WO2011110316A1

WO2011110316A1 - Medical device for removing concretions from hollow organs of the body

Info

Publication number: WO2011110316A1
Application number: PCT/EP2011/001085
Authority: WO
Inventors: Giorgio Cattaneo
Original assignee: Acandis Gmbh & Co. Kg
Priority date: 2010-03-10
Filing date: 2011-03-04
Publication date: 2011-09-15
Also published as: DE102010010848A1

Abstract

The invention relates to a medical device for removing concretions (40) from hollow organs of the body, comprising a guiding catheter (30), a microcatheter (20) arranged longitudinally movably in the guiding catheter (30), and a receiving element (10), which can be retracted into the microcatheter (20) and transferred from a compressed state into an expanded state. In the expanded state, the receiving element has a distally arranged axial inlet opening (11) which is adapted for the introduction of a concretion (40) into the receiving element (10). A negative pressure can be generated in the region of the receiving element (10) in order to move the concretion (40) at least partially into the receiving element (10). The invention is characterised in that the receiving element (10) has a transport channel (12), which in the expanded state of the receiving element (10) extends in the manner of a tube between the inlet opening (11) and the microcatheter (20) and in the expanded state of the receiving element (10) has a cross-sectional diameter that is larger than a diameter of the microcatheter (20). The transport channel (12) has a fluid-tight cover (13), which at a proximal end of the transport channel (12) has at least one opening (14) such that the transport channel (12) can be in fluid connection with the guiding catheter (30), wherein the guiding catheter (30) is or can be in fluid connection with a suction device in order to generate the negative pressure in the region of the receiving element (10).

Description

Medical device for removing concretions from hollow organs of the body

description

The invention relates to a medical device for removing concretions from hollow organs of the body according to the preamble of patent claim 1. Such a medical device is known, for example, from WO 2006/031410 A2.

A variety of life-threatening, acute illnesses are caused by blood clots or thrombi that form in blood vessels and inhibit blood flow. Due to the blockage of the blood vessel or the impairment of blood flow through the blood clot, downstream tissue areas are no longer sufficiently supplied with nutrients, in particular oxygen. In the affected

Tissue areas can lead to ischemia, ie the death of tissue cells.

From a medical point of view there is a need to restore the blood flow as quickly as possible, ie to recanalize the blood vessel. This is one hand

medically, for example with the help of drugs for thrombolysis, possible, wherein the thrombus or the concretion is generally resolved due to the biochemical reaction with the drug. However, drug-based thrombolysis is limited to a relatively limited group of patients, since strict criteria must be adhered to for the safe use of this therapy. For example, an efficient drug therapy of blood clots is only in a time window of up to three hours after the occurrence of the event or after the beginning of the first

Symptoms of a vascular occlusion successful.

On the other hand, medical devices are known which prevent the removal of

Allow blood clots or thrombi or general calculus by mechanical means. Such a device is known for example from WO 2008/088920 A2. In the known device is provided to advance a wire element through a catheter in the region of the vessel closure. The catheter is first pushed through the blood clot. The wire member is then held stationary while the catheter is withdrawn. Thereby, the distal end of the wire member comprising a shape memory material becomes exposed. Due to the shape memory properties, the wire element occupies a previously corkscrew-like shape set in the

Clot engages and essentially enters into a positive connection with the blood clot. The blood clot fixed in this way to the wire element can then be pulled out of the blood vessel.

The drawback with the known device is that pulling the flared distal end connected to the blood clot of the

Wire element is at risk that vessel walls are damaged or injured by the distal end of the wire member. Furthermore, there is the risk that, when the catheter is pushed through the blood clot, particles will escape which will reach downstream blood vessels and other vascular occlusions

can cause. Although the mechanical removal of blood clots or general concrements is usually faster to perform than a

medicinal lysis therapy. Due to the risk of injury to vessel walls and the risk of additional vascular occlusions, such medical devices for mechanically removing blood clots from mortality, such as stroke or apoplex, does not become significant

Improvement achieved.

An alternative device for the mechanical removal of blood clots is described in the aforementioned WO 2006/031410 A2. The known device comprises a receiving basket, which is guided in a compressed state within a supply and aspiration catheter to the treatment site. The delivery and aspiration catheter is longitudinally displaceable in a guide catheter. The guide catheter is guided as close as possible to the treatment area, the relatively large cross-sectional diameter of the guide catheter preventing the guide catheter from being introduced directly into the area of the blood clot. The positioning of the receiving basket directly on the blood clot is therefore via the supply and aspiration catheter. For this purpose, the supply and aspiration catheter is led to just before the blood clot and deployed the receiving basket in front of the blood clot. About the supply and aspiration catheter now a negative pressure in the region of the blood clot is generated, which pulls the blood clot in the receiving basket. To avoid sucking blood from proximal blood vessels by the negative pressure generated, the guide catheter has a balloon that expands prior to the generation of the negative pressure

Blood vessel proximal of the clot, in particular in the flow direction before the Clot, temporarily closed fluid-tight. This has the disadvantage that, during the treatment, ie during the removal of the blood clot, a blood flow into blood vessels which branch off in the vessel section between the balloon at the distal end of the guide catheter and the blood clot is prevented. The

Supply of previously unimpaired tissue areas with nutrients is thus interrupted, which can bring additional health risks for the patient.

In practice, vascular occlusions are usually formed by thrombi in comparatively small and strongly curved blood vessels. To achieve such vascular occlusions with a catheter, there is a need to make the catheter diameter as small as possible. However, a relatively small catheter diameter makes it difficult to aspirate a blood clot. It is therefore known to shatter the blood clot to the comparatively small aspiration catheter that

To remove blood clots particle-wise from the blood vessel. During the

Absaugbehandlung the generated negative pressure initially acts only on one, in particular proximal, side of the blood clot. However, the fragmentation is effective over the entire thrombus, so that also on the of the aspiration catheter

away side of the blood clot can dissolve particles. These particles are not detected by the negative pressure of the aspiration catheter and can be washed into smaller blood vessels and lead there to other vascular occlusions.

