a closable by the calculus to be removed, in particular forms proximal cavity, wherein the receiving element an actuating device is assigned, at least in use with the cover and / or the cavity in operative connection is such that in the cavity for moving, in particular for Release the calculus to be removed, another pressure is adjustable than outside the cavity, in particular on the distal side of the calculus to be removed.

The Invention has the advantage that the calculus by adjustment a lower pressure in the cavity than the physiological pressure (Vacuum) sucked into the cavity or the receiving element or by acting on the calculus higher physiological Pressure is pushed into the cavity. In this respect, by the actuator a force acting in the direction of the receiving element (causes by the pressure difference on both sides of the calculus) on the created to be removed calculus. It is also possible that at least temporarily the pressure gradient reversed is such that in the cavity an overpressure, d. H. one higher pressure than the physiological pressure is generated, so that the calculus for releasing briefly with an in acting distal direction force is applied. To suck in the Concrements in the receiving element is then a negative pressure again set in the cavity.

to Formation of the cavity delimits the receiving element in the axial direction, in particular in the distal axial direction open space, in use can be closed by the calculus to be removed. The limitation of the space or cavity in the other axial direction, in particular in the proximal axial direction is effected by the fluid-tight Cover. The fluid-tight cover is adapted, or extends as far in the distal direction of the receiving element, that the cover with the vessel wall in use fluid-tight. As a result, one takes place in one direction, in particular acting in the proximal direction sealing of the vessel. The seal in the other direction, especially in the distal Direction is taken over by the calculus, which is on the vessel wall abuts and closes the vessel.

For the closure of the cavity by the calculus, it is not necessary that the calculus rests directly on the sealed receiving element. It is sufficient if the cross section of the receiving element downstream vessel section and thus the Cross-sectional area of the distal opening of the receiving element is covered by the calculus, wherein the calculus is minor can be arranged spaced from the receiving element. A hermetic one Vascular closure by the calculus is not required to reduce the pressure gradient between the distal and build the proximal side of the calculus. It is enough if the amount of blood possibly flowing through the calculus so low is that a pressure equalization with time delay established.

there are cavities in the sense of logging generally spaces, the by an interaction of the calculus to be removed with the receiving element or the fluid-tight cover are formed and are completed substantially built-in and fluid-tight. In this way, the cavity can accommodate a recording function form the calculus and / or a sealed area in which a relative to the environment other pressure is adjustable. The cavity may contain liquid, in particular blood.

Under The term pressure are also used in the context of the present application not only positive pressures (overpressure), but explicitly also negative pressures (negative pressure) understood. An overpressure is a pressure that is higher as the pressure prevailing in the vessel. Corresponding For example, a negative pressure is a pressure lower than that prevailing in the vessel Print. In the possible occurring in the prior art Collapse of the vessel is the negative pressure so pronounced that the transmural pressure is negative.

The invention is particularly suitable for removing clots or thrombi from blood vessels. Although the invention is described below using the example of the removal of thrombi, other possible uses of the device, which concern the removal of concretions or objects from body cavities, of of the invention.

The Room designations or directions, in particular the designations distal and proximal, refer to the position of the user, in particular doctor, who operates the device. Distally arranged Objects are therefore arranged with respect to a proximal Object further away from the user or operator of the device arranged.

The Invention has the advantage that in use by the fluid-tight Cover the production of the pressure before the concretion locally limited is, d. H. that the pressure only in the area of the cavity, in particular the proximal cavity acts. Around the calculus or the thrombus to move into the receiving element, the cavity is preferably with a negative pressure, d. H. one opposite the blood pressure behind the thrombus lower pressure, applied, being not excluded is that the pressure within the cavity is at least temporary can be larger than outside the Cavity (overpressure). At the same time the vessel wall through the receiving element expanded in the vessel supported, allowing a vessel collapse avoided or prevented. Furthermore, by the closed, particular proximally arranged cavity reaches that at the Generating the pressure by fluid displacement only the volume or is discharged, which leads to the movement of the thrombus in the Recording element is necessary. The removal of relatively high blood volume is thus avoided. Outside the cavity, in particular proximal to the cavity, the blood pressure is not reduced, so that the vessel collapse and a possible Underprovision of brain areas is prevented.

By the fluid-tight cover of the receiving element becomes the thrombus essentially separated from the bloodstream, d. H. that in the cavity, in particular the proximal cavity substantially no flow is present. This will avoid that by the generation of pressure in the cavity high shear stresses on the thrombus act to release individual thrombus particles being able to lead. Rather, it is generated by the Pressure in the cavity reaches that of the thrombus completely dissolved and moved into the receiving element, as on the total cross-sectional area of the thrombus the same pressure gradient acts and the thrombus thereby slides homogeneously into the receiving element.

All in all the invention makes the negative effect of a vascular occlusion per se to use, by the closure in cooperation with the inventive Device is used to act on a pressure or negative pressure To create cavity in the vessel, which serves the Release the closure and close the closure body remove. The receiving element corresponds in its function a suction cup, d. H. the receiving element is like a suction cup educated.

at a preferred embodiment of the invention Device, the actuating device comprises a suction and / or pressure means fluidly connected to the cavity or is fluid-connectable. The suction and / or pressure device comprises preferably a pressure generating unit passing through a pressure line is fluidly connected to the cavity or fluidly connected, wherein the Pressure line arranged in or outside the feeder or is formed by the supply device itself. With the suction and / or printing device, in particular with the pressure generating unit, the pressure inside the cavity, especially the proximal one, can be Cavity particularly easy against the pressure outside the proximal cavity are changed, for example by Supply and / or removal of liquid or other fluids.

In In this context, it should be noted that the name Fluids in the context of the present application are not limited to liquids, but also refers to gases.

Preferably the actuating device comprises an actuating medium, in particular a liquid that is at least partially into the cavity, in particular proximally arranged cavity pumpable and / or sucked out of the cavity. With the actuating medium The pressure generation in the cavity can be easily done by a user be controlled from outside the body. It is also conceivable that the actuating medium mechanical Includes components.

in the Below, further structural features of the invention are described, the description of the device in use or in the expanded state of the receiving element refers.

The receiving element may be formed like a basket. The receiving element may further comprise a distal, substantially cylindrical portion which comprises an opening for receiving a concretion. The opening forming portion of the basket-like receiving element may also have a different contour. In use, the cylindrical portion, which may be formed substantially in the manner of a stent, on the vessel wall, whereby sufficient space and stability is ensured, on the one hand to accommodate the blood clot or the thrombus and on the other hand to stabilize the blood vessel so that the pressure generated in the cavity does not lead to a collapse of the blood vessel. The opening for receiving the thrombus is preferably arranged at the distal end of the receiving element and has approximately the diameter of the blood vessel, so that the blood clot can be received in one piece. It is possible that the cylindrical portion has a cutting region in the region of the opening, with which the release of the thrombus can be assisted.

Further the receiving element may have a proximal, substantially funnel-shaped Section which, with the actuating device, in particular the suction and / or pressure device is connected. The funnel shape of the proximal end of the receiving element has the Advantage that the receiving element when it received a thrombus has, can be easily withdrawn into a catheter, wherein the receiving element is compressed. The recorded thrombus becomes while firmly held in the receiving element and together with this for final removal withdrawn into a catheter.

at a preferred embodiment of the invention Device closes the cover of the receiving element with the actuating device, in particular the pressure line, fluid-tight. This will ensure that the pressure generated only within the cavity, in particular the proximal cavity acts on the clot. Especially when using of fluids to generate a negative pressure is prevented for example, blood from the surrounding blood vessels is pumped out. Rather, for example, a negative pressure in the proximal cavity by pumping a minimum volume of fluid be achieved.

Preferably the receiving element is a closing element, in particular a screen, which, in use, can be positioned distally to a calculus is. The final element can act as a filter, so that Prevents particles that may be from the thrombus, in downstream Purging vessels. Furthermore, with the termination element, the receiving element, in particular the opening of the receiving element, be closed once the concrement or the thrombus is arranged in the receiving element. Thus, can the thrombus essentially completely in the receiving element be encapsulated.

The End element may have a fluid-tight cover, the is adapted, in cooperation with at least the calculus a distal Cavity to form. This embodiment is special suitable for combination with the sealable proximal Cavity passing through the fluid-tight cover of the receiving element is formed. This has the advantage of being a safety feature is reached, in the case that the calculus the proximal Cavity does not close so tightly that a vacuum can be constructed in the proximal cavity. this could for example, when part of the thrombus dissolves and so forms a larger channel, the pressure equalization creates in the proximal cavity. In this context will be on it noted that a completely tight closure of the Cavity, in particular of the proximal cavity through the calculus is not necessary to establish the negative pressure, as long as the channels or openings present in the thrombus so small are that at least temporarily sufficient high pressure gradient between the proximal and distal sides of the thrombus or concretion is adjustable.

