WO2011066961A1

WO2011066961A1 - Supply system for a medical functional element

Info

Publication number: WO2011066961A1
Application number: PCT/EP2010/007303
Authority: WO
Inventors: Giorgio Cattaneo
Original assignee: Acandis Gmbh & Co. Kg
Priority date: 2009-12-01
Filing date: 2010-12-01
Publication date: 2011-06-09
Also published as: DE102009056448A1; DE102009056448B4

Abstract

The invention relates to a supply system for a medical functional element (50), comprising a catheter (10), an actuating element (20) that is arranged in the catheter (10) in a longitudinally displaceable manner, and a holding means (30) that can be connected to a proximal end (51) of the functional element (50) such that, during use, the functional element (50) can be moved by the actuating element (20) relative to the catheter (10). The invention is characterised in that the holding means (30) is connected to a decoupling mechanism (21) in a proximal manner, which exerts a release force onto the holding means (30) in order to release the functional element (50), wherein a flexible intermediate piece (40) is arranged between the decoupling mechanism (21) and the holding means (30) which places the decoupling mechanism (21) and the holding means (30) at a distance from each other and transmits the release force from the decoupling mechanism (21) to the holding means (30) in order to position the intermediate piece (40) and the holding means (30) with the fixed proximal end (51) of the functional element (50) outside of the catheter (10) before the release force acts upon the holding means (30).

Description

Delivery system for a medical functional element

description

The invention relates to a delivery system for a medical functional element according to the preamble of claim 1. Such a delivery system is

For example, from EP 1 374 801 AI known.

The known delivery system comprises a catheter in which a guide wire is longitudinally displaceable. In the region of the distal end of the guide wire, a plurality of coil-like elements are provided, which form a holding means for a stent. The stent to be implanted is clamped between two outer coils, the outer coils substantially filling the inner diameter of the catheter.

To release the stent, after the entire delivery system has been guided to the treatment site, for example in the region of a vascular aneurysm, the catheter is displaced relative to the guide wire. In particular, the catheter is withdrawn in the proximal direction. The radial boundary, which prevents the expansion of the stent, is thus removed, whereby the stent spans in the vessel. The clamping takes place from distal to proximal. This means that first the distal end of the stent expands and then the proximal end. The expansion takes place immediately after removal of the catheter or immediately upon emergence of the stent from the catheter tip. This results in several

constructional and functional disadvantages.

In the implantation of stents, it has proven to be expedient first to release the stent only partially, with the option of withdrawing the stent into the delivery system or the catheter. For example, the stent may be discharged to about 70% to 80% to verify, on the one hand, the correct position of the stent and, on the other hand, to monitor the influence of blood flow or pulse beat on the position of the stent. For this, the catheter is retracted to the area of the proximal end of the stent so that the proximal end remains in the catheter is fixed. In this way it is possible to re-compress the stent by advancing the catheter in the distal direction and to correct the implantation position. However, this method requires a high level of user sensitivity since a small distal movement of the catheter can result in complete stent deployment. With the known delivery system, there is the danger that the stent is released quickly and uncontrollably. It is also too

take into account that the actuation of the holding means or the relative movement between the catheter and holding means outside the body, so relatively far away from the place of action, takes place. Therefore, in conjunction with the elastic properties of the catheter material, movement at the proximal end of the catheter will affect the movement of the catheter tip differently, such that the release of the stent is relatively inaccurately controllable.

Another disadvantage is the implantation of the stent in vessel bends or in the distal vicinity of a vessel curvature. There is a risk that the catheter due to material properties, the dimensions of the vessel curvature can not fully follow and distal to the vessel curvature with the

Catheter tip to the vessel wall applies. When dismissing the stent is the

Catheter tip so not central, but decentralized arranged in the vessel. In this arrangement, when the stent is partially deflated, that is, the proximal end of the stent continues to be connected to the catheter tip, the decentering of the catheter tip causes a force on the stent that can prevent dislocation of the stent in the proximal direction. Thus, the user can be suggested that the stent is securely positioned in this position. When the stent is now completely released and the decentralized

When the force applied to the catheter tip becomes ineffective, the proximal end of the stent tensions asymmetrically. This can result in unexpected dislocation of the stent. Repositioning is no longer possible.