In the device according to WO 2006/031410 A2, the thrombus can also be pulled out of the blood vessel with the aid of the receiving basket. Analogous to the

Corkscrew-like device according to WO 2008/088920 A2 there is a risk of injury to the vessel walls. Specifically, the receiving basket or the wire element of the known devices rub during retraction, ie when removing the thrombus, on the vessel wall. The vessel wall can be injured, which can cause a stenosis or new blood clots.

The invention has for its object to provide a medical device for

To discard concretions from body cavities that allow efficient and rapid removal of concrements, reducing the risk of injury to healthy tissue and avoiding the formation of additional vessel obstruction. This object is achieved by the subject-matter of claims 1 and 13.

The invention is based on the idea of a medical device for

Removing concretions from body cavities with a guide catheter, a longitudinally displaceably arranged in the guide catheter microcatheter and retractable into the microcatheter receiving element indicate. The

Pickup element is convertible from a compressed state to an expanded state. In the expanded state, the receiving element has a distally arranged, axial inlet opening, which is adapted for introducing a concretion in the receiving element. In the region of the receiving element, a negative pressure can be generated in order to at least partially store the concrement in the

Move recording element. The receiving element further has a

Transport channel, which extends like a tube between the inlet opening and the micro-catheter in the expanded state of the receiving element and in the expanded state of the receiving element has a cross-sectional diameter which is greater than a diameter of the microcatheter. The transport channel comprises a fluid-tight cover, which at a proximal end of

Transport channel at least such an opening, that the transport channel with the guide catheter is fluid-connectable. The guide catheter is fluidly connected to a suction device or fluid-connected to the negative pressure in the

To produce area of the receiving element.

The invention is based on the idea, the receiving element with a

to provide expandable transport channel, which bridges the distance from the concretion to the guide catheter in concretely closed vessel. In this case, the transport channel is formed like a tube. The transport channel forms in the expanded state, a flexible tube with a fluid-tight envelope, which is fluidly connected to the guide catheter. The guide catheter is with a

Absaugvorrichtung connectable or connected, so that via the guide catheter through the at least one opening in the cover of the transport channel in the transport channel or generally in the receiving element, a negative pressure for sucking the concretion can be generated.

In general, a separation of functions is achieved in the invention, wherein the guide catheter to the negative pressure generated in the suction device for

Receiving element conducts, whereas the microcatheter, which within the Guide catheter is performed, causes the supply of the compressed receiving element to the treatment site. Through this separation of functions is advantageously achieved that the suction, namely the guide catheter, a relatively large

Can have cross-sectional diameter, so that an efficient extraction performance is achieved. At the same time, the microcatheter can be a relatively small

Have cross-sectional diameter, so that the receiving element can be guided into relatively small blood vessels. Due to the fluid-tight cover can also be dispensed with a temporary interruption of blood flow, for example by a balloon in the region of the distal end of the guide catheter. The fluid-tight cover causes the negative pressure within the body cavity to be effective primarily between the inlet port and the calculus. For this purpose, it is advantageous if a distal end of the receiving element in the expanded state seals against a vessel wall of the body cavity. An impairment of the supply of nutrients, especially oxygen, in branching

Body cavities between the concretion and the guide catheter is avoided with the construction according to the invention. In particular, the transport channel may advantageously comprise a cross-sectional diameter which is smaller than the cross-sectional diameter of the hollow body member, so that between the

Transport channel and the hollow body organ an annular space is formed, in which a body fluid can flow. However, it is not excluded that the transport channel has a cross-sectional diameter such that the

Transport channel rests against a vessel wall of the body hollow organ.

A further advantage of the device according to the invention is that during the aspiration or the aspiration detaching concretion particles are guided through the transport channel to the comparatively large-lumen guide catheter. The calculus particles are thus reliably removed from the body cavity. Since the cross-sectional diameter of the entire suction line formed by the guide catheter and the receiving element is comparatively large, concretion particles are prevented from blocking the suction line. This ensures that the concretion in the body cavity constantly a negative pressure acts. Due to the constantly acting negative pressure, it is avoided that detaching concretion particles move into branching body cavities and lead there to further closures or blockages.

The transport channel thus bridges the distance between the guide catheter and the concretion, which is sucked through the transport channel into the guide catheter becomes. The receiving element can therefore be kept stationary in the device according to the invention. Retraction of the receiving element to remove the calculus is not required. Appropriately, to remove the receiving element after treatment rather the microcatheter on the

Shucked receiving element to compress the receiving element or to convert in the compressed state. Therefore, a relative movement does not take place between the receiving element and the hollow body organ, but between the receiving element and the microcatheter. The risk of injuring the hollow body organ, in particular vessel walls of the hollow body organ, is thus reduced.

In a preferred embodiment of the medical invention

Device is provided a guide wire which is connected to the proximal end of the receiving element. The guidewire may be longitudinally displaceable within the microcatheter. The guidewire facilitates handling of the receiving element. In particular, a user can do the

Lead the receiving element with the aid of the guide wire on the one hand through the microcatheter to the treatment site. On the other hand, the guide wire allows the stationary fixation of the expanded receiving element, so that the receiving element is retractable by a relative movement between the guide wire and the microcatheter in the microcatheter. Specifically, the receiving element can be held stationary by means of the guide wire from outside the body to be treated, while the microcatheter is pushed in the distal direction over the receiving element. The receiving element expanded in the body cavity can thus be converted into the compressed state and placed in the microcatheter.

Generally, it is advantageous to hold the expanded receiving member stationary after suction of the blood clot and to push the microcatheter over the receiving member to compress the receiving member. This avoids that the expanded receiving element is moved in the hollow body organ. The risk of injury to the body hollow organ is reduced in this way. Because the microcatheter a comparatively small

Can have cross-sectional diameter, the device is also advantageously used for the removal of concretions from relatively small hollow organs, such as cerebral blood vessels. The receiving element may have a net-like support structure. The reticulated support structure can advantageously ensure a radial stability of the receiving element, in particular of the transport channel, in the expanded state, so that the negative pressure acting within the receiving element does not lead to a collapse of the receiving element or the transport channel.

