WO2012110619A1

WO2012110619A1 - Medical device for removing concretions, and system having a medical device of this kind

Info

Publication number: WO2012110619A1
Application number: PCT/EP2012/052724
Authority: WO
Inventors: Kirsi SCHÜSSLER; Giorgio Cattaneo; Frank Nagl
Original assignee: Acandis Gmbh & Co Kg
Priority date: 2011-02-17
Filing date: 2012-02-16
Publication date: 2012-08-23
Also published as: DE102011011510B4; DE102011011510A1; WO2012110619A9

Abstract

The invention relates to a medical device for removing concretions from hollow organs of the body, comprising compressible and expandable catching elements (10) that can be anchored in the concretion, wherein the catching elements (10) are connected to an actuating means (11) in such a way that they are movable relative to a delivery line. It is characterized in that the catching elements (10) form at least two limb-like individual segments (12a, 12b, 12c, 12d) which are arranged in succession along the actuating means (11) and are each separately connected to the actuating means (11), wherein the individual segments (12a, 12b, 12c, 12d) are compressible and expandable independently of one another.

Description

Medical device for removing concrements and

System with such a medical device

description

The invention relates to a medical device for removing concretions from hollow organs of the body and to a system with such a device. A medical device with the features of the preamble of claim 1 is known for example from WO 2006/031410 A2.

In the field of interventional neuroradiology, therapy becomes more acute

Thromboses used so-called thrombectomy system. Here are on

different principles of action based systems known. Among others, passive and active mechanical, pneumatic or bioactive methods are used. The previously known systems have high risks during use, for example, by the risk of injury to the vessel wall when removing the thrombi or by the detachment of parts of a thrombus to be removed, which enter the bloodstream. In addition, the effectiveness of the known systems is limited, so that in practice usually different systems are tried in succession until a thrombus can be finally removed.

The system known from the aforementioned WO 2006/031410 A2 is a mechanically acting device for the removal of thrombi or blood clots, which comprises a catheter which is used to supply a basket-like

Fangelements is adjusted. The basket-like catching element comprises a compressible and expandable grid structure. In the expanded state, the catch element is arranged distally of the catheter and has a rotationally symmetrical structure. To remove a thrombus, the capture element is guided through the catheter to the treatment site and released. The expansion forms the basket-like structure of the catchment. A catheter is further connected to a suction unit, so that a negative pressure in the region of the basket-like Fangelements can be generated, which pulls the thrombus in the catch element. The lattice structure of the catching element rests against the vessel wall of the blood vessel to be treated. The thrombus is encapsulated in the catching element and can then be drawn into the catheter together with the catching element. When pulling the slides

Lattice structure of the Fangelements along the vessel wall of the blood vessel along. By the contact of the Fangelements with the vessel wall this is mechanically stressed, which can lead to injuries in the vessel wall.

The invention is therefore based on the object to provide a medical device for removing concretions from hollow organs of the body, the safety of use is improved with ease of use. It is another object of the invention to provide a system having such a medical device.

According to the invention, we have achieved this object with a view of the medical device by the subject-matter of claim 1 and with regard to the system by the subject-matter of claim 15.

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

To indicate the removal of concretions from hollow organs of the body with compressible and expandable catching elements that can be anchored in the calculus. The catch elements are connected to an actuating means such that they are relatively movable with respect to a supply line of a supply system. The

Catching elements form at least two member-like individual segments, which are arranged below the actuating means below and in each case separately with the

Actuating means are connected, wherein the individual segments are independently compressible and expandable.

The invention is based on a different concept than the thrombectomy system known from WO 2006/031410 A2, in which an aspiration device is absolutely necessary in order to suck the thrombus into the collecting basket resting against the vessel wall. The catcher must be placed proximally from the thrombus. By contrast, the invention is adapted and provided for releasing the catch elements in the thrombus or at the level of the thrombus, ie, these

overlap, and at least partially penetrate the thrombus or the calculus during expansion. It is also possible that the catching elements abut against the inside of the thrombus if it does not completely block the blood vessel or the hollow body of the body, but is formed only on the vessel wall, or if the catching elements do not penetrate the thrombus during expansion, but laterally on the Press vessel wall. If at least one penetration of the thrombus by the capture elements takes place, a particularly secure adhesion between the thrombus and the device takes place, whereby the safety of use in the removal of the thrombus is improved. The invention works but also if the Thrombus is only partially penetrated. In this case, the thrombus can be supported by biomechanical mechanisms to grow the structure of the capture elements, thereby improving attachment. It is also possible that the thrombus and the catch elements do not penetrate or attachment in the sense of endothelialization takes place. In this case, the thrombus is arrested by the friction of the catching elements.

Overall, the compressible and expandable capture elements are adapted to hold the calculus or thrombus from the inside, so that the thrombus is located between the capture elements and the vessel wall during removal. A direct contact of the catch elements with the vessel wall is characterized

avoided, at least largely avoided. This reduces the risk of injury when removing the thrombus. In any case, the catch elements or, as a whole, the device according to the invention are adapted not to be arranged exclusively proximal to the concrement. The aspiration device is not absolutely necessary for the removal of the thrombus or concretion, but may additionally be provided in order to prevent parts of the thrombus which detach upon removal from entering the bloodstream but being sucked off by the aspiration device. The removal of the thrombus occurs in the

Invention mechanically by the transmission of dissolving forces by means of

Operating means and anchored in use with the calculus

Catchers. The anchored catch elements are also used to hold the dissolved calculus in the supply line when it is retracted.

For this purpose, the invention comprises compressible and expandable catch elements, which are anchored in the calculus, wherein the catch elements are connected to the actuating means such that they are relatively movable with respect to the supply line. It should be noted at this point that the invention is disclosed and claimed independently of the supply system, that is, independently of the supply line, which is mentioned in claim 1 only to explain the function of the actuating means.

In addition, the medical device is disclosed and claimed in connection with the system comprising the medical device for removing concrements and a supply device with a supply line in which the

Device is arranged, wherein the catching elements are movable by the actuating means relative to the supply line. To remove the calculus The catch elements can be at least partially, in particular completely discharged from the supply line and retracted together with the actuating means.