The The embodiment described above has the advantage that - in the event that a sufficient pressure gradient is not accessible, the end element or its fluid-tight Cover takes over the closing function, so that prevents that will take a larger amount of blood from the distal Side of the calculus is sucked. Besides, this one has Embodiment the advantage that the physiological pressure then on serving as a closure element closing element or its fluid-tight cover acts, creating a proximal direction directed force is generated on the end element that the End element together with the concretion in the direction of the receiving element pushes.

Advantageously, the end element with the pressure line, which is associated with the receiving element, or another, separate pressure line fluidly connected such that in the distal cavity for moving, in particular for releasing the concretion, a different pressure is adjustable than outside the distal cavity. The advantages described in connection with the proximal cavity, which is formed by the cover of the receiving element and at least the concretion, apply substantially equally to the closing element provided with the cover. In particular, this embodiment has the advantage that, by setting an overpressure in the distal cavity between the concretion and the closing element, the thrombus or, in general, the concretion is displaced in the direction of the receiving element. In contrast, in the case of the proximal cavity between the calculus and the receiving element, the movement of the concretion towards the receiving element is initiated by the negative pressure generated in the proximal cavity. in addition comes that in this embodiment, the overpressure generated in the distal cavity leads to a radial vessel widening, whereby the release of the clot is facilitated. Further, the removal of the clot may be assisted by anticoagulant drugs, such as thrombolytic agents, which are introduced into the distal cavity. The medication can be supplied through the pressure line.

at a preferred embodiment of the invention Device are the closing element and the receiving element with the actuating device, in particular the suction and / or pressure device, fluidly connected such that between the distal cavity and the proximal cavity for moving, in particular for releasing, a between the cavities arranged concrements different, in particular changeable, relative pressures adjustable are. Decisive for the release of the thrombus is the pressure differential between the pressure in the distal Cavity and the pressure in the proximal cavity, d. H. above the calculus, trains. The relative pressures in the two Cavities are therefore adjustable so that, for example in the distal cavity a relatively high and in the proximal cavity A relatively low pressure can be generated around the clot to move into the receiving element. This will cause the pressure drop and thus the force needed to release and move on the Clot works, increases. In the cavities can each independently an over- or Vacuum be generated. In particular, there is the possibility by fluid supply in the proximal cavity an overpressure and by liquid discharge in the distal cavity a negative pressure to create. The thrombus thereby moves distally, due to the overpressure in the proximal cavity comes to a proximal vessel widening, causing the Replacement of the thrombus is made possible. A pressure reversal and thus a reversal of motion can follow.

The End element and the receiving element can with a be connected to common pressure generating unit. In this way may be the pressure gradient necessary to release the clot be set centrally.

Preferably the common pressure generating unit is arranged extracorporeally and comprises at least one oscillatable partition, in particular Pressure diaphragm, at least in use with the closing element and / or the receiving element fluidly connected or fluid-connectable is. Through the pressure membrane, the pressure in the cavities easily and accurately adjusted and varied. This can be up simple way of overpressure or negative pressure in the proximal and distal cavities on both sides of the calculus by liquid supply (overpressure) or liquid removal (Negative pressure) are generated. Instead of the oscillatable pressure membrane Also, a simple syringe can be used to hydration and fluid drainage intuitively to regulate, the doctor manually release the required force and frequency thrombus by alternately pulling and pushing the Control syringe. It is therefore generally disclosed in this context, that the common pressure generating unit, for example, the syringe or another piston / cylinder arrangement is arranged extracorporeally. The pressure membrane or the syringe also have the advantage that the pressure in both cavities can be changed depending on each other is. In particular, in this way in a cavity, a negative pressure and at the same time an overpressure is generated in the other cavity, this pressure drop is easy and quick to reverse or is invertible.

alternative the common pressure generating unit may be a feed pump, in particular an intracorporal delivery pump, which is arranged within the pressure line such that the feed pump at least in use fluidly connected to the closing element and / or the receiving element or is fluid-connectable. This will do this for pressure generation moving fluid volume compared to an extracorporeal Pump is reduced, as the existing in the pressure line, essentially ineffective dead volume is not moved. The intracorporal delivery pump is therefore particularly efficient. Another advantage of the feed pump is that in the delivery system no fluids are present, but only power cable or a pump shaft. This has the advantage that the system is dimensioned with very small diameters can be.

The pressure generating unit, in particular the common pressure generating unit, is preferably assigned a control unit which is adapted such that a pressure change in at least one, in particular two, cavities frequency-dependent, in particular pulsating, in particular in the form of a sinusoidal curve, in particular a sinusoidal curve is controllable. The pressure distally and proximally of the clot is advantageously varied over time, so that changes the pressure gradient between the two cavities in its direction of action. This can be done, for example, by alternating supply and removal of fluid volume in a cavity or both cavities, so that the clot is vibrated, whereby the release of the clot is facilitated by the vessel wall. In this case, the change in pressure may be sinusoidal, wherein the time course of the pressure change before or after the clot is coordinated. There are also other zeitli Pressure changes possible, for example in the form of a sinusoidal curve, that is, in both cavities, for example, alternately carried out a removal of fluid volume.

The Control unit may further comprise at least one pressure measuring element, which is connected to the suction and / or pressure device is such, that the pressure which can be generated in the cavities can be measured and / or is adjustable. In this way it can be achieved that the Detaching the thrombus from the vessel wall is detected because when detaching the thrombus a characteristic Pressure change is generated. Further, by the pressure-dependent control the pressure in the cavities limited, whereby the risk of injury is reduced in the vessel, as an overstretching or collapse of the vessel is avoided.

at a further preferred embodiment of the invention Device is provided a flexible fluid-tight membrane, the on the one hand at least with a distal end of the receiving element and on the other hand operatively connected to the actuator is. Preferably, the flexible membrane forms with the cover of the receiving element, a chamber connected to the suction and / or pressure device, in particular the pressure line, fluid-connected is such that in Use by the pressure in the chamber of pressure in the proximal cavity is adjustable. In this way, the actuating medium, for example, a liquid completely within held the device, so that the actuating medium for example, not with the blood outside the cavity interacts. The risk of injury and infection for the Patients are thus reduced. At the same time it prevents that Body fluids penetrate into the device and an impairment of the function of the device cause. When the device with such a flexible membrane equipped, the actuating medium can also comprise a wire which is connected to the membrane, so that the pressure within the proximal cavity by clamping or Relax the membrane is generated. The pressure generation takes place in this variant by simply pulling the wire, resulting in the Medicine, especially in interventional radiology, one known and easy to handle procedure. Furthermore, the wire offers a feedback, giving the user a feeling develop for the force necessary to remove the thrombus and this can dose well. The flexible membrane or through the membrane formed chamber provides an effective part cavity within the proximal cavity, which is the receiving and pressure or negative pressure generating function takes over.

The Receiving element preferably comprises a proximal end portion, the substantially cylindrical shape and with the cavity is connected, wherein the longitudinal axial extent the end portion is adapted such that the end portion in Use at least partially arranged in the feeder is. The proximal end portion thus has the function, the receiving element for the concrement and the feeder in expanded State to connect, insofar as the longitudinal axial extent of the end portion is so dimensioned or adapted that the end portion in use, d. H. in the expanded state of the receiving element, at least partially disposed in the supply device. These Embodiment is without being limited thereto to be, for the combination with the embodiment suitable, in which the supply device itself as a pressure line, or is designed as aspiration catheter. This has the advantage that the cross-sectional diameter of the suction and / or pressure device or the supply device continuously formed relatively large can be, so the efficiency of the pressure / vacuum generation in the proximal cavity between the fluid-tight cover and the is increased to be removed calculus. The proximal end section may have an outside diameter equal to the inside diameter the supply device corresponds. As a result, pressure losses in the Feed system or avoided by the supply system or at least reduced.

Of the proximal end portion and the receiving element, in particular the funnel-shaped and the cylindrical section, are preferably formed in one piece. In this way, the Production of the device simplified.

Of the cylindrical section and / or the funnel-shaped Section and / or the proximal section can be a braid include. The wire elements can be twisted together, interwoven or intertwined or arranged generally crossing several times be. The braid has the advantage that the receiving element a has high flexibility, so that the device in Vascular curvatures can be used.