The reticulated grid structure advantageously comprises a wire mesh. By the wire mesh, or a braided grid structure or a mesh, on the one hand sufficient radial stability of the receiving element is achieved and on the other hand, a comparatively high flexibility of the receiving element

ensured, so that the receiving element can follow the course of the body hollow organ.

The wire mesh preferably has a braiding angle which is at least 30 °, in particular at least 40 °, in particular at least 45 °, in particular at least 50 °, in particular at least 55 °, in particular at least 60 °. By a relatively large braiding angle, a high radial force is provided, so that collapse of the receiving element, for example due to the negative pressure, is avoided. Specifically, a sufficient radial stability is provided by the aforementioned braid angle, so that the receiving element, in particular the transport channel, withstands the negative pressure acting within the receiving element.

Alternatively, the wire mesh may have a braiding angle which is at most 70 °, in particular at most 60 °, in particular at most 50 °, in particular at most 45 °, in particular at most 40 °, in particular at most 30 °, in particular at most 20 °. Such braiding angles allow a high flexibility of the receiving element, so that the receiving element adapts well to vessel curvatures. The receiving element can be used in this way in particularly highly curved vessel sections. Furthermore, the effect of "foreshortening", ie the shortening of the lattice structure during expansion, is reduced with the aforementioned braiding angles, thus facilitating the accurate positioning of the receiving element.

In the case of a wire mesh, the wire elements which overlap or intersect in intersection areas each have an axial direction with respect to one another

Receiving element extending lines at an acute angle. This acute angle between the running in the axial direction of a straight line and a Wire element is formed, is referred to as braiding. The braiding angle in the context of the present application thus relates to the angle between a wire element and a projection of the axis of rotation of the hose-like receiving element in a wall plane in which the wire element extends. The determination of the braiding angle takes place in the idle state or expanded state of the receiving element. Due to the geometric displacement of the wire elements upon compression of the receiving element, the angle between the axially extending straight line and the wire elements at the transition from the expanded to the compressed state changes. The braiding angle refers to the angle provided during braiding of the wire mesh between the straight line extending in the axial direction and the wire elements. The braiding angle therefore essentially corresponds to the angle between the straight line running in the axial direction and a wire element in the expanded state of the receiving element.

In a further preferred embodiment of the invention

medical device, the receiving element in the expanded state comprises a radially expanded, in particular basket-like, suction, which is connected to the transport channel. The suction section may have a fluid-tight cover. In particular, the fluid-tight cover may extend into the suction section. The suction section may be expandable such that the

In the expanded state of the receiving element against a suction

Inner surface or a wall of the hollow body organ seals. It is thus achieved that the negative pressure guided through the guide catheter and the suction element is limited in its effectiveness with respect to the hollow body of the body to the area between the suction section and the concretion. This means that between the suction section and the calculus a delimited aspiration of the

Body hollow organ is formed, which is acted upon by the negative pressure. The demarcated aspiration space is via the transport channel and the

Guide catheter fluidly connected to the suction device. Preferably, the suction section comprises the axial inlet opening of the receiving element. Of the

Aspiration section may be funnel-shaped. Specifically, the

Inlet opening have a cross-sectional diameter which is greater than a

Cross-sectional diameter of the transport channel is. The suction section can form a flowing transition between the inlet opening and the transport channel. Due to the different cross-sectional diameter between the inlet opening and the transport channel ensures that on the one hand, the aspiration space between the inlet opening and the concretion is defined fluid-tight and On the other hand, a supply of nutrients or body fluids in hollow organs of the body, which branch off between the inlet opening and the guide catheter, is ensured. It is particularly provided that the transport channel a

Cross-sectional diameter which is smaller than the cross-sectional diameter of the hollow body organ, in which the transport channel is arranged in use. In this way, an annular space is formed between the hollow body organ and the transport channel, which allows the supply of body fluids, in particular blood, in branching body hollow organs.

In a further preferred embodiment, the cover of the

Transport channel in use, especially in the expanded state of

Receptacle, fluid-tight with an inner surface of the guide catheter in abutment brought. The cover of the transport channel can seal in the expanded state of the receiving element against the inner surface of the guide catheter, so that a continuous fluid-tight suction line from the guide catheter to the

Inlet opening is provided in the expanded state of the receiving element. In particular, the sealing of the cover of the transport channel with the inner surface of the guide catheter ensures that the negative pressure transmitted by the guide catheter from the suction device is conducted directly into the receiving element, in particular the transport channel. A pressure loss at the

Joint between the guide catheter and the receiving element is thus avoided.

The transport channel may have a length which is at least 4 times, in particular at least 6 times, in particular at least 8 times, in particular at least 10 times, in particular at least 15 times, in particular at least 20 times, in particular at least 25 times, in particular at least 30 times, in particular at least 40 times, in particular at least 50 times, in particular at least 70 times, in particular at least 100 times, an inner diameter of

Guide catheter corresponds.

Preferably, the transport channel or the receiving element has an absolute length which is at least 5 cm, in particular at least 7 cm, in particular at least 10 cm, in particular at least 15 cm, in particular at least 20 cm. The abovementioned values essentially correspond to the distance of the guide catheter from a concretion, in particular a thrombus in one Blood vessel, this distance being determined by the anatomy of the blood vessels. Specifically, a guide catheter can be due to the relatively large

Cross section diameter at most up to 5 cm lead to a calculus. The transport channel or the receiving element bridges the distance between

Concrement and guiding catheter.

The guide catheter may have an inner diameter which is at least 0.8 mm, in particular at least 1.0 mm, in particular at least 1.2 mm,

in particular at least 1.4 mm, in particular at least 1.5 mm, in particular at least 1.6 mm, in particular at least 1.8 mm, in particular at least 2.0 mm, in particular at least 2.2 mm, in particular at least 2.5 mm,

in particular at least 3.0 mm. Alternatively or additionally, the

Guide catheter having an inside diameter which is at most 2.4 mm, in particular at most 2.2 mm, in particular at most 2.0 mm, in particular at most 1.8 mm, in particular at most 1.6 mm, in particular at most 1.4 mm, in particular at most 1 , 2 mm, in particular not more than 1.0 mm.

