DE102011054907B4 - Transport wire and feed system with a transport wire - Google Patents

Abstract

A medical wire (10) for transporting a medical compressible device (11) extending through the device (11) in use, comprising holding means (12) for the compressed state device (11) at least axial for transmission Forces adapted to the device (11), characterized by at least one anchoring element (13) for anchoring the transport wire (10) in a hollow organ, wherein - the anchoring element (13) distally from the holding means (12) and arranged with the transport wire (10) is connected for the transmission of forces and - the anchoring element (13) in the radial direction for anchoring in the hollow organ is expandable and compressible for removal from the hollow organ.

Description

The invention relates to a transporting wire for a medical, compressible device and to a delivery system with such a transporting wire. A transport wire with the features of the preamble of claim 1 is for example made EP 1 374 801 A1 known. A catheter for delivering a medical device is exemplary WO 95/11055 A1 known. In this case, the catheter may have two channels, in each of which a piston is guided. In this case, a proximal piston can be connected via a wire with a proximal sleeve, whereby the motive force of the piston can be transmitted by means of the wire to the sleeve.

In the field of interventional neuroradiology, two design variants of medical devices, in particular stents, have become established. One design variant includes the so-called closed-cell design and is being used increasingly, for example for the treatment of aneurysms. The other design variant includes the so-called open-cell design, which is axially more unstable compared to the closed-cell design. On the other hand, devices, especially stents, with an open-cell lattice structure offer mechanical advantages, such as greater flexibility and vascular adaptation in curvy anatomies or low foreshortening. However, the axial instability may make it difficult for the practitioner to correctly place a device with an open-cell design in the vessel without distorting the device by an unwanted relative movement between the delivery system and the vessel wall. Distortion can occur if the device or stent is partially released from the delivery system and partially anchored in the vessel wall.

The aforementioned EP 1 374 801 A1 describes a known stent delivery system having a transport wire on which the stent is mounted. By a relative movement between the catheter line and the transport wire therein, the stent attached to the transport wire can be released at the point to be treated in the vessel. For this purpose, the catheter line is introduced into the body and moved by means of a guide wire to the desired location. Thereafter, the transport wire is moved with the compressed stent in the catheter line to the desired location and the catheter line then retracted. As a result, the stent is released at the vascular site to be treated. As in 9 of the EP 1 374 801 A1 To recognize, the distal end of the stent end is released from the catheter line during release and anchored in the vessel. The proximal end is still arranged in the catheter line and connected to the transport wire. By an unwanted relative movement between the transport wire and the vessel wall of the partially anchored stent is moved from the desired position. A stent with an open-cell design can distort or damage the stent.

An example of the release of a stent with an open-cell design is in 1 (Prior art) shown. In 1 is the vessel wall with I , the transport wire with II , the catheter lead with III , The stop on which the proximal stent end abuts with IV and the stent with V designated. As seen in the figure, during deflation in region B, contact between the stent and the vessel wall and thus anchoring is established. There is no connection between stent and vessel wall in area A of the stent. The stent is released by fixing the wire by the practitioner and retracting the catheter at the same time. However, since the stent is still partially connected to the supply system, it can in case of an unwanted movement of the transport wire II in the area A to an axial compression and / or stretching of the stent during expansion come. This can lead to misposition and damage to the stent.

The object of the invention is to provide a transporting wire which is improved with regard to the release of a medical device in such a way that the risk of a misposition or unwanted structural change of the device due to a movement of the transporting wire is reduced. The invention is further based on the object of specifying a delivery system with a transport wire.

According to the invention the object is achieved by the subject matter of claim 1 and with a view to the supply device by the subject-matter of claim 10.

According to the invention, therefore, a transporting wire for a medical, compressible device is proposed, which extends in use through the device, wherein the transporting wire has a holding means for the device located in the compressed state. The holding means is adapted for transmitting at least axial forces to the device. The transport wire is characterized by at least one anchoring element, which is adapted for anchoring the transport wire in a hollow organ. The anchoring element is arranged distally of the holding means and connected to the transport wire for the transmission of forces. The anchoring element is expandable in the radial direction for anchoring in the hollow organ and compressible for removal from the hollow organ.