The invention is therefore based on the object, a supply system for a

specify medical functional element that allows improved handling and improved positioning accuracy for the functional element.

In particular, a supply system is to be provided with the invention, with which it is possible, the conditions during implantation, in particular the

Positioning of a functional element can be estimated improved with the option to reposition the functional element. According to the invention, this object is solved by the subject-matter of patent claim 1 and alternatively by the subject-matter of patent claim 16.

The invention is based on the idea to provide a delivery system for a medical functional element, wherein the delivery system is a catheter, a

Actuator and a holding means comprises. The actuator is longitudinally displaceable in the catheter. The holding means can be connected to a proximal end of the functional element in such a way that the functional element in the

Use by the actuator is movable relative to the catheter. The holding means is further connected proximally with a decoupling mechanism which exerts a release force on the holding means for releasing the functional element. Between the uncoupling mechanism and the retaining means is a flexible

Intermediate piece arranged, which spaced the decoupling mechanism and the holding means from each other. The flexible spacer further transmits the release force from the decoupling mechanism to the retaining means to position the spacer and the retaining means with the fixed proximal end of the functional member outside the catheter before the release force acts on the retaining means.

With the feed system according to the invention is advantageously achieved that the

Functional element on the one hand partially in the vessel is expandable, wherein at the same time a distance is provided between the catheter and the functional element, so that act on the catheter substantially no forces on the functional element. The implantation position of the functional element can be estimated improved in this way. In this case, the functional element is further fixed with a proximal end with the holding means, so that a repositioning is possible.

Specifically, the catheter can be pushed back over the functional element or the functional element can be pulled back into the catheter.

A special feature of the delivery system according to the invention is that between the decoupling mechanism and the holding means a flexible

Intermediate piece is arranged, whereby the functional element is kept at a distance from the catheter. In this case, the functional element is partially expanded, whereby the subsequent implantation position can be observed, for example, under X-ray control.

In contrast to the prior art, the delivery system according to the invention has a separate decoupling mechanism, which is an active actuation of the Holding means causes. To release the functional element so the decoupling mechanism is effective, which exerts the release force on the retaining means in the sequence.

Since the decoupling mechanism is arranged by the intermediate piece spaced from the holding means, the handling of the invention

Improved feed system. In particular, the intermediate piece allows a more precise control of the release of the functional element. A movement of the catheter in the proximal direction thus does not directly lead to a relatively rapid expansion and possibly uncontrolled release of the functional element. Rather, the distance between the holding means and the decoupling mechanism, ie by the length of the intermediate piece, causes a time delay in the release. In this way, the user can safely check the position of the functional element even before the final release, since no or at least only slight radial forces act on the proximal end of the functional element.

Another advantage that results from the flexible spacer is that the proximal end in the partially expanded state of the functional element, i. when the proximal end of the functional element is fixed in the holding means and the distal end of the functional element is expanded in the vessel, can be arranged centrally in the vessel. The position of the functional element in the partially expanded state thus largely corresponds to the final position in the implanted state. As a result, the user has the possibility of realistically observing, for example, the influence of pulse rate or fluid flow or of a drug treatment before the functional element is finally released. This makes it easier for the user to decide whether, for example, after the action of a drug at the treatment site, a complete release of the functional element is required or

Functional element is removed again after the drug treatment from the body. This may also be the case when the functional element, in particular a stent, is used to place coifs in a blood vessel. The coils are inserted between the meshes of the functional element, in particular stents, through an aneurysm. The coils are deformed within the

Aneurysms irregular and form ball-like structures. The stent placed in front of the aneurysm prevents the coils from entering the bloodstream. After successful positioning of the coils can then be decided whether the

Support of the stent continues to be needed and the stent is released as a permanent implant completely in the vessel. This may be useful, for example, when the coils arranged in the aneurysm from the against the stent structure apply a force. When removing the stent, there may be the risk that the coils are washed back into the bloodstream. If the coils, however, in the

Substantially self-locking positioned in the aneurysm, can be dispensed with an additional support of the blood vessel through the stent and the stent removed from the blood vessel. The delivery system according to the invention enables a simple and safe removal of the stent or, in general, of the functional element.