The appropriate values for the inner diameter of the guide catheter are dependent on the particular location of the medical device and are of the

Expert selected according to medical guidelines. It has been found that an inner diameter of about 1.5 mm of the guide catheter is sufficient, for example, to efficiently aspirate a thrombus with a cross-sectional diameter of about 3 mm. By smaller inner diameter (with the same wall thickness), however, the feedability of the guide catheter can be increased.

In a further preferred embodiment of the invention

medical device, a distal holding element is provided, which can be converted from a compressed state to an expanded state. The distal retaining element is retractable into the microcatheter. The retaining element is in

expanded state spaced from the inlet opening of the receiving element arranged. The holding element can be advantageously used to

Concrete particles, which are located on the side facing away from the negative pressure of the

Replace concrements, effectively withhold. The risk of a distal embolism, ie a vascular occlusion in downstream vascular areas, is thus effectively avoided. The distal holding element can be connected to the receiving element and / or the guide wire. In particular, the distal holding element can be actuated by the guide wire. Alternatively, the distal support member may be connected or connectable to a separate actuator. The distal holding element can be used in this way to push a concretion mechanically into the receiving element. It is therefore possible that the holding element performs a dual function, namely on the one hand to retain peeling concretion particles and on the other hand to move the concretion mechanically into the receiving element. The mechanical movement of the

Receiving element may additionally or separately for suction through the

Guide catheter and the receiving element done. Instead of a mechanical movement of the concretion by the holding element and a hydraulic movement can be effected via the holding element. For example, that can

Holding element to be fluidly connected to the guide catheter or the suction device, so that in the region of the holding element, specifically between the holding element and the concretion a negative pressure can be generated. Advantageously, between the holding element and the concretion, an overpressure can be generated, which drives the concretion into the inlet opening of the receiving element.

According to a secondary aspect, the invention is based on the idea of a medical device for removing concretions from hollow organs of the body with a guide catheter, a longitudinally displaceably arranged microcatheter in the guide catheter and a retractable into the microcatheter

Specify receiving element, which is convertible from a compressed state to an expanded state and in the expanded state has a distally disposed axial inlet opening. The axial inlet opening is adapted to introduce a concretion in the receiving element. The

Receiving element has a transport channel which in the expanded state of the receiving element like a tube between the inlet opening and the

Microcatheter extends and in the expanded state of the receiving element has a cross-sectional diameter which is greater than a diameter of the

Microcatheter is. The transport channel has at least one opening at a proximal end in such a way that the transport channel can be connected to the guide catheter. Distal to the receiving element, a holding element is arranged, which is connected to an actuating element such that the holding element is movable relative to the receiving element in order to introduce a concretion in the axial inlet opening. The retaining element is adapted to fix the concretion and to move into the inlet opening. In this case, the retaining element can grasp or fix the concrement both laterally, distally or proximally. In general, the holding means allows a mechanical movement of the concretion into the inlet opening of the receiving element. Alternatively, a pressure, in particular a fluid pressure, can be transmitted to the concretion via the holding element, which causes the movement of the concretion into the receiving element. The

Actuator may be, for example, a guide wire. The

Actuator preferably extends through the microcatheter or guide catheter. The holding element can be retractable both in the microcatheter, so also in the guide catheter.

By the transport channel is avoided not to move the receiving element in the expanded state within the body hollow organ. The recording or

Encapsulation of the calculus takes place essentially by a movement of the retaining element. This reduces the risk of injury to the vessel walls.

The invention will be described below with reference to embodiments

With reference to the accompanying schematic drawings explained in more detail. Show in it

Fig. 1 to 3 are each a side view of a medical invention

Device according to a preferred embodiment in different stages of the discharge of the receiving element from the microcatheter;

Fig. 4 is a side view of a medical device according to the invention according to a preferred embodiment in use; and

5 shows a longitudinal section through a medical according to the invention

Device according to a preferred embodiment.

The following definitions apply to all embodiments mentioned in the present application: In the context of the present application, the term pressure does not only mean positive pressures (overpressure), but explicitly also negative pressures (negative pressure). In this case, an overpressure is a pressure which is higher than the pressure prevailing in the vessel. Accordingly, a negative pressure is a pressure that is lower than the pressure prevailing in the vessel, in particular lower than a pressure within a vessel section, which is arranged distally of the concretion 40. By the

Pressure difference between the vessel sections before (proximal) and behind (distally) the concretion 40, the desired movement of the concretion 40 is effected.

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 uses of the

Device that is the removal of concrements or objects

Concerning body cavities, encompassed by the invention.

The space designations or directions, in particular the terms distal and proximal, refer to the position of the user, the

Device operated. Distally arranged objects are accordingly arranged further away from the user or operator of the device with respect to a proximally arranged object.

In the figures 1 to 3 successive stages during the discharge of the receiving element 10 from the micro-catheter 20 are shown. The receiving element 10 is disposed completely within the microcatheter 20 before discharge. The receiving element 10 has the compressed state in the arrangement within the micro-catheter 20. The following description of the structure of the medical device relates essentially to the at least partially expanded state of the receiving element 10, which occurs during the discharge of the receiving element 10 from the micro-catheter 20.

The receiving element 10 has an essentially rotationally symmetrical shape in the expanded state. In a distal end region of the receiving element

10, a suction portion 15 is formed, which has a substantially funnel-like shape. The suction section 15 opens in the distal direction and delimits an axial inlet opening 11 of the receiving element 10. The funnel shape of the suction section 15 is preferably adapted such that the inlet opening

11 over the entire cross-sectional area of a blood vessel 45 into which the Receiving element 10 is introduced and expanded therein extends. Preferably, the funnel-shaped suction section 15 seals against the vessel wall of the blood vessel 45.