The invention has the advantage that the transport wire is stabilized when discharging the device from a supply system in the vessel, whereby an unintentional relative movement between the transport wire and the vessel wall during the process of application of the device is achieved. The anchoring element allows the transport wire to be temporarily anchored in the vessel while the medical device is being released from the delivery system. After the medical device has been released, the transport wire with the anchoring element is retracted again into the supply device and removed from the hollow organ. The vessel anchoring of the transport wire is released again.

For this purpose, the anchoring element according to the invention is connected to the transport wire for the transmission of forces. The connection of the anchoring element with the transport wire allows the fixation and stabilization of the transport wire when the anchoring element is discharged from the supply system and connected to the vessel wall or the hollow organ. The connection between the anchoring element and the transport wire also allows the Einziehfunktion the anchoring element by the delivery system, in particular the supply line is pushed over the anchoring element in the distal direction after the release of the medical device or this is then fed into the feeder.

The expansion capability of the anchoring element in the radial direction allows anchoring in the hollow organ after the anchoring element has been released from the supply system. The compressibility of the anchoring element allows removal of the anchoring element from the hollow organ by retraction of the anchoring element in the supply line or the retraction after the device has been released.

The distal location of the anchoring element with respect to the retaining means results in the release of the device from the delivery system first of all releasing the anchoring element and then the device so that the anchoring engages before the medical device is released.

The transport wire according to the invention has the advantage that even medical devices, in particular implants, which have a low axial rigidity and a low foreshortening, are better and considerably safer to apply. Other medical devices, for example, stents with a closed-cell design can of course be implanted with the transport wire according to the invention, in which case the advantage is that by fixing and stabilizing the transport wire in the vessel an unwanted change in the position of the stent during discharge is avoided.

In the context of the invention, the transport wire itself, i. is disclosed and claimed without limitation to the associated delivery system and without limitation to the device mounted in use on the transport wire. Within the scope of the invention, the delivery system with such a transporting wire, for example in the form of a catheter, is also disclosed and claimed. In addition, the arrangement of a transport wire with a device mounted thereon, such as a stent, and the delivery system is disclosed and claimed.

Conveniently, the anchoring element has a grid structure, in particular with a closed-cell design, whereby the radial cross-sectional change of the anchoring element, i. the compressibility and expandability is made possible in a simple way. Other structures with which the radial cross-sectional change can be achieved are conceivable.

The anchoring element may have a closed, proximal end which is connected to the transport wire. In addition to the advantage of the simple shape, the closed proximal end can be used with suitable Feinmaschigkeit as a filter. The closed proximal end may have an insertion slope which tapers in the proximal direction, thereby facilitating the retractability of the anchoring element. A simple structure of the anchoring element is achieved when the anchoring element has a basket-like shape with an open distal end.

The holding means may comprise a stop which extends perpendicular to the transport wire, whereby the axial forces required for the positioning or axial movement of the device mounted on the transport wire are transmitted. The stopper may be formed integrally with the transport wire. Alternatively, the stop may be formed as a hollow cylinder, wherein the transport wire extends through the hollow cylindrical stop. The integral stop offers the advantage of security against displacement of the stop relative to the transport wire. The hollow cylindrical stop is easy to manufacture manufacturing technology.

In a preferred embodiment, at least one driver for the device between the stop and the anchoring element arranged. The driver causes the axial feed forces, which act on transporting the device in the supply line or on discharge, to distribute along the length of the device. This protects the structure of the device.

The invention will be explained below with reference to embodiments with reference to the accompanying schematic drawings with further details. In these show:

1 a cross-section through a supply system according to the prior art;

2 a side view of a transport wire according to an embodiment of the invention with an expanded anchoring element;

3a -F stepwise the process of the release process of a medical device with the transport wire according to 1 ;

4 an enlarged view of the 3C ;

5a C different views of the holding means of the transport wire; and

6a C different variants of the driver between the holding means and the (not shown) anchoring element.

