DE102010010849A1 - Medical device for removing concretions from hollow organs of the body and method for producing such a device - Google Patents

Abstract

The invention relates to a medical device for removing concrements from hollow body organs with a catheter (30), a guide element (20) arranged longitudinally displaceably in the catheter (30) and a flexible receiving element (10) connected to the guide element (20), which is supported by can be converted from a compressed state into an expanded state and, in the expanded state, at least in sections assumes a rotationally symmetrical shape, the receiving element (10) having a flexible wall (11) with at least two free longitudinal edges (14a, 14b) which, when the receiving element ( 10) from the compressed state to the expanded state in the longitudinal direction of the receiving element (10) form, at least in sections, a lateral receiving opening (16), the receiving opening (10) being able to be moved into an open position in order to pass a calculus arranged laterally next to the receiving element (10) the receiving opening (16) in the receiving element (10 ) and can then be transferred into a closed position in order to hold back the calculus in the receiving element (10). The invention also relates to methods of manufacturing such a device.

Description

The invention relates to a medical device for removing concretions from hollow organs of the body and to methods for producing such a device.

Systems are known in practice for catching and removing thrombi, ie blood clots in blood vessels, which are designed such that the thrombus is grasped from the distal side and connected to a catcher element of the system. In this distal thrombus attack, the capture element located at a distal tip of a guidewire is passed through a catheter to the treatment site. The catcher member is further advanced with the catheter from proximal to distal through the thrombus. Once the capture element is located distal to the thrombus, the catheter is withdrawn so that the capture element expands, ie radially spans. By a proximal movement of the guide wire, the thrombus can be gripped by the catcher element or connected to the catcher element. Such a device is for example in the WO 2008/088920 A2 disclosed.

For the distal thrombus attack, it is necessary to position the catheter or the distal catheter tip comparatively far behind the thrombus in order to create a space for the release of the catcher element. The catheter is pushed over a comparatively long distance through the thrombus. Since thrombi are often present in vessel bends or in the region of a branching of the vessel, ie a bifurcation, there is a risk that the tip of the catheter or the guide wire will injure distal, in particular curved, vascular sections when advancing the catheter or the guide wire. The widening of the catcher element distal to the thrombus can also lead to injuries to the vessel walls.

Another disadvantage is that the thrombus can indeed be pulled to remove by the catcher element in the proximal direction. However, the thrombus is guided into vessels which have a larger cross-sectional diameter, whereby a blood flow is made possible laterally around the thrombus, which can cause a detachment of Thrombuspartikeln. The thrombus particles may cause a re-occlusion downstream.

As an alternative to devices for distal thrombus attack, systems are known which allow proximal thrombus attack. In this case, the thrombus is grasped on the proximal side in order to be pulled out of the blood vessel by the catcher element. A device with these properties is for example in the US 2006/0058836 A1 described.

In the case of proximal thrombus attack, there is generally the disadvantage that the thrombus is not firmly connected to the capture element during the removal. By friction between the thrombus and the vessel wall, there is a risk that the thrombus or at least parts of the thrombus' detach and thus cause further vascular occlusions in downstream areas. Although the known devices for the proximal Thrombusangriff may have a suction device that continuously generates a negative pressure in the region of the thrombus to remove detached particles from the blood vessel. However, the distal side of the thrombus is unreachable due to the generated negative pressure, so that there detachable particles can move freely in downstream vessels.

The object of the invention is to provide a medical device for removing concretions from hollow organs of the body, which enables a safe and efficient removal of concrements, wherein the risk of particle detachment is reduced. Furthermore, the object of the invention is to provide a method for producing such a device.

According to the invention this object is achieved with regard to the device by the subject-matter of patent claim 1 and with regard to the method by the subject-matter of claims 15, 16 and 17.

The invention is based on the idea of specifying a medical device for removing concretions from hollow organs of the body with a catheter, a guide element arranged longitudinally displaceable in the catheter and a flexible receiving element connected to the guide element. The receiving element is convertible from a compressed state to an expanded state. In the expanded state, the receiving element takes at least partially a rotationally symmetric shape. The receiving element has a flexible wall with at least two free longitudinal edges, which at least partially form a lateral receiving opening at the transition of the receiving element from the compressed state to the expanded state in the longitudinal direction of the receiving element. The receiving opening can be converted into an open position in order to introduce a laterally arranged next to the receiving element concretion through the receiving opening in the receiving element. The receiving element can then be converted into a closed position in order to retain the concretion in the receiving element.

In the open position, the receiving element is adapted to receive a concretion in a receiving space formed within the receiving element. In the open position, the longitudinal edges thus at a distance from each other or form a receiving opening through which the calculus can penetrate into the receiving element. The receiving element may form in the open position at least partially a c-shaped cross-sectional profile.

During the transition of the receiving element from the compressed to the expanded state, in particular during the discharge of the receiving element from the catheter, the receiving opening is formed at least temporarily. The discharge of the receiving element from the catheter may have several temporal phases, wherein in at least one phase of the discharge, the receiving opening is formed. This means that the open position of the receiving opening is present in at least one expansion phase of the receiving element. In a further phase of the expansion, which is the time of the expansion phase, in which the receiving opening assumes the open position, the receiving opening assumes the closed position. The transition between the open position and the closed position of the receiving opening can be carried out fluently in the temporal sequence of the expansion of the receiving element.

Concretely, the expansion of the receiving element may comprise an opening phase of the receiving opening and a closing phase of the receiving opening. The transition between the opening phase and the closing phase of the receiving opening may be fluid. In the opening phase, the receiving opening widens to enclose a concretion or encapsulate or to receive the calculus in the receiving element. In the closing phase, the receiving opening closes, wherein the longitudinal edges in the circumferential direction of the receiving element approach to complete the wrapping or the encapsulation of the concretion, so that the concretion is retained in the receiving element. The distance between the free longitudinal edges to each other, d. H. the width of the receiving opening is preferably greater in the closed position than in the open position or in an opening phase of the receiving opening. At the transition of the opening phase in the closing phase, the receiving opening may have a width which is greater than the width of the receiving opening in the closed position or after completion of the closing phase.

The invention is based on the idea of attacking concretions in body cavities laterally. The device according to the invention has for this purpose the flexible receiving element which can be positioned and expanded in particular laterally of the concrement in order to enclose the concretion in the circumferential direction. The receiving element envelops the calculus in use. In this case, the receiving opening, which is formed by the two free longitudinal edges of the wall, allow access to the receiving space within the receiving element.

The lateral receiving opening allows a particularly gentle removal of the calculus. In particular, it is achieved by the lateral receiving opening that the receiving element when gripping the concretion acts on a comparatively large area, in particular a circumferential area, of the concretion. The forces acting on the concretion from the receiving element are distributed over the comparatively large area. The risk of embolism, d. H. a vessel closure, in particular by peeling off concretion particles, when retracting or removing the concretion is minimized.

Another advantage of the invention is that the positioning of catheters on the side of a concretion forms a routine medical procedure. For example, catheters for distal angiography are positioned on the side of a thrombus during routine procedures. The executive physician is therefore familiar with the handling, so that the device can be used quickly, safely and efficiently.

In a preferred embodiment of the device according to the invention, the flexible wall is folded or rolled in the compressed state of the receiving element about at least one longitudinal axis of the receiving element. In general, it is provided that the receiving element in the expanded state, in particular in the expanded state within a body hollow organ, forms a receiving space for receiving the concretion. In contrast, in the compressed state, the receiving element may be folded, rolled, stretched or the like compressed such that essentially no receiving space is recognizable. In this way it is ensured that the receiving element in the compressed state has a relatively small footprint. In particular, the receiving element in the compressed state preferably has a relatively small cross-sectional diameter. The field of use of the device is broadened as the device is thus suitable for removing concretions from small body cavities, for example cerebral blood vessels.