The suction section 15 is followed by a transport channel 12 in the proximal direction. The transport channel 12 is fixedly connected to the suction section 15.

In particular, the transport channel 12 is integrally formed with the intake section 15. The transition between the intake section 15 and the

Transport channel 12 may be formed substantially continuously or fluently.

The transport channel 12 can be transferred as part of the receiving element 10 from a compressed state to an expanded state. The transport channel 12 has a tube-like shape at least in the expanded state. In the expanded state, the transport channel 12 has a cross-sectional diameter which is greater than a cross-sectional diameter in the compressed state, in particular greater than a cross-sectional diameter of the microcatheter 20. Preferably, the transport channel 12 in the expanded state has a cross-sectional diameter which is smaller than the inner diameter of the blood vessel 45. In this way, between the transport channel 12 and the blood vessel 45 or generally the

Body hollow organ an annulus kept, so that body fluid, especially blood, freely from proximal to distal at least to the area of

Suction section 15 can flow. A supply of branching vessels with blood or nutrients is thus ensured during the treatment, ie during the removal of the concretion or concretely a thrombus from a blood vessel.

The transport channel 12 extends to a proximal end of the

Receiving element 10, wherein the receiving element 10 forms a taper 16 which limits the receiving member 10 at the proximal end axially. The taper 16 is connected to a guide wire 21 which extends through the microcatheter 20 and is axially displaceable within the microcatheter 20 (Figure 5). The connection between the receiving element 10, in particular the taper 16, and the guide wire 21 may be detachable. Preferably that is

Receiving element 10, in particular the taper 16, fixedly connected to the guide wire 21 or formed in one piece. In general, the receiving element 10 may comprise a net-like support structure. The support structure may be formed substantially stent-like. The support structure may be a laser-cut lattice structure or a braided

Have wire mesh. The laser-cut lattice structure is preferably formed from a tubular raw material. It is also possible that the

laser-cut lattice structure is made of a flat raw material, which is transferred after structuring in a cylindrical or generally rotationally symmetrical shape, in particular bent, is.

Preference is given to the use of a braided wire mesh or a

Grid mesh for the receiving element 10. Here are one or more

Wire elements substantially helically about a common longitudinal axis, in particular the longitudinal axis of the rotationally symmetrical shape of the

Receiving element 10 wound. At least two wire elements or two

Wire sections of a wire element are wound in opposite directions about the longitudinal axis and form at least one crossing point. The oppositely wound

Wire elements intersect, with one wire element passing over the other. A type of braid in which one wire element at a crossing point intersects another wire element is called a 1-over-1 weave. It is also possible for a wire element to cross over two further wire elements in a crossing point, so that an L-over-2 weave is formed. Other possible lichens are

for example, an I-over-3 weave, I-over-4 weave, 2-over-I weave, 2-over-2 weave, 3-over-I weave, 3-over-2 weave, or 4-on-2-braiding.

The braided wire mesh or mesh can both the suction section

15, as well as the transport channel 12 support. The receiving element 10 may have a total of a support structure of a grid mesh. This means that the

Suction section 15, the transport channel 12 and the taper 16 have the grid mesh. It is also possible for the grid mesh or at least one or more wires of the grid mesh to form the guide wire 21. The mesh may be at the proximal end of the receiving element 10, ie in the region of the taper

16, radially merge toward the longitudinal axis of the receiving element 10 and continue as a guide wire 21. The guide wire 21 may be formed by at least one wire element, which also forms the grid of the receiving element 10. At least the transport channel 12 of the receiving element 10 has a fluid-tight cover 13. The transport channel 12 is provided in particular with a cover 13 or with a coating or a Covering, with the

Receiving element 10 may be formed integrally or in one piece. The cover 13 forms a fluid-tight wall of the transport channel 12. The cover 13 may be produced by sputtering or another coating method as a cantilevered support structure. Preferably, the cover 13 comprises a

Plastic, in particular polyurethane (PU). The cover 13 may be fixedly connected to the net-like support structure or the mesh of the transport channel 12. In this case, the cover 13 can be arranged both on an inner surface of the transport channel 12, as well as on an outer surface or an outer periphery of the transport channel 12. The cover 13 may extend over the entire receiving element 10 or cover the receiving element 10 only partially, in particular in the region of the transport channel 12. Preferably, the transport channel 12 is completely provided with the cover 13. The transport channel 12 forms, in particular, a flexible hose which is completely closed fluid-tight on the circumference. The transport channel 12 has in the expanded state substantially one

hollow cylindrical shape with a flexible peripheral wall. The peripheral wall is completely covered fluid-tight. The cover 13 is made of a fluid-tight material that is sufficiently tight to withstand a pressure difference between the inside and outside of the cover 13.

The cover 13 may also extend over the entire receiving element 10, in particular via the suction section 15. Overall, the

Receiving element 10 have a cup-like shape, which is completely covered fluid-tight. The cup-like shape is in the region of the suction section 15

widened. The expansion, in particular cup-like expansion of the

The suction section 15 thus fulfills a support function for the blood vessel 45. For this purpose, the suction section 15 can provide an increased radial force, for example by a mesh with a comparatively large braiding angle , Preferably, the suction portion 15 comprises the cover 13, so that the suction portion 13 against the vessel wall of the

Körperhohlorgans or the blood vessel 45 fluid-tight covering. Alternatively, the suction section 15 may have a free grid structure. In this context, it should be noted that the term fluids in the context of the present application refers not only to liquids, but also to gases.