In 2 is a transport wire 10 for a medical, compressible device 11 shown. The medical device (not shown) can be implants that are applied permanently or temporarily. The medical device includes, for example, stents. Other implants can be applied by means of the transport wire.

In use, the transport wire extends 10 through the device 11 through, as in the 3 and 4 shown. The transport wire 10 has a stop 17 on, from the distal end of the transport wire 10 is spaced. The stop 17 forms a retaining agent 12 for the compressed device 11 , such as in 5A shown. The distance between the distal end of the transport wire 10 and the stop 17 is sized so that the compressed medical device 11 and the compressed anchoring element 13 between the stop 17 and the distal end of the transport wire (see 3A ). The anchoring element 13 can do this via the distal end of the transport wire 10 project or completely overlap. The distance between the stop 17 or in general the holding means 12 and the anchoring element 13 is sized to the device 11 can be arranged in the compressed state between or is arranged, without causing a collision or contact of the anchoring element 13 and the device 11 when expanding the two parts comes. This is achieved in that the connection point between the anchoring element 13 and transport wire 10 at least at the same height as the distal end of the compressed device 11 arranged or distally from the distal end of the compressed device 11 is spaced. An overlap of the distal end of the compressed device 11 and the junction is possible when the proximal end of the anchoring element 13 is designed so that a collision during expansion is avoided. This can, for example, by the inlet bevel described in more detail elsewhere 16 respectively.

Generally speaking, the distance between the holding means 12 and the anchoring element 13 set so that the medical device to be applied between the holding means 12 and the anchoring element 13 fits without it during expansion of the anchoring element 13 comes to a collision with the device. The device lies on the holding means 12 at. This is achieved, for example, by the fact that the axial length of the device at most the distance between the holding means 12 and the anchoring element 13 equivalent. In an axial overlap of the device with the anchoring element 13 is, for example, by an inlet slope of the anchoring element 13 avoided a collision.

The stop 17 is designed so that this at least axial forces on the compressed device 11 can transfer. In place of the stop 17 can use other retention means 12 used, for example, known per se holding means that transmit the transport force through a frictional connection between the transport wire and the device. The holding means 12 has the general function of acting in the axial direction forces for the transport movement of the device 11 to transfer to this. This is the holding means 12 firmly with the transport wire 10 connected. In the case of the stop 17 this extends so far in the radial direction that the proximal end of the compressed device 11 at the stop 17 is present (see 3A ). For other holding means 12 the power transmission can be solved in other ways.

Distal from the holding means 12 or stop 17 is the anchoring element 13 arranged. In the embodiment according to 2 the anchoring element is distally distanced from the stop 17 arranged. If the holding means 12 is otherwise formed, the anchoring element 13 directly to the holding means 12 connect or a smaller distance to the holding means 12 to have. If the anchoring means 13 distal to the stop 17 or holding means 12 is arranged, it is achieved that first the anchoring element 13 and then the device 11 be released from the supply system. In this case, as described above, a collision between the distal end of the device 11 and the proximal end of the anchoring element 13 can be avoided by the two ends are decoupled at least during expansion or free from each other.

The anchoring element 13 has a grid structure 14 on, its proximal end 15a firmly with the transport wire 10 connected is. Generally, the connection between the anchoring element 13 and the transport wire 10 such that sufficiently high axial and possibly also radial forces can be safely transmitted if the anchoring element 13 is expanded and fixed in the vessel, without causing a significant relative movement between the transport wire 10 and the anchoring element 13 comes. The connection can be made in the usual way by welding, gluing, crimping or by other types of connection.

The grid structure 14 is advantageous, but not mandatory. Other structures of the anchoring element that allow expansion and compression are possible. The lattice structure has the advantage that recourse can be had to the deformation mechanisms known per se.