In a further embodiment, at least the cylindrical portion comprises a cross braid, in particular with axially arranged bands. In this case, at least the proximal end portion may include a braid with spiral winding, in particular with axially arranged bands or an asymmetrical braid. The above-mentioned various types of braids may merge into each other such that, for example, the cross braid of the cylindrical portion merges into a spiral winding of the end portion and / or the funnel-shaped portion. The advantage of the axially arranged bands in the spiral wound mesh is that the bands have tensile forces and the spiral winding can absorb shear forces. The advantage of the cross braid with axially arranged bands is that the axial Kraftauf acquisition is improved at relatively low elongation. The advantage of the asymmetric braid is that it is highly flexible and can absorb forces and torques in the proximal and distal axial direction.

at the asymmetrical grid mesh, the wire elements, the overlap or intersect in intersection areas, with respect to a line extending in the axial direction different Angle or braid angle on. Due to the different braiding angles is achieved that the wire elements that are symmetrical Grid meshes can easily slide on each other, block each other, so that a particularly stable grid structure is formed. Of the asymmetrically braided proximal end portion can thus both Absorb axial forces as well as torques. The grid of the receiving element, which is in the region of the proximal end portion Continued or continued, leads through the asymmetric arrangement of the wire elements to a particularly stable structure of the proximal end portion.

at Another preferred embodiment, the proximal End portion and the supply device each have an end stop in such a way that an axial movement of the receiving element in the distal Direction is limited. The proximal end portion may be in the Feed device to be arranged axially movable, so that the receiving element for positioning in a body vessel relative is movable to the supply device. Through the interaction of the End stop of the proximal end portion and the end stop of the feeder is the feed movement limited or limited, so that a release the receiving element is avoided by the supply device. Much more becomes a part of the proximal end portion in the feeder retained. The end stops thus act as restraint and seal in the stop position the connection between end portion and supply from. Consequently can the entire lumen of the feeder or microcatheter be used to generate the pressure or negative pressure in the cavity. Another advantage is that when navigating the Feeding device or the microcatheter to the calculus, d. H. to the place of treatment, no further components, in particular catheter-like elements, located in the feeder, whereby the feeder has a high flexibility and a risk of injury is reduced.

Of the End stop of the proximal end portion may be at least one sleeve include, with the outer periphery of the proximal end portion connected is. The sleeve is a simple means to the Outer diameter of the proximal end portion locally limited to increase the formation of the end stop. The Sleeve also causes the itself in the stop position resulting connection between the end portion and the feeder or generally between the receiving element and the feeder is relatively short.

It is also possible to have more than one sleeve at the proximal Provide end portion, the other arranged proximally Sleeves or another proximal sleeve arranged improves the leadership of the basket or the receiving element.

The Sleeve can be cohesively bonded to the proximal end section, positive, non-positive or by a be connected coaxially arranged sleeve, wherein the proximal end portion is clamped between the two sleeves. The cohesive connection between sleeve and proximal end portion may, for example, by welding, Gluing, by spraying the sleeve or by soldering respectively.

The Clamping connection, wherein the proximal end portion between a arranged radially outside and one radially inward and coaxial arranged sleeve is jammed, has the advantage of secure mechanical connection that is easy to manufacture.

Of the End stop of the feeder or the microcatheter can at least a sleeve, which with the inner circumference of the supply device connected is. This version of the end stop is simple manufacture.

A Another possibility is that the end stop comprises a part of the distal tip of the feeder, wherein the part of the distal tip extends radially inward and has a smaller inner diameter than a proximal part the feeder. In this embodiment can the end stop, for example by reshaping the feeder be made easily in the area of the distal tip.

The supply device may comprise an adapter arranged axially movably in the supply device, which adapter is detachably connected to the receiving element, in particular to the proximal end section or to the funnel-shaped section, such that the receiving element is axially movable relative to the feed device. The detachable connection between the adapter and the receiving element or between the adapter and the proximal end portion has the advantage that the receiving element for positioning by the adapter with a Betätigungsele ment, for example, can be connected to a guide wire. The receiving element can then be moved in the proximal and distal axial direction through the adapter or through the guide wire connected to the adapter. When the receiving element is positioned, the adapter can be removed from the receiving element, in particular from the proximal end portion and from the supply device, so that it fulfills its dual function, namely the supply of the receiving element and the pressure supply.

at In another preferred embodiment, the receiving element is in particular the proximal end portion, with the feed device in one piece, in particular with the actuating device or formed with the suction and / or pressure device. Thereby is achieved that the suction and / or pressure means a relative includes large lumen, allowing the handling of the device improved and the efficiency of the treatment is increased. It is also possible that the receiving element by the in one piece with the supply device, in particular with the actuating device or the suction and / or pressure device, formed proximal end portion is controllable. Preferably, the receiving element has a grid structure which extends in the proximal direction into the supply device and thus the actuating device, in particular a Guide catheter, forms. The grid structure can at least in the proximal end portion or in the portion in which the lattice structure the actuating device forms an asymmetric grid mesh include. In this way, with the in the feeder Continuous grid structure controlled the receiving element, be moved in particular in the distal or proximal direction, wherein in the variant with an asymmetric lattice structure in the area the proximal end portion additional stability the actuator is reached.

One Another independent aspect of the invention is a device for removing concrements from body vessels, in particular according to at least one of claims 1 to 18, with a closure element that is distal in use can be positioned to a concretion and a fluid-tight cover which cooperates to form a distal cavity is adapted with at least one concretion, wherein the final element with an actuating device, in particular a suction and / or pressure device, is operatively connected such that in the distal Cavity for moving, in particular for releasing, the calculus another pressure is adjustable than outside the distal Cavity.

The Invention will be described below with reference to exemplary embodiments with reference to the attached schematic drawings explained in more detail. Show in it

1 a longitudinal section through a device for removing concrements according to an embodiment of the invention in use;

2 a longitudinal section through a device according to another embodiment of the invention in use;

3 a longitudinal section through the device according to 2 in the compressed state;

4 a longitudinal section through a device according to another embodiment of the invention;

5 a longitudinal section through a device according to the invention according to a further preferred embodiment in use;

6 a longitudinal section through a pressure line of the device according to 5 ;

7 a longitudinal section through a pressure generating unit of the device according to the 2 to 4 according to an embodiment of the invention;

8a . 8b in each case a time / pressure diagram for the proximal and the distal cavity of the device according to 5 according to a preferred embodiment;

9a . 9b in each case a longitudinal section through a device according to a further embodiment of the invention;

10 a longitudinal section through a device according to another embodiment of the invention;

11 a side view of a device according to another embodiment of the invention;

12a a side view of a device according to another embodiment of the invention with a variant of the end stops;

12b a side view of a device according to another embodiment of the invention with a further variant of the end stops;

13a a side view of a device according to another, inventive Aus guiding example, in which the proximal end stop is releasably connected to an adapter;

13b a variant of a basket-side sleeve, which is connectable to the adapter;

14a a side view of a device according to another embodiment of the invention in the compressed state; and

14b a side view of the device according to 14a in the expanded state.

In general, in the present application, a device for removing concretion or clots 51 from blood vessels 50 or other body cavities disclosing a receiving element 20 comprising a compressed state having a relatively smaller cross-sectional diameter and an expanded state having a larger cross-sectional diameter. The receiving element 20 is for insertion and positioning in a blood vessel 50 preferably in a feeder 10 or a catheter arranged. To take up the clot 51 is the receiving element 20 relative to the catheter, in particular in the distal direction, movable. The receiving element 20 is adapted to take the expanded state automatically. The catheter may comprise a suction and / or pressure unit, in particular a suction unit or an aspiration catheter, which are connected to the receiving element 20 connected is. At the proximal end of the catheter, the device may further comprise an operating unit connected to the catheter for insertion into the blood vessel 50 , and / or with the receiving element 20 for the transfer of the receiving element 20 from the compressed to the expanded state.

1 shows an inventive embodiment of a device for removing concrements in use, ie when receiving a concretion or clot 51 , The device comprises a receiving element 20 which is distal to the actuator 11 is arranged. The receiving element 20 is basket-shaped or funnel-shaped and has a tapered in the proximal direction funnel-shaped portion 24 on. The funnel-shaped section 24 is distally with a cylindrical section 22 connected, in particular coaxially connected. The cross-sectional diameter of the cylindrical section 22 of the receiving element 20 corresponds essentially to the diameter of the blood vessel 50 so that the cylindrical section 22 in the expanded state rests against the vessel wall and supports it. The cylindrical section 22 forms at the distal end 26 of the receiving element 20 a receiving opening 23 , which at least temporarily by the calculus or clot to be removed 51 is closable (s. 1 ). The distance between the receiving opening 23 and the funnel-shaped section 24 or generally the proximal end of the receiving element 20 is sized so that the calculus or clots to be removed 51 in the receiving element 20 completely or at least for the most part is absorbable.