At the proximal end of the receiving element 10, in particular in the region of

Rejuvenation 16, the cover 13 has at least one opening 14. The opening 14 may extend substantially axially. This means that the cover 13 forms a terminal edge, which extends in the region of the taper 16 in the circumferential direction around the receiving element 10. The axial opening 14 may be the opening of the hollow cylindrical shape of the transport channel 12 at the proximal end of the

Transportabkanals 12 and at the distal end of the taper 16 correspond. This means that the cover 13 can extend over the transport channel 12 as far as the taper 16. At least in sections, taper 16 has no cover 13. Rather, at least part of the taper 16 comprises a free one

Grid structure, in particular a free grid mesh. Alternatively, the

Cover 13 extend in the region of the taper 16, wherein the cover 13 has at least one opening 14 which extends along the circumference of the

Receiving element 10 and the taper 16 extends. The opening 14 may be aligned laterally or radially. The taper 16 may have a substantially hollow cone-like shape. The opening 14 may be formed in the conical surface, which is covered by the cover 13 and covered. The conical surface can also be interrupted at least in sections so that a frustoconical recess or opening 14 is formed in the region of the taper 16. A circumferential strip of the cover 14 may be left open in the region of the taper 16, so that at least in sections the support structure of the

Rejuvenation 16 and generally the receiving element 10 is exposed and thus

Openings 14 are provided.

As shown in Fig. 3, it is provided that the taper 16 of the

Receiving element 10 in the fully discharged state within a

Guide catheter 30 is arranged. The receiving element 10 is partially disposed in the discharged state within and partially outside of the guide catheter 30. The suction section 15 and the transport channel 12 are arranged outside of the guide catheter 30. The taper 16, however, is disposed within the guide catheter 30. The cover 13 extends at least partially into the region of the taper 16 and fluid-tightly seals with a distal axial end of the guide catheter 30, as shown in detail in FIG. The The opening 14 or the plurality of openings 14 in the region of the taper 16 establish a fluid connection between the guide catheter 30 and the transport channel 12 or generally the receiving element 10.

The guide catheter 30 has substantially a cross-sectional diameter sufficient to permit efficient aspiration, i. Extraction, a concretion 40, in particular thrombus allow. The guide catheter 30 includes a larger cross-sectional diameter than the microcatheter 20 that is longitudinally slidable within the guide catheter 30. Within the micro-catheter 20, the guide wire 21 is guided longitudinally displaceable. The receiving element 10 is also disposed within the microcatheter 20 in the compressed state.

The receiving element 10 may at least one in the region of the taper 16

Separating element 17 include, as indicated in Fig. 5. The separating element 17 may be formed, for example, by at least one wire element of the grid mesh. The separating element 17 is preferably formed between two openings 14 or intersects an opening 14 in the cover 13. The separating element 17 may comprise a cutting area. In particular, the separating element 17 may have a cutting edge, which is aligned substantially in the direction of the transport channel 12. The separating element 17 is adapted such that a concretion 40 or a

Thrombus, which is sucked or aspirated via the transport channel 12 into the guide catheter 30, is cut or separated in the region of the taper 16. In this way the aspiration performance is increased. The separator 17 may extend substantially in the circumferential plane of the taper 16. Alternatively it can be provided that in the region of the taper 16 radially inwardly directed separating elements 17 are arranged. The separating elements 17 may be aligned in a cross shape. For example, the separating elements 17 in one

Cross-sectional plane of the taper 16 may be arranged like a wheel spoke.

In a further preferred embodiment according to FIG. 4, the medical device additionally has a holding element 50, which is arranged distally distanced from the inlet opening 11 of the receiving element 10. The

Retaining member 50 has a cap-like shape with a tip 51 extending in the distal direction. The holding element 50 is provided with a

Actuator 52 is connected. The actuator may extend through the receiving member 10 and the microcatheter 20 and be operable from outside the body or extracorporeal. In particular, that can Actuator be slidable in the axial direction, so that the distance of the holding member 50 is adjustable from the inlet opening 11. By actuating the actuating element, the expanded holding element 50 can be pulled in the proximal direction, so that a between the receiving element 10 and the

Holding element 50 arranged concretion 40 is mechanically pulled into the receiving portion 10. The mechanical inclusion of the concretion 40 in the

Receiving element 10 can be supported by the aspiration, ie the negative pressure which is generated in the extracorporeal suction device and acts on the concretion 40 proximally via the guide catheter 30 and the receiving element 10.

The holding element 50 can also be connected to the receiving element 10, in particular the intake section 15. For example, it is possible to produce the device as a whole from a grid mesh, wherein the wire elements between the receiving element 10 and the holding element 50 are brought together and form a connection in the form of a strand 52. The receiving element 10 and the holding element 50 are preferably positioned such that the strand 52 is arranged at the level of the thrombus or concretion 40. In general, the retaining element 50 has a support structure, which may comprise a wire mesh. The support structure may also comprise a laser-cut lattice structure analogously to the construction of the receiving element 10. The holding element 50 may also have a cover 13. The cover 13 of the holding member 50 may be a

Have structuring, in particular a pore structure. The holding element 50 may be designed like a sieve. In general, the holding element 50 in such a way

be formed fluid permeable, on the one hand, a body fluid, in particular blood, the holding member 50 can flow through and on the other hand concretion particles are retained.

The receiving element 10 and / or the holding element 50 may have marker elements. The marker elements preferably comprise a radiopaque material, so that the position of the receiving element 10 or of the holding element 50 can be controlled under X-ray control. This applies to all embodiments.

The receiving element 10 and / or the microcatheter 20 and / or the

Guide catheter 30 may have a stop. Preferably, the receiving element 10 at the proximal end, in particular in the region of the taper 16 or between the taper 16 and the transport channel 12 or at a proximal end of the transport channel 12, a stop, so that the Receiving element 10 is prevented from completely emerge from the guide catheter 30. In this way, the taper 16 is held within the guide catheter 30. The microcatheter 20 may also include a stop which cooperates with a stop mating member within the guide catheter 30 to limit the displaceability of the microcatheter 20 within the guide catheter 30. In this way, it is ensured that the taper 16 between the distal axial end of the guide catheter and the distal axial end of the

Microcatheter be arranged and the transport channel 12 with the guide catheter 30 fluidly connected.