In a preferred embodiment, the retaining element comprises a first

Arretierungselement which is fixedly connected to an actuating element. Furthermore, the holding means may comprise a second locking element which is fixedly connected to the flexible intermediate piece. The second locking element is thus coupled via the flexible intermediate piece with the decoupling mechanism. In this way it is possible that between the first locking element on the actuating element and the second locking element, the

Decoupling mechanism is assigned, a relative movement is possible. The relative movement is preferably effected by the release force, the from the

Uncoupling mechanism goes out. By the relative movement between the first locking element and the second locking element so the fixation of the proximal end of the functional element is released.

The holding means may concretely have a holding position and a release position, the second locking element being offset in the holding position in the region of the first locking element and in the release position offset from the first

Arretierungselement is arranged. In the stop position are the

Arretierungselemente thus arranged at the same height with respect to the actuating element, so that the proximal end of the functional element is securely fixed. To release the functional element, the locking elements are offset, in particular offset in the longitudinal axial direction, arranged to each other, for example by the second locking element offset proximally or distally to the first

Arretierungselement is arranged. The proximal end of the functional element is thus released from the fixation. As a result, the proximal end of the functional element can expand.

Preferably, the first locking element is positively and / or frictionally connected to the proximal end of the functional element. The positive and / or frictional connection between the first locking element and the proximal end of the functional element allows a particularly simple and secure fixation of the proximal end, in particular in the longitudinal axial direction.

The frictional connection of the functional element with the retaining means can also be achieved by both locking elements, namely the first locking element and the second locking element. It is appropriate, the

Adjust friction coefficients between the proximal end of the functional element and the retaining means such that a secure release of the

Function element is possible. In particular, it is advantageous if the

Friction coefficient between the holding means and the functional element is greater than the coefficient of friction between the functional element and the catheter. The higher friction between the holding means and the functional element with respect to the friction between the functional element and the catheter also has advantages when the functional element is pulled in the proximal direction. This is

For example, the case when the distal end of the partially or completely released functional element is mispositioned and the functional element is to be pulled back into the catheter. The catheter exercises on the

Functional element from an axial force in the distal direction, whereby the risk that the functional element detaches from the holding means. Due to the larger coefficient of friction between the holding means and the functional element, the force acting on the functional element by the catheter is compensated and the unwanted detachment or release of the functional element is avoided.

In an advantageous embodiment, the first locking element comprises a deformable material. In this way, the first locking element can be easily and quickly adapted to any contour of the proximal end of the functional element. Thus, the feed system according to the invention with

different functional elements are combined, with a secure

Fixation of the proximal end of the respective functional element is ensured. In particular, the deformation of the material of the first locking element creates a positive connection between the first locking element and the functional element, as in the preparation of the compound in the first

Arretierungselement undercuts form, which is an evasion of

Prevent functional element at least in the axial direction. For example, the functional element at a proximal end marker elements, in particular sleeves, have, which is in the deformable material of the first locking element cut into it. The proximal end of the functional element is thus fixed at least against a release in the axial direction of the first locking element.

The first locking element can also be directed radially outward

Projection, in particular a pin, a pin or a hook. By such a projection is a particularly simple and effective

positive connection between the functional element and the first

Arretierungselement provided.

The second locking element preferably has a sleeve which in the

Haltestellung the first locking element engages. In this way, the principle is followed, the proximal end of the functional element by the first

To fix locking element in the axial direction and by the second

Arretierungselement a radial expansion of the proximal end of the

Function element to prevent. The proximal end of the functional element is thus securely fixed in the holding means. At the same time the sleeve allows a particularly simple operation of the holding means, in particular the simplest possible transfer of the holding means of the holding position in the release position. For example, can be repealed by a proximal movement of the second locking element or the sleeve, the radial fixation of the proximal end of the functional element, whereby an expansion of the proximal end of the functional element is made possible. It is advantageous if the coefficient of friction between the second locking element and the functional element is relatively small, to a slight actuation of the holding means, in particular the offset of the first

Arretierungselements with respect to the second locking element, reach.

Triggered by the decoupling mechanism, the functional element can thus be completely released.