The receiving element 20 can also have a different shape than those in 1 illustrated form. For example, the receiving element 20 a shortened cylindrical section 22 have such that the receiving element 20 essentially up to the receiving opening 23 funnel-shaped. The receiving element 20 can also be formed conical at least in sections. In addition to the rotationally symmetrical shape of the receiving element 20 Other cross-sectional profiles can also be realized.

The receiving element 20 is also at least with a cover 21 or provided with a coating or a Covering, with the receiving element 20 may be formed integrally or in one piece. The cover 21 forms a fluid-tight wall of the receiving element 20 , The cover 21 may be prepared by sputtering or another coating method as a cantilevered support structure. The cover 21 can be fixed with a grid structure of the receiving element 20 be connected. It can cover 21 both on an inner surface of the receiving element 20 , as well as on an outer surface or an outer periphery of the receiving element 20 be arranged. The cover 21 can be over the entire recording element 20 extend or the receiving element 20 only partially cover, leaving the cover 21 in use at least as far extends over the vessel cross-section that the blood vessel 50 is substantially completely closed in the proximal direction. For example, the cover 21 only the funnel-shaped section 24 cover. The cover is made of a fluid-tight material that is sufficiently tight to provide a pressure differential between the inside and outside of the cover 20 unbearable.

As in 1 shown, forms the cover 21 or the receiving element 20 a curved in the proximal direction recess or a proximal cavity 30a , The cover 21 or the cavity 30a itself is closed by the calculus to be removed. That means the diameter of the cavity 30a or the receiving element 20 corresponds approximately to the diameter of the calculus to be removed. The fluid-tight cover 21 extends so far in the distal direction, in particular to the receiving opening 23 that the proximal cavity 30a in cooperation ken with the calculus 51 is completed substantially pressure-tight or fluid-tight. Through the fluid-tight cover 21 on the one hand and the calculus to be removed 51 on the other hand, the proximal cavity 30a from all sides of the surrounding blood flow in the vessel 50 essentially cut off. It is important that the fluid-tight cover 21 is formed so that the receiving element 20 fulfills two functions, namely, on the one hand the function of an overpressure and / or vacuum chamber for moving, in particular for releasing the calculus and on the other hand, the function of a receiving space for the dissolved from the vessel calculus 51 ,

With regard to the release function of the receiving element 20 this is the actuator 11 assigned, at least in use with the cover 21 and / or the cavity 30a is in active connection. In this case, the actuating device 11 provided and designed in cooperation with the cover 21 and / or the cavity 30a the calculus 51 in the cavity 30a to move, in particular for releasing the calculus to be removed to set a different pressure than outside the cavity 30a , in particular in a region distal to the calculus 51 , For this purpose, the actuating device comprises 11 specifically a pressure line 15 , in particular a proximal pressure line 15a , The proximal pressure line 15a is at its distal end with the receiving element 20 , in particular with the funnel-shaped section 24 of the receiving element 20 connected. In this case, the tubular contour of the proximal pressure line is established 15a partly in the receiving element 20 continued. The pressure line 15 is how in 1 shown inside the feeder 10 , For example, arranged inside a microcatheter. The pressure line 15 . 15a can also be outside of the feeder 10 be arranged or by the feeder 10 be educated yourself. The actuating device 11 further comprises a suction and / or pressure device (not shown), which via the pressure line 15 . 15a with the cavity 30a fluid-connected or fluid-connected. By means of the suction and / or pressure device, an actuating medium 14 , in particular a liquid in the cavity 30a ge pumped and / or out of the cavity 30a be sucked off. By the liquid supply can by means of the actuator 11 or the suction and / or pressure device, the pressure in the proximal cavity 30a be increased if this, as in 1 closed at the distal end by the calculus to be removed. By liquid removal or suction in the cavity 30a located liquid, the pressure in the cavity 30a lowered below the physiological pressure (negative pressure). That means the physiological pressure on those from the cavity 30a opposite side of the calculus 51 acts as indicated by the in 1 to recognize marked arrows. As a result, in the proximal direction, ie in the direction of the receiving element 20 acting force on the calculus 51 generates the calculus 51 in the receiving element 20 or slides the basket. To solve the calculus 51 can support from the vessel wall, in the cavity 30a alternately an overpressure and underpressure are generated.

The receiving element 20 has a substantially stent-like structure and can either be braided from wires or made by laser cutting from a tube. A combination of a wire mesh and a laser cut structure is possible, for example, the funnel-shaped portion 24 braided and the cylindrical section 22 be laser cut. Preferably, the receiving element 20 from a shape memory material, for example nitinol. The cover 21 For example, it may comprise a plastic film or metal foil. Particularly suitable plastics are polyurethane, PTFE or silicone. The production of the metal foil can be done by a sputtering process. The cross-sectional diameter of the receiving element 20 may be between 1 mm and 10 mm, in particular 2 mm and 8 mm, in particular 3 mm and 6 mm. Depending on the application, it is also possible that the receiving element 20 a cross-sectional diameter between 0.5 mm and 20 mm, in particular 1 mm and 18 mm, in particular 2 mm and 15 mm. The length of the receiving element 20 is also dependent on the particular application, in particular on the treatment site, and may vary between 3 mm and 100 mm, in particular 5 mm and 60 mm, in particular 10 mm and 22 mm.

Overall result in the embodiment according to 1 the following advantages or effects:
The same pressure gradient prevails over the entire area of the thrombus and pushes the thrombus homogeneously into the basket. The handling is particularly safe and easy for the user as it creates the vacuum through limited volume changes, increasing or decreasing the vacuum arbitrarily and at a controlled rate, depending on the resistance exerted by the thrombus. The movement of the thrombus is felt by the force exerted by the user to generate the negative pressure. He can replace the thrombus with alternating, regular negative pressure and balancing phases from the vessel wall.

For this purpose, a proximal basket spreads out of a catheter (nitinol, superelastic area) and attaches to the vessel wall. The basket is coated by a dense structure so that the proxima le side of the thrombus is separated from the flow conditions in the circulation. The basket is connected to the catheter. Defined volume changes in the catheter create a negative pressure that acts on the entire proximal thrombus surface. The negative pressure is understood in relation to the blood pressure that prevails behind the thrombus. When there is a 50 mmHg pressure behind the thrombus, a pressure of 20 mmHg in front of the thrombus is defined as a negative pressure. This effect can be considered as inversion of the pressure gradient from distal to proximal. Distal to the thrombus may be high "arterial" pressure when collateral vessels by-pass the occluded vessel portion and deliver high pressure blood behind the thrombus. Behind the thrombus, a pressure of about 80 mmHg prevail. With a pressure gradient of about 100 mmHg in a vessel with a diameter of 3 mm, a total force on the thrombus of about 20 gr. Could be generated.

smaller But forces are already enough to fight the thrombus to move the low adhesion to the vessel wall. The degree of volume change can be very precisely defined by the user. It can, for. B. with a syringe happen, which is connected to the catheter. If a volume was sucked out, creates a vacuum in the entire space between the basket and the thrombus. From a certain negative pressure moves the entire thrombus towards the basket. The procedure can be very slow be carried out and thus differs significantly from the previous concepts, where high blood velocity is required for thrombus ablation.

According to a further embodiment is distal to the receiving element 20 a conclusion element 40 arranged ( 2 ). The final element 40 is formed substantially teardrop-shaped or umbrella-like and can as well as the receiving element 20 for insertion into the blood vessel 50 compressed to a minimum cross-sectional diameter. The final element 40 is central with a wire 14b connected, or axially displaceable on the wire 14b stored and fixed by stops. The wire 14b extends axially to the longitudinal axis of the receiving element 20 and the final element 40 , The wire 14b is in the actuator 11 guided and at least movable in the axial direction. In use, the wire penetrates 14b the clot 51 , The final element 40 has analogous to the receiving element 20 at least partially a distal cover 41 at least extending so far beyond the conclusion element 40 that extends the blood vessel 50 distal to the clot 51 is substantially completely blocked or closed. The distal cover 41 limited with the vessel wall of the blood vessel 50 and the clot 51 a distal cavity 30b , At the proximal end of the end element 40 is a stop 43 formed in use with the wire 14b the actuator 11 interacts in such a way that the clot 51 manually in the receiving element 20 is movable. In the area of the stop 43 can be the final element 40 with the distal cover 41 be provided. It is also possible that the final element 40 in the area of the stop 43 an open structure, such as a filter structure, so that the distal cavity 30b to the distal end of the end element 40 extends. The final element 40 includes a umbrella-like section in the distal region 44 that with the distal cover 41 is provided. The umbrella-like section 44 may also have an open structure, in particular a filter structure, when the stop 43 with the distal cover 41 equipped.