The following describes the mode of operation of the medical device:

To remove a concretion 40, specifically a thrombus, the guide catheter 30 is first guided, preferably with the aid of a guide wire 21, into a vessel section of the body cavity or blood vessel 45 to be treated, which is arranged away from the concretion 40. The flow area of the vessel portion in which the guide catheter 30 is placed is usually larger than the flow area of the vessel portion closed by the calculus 40. Specifically, the relatively large cross-sectional diameter of the guide catheter 30 prevents advancement of the guide catheter 30 into the relatively small blood vessel 45 occluded by the concretion 40. To prevent the guide catheter 30 from occluding the blood vessel 45 or blocking blood flow, the guide catheter 30 is positioned farther away from the calculus 40 in a vessel section having a larger cross-sectional diameter than the guide catheter 30. Due to the anatomical conditions of the catheter

Blood vessel system, the guide catheter 30 is preferably positioned about 5 cm to 20 cm in front of the concretion 40 and proximal to the concretion 40.

The guide catheter 30 then guides the microcatheter 20 to the proximal end of the concretion 40 or thrombus. It can be a

Guide aids (not shown), in particular an additional guide wire, are used, wherein the guide means first by the

Guide catheter 30 is pushed to the calculus 40. About the

Guide aid is pushed to the microcatheter 20 to the calculus 40 and the guide aid is then removed. In a next step that will be

Receiving element 10 is guided to the distal tip of the micro catheter 20. For this purpose, the receiving element 10 by the guide wire 21, with the Receiving element 10 is connected, pushed through the micro-catheter 20. Once the receiving member 10 has reached the tip of the microcatheter 20 and the proximal end of the concretion 40, the microcatheter 20 is pulled back in the proximal direction. The receiving element 10 is held stationary at the same time by an extracorporeal fixation of the guide wire 21. It is also possible the

Guide wire 21 during expansion slightly in the distal direction to move to compensate for a shortening of the receiving element 10 in the expansion ("Foreshortening")

Vascular wall rubs and causes injury. By removing the

Microcatheter 20 will dismiss the receiving element 10. This means that the receiving element 10 successively transitions from the compressed state to the expanded state. In the process, the suction section 15, including the inlet opening 11 (FIG. 1), first unfolds or expands. The suction section 15 seals against the vessel wall of the blood vessel 45. When the suction section 15 preferably has a fluid-tight cover 13, the suction section 15 sealing against the vessel wall forms a closed aspiration space with the concretion 40 closing the blood vessel 45.

In the further course of retraction of the microcatheter 20, the transport channel 12 of the receiving element 10 is released, as shown in FIG. The transport channel 12 is transferred to the expanded state. Due to the net-like

Supporting structure or the mesh braid and the flexible, relatively thin, in particular film-like, cover 13, the transport channel 12 has a high flexibility and adapts to the course of the body hollow organ or blood vessel 45. In Fig. 2 can be clearly seen that the receiving element 10, in particular the transport channel 12, the micro catheter 20 and the guide catheter 30 in

Essentially telescopically slide into each other or are displaced. Of the

Microcatheter 20 is retracted until the taper 16 is located between the distal end of the microcatheter and the distal axial end of the guide catheter, with the opening 14 in the taper 16 providing fluid communication between the guide catheter 30 and the transport channel 12.

The aspiration is accomplished by the guide catheter 30. The thrombus or concretion 40 is aspirated by the receiving element 10 and then passes into the guide catheter 30. Specifically, the guide catheter 30 is connected or connectable to a suction device at a proximal end, in particular extracorporeally. By the suction device, a negative pressure is generated by the guide catheter 30, the opening 14 in the taper 16, the transport channel 12 and the suction section 15 to act in the aspiration space, which is formed between the expanded suction portion 15 and the concretion 40. Under the influence of the negative pressure, the concretion 40 is drawn into the intake section 15. The aspirated concretion 40 is then sucked over the transport channel 12 to the guide catheter 30, which is fluidly connected via the opening 14 in the cover 13 with the transport channel 12. The concretion 40 is removed from the body via the guide catheter 30. This process will continue until the

complete removal of the thrombus or concretion 40 continued.

In Fig. 3, the receiving element 10 is in the fully released state, i. in use, shown. In the use state, which is described in the context of the application as a fully released state, the receiving element 10 is disposed completely outside of the micro-catheter 20. In this case, the distal end of the microcatheter 20 and thus also the proximal end of the receiving element 10, in particular the taper 16, are arranged within the guide catheter 30. The cover 13 of the transport channel 12 seals against an inner surface of the guide catheter 30, so that a fluid channel is formed which extends from the extracorporeally arranged suction device via the guide catheter 30 and the transport channel 12 into the suction section 15 or to the concretion 40 , The fluid connection between transport channel 12 and guide catheter 30 can be clearly seen in FIG.

When the blood vessel 45 is free, that is, the concretion 40 is completely removed, the receiving element 10 is retracted into the microcatheter 20, wherein the

Receiving element 10 again assumes the compressed state. Around

To avoid vascular injuries, the construction of the receiving element 10 allows the microcatheter 20 to be pushed over the receiving element 10 in the distal direction. A movement of the receiving element 10 in the proximal direction, which can lead to injuries of the vessel wall is thus avoided.

The microcatheter 20 may be both centered and decentered within the guide catheter 30. For example, as shown in FIG. 5, the microcatheter 20 may slide laterally along an inner surface of the guide catheter 30. The same essentially applies to the guide wire 21, which may also be centered or decentered within the guide catheter 30 and / or the microcatheter 20. In summary, the medical device offers the following advantages:

- The entire thrombus is aspirated, even if the thrombus consists of several areas. A distal embolism, ie a vascular occlusion of distal body organs, is avoided.

- Branching vessels remain open during treatment (annulus)

- The receiving element 10 is not pulled along the vessel wall, but the microcatheter 20 is placed over it, so that the risk of injury to vessel walls is reduced.