The guide element can be connected to a proximal end of the receiving element, in particular directly connected. The receiving element may form a distal end of the guide element. This arrangement of Guide element and receiving element allows a particularly simple and easy to handle construction of the medical device. Specifically, this arrangement facilitates the positioning of the receiving element laterally of the concretion as well as the proximal movement of the receiving element for removing the concretion. Preferably, the guide member extends through the catheter beyond the proximal end of the catheter such that a proximal end of the guide member is graspable and operable by a user. The proximal actuation can act directly on the distal end of the guide element, in particular the receiving element.

The term distal refers to more distant from the user components or sections of an element. The term proximal designates closer to the user arranged components or sections of components.

Preferably, the receiving element in the expanded state has a funnel-shaped portion. By the funnel-shaped portion is advantageously achieved that the concretion is secured in the longitudinal direction of the receiving element substantially positive fit. In particular, the funnel-shaped section prevents concretion particles, which detach from a longitudinal end, in particular the proximal or distal end, of the concretion from moving uncontrollably or freely into further regions of the hollow body of the body.

The funnel-shaped portion may be disposed at a distal end of the receiving member. In the removal of concrements, in particular thrombi, from blood vessels, such an arrangement is particularly advantageous since the medical device is preferably guided in the direction of flow to the treatment site. By means of the distally arranged funnel-shaped section, particles of concretion entrained by the blood flow can be arrested or captured. Closure of distal or downstream body organs or vessels is effectively avoided.

The funnel-shaped portion can also be arranged at a proximal end of the receiving element. In this way, the funnel-shaped portion allows a simple retraction of the receiving element into the catheter. In particular, it is achieved by the funnel-shaped section or by the cross-section diameter of the funnel-shaped section at the proximal end of the receiving element that increases from the proximal to the distal direction that the receiving element automatically compresses when retracted into the catheter. A repositioning of the receiving element is thus facilitated. Further, the funnel-shaped portion disposed at the proximal end of the receiving member reduces the risk of injury to hollow body organs when the receiving member is pulled proximally through the body hollow organ, for example, to remove a concretion from the body hollow organ.

It is also possible that the receiving element has both a proximally arranged, and a distally arranged funnel-shaped portion. The funnel-shaped sections can be directly connected to each other. It is also possible that between the funnel-shaped portion further, differently shaped portions of the receiving element are formed, for example, may be arranged between the proximal and the distal end funnel-shaped portion, a cylindrical portion.

The funnel-shaped portion may have a tip connected to a distal end of the guide member. The tip can form during the expansion of the receiving element. In particular, the free longitudinal edges of the flexible wall can be shaped or formed in such a way that the tip forms during the transition of the receiving element from the compressed state to the expanded state. The tip or generally the funnel-shaped portion may be formed at the proximal and / or distal end of the receiving element. The connection of the guide element with the receiving element is particularly advantageous in the region of the tip. In particular, when the tip is arranged at the proximal end of the receiving element, is achieved by the connection of the guide element with the tip, that the receiving element can be easily withdrawn into the catheter. Upon retraction, the interaction of the catheter with the tip of the funnel-shaped portion, the compression of the receiving element can be achieved. When the tip is formed at the distal end of the receiving element, stabilization of the distal end of the guiding element and / or the receiving element can be effected by the connection with the guide element. On the one hand, the guide element as a support element or stiffening element for the flexible receiving element, in particular the flexible wall, act. On the other hand, it is possible that the tip of the funnel-shaped portion at least in the partially expanded state of the receiving element causes a centering of the distal end of the guide element within the hollow body organ. In this way, a violation of the hollow body organ or a vessel wall can be avoided by the distal end of the guide wire. Preferably, the tip is substantially rounded or atraumatic.

In a further preferred embodiment of the medical device according to the invention, the receiving element in the expanded state, a cylindrical portion which is connected to the funnel-shaped portion, in particular directly connected, or integrally formed. The cylindrical portion allows on the one hand a uniform support of the receiving element on a wall of the hollow body organ or a vessel wall. On the other hand, a receiving space for the concretion is provided with the cylindrical portion, wherein the flexible wall of the receiving element in the cylindrical portion can create particularly close to the wall of the hollow body vessel. The efficiency in removing the calculus is thus increased.

The cylindrical portion may form an inclined end edge at an axial end of the receiving element. The oblique end edge can be connected to the guide element. Preferably, the inclined end edge is coupled in a region with the guide element, which forms an axial end point of the receiving element. The oblique end edge can also merge in one piece into the guide element. In general, the guide element can be integrally connected or formed with the receiving element.

The tip of the funnel-shaped portion of the receiving element may be aligned substantially in alignment with the common longitudinal axis of the receiving element. The tip can also be arranged outside the longitudinal axis of the receiving element. For example, the tip with the peripheral plane of the receiving element, in particular with the peripheral plane of the cylindrical portion, are aligned. The funnel-shaped portion may in this case be tapered in extension of the peripheral wall of the cylindrical portion.

The free longitudinal edges can be arranged parallel to each other at least in sections in the expanded state in the longitudinal direction of the receiving element. In this way it is achieved that move the free longitudinal edges in the expansion of the receiving element in a hollow body organ substantially uniformly over the inner circumference of the hollow body organ. The direction of movement of the longitudinal edges is substantially opposite. Due to the parallel alignment of the longitudinal edges is further avoided that the concretion when merging the longitudinal edges, ie when closing the receiving opening, moves in the axial direction or evades, since the parallel longitudinal edges the concretion during expansion simultaneously and uniformly in the circumferential direction and from loosen the vessel wall or wall of the hollow body organ.

It is also possible that the free longitudinal edges are formed spirally. The free longitudinal edges extend spirally along the receiving element. The free longitudinal edges can spiral around the longitudinal axis of the receiving element. Alternatively or additionally, at least one free longitudinal edge may be zigzag-shaped. The prongs formed by the zigzag shape allow for improved fixation of the concretion, especially when the receiving opening is not completely closed during expansion, in particular in the fully expanded state. The receiving opening may be open in the expanded state. The prongs of the two longitudinal edges can be aligned in such a way that the prongs interlock at least partially when closing the receiving opening. The receiving opening preferably forms a forceps-like or claw-like mouth. It is also possible that the prongs are at least partially directed radially inward. The teeth can thus intervene in the calculus.

In general, it is advantageous if the longitudinal edges are aligned at least in sections radially inward. This allows a simple and gentle compression of the receiving element, in particular when the receiving element is retracted into the catheter. The receiving element can be easily and gently repositioned in this way.

Preferably, the free longitudinal edges are arranged in the expanded state of the receiving element, in particular in the closed position of the receiving opening, at least in the region of the cylindrical portion in abutment. In other words, the dimensions of the receiving element, in particular the flexible wall, be adapted so that the free longitudinal edges are arranged in the expanded state in shock. This has the advantage that the receiving element in the implanted state forms a circumferentially completely closed wall, so that the concretion is securely held within the receiving element, in particular in a receiving space formed by the receiving element.

The expanded state can relate both to the resting state, ie the state unaffected by external forces, of the receiving element, and to the implanted state which the receiving element occupies within a body hollow organ. In the fully expanded state, the receiving element or the receiving opening forms the closed position. This applies to all embodiments mentioned in the application.

The free longitudinal edges can in the expanded state of the receiving element, in particular in the closed position of the receiving opening, be arranged overlapping at least in the region of the funnel-shaped portion, in particular to ensure that the funnel-shaped portion is completely closed in the implanted state. The funnel-shaped section can thus act as a catching device or filter device for self-detaching concretion particles.