The inventive device further provides that the catch elements form at least two member-like individual segments, which are arranged below the actuating means below and each separately connected to the actuating means. The individual segments are independently compressible and expandable. Due to the limb-like individual segments causes an axial elongation due to the retention force through the thrombus, which leads to a radial compression of the catch elements and thus to a reduction of the holding force, as far as possible avoided or at least greatly reduced. To clarify this advantage, reference is made to FIG. 1, which show a thrombectomy system which is formed without the individual segments according to the invention, but has a continuous lattice structure which is anchored to the calculus.

As can be seen in the upper part of Figure 1, a rotationally symmetric expansion body whose wall is made of a lattice structure, brought into the region of the thrombus to be removed and expanded there, so that the lattice structure penetrates into the thrombus. A part of the lattice structure is arranged distally (in FIG. 1 a to the left of the thrombus) and lies there directly against the vessel wall.

To remove and ultimately retract the thrombus into a catheter (not shown), a force acting in the proximal direction is applied through the wire connected to the proximal end of the lattice structure. Due to the retention force of the thrombus, as in the lower part of fig. 1, the lattice structure extended in the axial direction. This results in a radial compression of the lattice structure, as also well visible in Fig. 1, whereby a decoupling, at least a partial decoupling of the lattice structure of the thrombus takes place. Thus, the dissolving force is concentrated on a smaller area of the thrombus, optionally, as shown in Fig. 1, also on the part of the

Expansion body, which rests directly on the vessel wall distal to the thrombus. The mode of action of the thrombectomy system shown in FIGS. 1a, 1b is significantly worsened by this effect.

By inventively provided member-like individual segments prevents the radial compression along the entire device continues. By dividing the device into limb-like individual segments, the radial compression is reduced. By adjusting the axial length of the individual NEN segments can be selectively controlled how much the radial compression is reduced. The shorter the individual segments, the lower the radial compression. The applied by the actuating means axial tensile force is transmitted to the more distally arranged individual segments by the actuating means and not by the proximally arranged individual segments. This means that the axial extension of a distally arranged single segment does not lead to a stretching and thus not to a radial compression of the more proximal

arranged individual segments leads. The individual segments are thus substantially decoupled from each other, so that the transmission of the axial tensile forces is done separately only by the actuating means on each grid-like single segment. For this purpose, the invention provides that the limb-like individual segments, which are formed from the catching elements, are arranged below the actuating means below. By the subsequent arrangement of the individual segments, the required total length of the device is adjusted to keep the concretion as complete as possible. The length of the device is determined by the person skilled in the art by the length of the respective individual segments and / or the spacing of the individual segments

arranged individual segments set from one another if necessary. The individual segments are each separately connected to the actuating means, so that the above-described mode of action, namely the separate power transmission from

Actuating means is achieved on the individual segments. The individual segments are independently compressible and expandable, so that a

Power transmission of the individual segments with each other in the axial direction is avoided.

The limb-like individual segments have the additional advantage that the

Overall device is very flexible, whereby a retraction or general handling of the device in tortuous passages of the blood vessels is simplified. In the case of the inventive embodiment, the flexible adaptation of the individual segments to the shape of the hollow body of the body takes place primarily via the

Bending of the actuating means. Secondary secondary adjustment is made by a possible partial compression / expansion of the individual segments. Thus, in addition, the risk of the loss of the calculus by a

improved vessel apposition during the retraction process is reduced. In summary, a scale effect is achieved by the limb-like individual segments, by which the individual segments on the one hand adhere to the required length of the calculus to be removed and on the other hand, the individual segments in the axial direction or along the actuating means are decoupled from each other, so that a release force only on the actuating means and is not transferred to these via the individual segments.

In a preferred embodiment of the invention, the individual segments each have a proximal end and a distal end, the proximal end being connected to the actuating means and the distal end being radially movable for compressing and expanding the single segment. By the distance formed between the proximal and distal ends of the length of the single segment is determined, ie the length between the fixed to the actuating means and the freely movable end of the single segment. By adjusting this length, the adhesion of the respective individual segment to the concretion on the one hand and the axial elongation or, associated therewith, the radial compression of the single segment on the other hand, can be adjusted.

In a particularly preferred embodiment, the individual segments each have an axially tapering in the proximal direction axial portion, in particular first axial portion which is connected to the actuating means. The term "proximal" means closer to the user.The term "distal" means further away from the user. This definition applies to the entire application. By tapering in the proximal direction axial portion an inlet slope is formed, which facilitates the recoverability of the respective single segment in a supply line, in particular catheter line.

In a further particularly preferred embodiment of the invention, the individual segments each have at least one axial section, in particular second axial section, which is of cylindrical design at least in the expanded state and can be anchored to the calculus. Due to the cylindrical shape, an atraumatic configuration of the portion of the respective individual segments is achieved, which transfers the release force from the actuating means to the calculus. Moreover, the

Safety of the device improves in the event that the second axial section comes into direct contact with the vessel wall. The length Li of the tapered first axial portion in the axial direction and the length L _{2 of} the cylindrical second axial portion is

Li> L ₂ (1) or

Li <L ₂ (2).

In relation (1), the total length of the single segment is relatively short. The total length of the single segment is determined mainly by the length Li of the tapered first axial section. The length Li runs on the

Central axis of the first axial section and thus in the axial direction. When the adjustment of the aspect ratios is determined by the relationship (2), the length of the cylindrical portion is lengthened, thereby increasing the contact area between the apparatus and the thrombus. This leads to a particularly gentle removal behavior, in particular when releasing the calculus from the vessel wall.

If the individual segments have different maximum outside diameters

Expanded state, the different individual segments can be assigned different functions. For example, the

maximum outer diameter of the individual segments increase in the proximal direction. Due to the distally arranged individual segments with a smaller outer diameter, which increases in the proximal direction with further individual segments, an improved adaptation of the device to the anatomy of the blood vessels is possible. Distal vessels are generally smaller in diameter than proximal vessels, so improved vessel fitting is possible by increasing the maximum outer diameters of the successive discrete segments. The individual segments are therefore essentially atraumatic.