The combination of the distally arranged screen or end element 40 with the pressure or unterdruckbeaufschlagbaren receiving element 20 according to 2 leads to a further improvement in the safety of the retrieval system or retriever, since by the final element 40 potentially dissolving thrombus particles are effectively stopped, so that a further downstream vascular occlusion is avoided. It is also characterized by the closing element 40 due to the negative pressure in the proximal cavity 30a generated release force mechanically reinforced when the closing element 40 is pulled against the thrombus or the calculus in the proximal direction. In this respect, this is a combined hydraulic / mechanical system. The pressure line is in 2 not explicitly shown or may be formed so that the wire 14b in the pressure line 15 is guided. Alternatively, the wire 14b be designed as a hollow wire and an extension of the pressure line 15 represent in the area of the cavity 30a Having supply or discharge openings for the actuating medium.

The final element 40 will take up the clot 51 relative to the receiving element 20 , in particular in the proximal direction, moves, so that the closing element 40 , in particular the stop 43 , the receiving opening 23 of the receiving element 20 closes to the clot 51 completely in the receiving element 20 encapsulate. To finally remove the clot 51 from the blood vessel 50 becomes the actuator 11 , the receiving element 20 as well as the final element 40 in the proximal direction and in a tube-like catheter 10a moved, which has a larger diameter than the feeder 10 and to remove the thrombus or clot 51 serves. The funnel-shaped section causes this 24 of the receiving element 20 in that the receiving element 20 in the compressed state is transferred. Likewise, the final element 40 transferred into the compressed state, as reflected in the retraction in the feeder 10 tapered receiving opening 23 of the receiving element 20 the final element 40 compressed and compressed ( 3 ).

4 shows a further embodiment of the device according to the invention, wherein the receiving element 20 as well as the final element 40 have substantially the same structure as already to 2 described. One difference is that the final element 40 instead of a wire 14b centrally with a pressure line 15 is connected, which is an actuating medium 14 , in particular a fluid 14a , leads. Basically, the operation of the device for releasing a concretion or clot 51 So either by a mechanical actuation medium, such as a wire 14b , or by a fluid 14a ie a liquid or a gas.

The pressure line 15 points in the area of the closing element 40 , especially between the stop 43 and the umbrella-like section 44 proximal pressure ports 42a on, through which the fluid 14a in the distal cavity 30b can flow. In the embodiment according to 4 has the final element 40 in the area of the umbrella-like section 44 a distal cover 41 on, whereas the stop 43 comprises a substantially open structure. The distal cavity 30b thus extends from the umbrella-like section 44 to the calculus or clot 51 , That through the distal pressure openings 42b in the distal cavity 30b incoming fluid 14a causes an increase in pressure in the distal cavity 30b so that between the distal cavity 30b and the proximal cavity 30a a pressure gradient arises. Due to the pressure gradient on the clot 51 acting force becomes the clot 51 dissolved and in the receiving element 20 emotional. It is possible that the receiving element 20 no cover 21 has, but is designed as a receiving basket with an open grid structure. The receiving element 20 can additionally assume a filter function, ie that the lattice structure is closely meshed to dissolving particles of the clot 51 withhold.

As in 5 Good to see, the pressure line 15 also in the area of the proximal cavity 30a proximal pressure ports 43a exhibit. In this case, the receiving element 20 to form the proximal cavity 30a with a proximal cover 21 Mistake. The two cavities 30a . 30b are advantageously via separate pressure lines 15 with a pressure generating unit 13 coupled, wherein the proximal cavity 30a a proximal pressure line 15a and the distal cavity 30b a distal pressure line 15b assigned. The distal pressure line 15b can be within the proximal pressure line 15a run. Alternatively, a 2- or multi-lumen catheter may be used.

In a preferred embodiment, the two cavities 30a . 30b with a common pressure generating unit 16 operatively connected. In 6 is an example of such a common pressure generating unit 16 , in particular an intracorporal pump 18 represented centrally in a common pressure line 15 the two cavities 30a and 30b is arranged. The intracorporeal pump 18 is according to 6 designed as a screw conveyor or Archimedean screw and with a flexible shaft 18a connected to an extracorporeally arranged drive unit (not shown). The pump is arranged so that liquid from the proximal to the distal cavity 30a . 30b is relocatable. The drive unit and the intracorporeal pump 18 together form common pressure generating unit 16 , which is preferably connected to a control unit (not shown), so that the conveying direction of the intracorporal pump 18 frequency dependent is reversible. In this way, the volume of the actuating medium, the in the cavities 30a . 30b trapped blood or other body fluids between the cavities 30a . 30b postponed. Alternately, in the cavities 30a . 30b a negative or positive pressure can be set. This causes regular pressure changes in the cavities 30a . 30b that the clot 51 is vibrated and so from the vessel wall of the blood vessel 50 solves.

Alternatively, an extracorporeal pump can be used 17 be provided ( 7 ). The two cavities 30a . 30b are with the extracorporeal pump 17 through separate pressure lines 15a . 15b connected. The common pressure generating unit 16 or the extracorporeal pump 17 includes two pressure chambers 17c . 17d passing through a pressure membrane 17a are separated. The pressure membrane 17a is flexible and can be vibrated or oscillated. By the oscillation of the flexible pressure membrane 17a is in the pressure chambers 17c . 17d alternately generates an overpressure or underpressure, which flows through the pressure lines 15a . 15b to the cavities 17a . 17b is transmitted.

Generally, the vibration of the clot 51 be generated manually, as well as electronically or mechanically. For example, the actuator 11 a syringe or a suitable handle or piston to the vibrations or the oscillation of the clot 51 trigger. For electronically induced pressure changes, vibrations with Fre be generated at least 1 Hz, in particular at least 5 Hz, in particular at least 10 Hz, in particular at least 100 Hz, in particular at least 1000 Hz, in particular at least 20,000 Hz, in particular at least 100,000 Hz.

The proximal pressure chamber 17c ie the proximal cavity 30 associated pressure chamber 17c , further comprises a connection 17b with which a manual printer generating unit, such as a commercially available syringe or a suction device, can be connected. The manual pressure generating unit serves, for example, the clot 51 in a final step in the receiving element 20 to suck it as soon as it passes through the pressure membrane 17 generated vibrations is released from the vessel wall.

In essence, the vibration of the clot 51 thereby causing at least one of the cavities 30a . 30b alternately an actuating medium 14 , Specifically, a liquid, is added or removed. The thus caused temporal change of pressure before and / or behind the clot 51 can be done for example in the form of a sinusoidal oscillation. The pressure generating unit 13 or the common pressure generating unit 16 For example, it may be controlled such that in both cavities 30a . 30b alternately liquid is added or removed. Such control is shown in the diagram in FIG 8a , The solid line represents the pressure curve in the proximal cavity 30a and the broken line the pressure curve in the distal cavity 30b It is also possible that the oscillation of the clot 51 by alternate liquid removal in the cavities 30a . 30b done as in 8b shown (sinusoidal curve). To realize the pressure curve according to 8b are two independently acting pressure generator, for example, two pressure membrane required. The membrane can also only one of the two cavities 30a . 30b Further, by a syringe, a handle or a piston for each cavity 30a . 30b separately the Volumenab- or supply are made.

Another variant for generating pressure in the proximal cavity 30a show the 9a and 9b , In this variant of the device according to the invention is the actuating medium 14 as a wire 14b running, the central with a flexible membrane 25 connected is. The flexible membrane 25 is at the distal end 26 of the receiving element 20 hinged and divides the proximal cavity 30a in a chamber 31 and a receiving cavity 32 on. The wire 14b is in the actuator 11 guided. To the clot 51 in the receiving element 20 moving in the receiving cavity 32 ie in the part of the cavity 30a , distal to the membrane 25 is arranged to create a negative pressure by the wire 14b relative to the actuator 11 is moved in the proximal direction. This will be the flexible membrane 25 curious; excited ( 9b ).

As in the embodiment according to 4 it is not necessarily required in the embodiment described here that the receiving element 20 with a proximal cover 21 is provided.

As in 10 To detect the negative pressure in the chamber 31 also be generated by the fact that the receiving element 20 fluid-tight with the proximal cover 21 covered with the flexible membrane 25 confined a closed area, leaving in the chamber 31 by suction of an actuating medium 40 , in particular a fluid 14a , a negative pressure is generated. This leads to a proximal movement of the membrane 25 so that in the receiving cavity 32 also a negative pressure is caused, a suction of the clot 51 in the receiving cavity 32 causes.