In a preferred embodiment of the delivery system according to the invention, the decoupling mechanism can be arranged in the area of a distal end of the delivery system

Be arranged actuator. In particular, the decoupling mechanism is preferably located in the region of the catheter tip when the

Actuator is disposed completely in the catheter. Specifically, this means that the decoupling mechanism is preferably located a few centimeters from the catheter tip. The distance between the catheter tip and the decoupling mechanism is thus substantially smaller than the distance between the decoupling mechanism and a proximal end of the catheter, the outside the body, ie extracorporeal, is arranged. The distance between the holding means and the decoupling mechanism is determined essentially by the length of the intermediate piece and preferably comprises orders of magnitude of a few centimeters. It is particularly preferred if the length of the

Intermediate piece at least 2 cm, in particular at least 3 cm, in particular at least 4 cm, in particular at least 5 cm, in particular at least 6 cm, in particular at least 7 cm, in particular at least 8 cm, in particular at least 9 cm, in particular at least 10 cm, in particular at least 15 cm, in particular at least 20 cm, in particular at least 30 cm. The length of the intermediate piece can also correspond substantially to the length of the functional element.

In a further preferred embodiment of the invention

Delivery system is a proximal end of the decoupling mechanism with the

Actuator connected such that the decoupling mechanism is movable together with the actuating element. Further, a distal end of the decoupling mechanism may be connected to the flexible spacer. Between the proximal end and the distal end of the decoupling mechanism, there is advantageously arranged a triggering section, which is convertible from a radially compressed state to a radially expanded state such that a releasing force acts on the retaining means relative to the intermediate piece and / or the second locking element to move to the first locking element. By the proximal end, which is connected to the actuating element, is the

Decoupling mechanism fixed to the actuator. On the other hand, the distal end of the decoupling mechanism movable with respect to the operating member is connected to the intermediate piece to transmit a releasing force to the holding means. The release force is effected by the release portion, which has a substantially flexible structure that is radially expandable. The

Expansion of the trigger section causes an axial compression, ie a shortening of the trigger section. This shortening is made by the flexible

Transferring intermediate piece to the holding means, whereby the holding means in the

Release position is feasible. The expansion of the trigger section triggers one

Relative movement between the intermediate piece or the second locking element and the first locking element. By the radially expandable

Trigger section is thus created an easy way to move the holding means in the release position. This can be achieved, for example, by retracting the catheter beyond the release section, so that the Triggering section is arranged outside the catheter. This eliminates a radial boundary for the trigger section, so that they occupy the expanded state and thus can cause the release force.

The radially expandable structure of the triggering section additionally contributes to the fact that a time-delayed, in particular comparatively exact, release of the functional element is made possible. The triggering section essentially causes a reduction. This means that the distance that the catheter has over the

Trigger section is drawn in a reduction ratio to the

Displacement of the second locking element with respect to the first

Locking element affects. The axial offset of the second locking element thus correlates with the length of the triggering section, wherein upon release of the functional element, the distance traveled by the catheter tip in the region of the triggering section is significantly greater than the corresponding offset of the second locking element. For example, pulling the catheter 20 mm distally over the firing portion may cause axial shortening of the firing portion and thus proximal movement of the second

Locking element by 2 mm lead. The reduction ratio between the length of the trigger portion and the axial shortening of the trigger portion allows a particularly fine and accurate release of the functional element. For this purpose, the triggering section preferably has a length of at least 5 mm, in particular at least 10 mm, in particular at least 15 mm, in particular at least 20 mm, in particular at least 25 mm, in particular at least 30 mm, in particular at least 35 mm, in particular at least 40 mm, in particular at least 45 mm, in particular at least 50 mm. The triggering section may also have a length of at most 100 mm, in particular at most 95 mm,

in particular at most 90 mm, in particular at most 85 mm, in particular at most 80 mm, in particular at most 75 mm, in particular at most 70 mm, in particular at most 65 mm, in particular at most 60 mm, in particular at most 55 mm, in particular at most 50 mm.