The free longitudinal edges can limit a gap in the expanded state of the receiving element, in particular in the closed position of the receiving opening. In other words, the receiving element in kraftunbelasteten state, ie at rest or fully expanded state, form a gap-like receiving opening, which is bounded by two spaced-apart, free longitudinal edges. The two longitudinal edges can form a pincer-like gripping element in this configuration. In particular, the longitudinal edges can grip the calculus like a pincers. In the expanded state, there is no overlap of the longitudinal edges, but the gap formed by the receiving opening, so that a gentle removal of concrements can be achieved. In particular, the risk of injury to vessel walls of the hollow body organ is reduced when removing the calculus.

In a preferred embodiment, the wall is at least partially formed like a film. In particular, the wall may have a film produced by thin-film technology. By the foil-like design of the wall a reliable and safe encapsulation of the concretion is achieved. In addition, the film-like design is accompanied by high flexibility of the wall. For example, the wall may be simply folded or rolled to make the compressed state. Further, the film-like wall provides a substantially uniform and smooth surface, so that the wall can easily slide between a vessel wall and the calculus in the transition from the compressed state to the expanded state.

Alternatively or additionally, the wall may comprise a grid structure, in particular a laser-cut or braided grid structure. The grid structure allows a simple and compact compression of the wall or generally of the receiving element. In particular, the lattice structure has a high flexibility in the axial direction, in particular in the expanded state. Advantageously, the grid structure can therefore be used in regions of a hollow body organ, for example a blood vessel, which have a curvature. Due to the increased axial flexibility in the expanded state, the risk of injury to the body hollow organ is minimized when pulling the thrombus, in particular because the lattice structure can easily follow curvatures of the body hollow organ.

Furthermore, the wall can comprise a structuring, in particular a perforation, preferably a pore pattern, so that the receiving element can be stretched longitudinally axially in the compressed state. In general, therefore, it may be provided to structure the surface of the wall in order to allow increased flexibility of the compression or improved crimpability. This can be achieved particularly advantageously by a pore structure or perforation or, in general, a reduction of the material surface of the wall.

In general, the pore structure of the wall may be formed by a lattice structure. Thus, a flexibility in the circumferential direction of the receiving element is provided so that the circumferential width of the receiving element, so the distance between the longitudinal edges along the wall in the circumferential direction of the receiving element is variable. In particular, can be achieved by the lattice or pore structure of the wall, which may be formed generally stent-like, that the circumferential width of the wall increases in the expansion of the receiving element.

The circumferential width of the wall is referred to in the context of this application, the distance of the two free longitudinal edges in the circumferential direction along the wall. The circumferential width corresponds to the width of the wall in a flat-spreading state. The distance between the longitudinal edges over the receiving opening, ie the width of the receiving opening, is referred to in the context of the application, however, as the circumferential distance of the longitudinal edges. The sum of circumferential width of the wall and circumferential distance of the longitudinal edges gives the total circumference of the receiving element.

The circumferential distance of the longitudinal edges may increase in a first expansion phase to form the receiving opening (open position or opening phase). As the expansion progresses, the circumferential distance of the longitudinal edges may decrease. The free longitudinal edges approach each other, whereby the receiving opening is reduced (closed position or closing phase). In both phases of expansion, ie in the opening phase and in the closing phase, the circumferential width of the wall increases.

In a further preferred embodiment of the medical device according to the invention, the receiving element in the compressed state has two longitudinal axes, which extend in the longitudinal direction of the receiving element. The flexible wall preferably forms two windings, the space-saving to each one of Longitudinal axes are rolled. During the transition from the compressed state to the expanded state, the free longitudinal edges can slide along the circumference of the concretion. The expansion is thus facilitated. In particular, the longitudinal edges can be rolled up in the compressed state in such a way that the longitudinal edges are uncovered late during the rolling out or expansion of the wall. This reduces the risk of the longitudinal edges separating particles as they slide along the concretion. Further, by winding the receiving element in two areas, namely in each case about one of the two longitudinal axes, a repositioning of the receiving element facilitates. Specifically, in this way, the receiving element can be easily and gently withdrawn into the catheter.

It is also possible that the receiving element expands both by rolling out or unfolding of the wall, as well as by changing the circumferential width of the wall. For example, the receiving element may comprise a grid structure, which is at least partially wound or rolled in the compressed state about one or two longitudinal axes. During the expansion, on the one hand, a rolling out or unfolding of the lattice structure or, in general, of the wall of the receiving element and, on the other hand, a widening of the wall or the lattice structure in the circumferential direction can take place. The circumferential width of the wall increases. At the same time, the wall or the lattice structure shortens in the longitudinal direction. This effect of changing the circumferential width of a lattice structure is known per se, for example, from the expansion behavior of stents comprising a lattice structure. The underlying effect is called "foreshortening". In this case, the lattice structure shortens in the longitudinal direction during the expansion, wherein at the same time a widening of the circumference of the lattice structure takes place. This is due, among other things, to the fact that the angles of the mutually aligned grid webs of the grid structure change during the expansion. When claimed in the context of the application wall of the receiving element, which is bounded by two free longitudinal edges, the Foreshortening can be advantageously used for encapsulating or enveloping a concretion.

• – Herstellen einer ebenen Wandung zur Bildung des Aufnahmeelements unter Verwendung eines Dünnschichtprozesses, insbesondere eines Abscheideprozesses, vorzugsweise eines Sputterprozesses und/oder eines Ätzprozesses
• – Aufbringen der ebenen Wandung auf einen zumindest abschnittsweise rotationssymmetrischen, insbesondere zumindest teilweise trichterförmigen und/oder zumindest teilweise zylindrischen, Formkörper, wobei wenigstens zwei gegenüber angeordnete Kanten der ebenen Wandung die Längskanten des Aufnahmeelements bilden;
• – Wärmebehandeln der ebenen Wandung derart, dass die Wandung nach Entfernen des Formkörpers in einem kraftentlasteten Zustand im Wesentlichen die Form des Formkörpers beibehält oder selbsttätig einnimmt, wobei die Schließstellung der Aufnahmeöffnung festgelegt wird, in der die Längskanten in Umfangsrichtung benachbart oder auf Stoß oder überlappend angeordnet sind;
• – Verbinden der Wandung mit einem Führungselement; und
• – Anordnen des Aufnahmeelements mit dem Führungselement in dem Katheter.

In accordance with a secondary aspect, the invention is based on the idea of specifying a method for producing the above-described medical device, which comprises the following steps:

• - Producing a flat wall to form the receiving element using a thin-film process, in particular a deposition process, preferably a sputtering process and / or an etching process
• - Applying the flat wall to an at least partially rotationally symmetrical, in particular at least partially funnel-shaped and / or at least partially cylindrical, shaped body, wherein at least two oppositely disposed edges of the flat wall forming the longitudinal edges of the receiving element;
• Heat treating the flat wall so that the wall after removal of the shaped body in a force-relieved state substantially maintains or automatically assumes the shape of the shaped body, wherein the closed position of the receiving opening is determined in which the longitudinal edges in the circumferential direction adjacent or arranged in shock or overlapping are;
• - Connecting the wall with a guide element; and
• - Arranging the receiving element with the guide element in the catheter.

• – Bereitstellen eines Flechtdorns, der entlang seiner Längsachse auf dem Außenumfang in Reihe angeordnete Umlenkstifte aufweist;
• – Flechten eines im Wesentlichen zylinderförmigen Gittergeflechts aus Einzeldrähten auf dem Flechtdorn zur Bildung der Wandung des Aufnahmeelements in der Schließstellung der Aufnahmeöffnung, in der die Längskanten in Umfangsrichtung benachbart oder auf Stoß oder überlappend angeordnet sind, wobei jeweils ein Einzeldraht hauptsächlich in Umfangsrichtung um den Flechtdorn geführt und zur Bildung von Schlaufen um jeweils einen der Umlenkstifte gewunden wird, um die Wicklungsrichtung in Umfangsrichtung zu ändern, wobei jeweils eine Reihe von Schlaufen eine der Längskanten des Aufnahmeelements bildet;
• – Verbinden des Gittergeflechts mit einem Führungselement; und Anordnen des Aufnahmeelements mit dem Führungselement in dem Katheter.