The receiving element 20 can, as in 11 shown at a proximal end a proximal end portion 20a exhibit. The proximal end section 20a is preferably within the feeder 10 arranged, in particular in use of the device. The length of the proximal end section 20a is dimensioned such that at least a part of the proximal end portion 20a in the feeder 10 or in the micro-catheter with expanded basket or receiving element 20 is arranged. The proximal end section 20a thus forms an extension of the funnel-shaped section 24 in the feeder 10 in such a way, - that in the expanded state, a stable connection between the supply device 10 and the receiving element 20 is formed. The proximal cover 21 of the receiving element 20 extends into the feeder 10 or at least with the supply device 10 so off that the feeder 10 and the receiving element 20 form a substantially fluid-tight system, at least in the expanded state. The proximal cover 21 extends specifically over the cylindrical portion 22 , the funnel-shaped section 24 and the proximal end portion 20a so that the connection between feeder 10 and the receiving element 20 is completed substantially fluid-tight. In this way, the feeder can 10 at the same time as a suction and / or pressure device, in particular as a pressure line 15 be used. The efficiency, in particular the suction power, the suction and / or pressure device or the pressure generating unit 16 is increased because the inner diameter of the pressure line 15 the inner diameter the feeder 10 equivalent.

In the embodiment according to 11 is the receiving element 20 , in particular the funnel-shaped section 22 , formed from a wire mesh. The funnel-shaped section 22 includes a stent-like structure. The mesh may also alternatively or additionally the funnel-shaped portion 24 form and extend into the proximal end section 20a continue. It is possible that the grid mesh, in particular the arrangement of the wire elements or wires, along the receiving element 20 varied. The cylindrical section 22 and the funnel-shaped section 24 For example, they may have a cross braid. The proximal end section 20a may also include a helical arrangement of the wire elements. The transition between different types of braids may be fluid or continuous. It is also possible, the wire mesh of the receiving element 20 , in particular of the cylindrical portion 22 and the proximal end portion 20a to be provided with axially extending wire elements or bands, so that the stability of the device is increased in the axial direction. The axial bands may have the same material as the grid of the receiving element 20 , It is also possible that the axial bands comprise another material, in particular a more elastic material. The receiving element 20 can generally be formed in one piece. Suitable materials for the production of the receiving element 20 are shape memory materials, for example nickel titanium alloys, or plastics.

The proximal end section 20a of the receiving element 20 according to 11 also a proximal end stop 52a on. In addition, there is a distal end stop 52b provided, that of the feeder 10 assigned and firmly connected to this. The end stops 52a . 52b have overlapping diameters and are arranged such that axial movement of the receiving element 20 , in particular the proximal end portion 20a , is limited in the distal direction. This will prevent the receiving element 20 completely out of the feeder 10 exit. Between the feeder 10 and the receiving element 20 Thus, an axial relative movement is possible without the two components are separated from each other.

The proximal end stop 52a is substantially on an outer peripheral surface of the proximal end portion 20a arranged. The proximal end stop 52a For example, a sleeve 53a , in particular a cylindrical sleeve 53a include. The distal end stop 52b the feeder 10 forms a counter element to the proximal end stop 52a and is on an inner peripheral surface of the feeder 10 arranged so that the distal end stop 52b in the axial direction with the proximal end stop 52a flees. The distal end stop 52b can also be a sleeve 54 include.

As in 11 shown, the proximal end portion 20a another sleeve 53c which are proximal to the stop sleeve 53a is arranged. The further proximal sleeve 53c improves the axial guidance of the receiving element 20 or the basket. The advantage of the embodiments explained below 12a . 12b with only one stop sleeve 53a of the proximal end portion 20a consists in the comparatively higher flexibility.

The connection between the end section 20a and the sleeve 53a can be done for example by welding, gluing, by spraying or by soldering. Another example of the connection of the sleeves is in 12b shown. There it can be seen that the radially outwardly arranged stop sleeve 53a with a radially inner and coaxially arranged further sleeve 53b is compressed. Between the two pressed sleeves 53a . 53b is the tail of the proximal end section 20a arranged and between the two sleeves 53a . 53b trapped.

The difference between the embodiment according to 11 and the two embodiments according to 12a and 12b is that the proximal end section 20a in the embodiments according to 12a . 12b shorter than in the embodiment according to 11 is, with the longer version according to 11 from the additional proximal guide sleeve 53c results.

The pods 53a . 53b . 53c . 54 may be made of plastic, metal, shape memory metal or X-ray visible materials. The diameter of the proximal end section 20a is at the inside diameter of the end stop 52b or the stop sleeve 54 the feeder 10 customized. The inner diameter of the sleeves 53a . 54 , which correspond approximately to are smaller than 1.0, in particular smaller than 0.9, in particular special smaller than 0.8, in particular smaller than 0.7, in particular smaller than 0.5, in particular smaller than 0.4, in particular smaller than 0.3 mm. The sleeve wall thickness of the sleeves disclosed above 53a . 53b . 53c . 54 is less than 80 microns, in particular less than 70, in particular less than 60, in particular less than 50, in particular less than 40, in particular less than 30 microns. The above wall thicknesses have the advantage that the lowest possible pressure drop in the operation of the receiving element 20 he follows. In addition, by the slight change in the caliber of the sliding of the Basket or the receiving element 20 improved.

The edges of the sleeves can be rounded, resulting in a low pressure loss and a good sliding of the receiving element 20 or the proximal end portion 20a is beneficial. Furthermore, the edge rounding of the sleeves is gentle on the coating or the cover 21 ,

As in the 12a . 12b shown, the end stop 52b the feeder 10 as a sleeve, in particular as a catheter sleeve 54 be educated. The connection between the sleeve 54 and the feeder 10 can be cohesive, form-fitting, non-positive. For example, the sleeve 54 glued to the catheter tip or be press-connected with this. It is also possible the end stop 52b form as part of the catheter tip. The catheter tip 55 For example, it can be crimped, glued, pressed, hot-formed or formed by Swedging. It is also possible that the catheter or the supply device 10 is executed in several stages. Distally, the feeder may have a smaller diameter than at a proximal location of the feeder 10 , The change in diameter can be made in several sections, with the smallest distal diameter as an end stop for the basket sleeve 53a serves. In the area of the small diameter of the catheter or the supply device is highly flexible. In the area of larger diameters, the feed device is comparatively stiff.

The Feeding device is characterized by a high flexibility over other joining techniques and is good controllable.

The two end stops 52a . 52b form sealant, so that the feeder 10 with the receiving element 20 is connected fluid-tight. The seal between the receiving element 20 , in particular the proximal cover 21 , and the feeder 10 is done by appropriate interpretation of the tolerances of the end stops 52a . 52b , which may include, for example, stop sleeves. Suitable tolerance values are known to the person skilled in the art.

The embodiment according to 13a shows a further improvement of the device in which the receiving basket 20 or the receiving element 20 in both axial directions relative to the feeder 10 is movable. Also in this embodiment, the dual function of the feeder 10 on the one hand for the supply of the receiving element 20 and on the other hand for the pressure supply. For this purpose, the feeder 10 an axially movable in the supply device 10 arranged adapter 56 on that with the receiving element 20 , in particular with the proximal end portion 20a , is detachably connected. The adapter 56 can also with the funnel-shaped section 24 be connected. In this case, the receiving element 20 through the adapter 56 relative to the feeder 10 axially movable. At the distal end of the adapter 56 is a connector 57 arranged with a counterpart 58 the basket sleeve 53a is detachably connected. As in 13a to recognize the counterpart protrudes 58 the sleeve 53a over the proximal end of the proximal end portion 20a out and is for releasable connection with the connector 57 customized. That means the adapter 56 and the receiving element 20 temporarily for placing or for axially moving the receiving element 20 can be connected. The adapter 56 is part of a sliding and pulling device for the sleeve 53a of the end section 20a , This may be the adapter 56 For example, be connected to a guide wire or a push catheter (not shown). It is also possible that the adapter 56 in one piece with one in the feeder 10 arranged catheter or guide wire or is generally connected to an actuating element. The adapter 56 is only temporarily in the catheter or in the feeder 10 introduced and for moving or placing the receiving element 20 used. After that, the adapter 56 from the feeder 10 away.

The connection between the adapter 56 and the sleeve 53a can be done by positive locking, in particular by thread, barbs or by a click system. As in 13a shown, the connector has 57 radially outwardly extending noses 57a , in particular pins on, in corresponding recesses in the counterpart 58 the sleeve 53a intervention. It is possible a single nose 57a , two noses 57a (as in 13a shown), three, four or more noses 57a provided. The noses 57a can be arranged symmetrically to each other. At the noses 57a or pins are each a rigid elevation that extends so far beyond the outer circumference of the connector 57 projects that a power transmission from the connector 57 over the nose 57a or the noses 57a on the counterpart 58 the sleeve 53a is possible. For this purpose, a very small height, for example, of less than 1 mm may be sufficient. Other heights are possible. The noses 57a provide the prerequisite for a positive connection between the connector 57 and the counterpart 58 , where the counterpart 58 is adjusted accordingly. It is also possible the nose 57a or the noses 57a Made of an elastic material, so that the adapter 56 from the shell 53a can be separated by overcoming an elastic spring force. The nose 57a or the noses 57a can be designed to be retractable, in particular counter to a radially outwardly acting spring force retractable.