Alternatively to the in 2 illustrated closed-cell design or closed-cell structure of the grid structure of the anchoring element 13 , an open-cell design structure can be chosen. In this case, the open ends in the distal direction to the recoverability of the anchoring element 13 to reach.

The grid structure 14 of the anchoring element 13 is in the example according to 2 formed like a basket and has a closed proximal end 15a on that with the transport wire 10 connected is.

The anchoring element 13 points at the proximal end 15a a retraction area adapted to be transferred from the expanded state to the compressed state by a supply line. The pull-in area 15a For example, as an import or inlet slope 16 be formed, which tapers in the proximal direction. Other possibilities, the recoverability of the expanded anchoring element 13 to allow in a catheter line, are conceivable.

The distal end 15b of the anchoring element 13 is open, so that in this area free ends of the lattice structure 14 are formed, not with the transport wire 10 are connected. This makes the expandability of the anchoring element 13 facilitated. It is also possible to use another form of lattice structure 14 to choose the the expandability of the lattice structure 14 allows.

At the distal end of the anchoring element 13 One or more x-ray markers may be appropriate.

The expanded diameter of the anchoring element 13 may be equal to or less than the expanded diameter of the device. This takes into account the fact that the diameter of the vessels decreases in the distal direction.

For the design of the proximal stop 17 There are different possibilities in the 5a C are shown. For example, the proximal stop 17 be formed by a solid body with the transport wire 10 connected is. This hollow cylindrical body or hollow cylindrical stop 17 may be formed for example by a sleeve, a contoured sleeve, a spring or a hose. The firm connection between the body or the hollow cylindrical stop 17 and the transport wire 10 can be realized in a conventional manner by gluing, welding or other joining techniques. This is in 5A shown.

According to 5b can the proximal stop 17 into the body of the transport wire 10 be integrated. According to 5c can the hollow cylindrical stop 17 be executed with an intermediate sleeve. In all embodiments, the transmission of axial forces from the stop 17 on the device 11 by a correspondingly firm connection between the stop 17 and the transport wire 10 reached.

The portability or the pushability of the device 11 in the delivery system can be determined by the in 6a C variants are improved. These are between the stop 17 or holding means 12 and the anchoring element (not shown) 13 at least one or more drivers 18 arranged. In the embodiments according to 6a -C are each two drivers 18 intended. The drivers 18 are stuck with the transport wire 10 connected for the transmission of axial forces. The configuration of the drivers 18 essentially corresponds to the configuration of the respective stops 17 , So in the example is the driver 18 according to 6a ring-shaped and according to 6c cone-shaped. According to 6c are the takers 18 and the stop 17 each integral with the transport wire 10 educated. The transport wire 10 is to train the driver 18 contoured accordingly.

A combination of different drivers 18 and stops 17 is possible as in 6b shown. The drivers 18 are along the transport wire in the area of the compressed device 11 or of the compressed implant. The radial extent of the driver 18 is sized to be on the inside of the compressed device 11 abut in order to bear the required axial forces. Preferably corresponds approximately to the outer diameter of the driver 18 the outer diameter of the respective stop 17 , By means of the drivers 18 For example, the required transport force, which must be applied when the system is supplied by the catheter or the transporting wire with the charged device, is introduced at different locations into the compressed device. This reduces the risk of excessive deformation of the device or of the implant.

The transport wire 10 or the combination of transport wire 10 and the supply system or the supply line works, as shown by the 3a -F shown:
According to 3a the system will be the supply line 19 , the transport wire 10 and those on the transport wire 10 attached compressed device 11 placed in the target area, ie in the area of the vessel to be treated. By a relative movement between the supply line 19 and the transport wire 10 First, the anchoring element 13 dismiss. As in 3b shown, the anchoring element expands 13 and comes into contact with the vessel wall. This will be the transport wire 10 fixed at least in the axial direction. In step c, the implant or the device 11 dismiss. By stabilizing the transport wire 10 The risk is reduced by an unwanted movement of the transport wire 10 the structure of the device 11 distorted or the position of the device 11 is changed. Due to the fixation of the transport wire 10 is the device in the partially released state 11 existing connection between the device 11 and the transport wire 10 at the proximal end of the device 11 harmless.