A further, subsidiary aspect of the invention provides a method for producing the above-described medical device, comprising the following steps:

• - Providing a braiding mandrel having along its longitudinal axis on the outer circumference arranged in series deflection pins;
• Braiding a substantially cylindrical grid mesh of individual wires on the braiding mandrel to form the wall of the receiving element in the closed position of the receiving opening, in which the longitudinal edges adjacent circumferentially or abutting or overlapping, wherein each a single wire guided mainly in the circumferential direction around the braiding mandrel and winding loops around each one of the turning pins to circumferentially change the winding direction, wherein each one row of loops forms one of the longitudinal edges of the receiving member;
• - Connecting the grid mesh with a guide element; and arranging the receiving element with the guide element in the catheter.

• – Bereitstellen einer ebenen Matrize, die in Längsrichtung zwei parallel angeordnete Reihen von Umlenkstiften aufweist;
• – Flechten eines im Wesentlichen ebenen Gittergeflechts aus Einzeldrähten auf der ebenen Matrize zur Bildung der Wandung des Aufnahmeelements, wobei jeweils ein Einzeldraht zur Bildung von Schlaufen abwechselnd um jeweils einen Umlenkstift jeder Reihe gewunden wird, wobei jeweils eine Reihe von Schlaufen eine der Längskanten des Aufnahmeelements bildet;
• – Verbinden des Gittergeflechts mit einem Führungselement;
• – Rollen oder Wickeln des ebenen Gittergeflechts um eine gemeinsame Längsachse zur Bildung einer im Wesentlichen rotationssymmetrischen Form, die die Schließstellung der Aufnahmeöffnung festlegt, in der die Längskanten in Umfangsrichtung benachbart oder auf Stoß oder überlappend angeordnet sind; und
• – Anordnen des Aufnahmeelements mit dem Führungselement in dem Katheter.

Another alternative method of manufacturing the medical device described above forms a further, ancillary aspect of the invention. The method comprises the following steps:

• - Providing a flat die, which has two parallel rows of guide pins in the longitudinal direction;
• Braiding a substantially flat mesh braid of individual wires on the planar die to form the wall of the receiving element, wherein a single wire is wound alternately to form loops around each deflection pin of each row, wherein each of a series of loops forms one of the longitudinal edges of the receiving element ;
• - Connecting the grid mesh with a guide element;
• - rolling or wrapping the planar mesh braid about a common longitudinal axis to form a substantially rotationally symmetrical shape defining the closed position of the receiving opening in which the longitudinal edges are circumferentially adjacent or abutting or overlapping; and
• - Arranging the receiving element with the guide element in the catheter.

The individual process steps can be varied in chronological order. This applies to all disclosed and claimed methods. For example, in the manufacturing process in which a flat mesh is first braided on a flat matrix, it is possible to first convert the planar mesh into a rotationally symmetric shape and then connect the mesh to the leader, or vice versa. In general, mesh braids and / or walls produced by thin-film technology can be subjected to a heat treatment which has a shaping effect.

The invention is explained in more detail below on the basis of exemplary embodiments with reference to the attached schematic drawings. Show in it

1 a receiving element of the device according to the invention in the expanded state according to a preferred embodiment;

2 a receiving element of the device according to the invention in the expanded state according to a further preferred embodiment;

3 a receiving element of the device according to the invention in the expanded state according to a further preferred embodiment;

4 a development of a grid structure for a receiving element of the device according to the invention according to a preferred embodiment;

5 a development of a receiving element of the device according to the invention according to a preferred embodiment;

6 a development of a grid mesh for a wall of a receiving element of the device according to the invention according to a preferred embodiment;

7 a development of a grid mesh for a wall of a receiving element of the device according to the invention according to a further preferred embodiment;

8a to 8e a front view of the device according to the invention according to a preferred embodiment when transferring the compressed state in the expanded state in a hollow body member with a concretion;

9 a front view of the device according to the invention according to a preferred embodiment in the expanded state in a hollow body member with a concretion;

10 a front view and a corresponding side view of the medical device according to the invention according to a preferred embodiment when positioning the side of a concretion in a hollow body organ; and

11 a front view and a corresponding side view of the medical device according to the invention according to a preferred embodiment in the expanded state, in particular when embracing a concretion, in a hollow body organ.

In 1 is a pickup element 10 represented the medical device in the expanded state. The receiving element 10 has a flexible wall 11 on, extending around a common longitudinal axis of the receiving element 10 bulges. The receiving element 10 is formed substantially rotationally symmetrical. In particular, the receiving element 10 a cylindrical section 12 on, which forms a substantially rotationally symmetrical shape. As part of the registration, it is not necessary that the cylindrical section 12 forms a strictly rotationally symmetrical shape. It is sufficient if a curvature about the longitudinal axis of the receiving element 10 is recognizable. In this respect, the cylindrical section 12 have an at least partially oval shape or generally flattened areas. In general, the receiving element forms 10 or the wall 11 of the receiving element 10 in use, the shape of the inner circumference of a body hollow organ, for example a blood vessel, to be treated. The wall can therefore in the expanded state or in use irregularities, especially bumps have. Such deformities do not affect the definition according to the application of the rotationally symmetrical shape.

It is also possible that the receiving element 10 no cylindrical section or cylindrical section 12 having. The receiving element 10 can, for example, a to form a double conical shape. In particular, the receiving element 10 two funnel-shaped sections 13 include, which are directly connected. Here are in the expanded state of the receiving element 10 the bases of the funnel-shaped sections 13 interconnected so that the receiving element 10 each at a distal, as well as at a proximal end in each case a tip 15 having. The receiving element 10 may generally comprise a rectilinear rotational axis. Alternatively, the axis of rotation, that of the rotationally symmetrical shape of the receiving element 10 is based, not even rectilinear, in particular curved, preferably spiral, be formed.

The receiving element 10 can be spirally wound overall. The spiral shape of the receiving element 10 For example, it may be of the type as disclosed in the copending, post-published application German Patent Application No. 10 2009 052 002 described.

The receiving element 10 according to 1 also has a funnel-shaped section 13 on. The funnel-shaped section 13 is with the cylindrical section 12 directly connected. In particular, the funnel-shaped section 13 with the cylindrical section 12 formed in one piece. The funnel-shaped section 13 makes a tip 15 that the receiving element 10 limited in the axial direction. Preferably, the tip 15 at a distal end of the receiving element 10 arranged.

The summit 15 can also be a proximal end of the receiving element 10 form. The summit 15 is aligned with the peripheral plane of the cylindrical portion 12 aligned. In other words, the wall is 11 of the cylindrical portion 12 in the circumferential plane partially to the top 15 extended.

The wall 11 or generally the receiving element 10 also has two free longitudinal edges 14a . 14b on. The long edges 14a . 14b extend over the entire length of the receiving element 10 , In particular, the longitudinal edges extend 14a . 14b over the cylindrical section 12 , where the longitudinal edges 14a . 14b spaced apart in the expanded state. The long edges 14a . 14b limit a receiving opening 16 in the expanded state according to 1 over the entire length of the receiving element 10 is open. The receiving opening 16 forms an access to a reception room 18 passing through the wall 11 is limited in the circumferential direction. Overall, in the receiving element 10 in the expanded state, a recording room 18 formed, which is provided for receiving a concretion.

It is also possible that the longitudinal edges 14a . 14b about a part, in particular a portion, of the receiving element 10 extend. The long edges 14a . 14b can converge towards each other or converge. The long edges 14a . 14b can touch or form an intersection or junction. For example, the longitudinal edges 14a . 14b a gap 19 limit, at least partially, along the cylindrical portion 12 extends. The funnel-shaped section 13 can be a completely closed wall 11 exhibit.