Alternatively, it is also possible that the maximum outer diameter of the individual segments decrease in the proximal direction. This means that the individual segments with a relatively large outer diameter are arranged distally and the individual segments with a relatively smaller outer diameter are arranged proximally. The increased distal outer diameter achieves a protective function which prevents or reduces the risk that individual parts or even the entire concretion will be lost when the device is re-drawn into the catheter or when the object is recovered. The distally arranged individual segments with the relatively larger outer diameters essentially act as filters. If at least three individual segments are provided, the proximal and distal outer segments may have a larger or smaller maximum outer diameter than the arranged between the outer individual segments inner single segment or as arranged between the outer individual segments inner individual segments. In the alternative, in which the individual segments with the smaller maximum outer diameters are arranged between the outer individual segments with the larger outer diameters, the calculus can be clamped between the outer individual segments. If the individual segments are arranged with the larger maximum outer diameters inside, ie between the outer individual segments, a particularly large anchoring force can be set in the area of the calculus to be removed, while at the same time preserving the individual segments at the axial ends of the thrombus.

Preferably, the individual segments each have a compressible and expandable, in particular self-expandable grid structure. Especially the self-expandable lattice structure has the advantage that the handling of the individual segments is simplified because they are released for deployment without further aids from the supply system and expand automatically.

The various individual segments may have different lattice structures. This also makes it possible to assign different functions to the different individual segments.

A simple production of the individual segments, for example by laser cutting, can be achieved if at least a part of, in particular all individual segments, cells which are formed leaf-like at least in the expanded state and each have a longitudinal axis L _z , wherein the longitudinal axis L _z at least egg ner cell and the longitudinal axis L _{B of} the currently arranged actuating means in the same plane. Thereby, a basket-like structure is provided, which has a relatively short length and is expandable or compressible.

In a further advantageous embodiment of the invention, at least a portion of, in particular all, individual segments on closed cutting cells, which are arranged adjacent to open holding cells with flexible tongues, which are deflected when expanding through the concretion radially inwardly. These Embodiment has the advantage that the radially inwardly deflected tongues increase the resistance area of the respective individual segment, so that the release forces acting in the axial direction can be transmitted particularly well from the respective individual segment to the thrombus. This is particularly advantageous when the cutting cells substantially completely penetrate the thrombus and are therefore less strongly anchored in the thrombus.

Preferably, x-ray markers are respectively arranged at the distal ends of the individual segments. As a result, radiopaque regions are created along the device. Their expansion allows the user to evaluate the area of the thrombus, in particular an incomplete one

Expansion. In addition, it can be evaluated whether the device is fully expanded distal to the thrombus and exerts a distal filtering function.

The individual segments may be arranged in the compressed state overlapping or non-overlapping. The overlapping arrangement of the individual segments can be achieved by the axial elongation of the system, for example when compressing to the feed diameter. In this way, it is possible that the distance between two individual segments in the expanded state is minimized or even brought to zero. In addition, it is possible that the overlap is set to be in the compressed and expanded states. It is possible to overlap some individual segments and arrange some individual segments non-overlapping. If the individual segments in the compressed state, in particular in the catheter in the non-overlapped state are arranged one behind the other, these are spaced apart during expansion by the concomitant axial shortening. It is possible that individual identical or differently formed individual segments each have different distances to the correspondingly arranged in front of or behind these individual segments.

Due to the overlap or non-overlap, the length of the overall device on the one hand and the feed diameter on the other can be influenced.

The invention will be explained in more detail by means of embodiments with reference to the accompanying schematic drawings. In these show:

Fig. 1 above a thrombectomy device with a lattice structure without

limb-like individual segments; Fig. 1 at the bottom in the elongated state, the partial radial compression of the grid structure is visible;

Fig. FIG. 2 is a plan view of the individual segments of a device according to an embodiment of the invention; FIG.

FIG. 3 shows the device according to FIG. 2 in the blood vessel; FIG.

FIG. 4 shows the device according to FIG. 2 with bent actuating means; FIG.

5 shows a further embodiment of the invention with individual segments whose outer diameter increases in the proximal direction;

6 shows a further embodiment of the invention with individual segments, the outer diameter of which decreases in the proximal direction;

Fig. 7 shows another embodiment with individual segments whose

Outer diameter are formed differently;

8a shows a further embodiment in which the proximal and distal outer individual segments have a larger outer diameter than the individual segments arranged therebetween;

Fig. 8b, the device of FIG. 8a in the blood vessel anchored

calculus;

9 shows a further embodiment of a device in which the

Individual segments have different lattice structures;

10 shows a device according to an embodiment of the invention with a modified grid structure in which cutting teeth and holding teeth are provided;

Fig. 11 shows a device according to another invention

Embodiment with modified grid structure in which the individual segments have the same outer diameter; Fig. 12 shows a device according to an embodiment of the invention with a modified lattice structure, in which the individual segments

have different outer diameter;

Fig. 13 shows a device according to an embodiment of the invention, which represents a variant of the example according to FIG. 5;

Fig. 14 shows a further embodiment of the invention, which is a variant of

Embodiment of FIG. 6 represents;

Fig. 15 shows a further embodiment of the invention, which is a variant of

Embodiment of FIG. 8a represents;

Fig. 16 shows a further embodiment of the invention, which is a variant of

Embodiment of FIG. 2 represents;

Fig. 17 anchored the device of FIG. 15 in the blood vessel

calculus;

18 shows a plan view of the insertion segments of a device according to a further embodiment of the invention;

19 is a front view of a single segment of the device of FIG.

18;

Fig. FIG. 20 is a plan view of the single segment of FIG. 19; FIG.

Fig. 21 is a plan view of a variant of the device according to FIG. 18 with modified connecting means; and

FIG. 22 shows a front view of a single segment of the device according to FIG.

21st

Fig. 2 shows schematically a plan view of a medical device for removing concretions from hollow organs of the body, which is used in practice in a thrombectomy system. Concretely, the device according to FIG. 2 is arranged in the supply line of a catheter and axially in the proximal and in the distal direction Sliding direction. The axial displaceability of the device in the

Supply line (not shown) serves on the one hand to transport the device in the region of the catheter tip. On the other hand, the axial mobility serves to release the device placed in the region of the catheter tip from the supply line and, if necessary, to collect it again.