It is also possible, the arrangement according to 13a to reverse such a way that the nose 57a or the noses 57a on an inner surface of the counterpart 58 the sleeve 53a are arranged. The connector 57 has corresponding recesses, which are adapted such that between the adapter 56 and the sleeve 53a a releasable positive connection can be produced.

It is also possible that a different type of releasable connection is chosen. For example, the adapter 56 a connector 57 having an external thread, which in a corresponding internal thread of the counterpart 58 the sleeve 53a can be screwed. The thread may be formed as a helical profile to the flexibility of the adapter 56 to increase. The adapter 56 may be made of plastic, metal, shape memory metal or X-ray visible materials.

An example of the basket side arranged sleeve 53a with counterpart 58 is in 13b shown, which is a side view of the sleeve 53a shows. The sleeve 53a includes at the proximal end of the counterpart 58a , for releasable connection with the connector 57 of the adapter 56 or the guide wire is adjusted. The distal end of the sleeve 53a is for connection to the basket 20 formed and includes a holding section 59a , The holding section 59a is also in 13a shown. In the area of the holding section 59a is the proximal end of the basket 20 arranged and with an inner surface of the sleeve 53a firmly connected, for example by gluing, soldering or pressing. Other connection types are possible.

The counterpart 58 is structured as follows:
The counterpart 58 the sleeve 53a includes a substantially L-shaped recess 58a with one in the axial direction of the sleeve 53a extended longitudinal limb, in particular longitudinal slot and a substantially in the circumferential direction of the sleeve 53a extended transverse leg, in particular transverse slot. It is possible to form the two legs as slots or as recesses formed in the inner surface of the sleeve 53a are arranged, wherein the outer surface of the sleeve is closed. It is also possible according to 13b Arranged at right angles to the longitudinal leg transverse leg at a different angle, for example, at an angle <90 °.

The number of recesses 58 corresponds to the number of noses 57a ,

The recess 58a acts like a bayonet with the noses 57a of the connector 57 together. The connection of the two parts is made by a combined plug-and-turn movement, with a nose 57a in the longitudinal leg 58a the recess inserted and by turning in the region of the transverse leg of the recess 58a is secured. To release the connection, the plug-in rotary movement takes place in reverse order.

Other ways of achieving the releasable connection between the counterpart 58 , the sleeve 53a and the connector 57 of the adapter 56 also exist. For example, it is possible to replace the L-shaped recess 58a in the area of the counterpart 58 to provide a thread into which the noses 57a or a mating thread of the connector 57 intervention. Other types of connection, such as latching connections are conceivable.

In the embodiment according to 13b is the sleeve 53a at least in the region of the distal end with a coil section 59 Mistake. This will increase the flexibility of the sleeve 53a improved. The proximal end with the counterpart 58 is rigid. It is also possible to use the distal portion of the sleeve 53a rigid form. To form the coil section 59 is in the sleeve 53a cut a spiral or helix, which is about 2/3 of the total length of the sleeve 53a extends. A shorter or longer helical coil section 59 is possible. In 13b points the coil section 59 three turns up. A different number of turns, for example, two or more than three turns are possible.

It is also possible the entire sleeve 53a form as a coil such that the wall of the sleeve over its entire length has a spiral-shaped structure. In the area of the counterpart 58 The spiral structure forms a thread in which the profile of the connector releasably engages. The arrangement according to 13b can also be reversed, so that the proximal counterpart 58 is designed as Gewindecoil. The distal holding section 59a may have a closed wall, with the basket 20 is firmly connected.

Additionally or alternatively to the coil section 59 may be in the area of the distal end, that is distal to the coil section 59 a plurality of longitudinal grooves may be provided, in which the proximal end of the basket is pressed, whereby a frictional connection between the sleeve 53a and the basket 20 will be produced. Other types of connection between the holding area 59a and the basket 20 are possible as described above.

When using the device according to the 11 . 12a . 12b this will be done first within the feeder 10 arranged in the compressed state receiving element 20 transported to the area of the treatment site. With the help of egg nes additional catheter, in particular a push catheter, the device temporarily within the Zufuhreinrich 10 is arranged, the receiving element 20 in the distal direction relative to the feeder 10 emotional. The receiving element 20 So it is with the help of the push catheter from the feeder 10 pushed out. The receiving element 20 , in particular the cylindrical section 22 and the funnel-shaped section 24 , expands or expands. The feed movement of the receiving element 20 gets through the two end stops 52a . 52b limited.

It is possible that the receiving element 20 first in the compressed state in the feeder 10 is loaded, ie before the feeder 10 is guided or navigated to the treatment location. Alternatively, the receiving element 20 in the feeder 10 be charged when the feeder 10 already arranged in the area of the treatment location.

To the receiving element 20 after expansion in a body vessel back into the feeder 10 To lead or pull, can in a device according to 11 . 12a . 12b a withdrawal means or catheter-like return tool (not shown) may be provided, which in the supply device 10 introduced and to the proximal end portion 20a is advanced. The return tool can by suitable measures with the receiving element 20 get connected. In addition to the adapter according to 13a For example, other possible types of connections include positive connections, such as a thread or a key bit. The connection can also be made non-positively. For example, the catheter-like retrieval tool may comprise a microballoon which extends into the funnel-shaped section 24 of the receiving element 20 is advanced. The funnel-shaped section 24 arranged microballoon is inflated so that between the funnel-shaped section 24 and the microballoon creates a frictional or frictional connection. The frictional force between the microballoon and the funnel-shaped section 24 is enough to the receiving element 20 in the feeder 10 withdraw.

According to a further embodiment, the device may be formed completely in one piece. In this case, form the supply device 10 and the receiving element 20 a single, tubular or catheter-like component. 14a shows such a device formed in the compressed state of the receiving element 20 , The compressed receiving element 20 and the feeder 10 have substantially the same cross-sectional diameter and form a tubular or hose-like body. The feeder 10 forms a rigid section 60 the tubular body and is arranged substantially proximal. Distal of the rigid section 60 is a flexible section 61 arranged, which in use the receiving element 20 forms. The rigid section 60 is different from the flexible section 61 in that the rigid section 60 or the supply device 10 has a radial stability, so that the cross-sectional diameter of the rigid portion 60 is essentially unchanging. The flexible section 61 allows an axial change in length and at the same time a radial change in diameter. The flexible section 61 or the receiving element 20 can therefore expand.

14b shows the device according to 14a in the expanded state, the flexible section 61 or the receiving element 20 has a larger cross-sectional diameter than in the compressed state ( 14a ). The flexible section 61 or the receiving element 20 can be expanded by a suitable mechanism, for example, within the receiving element 20 a balloon arranged to expand the receiving element 20 inflated or filled with a fluid. The balloon can be fixed to the receiving element 20 be connected or for expansion within the receiving element 20 arranged and then out of the receiving element 20 be removed. A fixed balloon, for example, have a tuning fork-shaped longitudinal section, which in the direction of the distal end 26 of the receiving element 20 is open. Further, the balloon may include a plurality of expansion pads, such as airbags, disposed on the inner peripheral surface of the receiving member 20 are arranged. The rigid section 60 or the supply device 10 can have several lumens or channels. For the function of inflating or filling the balloon or the pillows and for the function of aspiration of the thrombus, different channels may be provided.

In summary, the invention offers the following advantages:
Controlled thrombus aspiration by limiting the negative pressure area. The negative pressure prevails in a closed area between the proximal basket and the thrombus. A vessel collapse is not possible.

defined Aspiration Volume: Only the volume that absorbs the movement is aspirated thrombus in the basket. No more blood volume is removed from the vessel.

Limiting the risk of particle separation: The negative pressure is generated when the blood is practically stationary. There are no high blood speeds necessary because no particles due to high Shearing stresses (shear stress) are removed from the thrombus.

full and 1-step thrombus aspiration: The invention will not the removal of thrombus particles, but the complete Movement of the thrombus reached.