The long edges 14a . 14b can at an axial end of the receiving element 10 in a final edge 17 pass. The closing edge 17 For example, the cylindrical section 12 axially limit, as in 1 shown. The junction or the transition between the longitudinal edges 14a . 14b and the trailing edge 17 can be rounded. The closing edge 17 can be in a vertical plane to the longitudinal axis of the receiving element 10 be arranged. It is different possible that the end edge 17 in a plane which extends obliquely to the longitudinal axis of the receiving element 17 is arranged. The plane of the trailing edge 17 may also have a curvature. In other words, the trailing edge 17 obliquely relative to the longitudinal axis of the receiving element 10 be arranged. The angle of inclination is arbitrarily adjustable, for example via a variation of the braiding angle of the wall 11 forming grid mesh 50 , The closing edge 17 limits a planar opening of the axial end of the receiving element 10 , It is also possible that the trailing edge 17 has a curved contour, in particular a concave or convex curved contour. This applies to all embodiments described in the application.

In the embodiment according to 1 are the long edges 14a . 14b arranged in the expanded state substantially parallel to each other and limit over the entire length of the receiving element 10 the open receiving opening 16 or the gap 19 , The long edges 14a . 14b or the receiving opening 16 , especially the gap 19 , can also spiral around the longitudinal axis of the receiving element 10 squirm. In general, the receiving opening 16 , especially the gap 19 , form different longitudinal contours. For example, the receiving opening 16 transverse to the longitudinal axis of the receiving element 10 run and / or have a zigzag or wavy longitudinal contour. The receiving opening 16 or the gap 19 may have a different course, that is not rectilinear and parallel to the longitudinal axis of the receiving element 10 be aligned.

Generally, the distance between the longitudinal edges 14a . 14b along the receiving element 10 vary in the expanded state. The through the longitudinal edges 14a . 14b limited intake opening 16 may extend over a part or a portion of the receiving element 10 extend. The receiving opening 16 can parallel to the longitudinal axis of the receiving element 10 or spirally about the longitudinal axis of the receiving element 10 be arranged. The receiving opening 16 is preferably in the cylindrical section 12 of the receiving element 10 arranged.

The long edges 14a . 14b can be aligned or arranged so that the wall 11 at least in sections along the receiving element 10 overlapped in the expanded state. Such a configuration is in 2 shown.

The receiving element 10 according to 2 is essentially analogous to the receiving element 10 according to 1 built with the difference that the wall 11 in the area of the funnel-shaped section 13 overlapped in the expanded state. The wall 11 points in the area of the funnel-shaped section 13 an overlap section 18 on, in the expanded state one of the two longitudinal edges 14a . 14b overlaps. Concretely, the receiving element comprises 10 or the wall 11 a first longitudinal edge 14a and a second longitudinal edge 14b , wherein the second longitudinal edge 14b in the area of the funnel-shaped section 13 the first longitudinal edge 14a overlaps. In the transition area between the cylindrical section 12 and the funnel-shaped section 13 the long edges intersect 14a . 14b , The second longitudinal edge 14b runs above the first longitudinal edge 14a , The second longitudinal edge 14b is thus in the expanded state on the wall 11 on. In this way, a closed funnel-shaped section 13 educated. In other words, the receiving opening 16 in the funnel-shaped section 13 in the expanded state of the receiving element 10 closed. The recording room 18 is through the funnel-shaped section 13 axially limited, in particular closed.

In the area of the cylindrical section 12 are the long edges 14a . 14b spaced apart from each other and form the open receiving opening 16 , The receiving opening 16 is here as a gap 19 shaped in the circumferential direction of the receiving element 10 through the longitudinal edges 14a . 14b and in the axial direction through the intersection of the longitudinal edges 14a . 14b is limited. To the end edge 17 there is the 19 open.

The receiving opening 16 can also be completely closed in the expanded state. In particular, the receiving opening 16 in the expanded state over the entire length of the receiving element 10 be closed as in 3 shown. The long edges 14a . 14b are in this case preferably arranged on impact or touch each other. The one through the expanded wall 11 formed reception room 18 is completely closed in the circumferential direction. In the axial direction is the receiving space 18 through the closed funnel-shaped section 13 limited. Overall, the receiving element 10 according to 1 to 3 in the expanded state a quiver-like shape.

For all embodiments, that the receiving element 10 with a guide element 20 connected or connectable. In particular, the guide element 20 with the receiving element 10 be welded or glued. The guide element 20 can be designed as a guide wire. Preferably, the guide element 20 longitudinally displaceable in a catheter 30 arranged. The guide element 20 can with an axial end of the receiving element 10 be connected. Preferably, the guide element 20 with a proximal end of the receiving element 10 connected. Generally, the guide element 20 with the funnel-shaped section 13 , especially the top 15 , and / or the cylindrical portion 12 of the receiving element 10 be connected. The receiving element 10 may have an orientation in which the funnel-shaped portion 13 the distal end and the cylindrical portion 12 the proximal end of the receiving element 10 forms, wherein the guide element 20 connected to the proximal end. It is preferred if the guide element 20 through the receiving element 10 extends and with the distal end, in particular the tip 15 , connected is. The guide element 20 can at least along the receiving element 10 a part of the wall 11 form. This applies to all embodiments described in the application.

In general, the medical device, in particular the receiving element 10 be made by a thin film technique. Preferably, the receiving element comprises 10 a film or sheet-like structure made by a thin film technique, for example, a sputtering method and / or an etching method. In this case, a thin film can be produced in a planar shape and then heat-treated on a cylindrical, funnel-shaped or generally round shaped body. The film can be made directly in a cylindrical shape. The film can be deposited, for example, directly on the molding. Alternatively, the receiving element 10 from a pipe, in particular a sputtered pipe. The foil or the wall formed by the film 11 may be closed or openings, such as pores, mesh or cells 41 , exhibit. The structuring, in particular the production of the openings, can be carried out by laser cutting or by etching. The film preferably has a layer thickness which is at most 30 μm, in particular at most 25 μm, in particular at most 20 μm, in particular at most 15 μm, in particular at most 10 μm, in particular at most 8 μm, in particular at most 5 μm.

The receiving element 10 can be a stent-like lattice structure 40 include. The grid structure 40 can mesh or cells 41 exhibit. The meshes or cells 51 may be diamond-shaped. A suitable grid structure 40 is exemplary in 4 shown.

4 shows a grid structure for a receiving element 10 in a unfolded state. That means the wall 11 of the receiving element 10 is shown laid out in one plane. The grid structure 40 has webs 42 on that the cells 41 the lattice structure 40 limit. The grid structure 40 or through the grid structure 40 formed wall 11 has a first longitudinal edge 14a and a second longitudinal edge 14b on. The long edges 14a . 14b each comprise a first edge region 14c and a second edge region 14d , The first two edge areas 14c the two longitudinal edges 14a . 14b form a V-shaped boundary for the funnel-shaped section 13 of the receiving element 10 , The first edge areas 14c are by footbridges 42 formed, which have the same orientation direction, so that the first edge portions 14c make a smooth edge overall. The two second edge areas 14d limit the cylindrical section 12 of the receiving element 10 in the circumferential direction and are substantially parallel to each other. The second edge areas 14d are by footbridges 42 the lattice structure 40 formed, which have alternately or alternately a different orientation direction. The second edge areas 14d thus form a serrated, especially zigzag-shaped edge.