The functional reduction, which is provided by the operation of the detachment section at the discharge of a functional element from the delivery system, is particularly advantageously used in conjunction with a functional element having a shape at the proximal end, which is a progressive

Expansion of the functional element allows. For example, such a functional element at the proximal end a plurality of offset loops or cells or Mesh on. The proximal axial end thus preferably extends in an oblique plane with respect to a central axis of the functional element. This ensures that the proximal end of the functional element widens in sections when discharged. The positioning of the functional element can thus be closely monitored and corrected as needed. The skewed widening is enhanced by the reduction of the delivery system. It is advantageous if the reduction ratio, ie the ratio between catheter movement over the triggering section and axial movement of the second locking element, greater than 1, in particular greater than 2, in particular greater than 5, in particular greater than 10, in particular greater than 20, is.

Preferably, it is provided that the trigger section a

Self-expandable structure, in particular lattice structure or web structure, or at least partially radially expandable spring, in particular coil spring comprises. The radial expansion of the trigger section is thus preferably effected automatically or automatically, for example, by a radially outer

Limitation, for example, the catheter is removed. Specifically, the

Trigger section on an expanded state or resting state with a shortened longitudinal extent. This self-expanding structure of the trigger section automatically assumes this resting state when the outer boundary in the form of the catheter is removed. This ensures that the delivery system is easy and intuitive for the user.

Preferably, the intermediate piece and / or the proximal end of the

Uncoupling mechanism on a coil or a spring, in particular coil spring, or a flexible hose on. By the aforementioned alternative components increased flexibility is ensured in particular for the intermediate piece. Moreover, the coil-like or spring-like or hose-like structure of the intermediate piece forms a particularly simple structural possibility for realizing a spacing of the holding means from the coupling-off mechanism in the form of a spacer.

It has also proven to be advantageous if the holding means by the

Uncoupling mechanism is remotely operable. This means that the holding means is acted upon from a distance with the release force or controlled from a distance. In this case, the decoupling mechanism assumes an active function, namely the provision of the release force, which acts on the spaced apart from the decoupling mechanism holding means. The active transfer of the holding means from the holding position in the Release position, is triggered by the decoupling mechanism, an additional component, or operated remotely. The release of the functional element is not carried out, as known from the prior art, directly by a relative movement between the catheter and actuator, but rather the relative movement between the catheter and actuator on the decoupling mechanism, which generates the release force for the release of the functional element in the sequence and thus actuates or controls the spaced-apart holding means, in particular remotely controlled.

The release force for releasing the functional element can act on the retaining means in the axial direction. In this preferred embodiment, it is thus advantageously provided that the release force acts on the holding means in such a way that, for example, the second arresting element in the axial direction with respect to the first

Arretierungselements is relatively moved. As a result, the radial fixation of the proximal end of the functional element can be released or removed, whereby the expansion of the proximal end of the functional element is permitted.

The trigger section may also be radially biased in the compressed state to automatically assume the expanded state in a position outside the catheter and to generate the release force for releasing the retaining means. Of the

Triggering section may thus have spring-like properties which act radially outward. In the compressed state, the spring-like properties or the bias are limited by the catheter. As soon as the radial limitation is eliminated, the bias or a radial spring force is effective, causing the

Trigger section occupies the radially expanded state and at the same time undergoes a shortening, which in turn causes the release force, which is used to release the

Function element in the region of the holding means is effective. It is possible the

Decoupling mechanism, in particular the trigger section, after partial or complete discharge from the catheter to retract back into the catheter. If the decoupling mechanism has been only partially released, that can

Functional element still be connected to the decoupling mechanism. In this case, it is possible to share the functional element with the

Disconnect mechanism to lead back into the catheter. In the other case as well, when the functional element has been completely released and also the decoupling mechanism is completely outside the catheter, it is possible to recover the entire actuating element, in particular the guide wire to move back into the catheter. In this way a safe removal of the entire delivery system from the body is ensured.

The actuating element and / or the first locking means are preferably adapted to exert a return force on the functional element such that the functional element can be transferred from a position outside the catheter into a position within the catheter. Preferably, the actuating element and / or the first locking means are thus designed such that the

Functional element is traceable to the compressed state. In this way, the functional element after the parts expansion in the vessel again within the

The catheter can be positioned to adjust the position of the functional element

Correct treatment site or in the vessel. It is also possible that

To completely remove functional element in this way. The functional element can be arranged in the part-expanded state in the vessel for a certain period of time and then completely removed from the vessel.