The functional elements described above, in particular the

Receiving element 10 and the holding member 50 may by sputtering and

photolithographic etching. In particular, by the recently developed manufacturing techniques for the production of self-supporting, in particular sputtered functional elements can be very thin wall thicknesses achieved. This applies to both cylindrical and planar functional elements, which are converted into cylindrical shape in use. It is also possible to use the above

described wall thicknesses by interweaving correspondingly thin wire elements produce. As materials for the thin-film technique as well as wire materials are nickel-titanium alloys, chromium-cobalt alloys such as Phynox, Elgiloy, stainless steels (e.g., 316 LVM), platinum and / or

Platinum alloys, in particular platinum-iridium alloys, magnesium and / or magnesium alloys and tungsten or tungsten alloys, in particular titanium-tungsten alloys or tungsten-rhenium alloys in question. In general, materials such as magnesium, iron or tungsten and their alloys can be used, which have bioadsorbable properties. It is also possible to use plastic filaments such as Dynema to form the support structure. The thin-walled functional elements described can also be made of other plastics, in particular polyurethane or bioresorbable plastics.

LIST OF REFERENCE NUMBERS

10 receiving element

11 entrance opening

12 transport channel Cover opening

Intake section Rejuvenation Separator Micro catheter Guide wire Guide catheter Concretion Blood vessel

Retaining element tip

strand

Claims

claims

Medical device for removing concrements (40)

Hollow body organs with a guide catheter (30), one in the

Guide catheters (30) longitudinally displaceable microcatheter (20) and a retractable into the microcatheter (20) receiving element (10), which is convertible from a compressed state to an expanded state and in the expanded state, a distally disposed, axial

Inlet opening (11) adapted for introducing a concretion (40) in the receiving element (10), wherein in the region of

Receiving element (10) a negative pressure can be generated in order to move the concretion (40) at least partially into the receiving element (10),

d a d u r c h e n c i n e s that

the receiving element (10) has a transport channel (12) which extends in the expanded state of the receiving element (10) like a tube between the inlet opening (11) and the microcatheter (20) and in

expanded state of the receiving element (10) a

Has a cross-sectional diameter greater than a diameter of the

Microcatheter (20), wherein the transport channel (12) is a fluid-tight

Cover (13) having at least one opening (14) at a proximal end of the transport channel (12) such that the transport channel (12) with the guide catheter (30) is fluid-connectable, wherein the

Guide catheter (30) fluidly connected to a suction device or is fluid-connectable to generate the negative pressure in the region of the receiving element (10).

Medical device according to claim 1,

marked by

a guidewire (21) connected to the proximal end of the

Receiving element (10) connected and longitudinally displaceable within the microcatheter (20) can be arranged.

Medical device according to claim 1 or 2,

d a d u rc h e n c i n e s that

the receiving element (10) has a net-like support structure.

4. Medical device according to claim 3,

d a d e d e r c e n ts i c h n et that

the reticulated support structure comprises a wire mesh.

5. Medical device according to claim 4,

d a d u rc h e e n c e s n e s that

the wire mesh has a braid angle which is at least 30 °,

in particular at least 40 °, in particular at least 45 °, in particular at least 50 °, in particular at least 55 °, in particular at least 60 °, and / or at most 70 °, in particular at most 60 °, in particular at most 50 °, in particular at most 45 °, in particular at most 40 °, in particular at most 30 °, in particular at most 20 °.

6. Medical device according to at least one of claims 1 to 5,

d a d e d u rch e n d e s c h n et that

the receiving element (10) has at least one separating element (17) at the proximal end, which comprises a cutting region for severing the concretion (40).

7. Medical device according to at least one of claims 1 to 6,

d a d e d u rch e n d e s c h n et that

the receiving element (10) in the expanded state a radial

expanded, in particular basket-like, suction portion (15) which is connected to the transport channel (12).

8. Medical device according to at least one of claims 1 to 7,

d a d u rch e ke n n zeic h n et that

the cover (13) of the transport channel (12) in use, in particular in the expanded state of the receiving element (10), fluid-tight with an inner surface of the guide catheter (30) can be brought into abutment.

9. Medical device according to at least one of claims 1 to 8,

There is no mention that

the transport channel (12) has a length which is at least 4 times, in particular at least 6 times, in particular at least 8 times, in particular at least 10 times, in particular at least 15 times, in particular at least 20 times, in particular at least 25 times, in particular at least 30 times, corresponds to an inner diameter of the guide catheter (30).

10. Medical device according to at least one of claims 1 to 9,

d a d u rch e ke n ze i c h n et that

the guide catheter (30) has an inner diameter which is at least 0.8 mm, in particular at least 1.0 mm, in particular at least 1.2 mm, in particular at least 1.4 mm, in particular at least 1.5 mm, in particular at least 1.6 mm , in particular at least 1.8 mm, in particular at least 2.0 mm, in particular at least 2.2 mm, in particular at least 2.5 mm, in particular at least 3.0 mm, and / or at most 2.4 mm, in particular at most 2.2 mm, in particular not more than 2.0 mm, in particular not more than 1.8 mm, in particular not more than 1.6 mm, in particular not more than 1.4 mm, in particular not more than 1.2 mm,

in particular at most 1.0 mm.

11. Medical device according to at least one of claims 1 to 10, characterized in that in

a distal holding element (50) is provided, which is convertible from a compressed state into an expanded state and retractable into the microcatheter (20), wherein the holding element (50) in the expanded state spaced from the inlet opening (11) of the receiving element (10) is arranged.

12. Medical device according to claim 11,

d a d u rch e ke n ze i c h n et that

the distal holding element (50) is connected to the receiving element (10) and / or the guide wire (21).

13. Medical device for removing concrements (40)

Hollow body organs with a guide catheter (30), one in the

Inlet opening (11) which for introducing a concretion (40) in the receiving element (10) is adapted, wherein the receiving element (10) has a transport channel (12) which extends in the expanded state of the receiving element (10) like a tube between the inlet opening (11) and the microcatheter (20) and in the expanded state of the

Receiving element (10) has a cross-sectional diameter which is greater than a diameter of the microcatheter (20), wherein the transport channel (12) at a proximal end at least one opening (14) such that the transport channel (12) with the guide catheter (30 ), wherein distally of the receiving element (10) a holding element (50) is arranged, which is connected to an actuating element such that the holding element (50) relative to the receiving element (10) is movable to a concretion (40) in the to introduce axial inlet opening (11).