In the transition from the compressed state to the expanded state, or vice versa, deforms the stent-like lattice structure 40 , In particular, the cells deform when the state changes 41 the lattice structure 40 , The angle between two intersecting or interconnected webs 42 it changes. In this way it is possible that the receiving element 10 in the funnel-shaped section 13 rolls up or rolls up when compressing, without the wall 11 overlaps or curls. Specifically, the width or circumferential extent of the wall 11 variable and can therefore at the change of state of the receiving element 10 be converted from a substantially cylindrical or other form into a funnel shape. This can, for example, by a suitable, partially different choice of the angle between the webs 42 be achieved. The wall 11 or generally the receiving element 10 can be made in a flat shape and then compressed without affecting the wall 10 rolls or curls. The grid structure 40 can also be rolled, wrapped or folded in the compressed state, so that during the expansion of a combination of rolling or unwrapping or unfolding and change, in particular increase, the circumferential width of the wall 11 results. By a suitable adjustment of the geometry of the cells 41 It is possible already during the production of a flat wall 11 the deformation of the cells 41 in the formation of the funnel-shaped section 13 , in particular during winding or rolling, to be considered. It is possible, for example, to adjust the cell geometry such that the wall 11 in the area of the funnel-shaped section 13 does not overlap, but the longitudinal edges 14a . 14b , in particular the first edge regions 14c , are arranged on impact or touch each other.

The receiving element 10 or the wall 11 can be in the form of a wound single wire 51 be prepared as in 5 shown. Here is the single wire 51 meandering in one plane. The sweeping or loops 52 the meandering turns are in the longitudinal direction of the receiving element 10 arranged in alignment with each other and form the longitudinal edges 14a . 14b , Instead of the wound single wire 51 can the wall 11 also be made by laser cutting or etching of a film or a tube.

In general, the wall can 11 a grid 50 include. The grid can be braided on a shaped body, in particular a braiding mandrel, wherein the individual wires 51 less than 360 ° about the longitudinal axis of the receiving element 10 be wrapped. The braiding mandrel has deflecting pins which are arranged in two rows along the longitudinal axis of the braiding mandrel. The single wires 51 are deflected at the deflecting pins, so that loops 52 or make sweeping. In this way, a cylindrical, funnel-shaped or generally rotationally symmetrical braid is formed, which is open in the circumferential direction or two free longitudinal edges 14a . 14b has, for example, in 6 shown. The braiding mandrel can also have one or more funnel-shaped regions, such that the funnel-shaped section 13 through a grid 50 can be formed. At the grid mesh 50 according to 6 is also provided, the wire ends of the individual wires 51 merge at the axial ends and with a Connecting element, in particular a sleeve 53 , to fix.

Generally, the grid can be 50 be formed such that the receiving element 10 has a substantially planar shape in the compressed state. That means the long edges 14a . 14b may be arranged substantially in a plane in the compressed state, wherein the wall 11 flat or stretched. Through the grid mesh 50 can the wall 11 stretch when compressing, so lengthen in the longitudinal direction. In the stretched or compressed state, the wall can 11 essentially a flat band comprising the grid mesh 50 form. During expansion, the mesh braid shortens 50 the wall 11 or in general of the receiving element 10 , whereas the width of the lattice mesh 50 increases. In this case, the grid can be 50 at the same time about the longitudinal axis of the receiving element 10 roll or wrap.

It is also possible that the grid mesh 50 in the catheter 30 both wound and stretched. The grid 50 can therefore be rolled in the compressed state, wherein the grid mesh 50 or the receiving element 10 is extended in the axial direction compared to the expanded state. In the expansion of the receiving element 10 or the mesh braid 50 it comes to the shortening (Foreshortening). Incidentally, this also applies to lattice structures 40 produced by laser cutting or other manufacturing methods from a tubular raw material. The behavior of the expansion of the lattice mesh 50 is mainly through the loops 52 determines the longitudinal edges 14a . 14b form. When the receiving element 10 is stretched (compression), takes the loop angle or the radius of curvature of the loops 52 to. During expansion, the loop angle or the radius of curvature of the loops is reduced 52 , Here is the restoring force of the loops 52 effective, so that the expansion essentially takes place automatically.

A particularly suitable variant of a receiving element 10 with a grid 50 is in 7 shown. The grid 50 forms the wall 11 of the receiving element 10 with two free longitudinal edges 14a . 14b , The free longitudinal edges 14a . 14b may be in the expanded state touching, overlapping or spaced from each other, as in connection with the 1 to 3 explained. The grid 50 has a plurality of individual wires 51 on, the mesh or cells 41 limit. At the axial ends of the receiving element 10 forms the grid 50 one final stitch each 55 , One of the final stitches 55 , preferably at the proximal end of the receiving element 10 arranged final mesh 55 , is with the guide element 20 connected. The guide element 20 can at least partially by twisted strands 51 of the lattice braid 50 be formed. The individual wires are partly to strands 54 twisted, extending through the grid 50 pull. At the axial ends become the strands 54 isolated and the single wires 51 in a smooth final edge 17 or first edge areas 14c the longitudinal edges 14a . 14b transferred.

The strands 54 whose compared to the isolated individual wires 51 an increased deformation force in the transition from the expanded state to the compressed state. Through the strands 54 Thus, an increased restoring force for the grid mesh 50 achieved, which has a positive effect on the expansion behavior of the receiving element 10 effect. It is also possible that the grid mesh 50 individual wires 51 having different wire thicknesses, wherein comparatively thicker or stronger individual wires 50 significantly the expansion force of the receiving element 10 influence. This applies to all embodiments mentioned in the application, which is a grid mesh 50 include.

In the 7 shown wicker configuration is in the post-published German Patent Application No. 10 2009 056 450 described in detail, which dates back to the applicant. The content of patent application no. 10 2009 056 450 is incorporated by reference in its entirety into the present application.

An alternative, suitable braiding configuration is post-published in the same to the Applicant German Patent Application No. 10 2010 006 962 whose contents are also fully incorporated in the present application. The weave configuration disclosed therein is characterized in that when expanding the grid structure not only an increase in the circumferential width of the wall is achieved, but at the same time a rotation of the grid structure 40 or the wall 11 around a common longitudinal axis is achieved. This rotation can be advantageously used in the present medical device for peeling off a concretion from the vessel wall of a hollow body organ.

In the 8a to 8e the operation of the medical device is shown. In particular, in the 8a to 8e the transition of the receiving element 10 from the compressed state to the expanded state when using the medical device for removing a concretion, in particular a thrombus 61 , from a body cavity, in particular a blood vessel 60 , shown.

As in 8a to recognize, has the receiving element 10 according to this embodiment, a wall 11 on, which is wound in the compressed state about two longitudinal axes. The wall 11 includes two longitudinal edges 14a . 14b , each inside a through the wall 11 formed roll or winding are arranged. In other words, the wall is 11 each starting from a longitudinal edge 14a . 14b snail-like wrapped. The compressed receiving element 10 is in the catheter 30 arranged longitudinally displaceable. The catheter 30 is laterally next to a calculus 61 guided or positioned. In particular, the catheter 30 with the receiving element 10 between the vessel wall 62 of the blood vessel 60 and the calculus 61 positioned.

To the expansion of the receiving element 10 In a next step, the catheter is allowed to admit 30 pulled in the proximal direction, wherein the receiving element 10 , preferably by corresponding actuation of the guide element 20 , is held stationary. Alternatively, the catheter can also be used 30 held stationary and the receiving element 10 be pushed in the distal direction. The spiral-like rollers or windings of the wall 11 unfold during the expansion. The expansion preferably takes place automatically. As in the 8b to 8d good to see, the wall slides 11 between the vessel wall 62 and the calculus 61 , The wall 11 rolls along the vessel wall 62 out. At the same time the wall forms 11 the recording room 18 out. The recording room 18 becomes during the expansion of the receiving element 10 shaped. At the same time, the longitudinal edges form 14a . 14b the receiving opening 16 that the thrombus 61 mouth-like in the receiving space 18 receives.