According to a secondary aspect, the invention is based on the idea to provide a delivery system for a medical functional element comprising a catheter, an actuator which is longitudinally displaceable in the catheter, and a holding means, which with a proximal end of the functional element

is connectable such that the functional element in use by the

Actuator is movable relative to the catheter. The holding means is connected proximally with a decoupling mechanism, which is used to release the

Functional element exerts a releasing force on the holding means, wherein the

Decoupling mechanism comprises a radially expandable spring or generally a radially expandable, resilient element, in particular a tension spring, which is stretched within the catheter and is shortened upon release from the catheter by a radial expansion such that the holding means for

completely releasing the functional element moves relative to the proximal end of the functional element.

The invention will be described below with reference to embodiments

With reference to the accompanying schematic drawings explained in more detail. Show in it a plan view of a supply system for a medical

Functional element according to the prior art in

Positioning the functional element;

FIG. 2 shows a plan view of a feed system according to the invention in a preferred exemplary embodiment during the positioning of the functional element; FIG.

Fig. 3-6 is a side view of an inventive delivery system

According to a preferred embodiment in different phases in the release of a

Functional element;

Fig. 7-9 is a detail view of the holding means of an inventive

Feed system according to each one preferred

Embodiment;

Fig. 10 is a side view of a feed system according to the invention according to a preferred embodiment in use;

Fig. 11 is a plan view of the supply system of FIG. 10 at

Positioning the functional element; and

12 and 13 are each a side view of an inventive

Supply system according to another preferred embodiment in different phases in the

Release of the functional element.

Fig. 1 clearly shows the problem that arises in the supply systems of the prior art, in particular in the supply system according to EP 1 374 801 AI. The known delivery system comprises a catheter 10 'and an actuating element, not shown, which is at least temporarily connectable to a functional element 50', in particular a stent. The actuator is adapted to fix the stent compressed within the catheter 10 'while the catheter 10' is withdrawn in the proximal direction. When the stent or functional element 50 'is to be positioned or implanted distally of a vessel curvature 61, as shown in FIG. 1, the retraction of the catheter results 10 ', the position of the catheter tip 1 shown in Fig. 1. In particular, the relatively low flexibility of the catheter 10 'causes the catheter tip 11' to be applied to the vessel wall. The catheter 10 'may be the radius of curvature of the

Vascular curvature 61 so not completely follow. In case of partial dismissal or

Partial expansion of the functional element 50 'will therefore be the proximal end of the

Functional element 50 'arranged decentrally in the vessel. The catheter 10 'thus exerts a force on the proximal end of the functional element 50' or of the stent, which makes it more difficult to estimate the correct and secure positioning of the stent or functional element 50 '.

With the delivery system according to the invention, however, it is possible to hold the proximal end 51 of the functional element 50 substantially centrally in the vessel and thus to be able to better estimate the final positioning of the functional element 50. For this purpose, it is provided that, as shown in FIG. 2, the proximal end 51 of the functional element 50 is also firmly connected to the actuating element 20 when the catheter 10 is arranged at a distance from the functional element 50. In the delivery system, the release or release of the functional element 50 thus does not take place directly at the exit of the proximal end 51 of FIG

Functional element 50 from the catheter 10, but only by an operation of a holding means 30, which in a distal region of the actuating element 20th

is arranged.

The structural design of a supply system according to an inventive

Exemplary embodiment is explained in more detail below:

The delivery system includes a catheter 10 in which an actuator 20 is longitudinally displaceable. The catheter 10 is preferably tubular and comprises at least one plastic material. Specifically, the

Catheter 10 one or more plastics and, if necessary, a

Have reinforcing structure. The reinforcing structure comprises, for example, a coil-like or net-like metal structure (coiling or braiding). Of the

Inner diameter of the catheter 10 is preferably at most 2 mm, in particular at most 1.5 mm, in particular at most 1.0 mm, in particular at most 0.8 mm, in particular at most 0.6 mm, in particular at most 0.5 mm.

The actuating element 20 is preferably designed as a guide wire. Suitable guide wire materials are known to those skilled in the art. On the Guide wire or actuator 20 is in use

Functional element 50 is arranged. Specifically, the functional element 50 is releasably coupled to a distal end of the actuator 20. The functional element 50 may be a stent, a filter, a stent graft, or another medical device

Include implant. Preferably, the functional element 50 is designed as a stent. The functional element 50 has a proximal end 51 and a distal end 52, wherein the proximal and distal ends 51, 52 of the functional element 50 can be equipped with a radiopaque material.