The medical device is therefore both intrinsically, i. disclosed and claimed without the supply line as well as in connection with the Thrombektomiesystem. In the latter case, the device is part of the system (thrombectomy system with a medical device for removing concrements) and axially displaceable in a supply line of the system.

All figures and the corresponding descriptions refer to the

expanded state of the device, unless the compressed state is explained explicitly.

The device according to FIG. 2 has compressible and expandable elements 10. The catch elements 10 extend radially outward and form in the

expanded state, a contact surface, which rests against the concretion or thrombus to be removed or penetrates into it, so that the catching elements 10 are anchored to the calculus. The catch elements 10 are each connected to an actuating means 11, which may be for example a feed wire.

Other actuating means, for example tubular components are possible. The actuating means are flexible to allow the device to adapt to vessel bends. At the same time, the actuating means 11 is adapted to transmit forces in the proximal direction and in the distal direction, in particular the forces required to release and recover the calculus.

The catch elements 10 each form limb-like individual segments 12a, 12b, 12c, 12d. As can be seen in FIG. 2, the limb-like individual segments 12a, 12b, 12c, 12d are arranged along the actuating means 11. The individual segments 12a, 12b, 12c, 12d are arranged below, ie lined up one behind the other. The individual segments 12a, 12b, 12c, 12d are each spaced from each other. It is also possible that the individual segments are aligned directly, ie without spacing behind each other. In the straight state of the actuating means 11, the longitudinal axis of the actuating means 11 at the same time forms the central axis of the member-like individual segments 12a, 12b, 12c, 12d. In this respect, the individual segments 12a, 12b, 12c, 12d are even Actuating means 11 arranged coaxially. The individual segments 12a, 12b, 12c, 12d are rotationally symmetrical.

The individual segments 12a, 12b, 12c, 12d are each connected separately to the actuating means 11 and are independently compressible and expandable. Due to the separate connection of the individual segments 12a, 12b, 12c, 12d with the actuating means 11, the axial force transmitted by the actuating means 11 is introduced individually into each individual individual segment 12a, 12b, 12c, 12d. In addition, the individual segments 12a, 12b, 12c, 12d are independently compressible and expandable, so that the individual segments 12a, 12b, 12c, 12d are mechanically decoupled from each other. The mechanical decoupling causes the forces transmitted by the actuating means 11 is not transmitted from a single segment 12a to the next single segment 12b, etc., but due to the separate attachment of the individual segments 12a, 12b, 12c, 12d with the actuating means 11 only by the actuating means 11th In the exemplary embodiment according to FIG. 2, the mechanical decoupling is achieved concretely in that the distal ends 13b of the individual segments 12a, 12b, 12c, 12d are not connected to the respective following individual segment 12a, 12b, 12c, 12d. The distal ends 13b of the individual segments 12a, 12b, 12c, 12d are free. The connection of the respective individual segments 12a, 12b, 12c, 12d with the actuating means 11 takes place at the proximal end 13a of the respective individual segment 12a, 12b, 12c, 12d, in particular only at the proximal end 13a of the respective single segment 12a, 12b, 12c, 12d. The free distal ends 13b are radially movable to compress and expand the respective single segment 12a, 12b, 12c, 12d. The radial movement takes place by discharging the respective individual segment 12a, 12b, 12c, 12d from the supply line (not

shown).

For the retracting function, each individual segment 12a, 12b, 12c, 12d has a first axial section 14a, which tapers in the proximal direction. In the area of the proximal end 13a of the respective individual segment 12a, 12b, 12c, 12d, the smallest diameter of the first axial section 14a is located. In this area, the single segment 12a, 12b, 12c, 12d is connected to the actuating means 11. The first axial section 14a changes in the distal direction into a second axial section 14b, which is of cylindrical design. The second axial section 14b ends in the region of the distal end 13b of the respective individual segment 12a, 12b, 12c, 12d and forms an atraumatic contact surface of the concretion. The transition from the first axial section 14a to the second axial section 14b takes place continuously. The above-mentioned basic structure of the individual segments 12a, 12b, 12c, 12d is disclosed and claimed in common with all embodiments and accordingly in connection with all embodiments.

The embodiment according to FIG. 2 specifically has a basket-like or basket-shaped grid structure 15. The first axial section 14a, which tapers in the proximal direction and at which the individual segments 12a, 12b, 12c, 12d are respectively connected to the actuating means 11, has a conical shape. The conical region merges into the cylindrical region of the second axial section 14b. The cells of the lattice structure of the respective individual segment 12a, 12b, 12c, 12d are sheet-like and extend outwardly at an increasing opening angle. The cells 16 are each formed from at least four webs 23, which have an approximately diamond-shaped basic shape in the plan view or projection. The distal tip 24 of the respective cell 16 is rounded and acts thereby

atraumatic. The opening of the basket-like structure faces in the distal direction.

Other lattice structures in which compressible and expandable capture elements are formed are possible.

The second axial section 14b or the distal end 13b of the respective individual segment 12a, 12b, 12c, 12d can protrude radially inwards, whereby the risk of injury is further reduced. The distal end 13b may also project radially outward. This allows a better grip of the thrombus. In either case, the distal ends 13b may project vertically outwardly or inwardly and / or may be inclined in the distal and / or proximal directions. The distal end 13b may also be located on the cylindrical lateral surface.

In general, the individual member-like individual segments 12a, 12b, 12c, 12d are adapted in such a way that they can be retracted into a delivery catheter. Therefore, for example, the open bridge tips are usually directed in the feed direction, ie they point in the distal direction, so that they do not tilt with the inlet opening of the supply line. In addition, this leads to an improved atraumatic behavior of the device with respect to the vessel wall. It is also conceivable, as described above, that the distal ends 13b protrude perpendicularly outwardly and / or are inclined in the proximal direction, so that they act like a barb. In this case, the ends should be anchored in the thrombus so that they are embedded in the material of the thrombus and thus not with the edge of the thrombus Feed line collide. It is also possible to provide for single segments with different diameters only the individual segments with dress ner diameter with barb-shaped ends 13 b, which can be easily retracted, since the diameter of the supply line is greater than that

Expansion diameter of the smaller individual segments.