Overall, the expansion process, as in the 8b to 8d shown, divided into different phases. In a first unfolding phase, the areas of the wall wound around a longitudinal axis in each case roll 11 out, with the wall 11 glides on each other. This means that touch in the first deployment phase, the two spiral windings or worm-like rollers. The worm-like rollers rotate in opposite directions in the unfolding phase, with the contacting wall sections of the worm-like rollers rolling on one another or sliding on one another. The unfolding phase is essentially in 8b shown, for reasons of clarity between the two helical rollers, a distance is shown. In practice, the distance between the helical rollers, which also forms part of the receiving opening 16 may be at a later stage of expansion of the receiving element 10 ,

In a second sliding phase of the expansion of the receiving element 10 slide the helical rollers or generally slides the wall 11 along the thrombus 61 , In particular, the wall slides 11 or the snail-like roles in an area between the thrombus 61 and the vessel wall 62 , In this way, a bed or a support for the calculus forms 61 , as in 8c shown. The sliding phase can on the one hand by self-expanding properties of the wall 11 or in general of the receiving element 10 be effective. Alternatively or additionally, the calculus or the thrombus 61 the widening of the wall 11 cause or support the sliding phase. The sliding phase preferably lasts until the longitudinal edges 14a . 14b emerge from inside the snail-like rollers, as in 8d shown.

8d shows the transition state between the sliding phase and a third opening phase of the expansion of the receiving element 10 , In the opening phase, the receiving opening forms 16 made up essentially by the longitudinal edges 14a . 14b is formed. The receiving element 10 forms in the opening phase or in the open position substantially a c-shaped cross-sectional contour. Furthermore, in the opening phase, the bed for the concrement or thrombus originally formed in the sliding phase is formed 61 a recording room 18 ,

Subsequent to the opening phase in which the receiving opening is in the open position, the expansion of the receiving element occurs 10 in a fourth closing phase. In the closing phase, the longitudinal edges approach 14a . 14b each other to the calculus or the thrombus 61 encapsulate or envelop. The receiving opening 16 it shrinks. Towards the end of the closing phase takes the receiving opening 16 the closed position, as in 8e shown. The long edges 14a . 14b are in the closed position, so after complete expansion, in the circumferential plane of the wall 11 arranged. Between the long edges 14a . 14b there is a gap. In the present embodiment, the receiving element 10 in the expanded state so an open receiving opening 16 or a gap 19 on. In the expanded state, the receiving element wrapped 10 the calculus or the thrombus 61 ,

In general, the expansion of the receiving element 10 with a progressive change of the receiving opening 16 accompanied. That means the long edges 14a . 14b progressively from each other or can approach each other. The widening of the receiving opening 16 in the opening phase or the closure of the receiving opening 16 in the closing phase can thus in the longitudinal direction of the receiving element 10 time-shifted respectively. The receiving opening 16 can in the longitudinal direction of the receiving element 10 also be made in sections with different degrees of opening or closing.

In 9 is another embodiment of the receiving element 10 shown, wherein the receiving element 10 a wall 11 that in the compressed state in the catheter 30 is collapsible. The wall 11 can be folded accordion-like or star-shaped in the compressed state. During expansion, the wall unfolds 11 and envelops the thrombus 61 ,

The folded or wavy structure of the wall 11 can be made for example by a heat treatment, wherein the wall 11 applied to a shaped body with appropriate structuring and then subjected to the heat treatment. The wall 11 can also have a corrugated shape in the fully unwound or expanded state. The receiving element 10 In this way it can be particularly good at the thrombus 61 or generally anchored to a calculus. The on the wall 11 embossed structuring may also include a spiral shape, depressions, dents or the like unevenness.

The cladding of the thrombus 61 through the receiving element 10 is good the 10 and 11 to recognize. 10 shows a front view of the receiving element 10 in the catheter 30 , where the wall 11 of the receiving element 10 in contrast to the embodiment according to 8a rolled around a single longitudinal axis. The wall 11 does not overlap in the compressed state. In the embodiment according to 10 and 11 is the wall 11 through a grid 50 or a grid structure 40 educated. As a result, the receiving element stretches 10 in the compressed state, as shown in the side view 10 to recognize. During expansion, the wall slides 11 along the vessel wall 62 where the width of the wall 11 or the receiving element 10 increases. At the same time the receiving element shortens 10 ,

The wall 11 may generally comprise a plastic, in particular polyurethane, polytetrafluoroethylene or silicone. In particular, the provided with a structuring wall 11 , preferably the lattice structure 40 or the grid mesh 50 to include a plastic cover. The cover can be the pores, cells or mesh of the wall 11 completely or at least partially cover. Furthermore, the receiving element 10 Have marker elements. The marker elements may comprise a radiopaque material. Preferably, the marker elements are at least at the axial ends of the receiving element 10 arranged. By the marker elements, the positioning of the receiving element 10 relieved laterally of a concretion.

The cross-sectional diameter of the receiving element 10 can at rest, ie in the fully expanded, kraftunbelasteten state, the diameter of the body cavity to be treated or blood vessel 60 correspond. It is also possible that the receiving element 10 has a smaller cross-sectional diameter than the body cavity to be treated to exert a higher pressure on the calculus. Alternatively, the cross-sectional diameter of the receiving element 10 greater than the cross-sectional diameter of the body cavity to be treated, so that improved adhesion to the vessel wall of the body cavity is achieved.

The receiving opening 16 can be closed at rest. In particular, the longitudinal edges 14a . 14b be arranged in the resting state at impact or overlapping or spaced from each other. The overlapping arrangement at rest has the advantage that in use the concretion is completely enveloped. In the spaced arrangement of the longitudinal edges 14a . 14b at rest results in a smaller width of the developed wall 11 so that the receiving element 10 in a comparatively small catheter 30 is insertable.

The receiving opening 16 or the gap 19 may in the closed position at least partially have a width which is at most 50%, in particular at most 40%, in particular at most 30%, in particular at most 20%, in particular at most 15%, in particular at most 10%, in particular at most 5%, of the circumference of the receiving element 10 equivalent. The width of the receiving opening 16 refers to the distance between the free longitudinal edges 14a . 14b to each other and is used as the circumferential distance of the free longitudinal edges 14a . 14b designated. The width of the receiving opening 16 in the circumferential direction of the receiving element 10 So corresponds to the circumferential distance of the free longitudinal edges 14a . 14b , The length of the connecting path of the longitudinal edges 14a . 14b to each other along the wall 11 is, however, in the context of the application as the circumferential width of the wall 11 designated. The circumferential width of the wall 11 corresponds to the distance between the longitudinal edges 14a . 14b if the wall 11 is arranged in a flat surface.

Alternatively, the circumferential distance of the longitudinal edges 14a . 14b to each other, so the width of the receiving opening 16 or the gap 19 in the closed position, at least in sections at least 5%, in particular at least 10%, in particular at least 15%, in particular at least 20%, in particular at least 30%, in particular at least 40%, in particular at least 50%, of the circumference of the receiving element 10 correspond. This ensures that the free longitudinal edges 14a . 14b do not overlap in the closed position. This is particularly advantageous when using the device in small hollow organs of the body, for example cerebral blood vessels. Rather, the free longitudinal edges have 14a . 14b in the closed position a safety distance from each other.

Overall, the receiving element forms 10 with the free longitudinal edges 14a . 14b an open structure. When the receiving element 10 a grid 50 In the expansion, not just a twist of the individual wires is involved 51 , but also a deformation of the loops 52 or sweeping causes, whereby an increased restoring force of the grid mesh 50 is reached.

It is possible that the receiving element 10 Marker elements, in particular the recognizability of the receiving element 10 under X-ray control. The marker elements therefore preferably have a radiopaque material. The marker elements can advantageously be in the region or on the longitudinal edges 14a . 14b the wall 11 be positioned. It is also possible to use the marker elements in the area of the wall 11 to arrange, in the expanded state of the receiving element 10 the longitudinal edges 14a . 14b is arranged opposite. There may be provided a plurality of marker elements that extend beyond the circumference of the receiving element 10 are arranged distributed. In particular, marker elements in the region of the longitudinal edges 14a . 14b and in an opposite wall area of the wall 11 be arranged. By the marker elements both the position, and the expansion process of the receiving element 10 be controlled easily and safely.