The functional element 50 is coupled to the actuating element 20 via a retaining means 30. The holding means 30 is preferably constructed in two parts. In particular, the holding means 30 comprises a first locking element 31 and a second

Arretierungselement 32. The first locking element 31 is connected to the

Actuator 20 firmly connected, in particular with respect to

Actuator 20 fixed in position. The second locking element 32 is slidably mounted or movable relative to the actuating element 20. In particular, the second locking element 32 is fixedly connected to an intermediate piece 40, wherein the intermediate piece 40 is arranged proximal to the second locking element 32. The flexible intermediate piece 40 advantageously comprises a coil which is wound around the actuating element 20. The coil or the intermediate piece 40 is displaceable on the actuating element 20. Instead of the coil, the intermediate piece 40 may also comprise a spring or a flexible hose. Furthermore, the

Intermediate piece 40 has a combination of a coil and a flexible material or a plastic. Preferably, the intermediate piece 40, in particular the hose, in the transverse axial direction is flexible. This means that the hose can bend or follow a curve. A change in the diameter of the hose is not required for the functionality of the intermediate piece 40.

The intermediate piece 40 is proximal to a decoupling mechanism 21

connected. The decoupling mechanism 21 includes a proximal end 21a and a distal end 21b. The proximal end 21a of the decoupling mechanism 21 may comprise, analogously to the intermediate piece 40, a coil, a spring, in particular a spiral spring, or a flexible hose. The proximal end 21a of the

Uncoupling mechanism 21 is fixedly connected to the actuating element 20.

Thus, the proximal end 21a of the decoupling mechanism 21 forms an abutment for the movement of the intermediate piece 40 and the second locking means 32, respectively. The distal end 21 b of the decoupling mechanism 21 has a triggering portion 23. The trigger section 23 is expandable in the radial direction. This means that the trigger section 23 has a cross-sectional diameter, the

is expandable. For example, the trigger portion 23 may include a braided or laser cut lattice structure extending between the proximal end 21a of the decoupling mechanism 21 and the spacer 40. The trigger section 23 may also have a web structure. In particular, the triggering section 23 may have a plurality of bars or webs arranged parallel to one another on the circumference of the triggering section 23 and extending radially outward

are expandable with respect to the center axis of the delivery system.

The decoupling mechanism 21 is entirely in a distal region of the

Actuator 20 is arranged. The decoupling mechanism 21 thus forms, with the intermediate piece, the holding means and the functional element 50, the distal tip of the actuating element 20.

As can further be seen in FIG. 3, the coils which form the proximal end 21 a of the decoupling mechanism 21 and the intermediate piece 40 fill the inner cross-section or the lumen of the catheter 10 for the most part, in particular completely. The catheter 10 thus serves as a radial barrier for the functional element 50 and the triggering section 23, so that both the triggering section 23, and the

Functional element 50 maintain the compressed state.

In this context, it should be noted that both the

Functional element 50, as well as the trigger section 23 advantageously comprise a self-expanding material. It is not excluded that the trigger section 23 or the functional element 50 each have a different material.

The delivery system is particularly suitable for the implantation of stents. The

Functional element 50 may thus comprise a stent, which, as in the figures

represented, for example, at the proximal end 51 and at a distal end 52 radiopaque sleeves or generally marker elements 54 may have. For radiopacity, the marker elements 54 may include, for example, platinum. It is also possible that the stent or, more generally, a body implant containing the

Functional element 50 forms, marker-free ends. It is also possible that the functional element 50 has other configurations, which the Ensure radiopacity. For example, the functional element 50 may be constructed of partially radiopaque and partially radiopaque wire elements.