10

feeder

10a

tubular catheter

11

actuator

13

Pressure generating unit

14

operating medium

14a

fluid

14b

wire

15

pressure line

15a

proximal pressure line

15b

distal pressure line

16

common Pressure generating unit

17

extracorporeal pump

17a

pressure membrane

17b

connection

17c

proximal pressure chamber

17d

distal pressure chamber

18

intracorporeal pump

18a

flexible wave

20

receiving element

20a

proximal end

21

proximal cover

22

cylindrical section

23

receiving opening

24

funnel-shaped section

25

membrane

26

distal The End

30a

proximal cavity

30b

distal cavity

31

chamber

32

receiving cavity

40

termination element

41

distal cover

42a

proximal pressure opening

42b

distal pressure opening

43

attack

44

umbrella-like section

50

blood vessel

51

clot

52a, 52b

end stop

53a, b, c

shell of the end section

54

shell the feeder

55

top

56

adapter

57

joint

57a

nose

58

counterpart

58a

recess

59

Coilabschnitt

59a

holding section

60

rigid section

61

flexible section

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• WO 2006/031410 [0001]
• WO 2006/031410 A1 [0004]

Claims (28)

Device for removing concrements from body vessels with at least one compressible receiving element ( 20 ) for receiving concrements and a supply device ( 10 ) for guiding the compressed receiving element ( 20 ), characterized in that the receiving element ( 20 ) a fluid-tight cover ( 21 ), which can be closed by the concretion to be removed, in particular proximal cavity ( 30a ), wherein the receiving element ( 20 ) an actuating device ( 11 ) associated with at least in use with the cover ( 21 ) and / or the cavity ( 30a ) is in operative connection such that in the cavity ( 30a ) for moving, in particular for releasing, the concretion to be removed another pressure is adjustable than outside the cavity ( 30a ). Device according to claim 1, characterized in that the actuating device ( 11 ) comprises a suction and / or pressure device connected to the cavity ( 30a ) is fluidly connected or fluid-connectable. Apparatus according to claim 2, characterized in that the suction and / or pressure means a pressure generating unit ( 13 ) passing through a pressure line ( 15 ) with the cavity ( 30a ) is fluidly connected or fluid-connectable, wherein the pressure line ( 15 ) in or outside the feeder ( 10 ) or by the supply device ( 10 ) itself is formed. Device according to at least one of claims 1 to 3, characterized in that the actuating device ( 11 ) an actuating medium ( 14 ), in particular a liquid, which at least partially into the cavity ( 30a ) pumpable and / or out of the cavity ( 30a ) is sucked. Device according to at least one of claims 1 to 4, characterized in that the receiving element ( 20 ) is formed like a basket and a distal, substantially cylindrical portion ( 22 ), which has a receiving opening (17) for receiving a concretion ( 23 ). Device according to at least one of claims 1 to 5, characterized in that the receiving element ( 20 ) a proximal, substantially funnel-shaped portion ( 24 ) which is connected to the actuating device ( 11 ), in particular the suction and / or pressure device, is connected. Device according to at least one of claims 1 to 6, characterized in that the cover ( 21 ) with the actuating device ( 11 ), in particular the pressure line ( 15 ), fluid-tight manner. Device according to at least one of claims 1 to 7, characterized in that the receiving element ( 20 ) a conclusion element ( 40 ), in particular a screen, which in use is positionable distal to the calculus. Apparatus according to claim 8, characterized in that the closing element ( 40 ) a fluid-tight cover ( 41 ) adapted, in cooperation with at least the calculus to be removed, a distal cavity ( 30b ) to build. Apparatus according to claim 8 or 9, characterized in that the closing element ( 40 ) with the pressure line ( 15 ), which the receiving element ( 20 ), or another, separate pressure line is fluid-connected such that in the distal cavity ( 30b ) for moving, in particular for releasing, the concretion a pressure other than outside the distal cavity ( 30b ). Device according to at least one of claims 8 to 10, characterized in that the closing element ( 40 ) and the receiving element ( 20 ) with the actuating device ( 11 ), in particular the suction and / or pressure device, are fluid-connected such that between the distal cavity ( 30b ) and the proximal cavity ( 30a ) for moving, in particular for releasing, the between the cavities ( 30a . 30b ) arranged concrements different, in particular changeable, relative pressures are adjustable. Device according to at least one of claims 8 to 11, characterized in that the closing element ( 40 ) and the receiving element ( 20 ) with a common pressure generating unit ( 16 ) are connected. Apparatus according to claim 12, characterized in that the common pressure generating unit ( 16 ) is arranged extracorporeally and at least one oscillatable pressure membrane ( 17a ), which at least in use with the closure element ( 40 ) and / or the receiving element ( 20 ) is fluidly connected or fluid-connectable. Apparatus according to claim 12, characterized in that the common pressure generating unit ( 16 ) a feed pump, in particular an intracorporeal feed pump ( 18 ), which within the pressure line ( 15 ) is arranged such that the delivery pump at least in use with the closing element ( 40 ) and / or the receiving element ( 20 ) fluidly connected or fluidly connectable is. Device according to at least one of claims 3 to 14, characterized in that the pressure generating unit ( 13 ), in particular the common pressure generating unit ( 16 ), a control unit is assigned, which is adapted such that a pressure change in at least one, in particular two, cavities ( 30a . 30b ) frequency-dependent, in particular pulsating, in particular in the form of a sinusoid, in particular a sinusoidal curve, is controllable. Apparatus according to claim 15, characterized in that the control unit comprises at least one pressure measuring element which is connected to the suction and / or pressure means such that in the cavities ( 30a . 30b ) producible pressure is measurable and / or adjustable. Device according to at least one of claims 1 to 16, characterized in that the receiving element ( 20 ) a flexible, fluid-tight membrane ( 25 ), which on the one hand at least with a distal end ( 26 ) of the receiving element ( 20 ) and on the other hand with the actuating device ( 11 ) is operatively connected. Device according to claim 17, characterized in that the flexible membrane ( 25 ) with the cover ( 21 ) of the receiving element ( 20 ) a chamber ( 31 ) forms, which with the suction and / or pressure device, in particular the pressure line ( 15 ) is fluidly connected such that in use by the pressure in the chamber ( 31 ) the pressure in the proximal cavity ( 30a ) is adjustable. Device for removing concrements from body vessels, in particular according to at least one of claims 1 to 18, with a closure element ( 40 ), which in use is positionable distally to a calculus and a fluid-tight covering ( 41 ), which is used to form a distal cavity ( 30b ) is adapted to cooperate with at least one concretion, wherein the closing element ( 40 ) with an actuating device ( 11 ), in particular a suction and / or pressure device, is operatively connected such that in the distal cavity ( 30b ) for moving, in particular for releasing, the concretion a pressure other than outside the distal cavity ( 30b ). Device according to at least one of claims 1 to 19, characterized in that the receiving element ( 20 ) a proximal end portion ( 20a ), which is substantially cylindrical and with the cavity ( 30a ), wherein the longitudinal axial extent of the end portion ( 20a ) is adapted such that the end portion ( 20a ) in use at least partially in the feeder ( 10 ) is arranged. Apparatus according to claim 20, characterized in that the cylindrical portion ( 22 ) and / or the funnel-shaped section ( 24 ) and / or the proximal end portion ( 20a ) comprise a mesh. Apparatus according to claim 20 or 21, characterized in that at least the cylindrical portion ( 22 ) a cross braid, in particular with axially arranged bands and at least the proximal end portion ( 20a ) comprise a braid with spiral winding, in particular with axially arranged bands or an asymmetrical braid. Device according to at least one of claims 20 to 22, characterized in that the proximal end portion ( 20a ) and the feeder ( 10 ) each have an end stop ( 52a . 52b ) such that an axial movement of the receiving element ( 20 ) is limited in the distal direction. Device according to claim 23, characterized in that the end stop ( 52a ) of the proximal end portion ( 20a ) at least one sleeve ( 53a ), which is connected to the outer periphery of the proximal end portion (FIG. 20a ) connected is. Device according to claim 24, characterized in that the sleeve ( 53a ) with the proximal end portion ( 20a ) cohesively, positively, frictionally or by a further coaxially arranged sleeve ( 53b ), the proximal end portion ( 20a ) between the two sleeves ( 53a . 53b ) is trapped. Device according to at least one of claims 23 to 25, characterized in that the end stop ( 52b ) of the supply device ( 10 ) at least one sleeve ( 54 ) connected to the inner periphery of the feeder ( 10 ) or part of the distal tip ( 55 ) of the supply device ( 10 ) which extends radially inwardly and has a smaller inner diameter than a proximal part of the feed device (FIG. 10 ). Device according to one of claims 1 to 26, characterized in that the supply device ( 10 ) axially movable in the feeder ( 10 ) arranged adapter ( 56 ), which is connected to the receiving element ( 20 ), in particular with the proximal end portion ( 20a ) or the funnel-shaped section ( 24 ) is releasably connected such that the receiving element ( 20 ) relative to the feeder ( 10 ) is axially movable. Device according to one of claims 1 to 27, characterized in that the receiving element ( 20 ), in particular the proximal end portion ( 20a ), with the supply device ( 10 ), in particular with the actuating device ( 11 ) or with the suction and / or pressure device, is integrally formed.