LIST OF REFERENCE NUMBERS

10

receiving element

11

wall

12

cylindrical section

13

funnel-shaped section

14a

first longitudinal edge

14b

second longitudinal edge

14c

first edge area

14b

second edge area

15

top

16

receiving opening

17

terminal edge

18

accommodation space

19

gap

20

guide element

30

catheter

40

lattice structure

41

cell

42

web

50

wickerwork

51

single wire

52

loop

53

shell

54

strand

55

end loop

60

blood vessel

61

thrombus

62

vessel wall

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2008/088920 A2 [0002]
• US 2006/0058836 A1 [0005]
• DE 102009052002 [0060]
• DE 102009056450 [0083]
• DE 102010006962 [0084]

Claims (17)

Medical device for removing concretions from hollow organs of the body with a catheter ( 30 ), one in the catheter ( 30 ) longitudinally displaceably arranged guide element ( 20 ) and one with the guide element ( 20 ), flexible receiving element ( 10 ), which can be converted from a compressed state into an expanded state and at least partially assumes a rotationally symmetrical shape in the expanded state, wherein the receiving element ( 10 ) a flexible wall ( 11 ) with at least two free longitudinal edges ( 14a . 14b ), which at the transition of the receiving element ( 10 ) from the compressed state to the expanded state in the longitudinal direction of the receiving element ( 10 ) at least in sections a lateral receiving opening ( 16 ), wherein the receiving opening ( 10 ) is convertible into an open position, to a laterally adjacent to the receiving element ( 10 ) arranged concretion through the receiving opening ( 16 ) in the receiving element ( 10 ), and then into a closed position can be transferred to the concretion in the receiving element ( 10 ) withhold. Medical device according to claim 1, characterized in that the flexible wall ( 11 ) in the compressed state of the receiving element ( 10 ) about at least one longitudinal axis of the receiving element ( 10 ) folded or rolled. Medical device according to claim 1 or 2, characterized in that the guide element ( 20 ) with a proximal end of the receiving element ( 10 ), in particular directly connected, is. Medical device according to at least one of claims 1 to 3, characterized in that the receiving element ( 10 ) in the expanded state a funnel-shaped section ( 13 ) having. Medical device according to claim 4, characterized in that the funnel-shaped portion ( 13 ) a peak ( 15 ) having a distal end of the guide element ( 20 ) connected is. Medical device according to at least one of claims 4 or 5, characterized in that the receiving element ( 10 ) in the expanded state a cylindrical portion ( 12 ), which is connected to the funnel-shaped section ( 13 ), in particular directly connected, or is formed in one piece. Medical device according to at least one of claims 1 to 6, characterized in that the free longitudinal edges ( 14a . 14b ) in the expanded state in the longitudinal direction of the receiving element ( 10 ) are arranged parallel to each other at least in sections. Medical device according to at least one of claims 6 or 7, characterized in that the free longitudinal edges ( 14a . 14b ) in the expanded state of the receiving element ( 10 ), in particular in the closed position of the receiving opening ( 16 ), at least in the region of the cylindrical portion ( 12 ) are arranged on impact. Medical device according to at least one of claims 4 to 8, characterized in that the free longitudinal edges ( 14a . 14b ) in the expanded state of the receiving element ( 10 ), in particular in the closed position of the receiving opening ( 16 ), at least in the area of the funnel-shaped section ( 13 ) are arranged overlapping. Medical device according to at least one of claims 4 to 9, characterized in that the free longitudinal edges ( 14a . 14b ) in the expanded state of the receiving element ( 10 ), in particular in the closed position of the receiving opening ( 16 ), a gap ( 19 ) limit. Medical device according to at least one of claims 1 to 10, characterized in that the wall ( 11 ) is at least partially formed like a film, in particular sputtered and / or etched, is. Medical device according to at least one of claims 1 to 11, characterized in that the wall ( 11 ) a lattice structure ( 40 ), in particular a laser-cut lattice structure ( 40 ) or a grid mesh ( 50 ). Medical device according to at least one of claims 1 to 12, characterized in that the wall ( 11 ) a structuring, in particular a perforation, preferably a pore pattern, comprises such that the receiving element ( 10 ) is longitudinally axially stretchable in the compressed state. Medical device according to at least one of claims 1 to 13, characterized in that the receiving element ( 10 ) in the compressed state has two longitudinal axes extending in the longitudinal direction of the receiving element ( 10 ), wherein the flexible wall ( 11 ) forms two windings, which are space-saving rolled around one of the longitudinal axes. A method of manufacturing a medical device according to claim 1, comprising the following steps: - making a flat wall ( 11 ) for forming the receiving element ( 10 ) using a thin-film process, in particular a deposition process, preferably a sputtering process and / or an etching process - application of the planar wall ( 11 ) on an at least partially rotationally symmetrical, in particular at least partially funnel-shaped and / or at least partially cylindrical, shaped body, wherein at least two oppositely disposed edges of the flat wall ( 11 ) the longitudinal edges ( 14a . 14b ) of the receiving element ( 10 ) form; Heat treating the flat wall ( 11 ) such that the wall ( 11 ) after removal of the shaped body in a force-relieved state substantially maintains the shape of the shaped body or automatically assumes, wherein the closed position of the receiving opening ( 16 ), in which the longitudinal edges ( 14a . 14b ) are circumferentially adjacent or abutting or overlapping; - connecting the wall ( 11 ) with a guide element ( 20 ); and - arranging the receiving element ( 10 ) with the guide element ( 20 ) in the catheter ( 30 ). A method of manufacturing a medical device according to claim 1, comprising the following steps: - providing a braid mandrel having deflection pins arranged in series along its longitudinal axis on the outer circumference; Braiding of a substantially cylindrical grid ( 50 ) of individual wires ( 51 ) on the braided mandrel to form the wall ( 11 ) of the receiving element ( 10 ) in the closed position of the receiving opening ( 16 ), in which the longitudinal edges ( 14a . 14b ) are arranged adjacent to one another in the circumferential direction or in abutment or overlapping, one individual wire ( 51 ) mainly in the circumferential direction around the braid mandrel and to form loops ( 52 ) is wound around in each case one of the deflection pins in order to change the winding direction in the circumferential direction, wherein in each case a series of loops ( 52 ) one of the longitudinal edges ( 14a . 14b ) of the receiving element ( 10 ) forms; - connecting the mesh braid ( 50 ) with a guide element ( 20 ); and - arranging the receiving element ( 10 ) with the guide element ( 20 ) in the catheter ( 30 ). A method of manufacturing a medical device according to claim 1, comprising the following steps: - providing a planar die having longitudinally two parallel rows of turning pins; Braiding a substantially flat grid mesh ( 50 ) of individual wires ( 51 ) on the flat die to form the wall ( 11 ) of the receiving element ( 10 ), each with a single wire ( 51 ) for forming loops ( 52 ) is alternately wound around a respective deflecting pin of each row, wherein in each case a series of loops ( 52 ) one of the longitudinal edges ( 14a . 14b ) of the receiving element ( 10 ) forms; - connecting the mesh braid ( 50 ) with a guide element ( 20 ); - Rolling or winding the flat grid mesh ( 50 ) about a common longitudinal axis to form a substantially rotationally symmetrical shape, the closed position of the receiving opening ( 16 ), in which the longitudinal edges ( 14a . 14b ) are circumferentially adjacent or abutting or overlapping; and - arranging the receiving element ( 10 ) with the guide element ( 20 ) in the catheter ( 30 ).

Images