For the connection of the respective individual segments 12a, 12b, 12c, 12d are

Connecting elements 22 at the proximal end 13a of the respective single segment 12a, 12b, 12c, 12d provided. The connecting means 22 may be formed as a third axial section 14c of the respective individual segment 12a, 12b, 12c, 12d. The third axial section 14 c is cylindrical and has an outer diameter that approximately corresponds to the minimum outer diameter of the first axial section 14 a. The first axial section 14a merges into the third axial section 14c. The inner diameter of the third axial section 14 c is dimensioned such that the

Actuator 11 passes through and can be connected to this or is connected. The third axial section 14c is either a separate component, for example a sleeve, which is connected to the first axial section 14a, for example by material bonding by welding. Alternatively, the first

Axial portion 14a and the third axial portion 14c to be integrally formed. This can be achieved by the third axial section 14c or the

Connecting means 22 and the catch elements 10 are made of the same pipe material in one piece, for example by laser cutting. In this case, a tube is structured such that individual sections are expanded more, which then form the catch elements 10, as other sections, which then form the connecting elements 22. Concretely, it is possible not to expand the connecting elements 22 and / or not to structure, so that the original pipe diameter is maintained.

For the attachment of the connecting means 22 and the third axial portion 14c are particularly suitable crimping or welding.

The operation of the device according to FIG. 2 will be explained in more detail with reference to FIG. 3.

To place the device is first a guide wire to the

brought treatment site over which a catheter tube is pushed. When the catheter tip is at the level of the thrombus to be removed, with the If necessary, the catheter tip pierces through the thrombus, the

Guidewire withdrawn and advanced the device of FIG. 2 through the catheter line to the calculus. When the device is positioned at the level of the thrombus, the catheter lead is withdrawn. Due to the relative movement, the device is successively discharged from the catheter line and expand the individual segments. The fully expanded device is shown in FIG. Some individual segments 12b, 12c push the thrombus radially and locally outward or partially penetrate into the thrombus. This results in an anchoring of the catch elements 10 in the thrombus. It is not necessary that all individual segments 12a, 12d are anchored in the thrombus. Some individual segments may expand distally and / or proximally from the thrombus. The thrombus is acted on by the radial force of the catch elements 10 arranged in the region of the thrombus. To remove the thrombus is pulled on the actuating means 11 until the thrombus dissolves from the vessel wall. Due to the radial force of

Capture elements 10 of the thrombus adhere to these and can be retracted into the catheter or the catheter line. Upon retraction, the individual segments 12a, 12b, 12c, 12d are successively compressed by the tapered first portion 14a until they reach the feed diameter or crimp diameter and fit into the feed line. The stuck between the individual segments 12a, 12b, 12c, 12d thrombus is taken along and also introduced into the supply line. Then the thrombus can be retrieved from the body together with the catching elements 10 now located in the supply line.

The advantage of the link-like individual segments 12a, 12b, 12c, 12d is that the pulling force does not set any elongation of the individual segments or at least no significant elongation and no associated radial compression, so that the of the individual segments 12a, 12b, 12c, 12d on the thrombus

applied radial force is maintained. Recovery of the thrombus can be assisted by an aspiration device or aspiration catheter. In addition, it is possible to avoid the washing away of detached parts of the thrombus by means of a distally arranged filter.

A further advantage of the device according to FIG. 2 is that the individual segments 12a, 12b, 12c, 12d are connected to one another in an articulated manner by the actuating means 11, so that the individual segments 12a, 12b, 12c, 12d are connected to vessel segments. Adjust curvature without being flexible or flexible in itself. This is shown in FIG. 4 to recognize.

The flexibility that can be achieved on account of the articulated arrangement of the individual segments 12a, 12b, 12c, 12d is promoted by a construction having a relatively large number of individual segments 12a, 12b, 12c, 12d. Advantageously, at least 2, in particular at least 3, at least 4, at least 5, at least 6 individual segments are provided. The upper limit can be, for example, a maximum of 20 individual segments. The upper limit may vary according to different purposes. Furthermore, relatively short individual segments 12a, 12b, 12c, 12d are advantageous, for example, a maximum length of 1.5, in particular of at most 1, in particular at most 0.8, in particular at most 0.6, in particular at most 0.4 cm per single segment 12a , 12b, 12c, 12d.

The basic principle of the limb-like structure of the device or of the thrombectomy system explained on the basis of the exemplary embodiment according to FIG. 2 is also disclosed in connection with the following exemplary embodiments, which are based on the same basic principle. The following embodiments

differ from the embodiment of FIG. 2 through structural details, which are explained in more detail below.

In the Figs. FIGS. 5 to 8 b show various exemplary embodiments in which the individual segments 12 a, 12 b, 12 c, 12 d have different maximum outer diameters. This applies to the expanded state. The maximum outer diameter of a single segment is determined by that portion of the single segment which protrudes furthest in the radial direction or the largest distance to the

Has center axis of the single segment. In the embodiments according to FIGS. 5 to 8b, the maximum outer diameter of a single segment 12a, 12b, 12c, 12d corresponds to the outer diameter of the cylindrical second axial section or generally the distal outer section of a single segment which bounds the distal-facing opening of the single segment in the radial direction. The radial outer diameter of a single segment corresponds approximately to the maximum opening diameter plus the wall thickness of the single segment. In which

Embodiment of FIG. 5 takes the maximum outer diameter of

Single segments 12a, 12b, 12c, 12d in the proximal direction to. This means that the maximum outer diameter of a single segment is greater than the maximum outer diameter of the individually arranged downstream in the distal direction. Segment. The change in the outer diameter may be constant, so that in each case between two consecutively arranged individual segments the same change in particular decrease of the outer diameter is present. Other

Shades of the maximum outside diameter are possible. The device according to FIG. 5 has the advantage that by the reduction of the outer diameter in the distal direction (or the increase of the outer diameter in the proximal direction), an improved adaptation of the device to the usually decreasing

Diameter of distal vessels is adjusted. This will increase the effectiveness of

Device improved because the overall profile of the device essentially follows the decreasing vessel size.