According to 3d is the device or the implant 11 completely dismissed and is in the final position. In step 3e, the anchoring element is in the supply line 19 recovered. This is the anchoring element 13 compressed. This is achieved in that the tip of the supply line has a radially inwardly acting force on the proximal end, in particular the region of the inlet slope 16 of the anchoring element 13 exercises. With increasing retracted length of the anchoring element 13 compresses this stronger. After the anchoring element 13 completely retracted into the supply line and thus the bond between the anchoring element 13 and the vessel wall is removed, the entire system comprising the transport wire, the anchoring element 13 and the supply line 19 through the expanded device 11 or the expanded stent withdrawn and removed in the proximal direction.

In 4 is the axial stabilization of the transport wire 10 shown. It can be seen that the supply line 19 in the proximal and distal directions is axially movable (see double arrow), which is required to the device 11 release. By anchoring the anchoring element 13 with the vessel wall, however, is an axial mobility of the transport wire 10 prevented (see crossed-out double-headed arrow).

LIST OF REFERENCE NUMBERS

10

 transport wire

11

 medical device

12

 holding means

13

 anchoring element

14

 lattice structure

15a

 proximal end

15b

 distal end

16

 run-in slope

17

 attack

18

 takeaway

19

 supply line

Claims (11)

Transport wire ( 10 ) for a medical, compressible device ( 11 ) in use by the device ( 11 ), comprising a holding means ( 12 ) for the device in the compressed state ( 11 ) for transmitting at least axial forces to the device ( 11 ), characterized by at least one anchoring element ( 13 ) for anchoring the transport wire ( 10 ) in a hollow organ, wherein - the anchoring element ( 13 ) distal to the holding means ( 12 ) and with the transport wire ( 10 ) is connected to transmit forces and - the anchoring element ( 13 ) is expandable in the radial direction for anchoring in the hollow organ and is compressible for removal from the hollow organ. Transporting wire according to claim 1, characterized in that the anchoring element ( 13 ) a grid structure ( 14 ), in particular with a closed-cell design. Transport wire according to claim 1 or 2, characterized in that the anchoring element ( 13 ) a closed proximal end ( 15a ), which is connected to the transport wire ( 10 ) connected is. Transporting wire according to claim 3, characterized in that the closed, proximal end ( 15a ) an import slope ( 16 ), which tapers in the proximal direction. Transporting wire according to one of the preceding claims, characterized in that the anchoring element ( 13 ) a basket-like shape with an open distal end ( 15b ) having. Transporting wire according to one of the preceding claims, characterized in that the holding means ( 12 ) a stop ( 17 ), which is perpendicular to the transport wire ( 10 ). Transporting wire according to claim 6, characterized in that the stop ( 17 ) integral with the transport wire ( 10 ) is trained. Transporting wire according to claim 6, characterized in that the stop ( 17 ) is formed as a hollow cylinder, wherein the transport wire ( 10 ) through the hollow cylindrical stop ( 17 ). Transporting wire according to one of claims 6 to 8, characterized in that between the stop ( 17 ) and the anchoring element ( 13 ) at least one driver ( 18 ) for the device ( 11 ) is arranged. Feed system with a transport wire ( 10 ) according to one of the preceding claims, comprising a supply line ( 19 ), in which the transport wire ( 10 ) is arranged relatively movable in the longitudinal direction. Feeding system according to claim 10, characterized in that on the transport wire ( 10 ) a compressed medical device ( 11 ), wherein - axial forces by the holding means ( 12 ) on the device ( 11 ) are transferable such that the device ( 11 ) relative to the supply line ( 19 ), and - the anchoring element ( 13 ) distal to the device ( 11 ) is arranged.

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