In the embodiment according to FIG. 6, the change in the maximum outside diameter is reversed as in the embodiment according to FIG. 5. The maximum outside diameter decreases in the proximal direction or increases in the distal direction. Incidentally, the remarks on the structural design of the embodiment of FIG. 5 referenced. The distally

increasing outer diameter causes a filter function and also causes the thrombus to jam in the axial direction, so that it prevents individual parts of the calculus or the entire concretion is lost during recovery.

The ratio between the maximum outer diameter of the smallest single segment and the largest single segment is at most 0.8, in particular at most 0.6, in particular at most 0.4. This applies to both embodiments according to FIG. 5 and 6 and for all other embodiments in which

different maximum outer diameter of the various individual segments are present.

Further exemplary embodiments, in which the individual segments 12a, 12b, 12c, 12d have different maximum outer diameters, are shown in FIGS. 7 to 8b shown. In both embodiments, several individual segments

provided, each having a smaller maximum outer diameter, in particular the same maximum outer diameter, and a plurality of individual segments having a larger maximum outer diameter, in particular the same larger maximum outer diameter, wherein the individual segments are grouped with the smaller maximum outer diameter. It means that

at least two, in particular at least 3, in particular at least 4, in particular at least 5, in particular at least 6 individual segments with the smaller maximum outer diameter are arranged directly one behind the other. The individual segments with the smaller maximum outer diameter are intended to expand in the area of the thrombus. By the smaller one

maximum outside diameter limits the radial force acting on the thrombus, which enables a particularly vessel-friendly detachment of the calculus. In both embodiments according to FIGS. 7 and 8a, it is distal to the individual segments with the smaller maximum outside diameter

At least 1, in particular at least 2, in particular at least 3, in particular at least 4 Einzelseg elements arranged with egg NEM larger maximum outer diameter. This combination of the individual segments having the smaller maximum outside diameters and the larger maximum outside diameters means that in addition to the adhesion due to the radial force of the individual segments having the smaller maximum outside diameters, an axial force can act on the concretion from the distally disposed single segments having the larger maximum outside diameter is exercised when pulling on the actuating means 11.

As a result, a combined Kraftei nleitung is achieved by the catch elements 10 in the concretion, once by the radial contact pressure of the single segment with the smaller maximum outer diameter and by anchoring the thrombus in the axial direction of the individual segments with the larger maximum outer diameters. The anchoring of the thrombus in the axial direction is narrowed by pinching the thrombus between the distally

tapered and meeting web pairs 23 in the area of the tip 24 reached.

In the embodiment according to FIG. 7, a first group of individual segments 12c, 12d with a small maximum outside diameter and a second group of individual segments 12a, 12b with a larger maximum outside diameter are provided, wherein the second group is arranged distally of the first group. Proximally from the first group no catch elements are provided.

The embodiment of FIG. 8a differs from the embodiment of FIG. 7b characterized in that the first group of the individual segments 12b, 12c is arranged with the smaller maximum outer diameter between two individual segments 12a, 12d with a larger maximum outer diameter. Instead of the two outer individual segments 12a, 12d, the distal and proximal of the inner or

middle individual segments 12b, 12c are arranged with the smaller maximum outer diameter, analogous to the embodiment of FIG. 7 groups of Single segments with greater maximum outer diameter may be provided, which are arranged both proximally and distally of the first middle group.

In Fig. 8b, the device of FIG. 8a is shown in use, wherein the catch elements 10 of the respective individual segments 12a, 12b, 12c, 12d with a

Concrete are anchored. It can be clearly seen that the concretion is clamped between the distal and proximal arranged individual segments 12a, 12d. The anchoring is assisted by the inner individual segments 12b, 12d having the smaller maximum outer diameter, which exert on the calculus a reduced radial force compared to the outer individual segments 12a, 12d.

In Fig. 8b can be further seen that a portion of the concretion in the region of the distal outer segment 12a penetrates through the lattice cells 16 of the lattice structure and is held in the region of the tip 14 of jewei time cell. This results in the desired axial anchoring of the calculus.

The tip 14 is located approximately at the level of the transition from the conical first portion 14a to the cylindrical second axial portion. The web pairs 23, which are brought together in the area of the tip 24, are inclined relative to a plane running through the central axis or the actuating means 11 which is arranged straight, and form the conical shape of the first axial section tapering in the proximal direction.

The above detailed explanation of the lattice structure in the region of the first

Axial section will be disclosed in connection with all embodiments.

The embodiments according to FIGS. 5 to 8b are based on individual segments 12a, 12b, 12c, 12d, which have a sheet-like lattice structure, wherein each individual segment consists of a single row of cells 16, which on the circumference of the respective single segment 12a, 12b, 12c , 12d are arranged. This basic structure applies to all individual segments 12a, 12b, 12c, 12d of the aforementioned embodiments. The elements in the conical area can therefore be single cells (like leaves). This means that no further cell is arranged downstream in the radial and axial direction. These single cells may have a curved shape. A single cell forms both the conical and the cylindrical portion of the segment. Alternatively, the individual segments 12a, 12b, 12c, 12d may have a lattice structure of a plurality of cell rows. In other words, several cells may be arranged downstream in the radial and axial directions. It may be that only in the conical region two or more cells are arranged downstream. The limb-like structure of the overall device is maintained, as for example, from the embodiment of FIG. 9 and from the embodiments of FIG. 10 to 12 can be seen.

In the embodiment according to FIG. 9, the middle individual segment 12b is formed with closed cutting cells 18 which surround open holding cells 19 with flexible tongues 20. The flexible tongues 20 are deflected during expansion by the contact with the concretion radially inwardly. The structure of the middle single segment 12b is in the applicant

DE 10 2010 045 367, in particular on pages 12 to 19 in conjunction with FIGS. 1 to 4 and on pages 22 to 23 in conjunction with FIG. 10 described. For general operation of the lattice structure of the central single segment 12b, reference is made to pages 2 to 7 of the aforementioned application, wherein in the single segment according to FIG. 9, the retaining elements need not necessarily be connected to the actuating means 11. In the embodiment according to FIG. 9, the holding cells or tongues 20 are freely arranged and due to the greater flexibility compared to the cutting cells 18 can be deflected radially inwardly by the contact with the concretion.

The basic structure of the middle single segment 12b according to FIG. 9 follows in connection with the individual segments according to FIGS. 1 to 8 explained basic construction and has a conical or in the proximal direction tapering first axial portion 14a and a subsequent to the first axial portion second cylindrical axial portion 14b. In contrast to the individual segments of FIG. 1 to 8, the cylindrical second axial portion is formed longer, so that a total of a larger contact area between the

Single segment 12b and the calculus sets. This leads to a particularly gentle detachment of the calculus from the vessel wall. The central single segment 12b is therefore predominantly cylindrical and can be represented or realized as a stent-like structure with a conical end section (first axial section 14a). The ratio of the length of the conical first axial section 14a to the total length (length of the first and second axial section) is at most 0.5, in particular at most 0.4, in particular at most 0.3, in particular at most 0.2, in particular at most 0, 1. In the embodiment according to FIG. 9, the conical first axial section has arm-shaped extensions, which are continued from the stent-like structure and bent inwards. The extensions 25 are connected to the actuating means 11.

The cylindrical area of a catchment is limited in length. In the case of multicellular individual segments 12a, 12b, 12c, 12d, the cylindrical region may have at most 3 cells, in particular at most 2 cells, in particular 1 cell. The cylindrical area is preferably at most 1.3 cm, in particular at most 0.8 cm, in particular at most 0.6 cm, in particular at most 0.3 cm long. When

Lower limit can be set to a length of 0.1 cm. The total length of a single segment 12a, 12b, 12c, 12d may be at most 1.5 cm, in particular at most 1.0 cm, in particular at most 0.8 cm, in particular at most 0.5 cm. The lower limit can be set to a length of 0.3 cm.

The X-ray markers 26 provided at the distal ends 13b facilitate the location of the device.

The individual segments 12a, 12b, 12c, 12d can be connected to the actuating means 11 by welding, riveting, gluing, soldering, crimping, etc. The proximal ends of the respective individual segments can be connected directly to the actuating means 11. Alternatively or additionally, connecting elements, such as sleeves, may be provided.

The difference between the variants according to FIGS. 13, 14, 15 and 16 and the associated devices according to FIG. 5, 6, 8a and 2 is that the

Single cells 16, from which the catch elements 10 are constructed, are the same, in particular identical, for each individual segment 12a, 12b, 12c, 12d. In particular, the length L of the respective cells 16 projected onto the actuation means 11 arranged in the straight state is the same (see, for example, FIG. The free tips 24 of the

Single cells 16 are located in a plane, in particular in the same plane which intersects the actuating means 11 orthogonally in the straight state of the actuating means 11. The shape of the cells 16 is the same. Specifically, the individual cells 16 jewei ls on a diamond-shaped basic shape. In the exemplary embodiments provided according to FIG. 13-16 four individual cells 16 are provided per single segment 12a, 12b, 12c, 12d, which form the basket-like catch elements 10 like a leaf. The individual cells 16 are on the circumference of each individual element 12a, 12b, 12c, 12d to the actuating means 11 arranged around. Otherwise, those shown in FIGS. 13-16 and in Figs. 5-8a and 2 illustrated embodiments, so that all in connection with FIGS. 5a, 6, 7, 8a and 2 disclosed features also in connection with the devices of FIG. 13, 14, 15 and 16 are disclosed.

The same applies to the use of the device according to FIG. 15 shown in FIG. 17. In connection with the use according to FIG. 17, all the functions, advantages, and modes of operation disclosed in connection with the use of FIG. 8b are disclosed.

In the Figs. 18-20, another embodiment of the invention is disclosed, which is based on the concept of single cells 16. As can be seen in FIG. 19, the device has four outer single cells 16a and four inner single cells 16b. The inner single cells 16b are inscribed in the outer single cells 16a. Specifically, the outer and inner single cells 16a, 16b have the same shape, and the inner single cells 16b are smaller than the outer single cells 16a. The outer single cells 16a form a sheet-like structure that widens distally. The distal end 13b of the structure is exposed, as clearly seen in FIG. The proximal end 13 a of the structure is connected to the actuating means 11. The connection with the actuating means 11 can be done, for example by gluing or welding, so generally cohesively. Alternatively, by reducing the diameter, the proximal end may be mechanically connected to the actuating means 11, for example by crimping.

As can be seen in the front view according to FIG. 19, the device has four cross-shaped main webs 23a. The main webs 23a have a greater width than the other webs. At the main webs 23a, the side webs 23b, 23c of the outer cells 16a set. Two side webs 23b, 23c together with two main webs 23a form an outer single cell 16a. The side webs 23b, 23c are in turn connected to each other and form the cell tip 24. The side webs 23b, 23c engage the distal end of the main webs 23a.

The remaining outer individual cells 16a are constructed accordingly.

The inner individual cells 16b have side webs 23d, 23e, which also engage the main webs 23a. The side bars 23d, 23e of the inner single cells 16b are connected to each other and form a tip 24. The side bars 23d, 23e engage in the embodiment of FIG. 19 at about halfway up the main webs 23a. A different size distribution between the outer and inner single cells 16a, 16b is possible. In addition, more than four outer single cells 16a and corresponding inner single cells 16b may be provided. This also changes the arrangement and number of main webs 23a accordingly. The side bars 23d, 23e may also be referred to as brackets

The side contour of the single segment according to FIG. 19 can be clearly seen in FIG. There, it can be seen that the first axial section 14a, which forms the part of the single segment conically tapering in the proximal direction, is formed by the main webs 23a. In the proximal direction, the first axial section 14a goes into the third axial section 14c via which the connecting means 22 for connecting the

Individual segments with the actuating means 11 forms. In the distal direction, the first axial section 14a merges into a modified second axial section 24b 'which, in contrast to the preceding embodiments, widens conically outwards with a greater angle of inclination. In the region of the transition 26 between the first and second axial section 14a, 14b 'changes

Expansion angle, wherein in the region of the second axial portion 14b ', the cone-shaped basic shape of the single segment is maintained. The widening angle is greater in the region of the second axial section 14b 'than in the region of the first

Axial section 14a. The transition 26 corresponds to the point where the side webs 23b, 23c engage the main web 23a. As shown in FIG. 20, the first axial section 14a extends substantially rectilinearly. The second axial section 14b 'is curved. In Fig. 20, it can further be seen that the inner single cells 16b protrude radially outwardly beyond the main webs 23a. Concretely, the side webs 23d, 23e of the inner individual cells 16b protrude beyond the main webs 23a, so that the widening angle in the region of the side webs 23d, 23c is greater than that

Expansion angle of the main webs 23a.

In other words, the side webs 23b, 23c of the outer single cells 16a form a serrated crown with round tips 24 which touches on the conically outwardly extending main webs 23a.

In the embodiment according to FIG. 18, three individual segments 12a, 12b, 12c are provided, each of which is constructed accordingly. The shape of the single segment as shown in FIG. 20 can be combined with the different arrangements of the individual segments, as shown in FIGS. 2-8a or in FIGS. 13-16.

FIGS. 21 and 22 show a variant of the exemplary embodiment according to FIG. 18, in which the third axial portion 14c or the connecting means 22 is alternatively configured. In contrast to the sleeve-like extension of the grid structure shown in FIG. 18 is in the embodiment of FIG. 21 and Fig. 22, respectively, that the third axial portion 14c and the connecting means 22 is slotted. For this purpose, two diametrically opposed inner individual cells 16b are designed as open cells. The respective other, offset by 90 ° inner single cells 16b are, as in the embodiment of FIG. 18, designed as closed cells. This results in the arrangement or configuration of the connecting means 22 as shown in FIG. 22. The juxtaposed main webs 23a are connected by a connecting web 23f. The connecting web 23f forms the closed side of the closed inner single cells 16b.

LIST OF REFERENCE NUMBERS

10 catch elements

11 actuating means

12a, 12b, 12c, 12d individual segments

13a proximal end

13b distal end

14a first axial section

14b second axial section

14c third axial section

15 grid structure

16 cells

16a outer cells

16b inner cells

17a first longitudinal end

17b second longitudinal end

18 cutting cells

19 holding cells

20 tongues

21 x-ray markers Lanyard bridge

a Hauptstega, 23b, 23c, 23d Seitenstegef connecting bridge

top

projections

crossing

Claims

claims

1. Medical device for removing concrements from

Hollow body organs with compressible and expandable catch elements (10) which are anchored in the calculus, wherein the catch elements (10) are connected to an actuating means (11) such that they are relatively movable with respect to a supply line,

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

the catch elements (10) form at least two member-like individual segments (12a, 12b, 12c, 12d) which are arranged below the actuating means (11) and are each connected separately to the actuating means (11), wherein the individual segments (12a, 12b, 12c , 12d) are independently compressible and expandable.

2. Apparatus according to claim 1,

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

the individual segments (12a, 12b, 12c, 12d) each have a proximal end (13a) and a distal end (13b), the proximal end (13a) being connected to the actuating means (11) and the distal end (13b) to

Compressing and expanding the single segment (12a, 12b, 12c, 12d) is radially movable.

3. Apparatus according to claim 1 or 2,

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

the individual segments (12a, 12b, 12c, 12d) each have a proximal axial direction tapered axial portion, in particular first axial portion (14a), which is connected to the actuating means (11).

4. Device according to one of the preceding claims,

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

the individual segments (11) each have at least one axial section, in particular second axial section (14b), which is cylindrical in shape at least in the expanded state and can be anchored to the calculus.

5. Apparatus according to claim 4,

dadu rc hge ke nn ze ichn et that the length Li of the tapered first axial portion (14a) in the axial direction and the length L _{2 of} the cylindrical second axial portion (14b) are as follows:

Li> L ₂ (1) or

Li <L ₂ (2).

6. Device according to one of the preceding claims,

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

the individual segments (12a, 12b, 12c, 12d) in the expanded state

have different maximum outer diameter.

7. Apparatus according to claim 6,

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

the maximum outer diameters of the individual segments (12a, 12b, 12c, 12d) increase or decrease in the proximal direction.

8. Apparatus according to claim 6 or 7,

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

at least three individual segments (12a, 12b, 12c, 12d) are provided, wherein the proximal and distal outer segments (12a, 12b, 12c, 12d) have a larger or smaller maximum outer diameter than that between the outer individual segments (12a, 12d) arranged inner individual segments (12c, 12d).

9. Device according to one of the preceding claims,

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

the individual segments (12a, 12b, 12c, 12d) each have a compressible and expandable lattice structure (15).

10. Device according to one of the preceding claims,

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

the individual segments (12a, 12b, 12c, 12d) have different lattice structures (15).

11. Device according to one of the preceding claims,

dadu rc hge ke nn ze ichn et that at least a part of, in particular all, individual segments (12a, 12b, 12c, 12d) cells (16) which are formed leaf-like at least in the expanded state and each have a longitudinal axis L _z , wherein the

Longitudinal axis L _z at least one cell and the longitudinal axis L _{B of} the currently arranged actuating means (11) extend in the same plane.

12. Device according to one of the preceding claims,

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

at least a portion of, in particular all, individual segments (12a, 12b, 12c, 12d) have closed cutting cells (18) adjacent to open ones

Holding cells (19) are arranged with flexible tongues (20), wherein the flexible tongues (20) during expansion through the concretion can be deflected radially inwardly.

13. Device according to one of claims 2 to 12,

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

X-ray markers (21) are respectively arranged at the distal ends (13b) of the individual segments (12a, 12b, 12c, 12d).

14. Device according to one of the preceding claims,

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

the individual segments (12a, 12b, 12c, 12d) in the compressed state

are arranged overlapping or non-overlapping.

A system with a medical device for removing concrements according to any one of the preceding claims and a supply means with a supply line in which the device is arranged such that the catch elements (10) are movable relative to the supply line by the actuating means (11).