The operating principle of the delivery system becomes clear from consideration of FIGS. 3 to 6:

Within the catheter 10, the functional element is in the compressed state. The functional element 50 thus has a relatively small cross-sectional diameter. As soon as the functional element 50 or the catheter tip 11 is positioned at the treatment location, the actuating element 50, as well as the holding means 30, the intermediate piece 40 and the uncoupling mechanism 21, surround the actuating element 20 30 is connected to the actuating element 20, held stationary. The catheter 10 is withdrawn, so that the radial boundary, which forms the catheter 10 for the functional element 50, is released in sections. The functional element 50 expands as soon as the catheter 10 is withdrawn. The expansion takes place in sections from distal to proximal, that is from the distal end 52 to the proximal end 51. The distal end 52 is, as shown in FIG. 4, immediately released or expanded. The proximal end 51 of the functional element 50, however, is still kept in the compressed state, for which purpose the

Holding means 30 is effective. The holding means 30 thus fixes the proximal end 51 of the functional element 50, as long as the decoupling mechanism 21 is not effective.

As shown in FIG. 5, the effectiveness of the decoupling mechanism 21 is achieved by further pulling the catheter 10 proximally exposing the trigger portion 23. Substantially analogous to the expansion of the functional element 50, i. following the same principle, the

Triggering section 23, as soon as the radial boundary in the form of the catheter 10 is removed. From the radial expansion of the trigger section 23 results in a

Length change of the trigger section 23. In particular, the axial length of the trigger section 23 is shortened or the distance between the fixed with the

Actuator connected proximal end 21a of the decoupling mechanism 21 and the intermediate piece 40 is reduced. In this case, the intermediate piece 40 is moved relative to the actuating element 20 in the proximal direction. By the solid

Connection of the second locking element 32 with the spacer 40 is Also, the second locking element 32 moves in the proximal direction and thus arranged offset to the first locking element 31.

The second locking element 32 is preferably designed as a sleeve 34, which encloses the proximal end 51 of the functional element 50 in the holding state. in the

Holding state is thus the second locking element 32 arranged at the same height as the first locking element 31. In this case causes the first locking element 31, which is preferably frictionally or positively connected to the functional element 50, in particular the proximal end 51, an axial fixation of the functional element 50th Thus, the function of the first locking element 31 is an axial movement of the functional element 50 with respect to the

To prevent actuator 20. For this purpose, the first locking element 31 may comprise a deformable material which is firmly connected to the actuating element 20. For example, the first locking element 31 a

rubbery material, for example in the form of a rubber-like tube, preferably comprising silicone. The proximal end 51 of the

Functional element 50 may at least partially submerge in the moldable material, so that a substantially positive connection is achieved. In this case, the deformation of the rubber-like material form an elastic and / or plastic deformation. The rubber-like material may be connected to the actuating element 20 cohesively or positively. For example, that can

rubber-like material glued to the actuator 20 or locked between two sleeves, which are spaced from each other on the actuator 20 are arranged. The rubbery material may partially comprise a plastic and / or partially a metal, for example in the form of a coil-like reinforcement.

Alternatively, the first locking element 31 may have one or more projections, which engage in corresponding recesses of the functional element 50, so that a positive connection between the functional element 50 and the first locking element 31 is achieved. Instead of or in addition to a positive connection, a frictional connection between the first locking element 31 and the functional element 50 may be provided. The connection between the functional element 50 and the first locking element 31 is preferably adapted such that the functional element 50 is fixed at least in the axial direction. The second locking element 32, on the other hand, effects a radial fixation of the functional element 50, in particular of the proximal end 51. Similar to the catheter 10, which forms a radial boundary for the distal end 52 of the functional element 50, the sleeve 34 or generally the second locking element 32 forms a radial boundary for the proximal end 51 of the functional element 50. In the holding state, the second locking element 32 surrounds the first

Locking element 31, wherein between the first locking element 31 and the second locking element 32, the proximal end 51 of the functional element 50 is arranged. In this way, the functional element 50 is fixed both axially and radially. The proximal end 51 of the functional element 50 can with the

Holding means 30 can be clamped or clamped, wherein the clamping between the first locking element 31 and the second locking element 32 takes place. In other words, the proximal end 51 of the functional element 50 can be frictionally clamped between the first locking element 31 and the second locking element 32.

In the release state, as shown in Fig. 5, the second locking element 32 is arranged offset relative to the first locking element 31, in particular axially offset. By the movement of the intermediate piece 40 in the proximal direction, the second locking element 32 is offset in the proximal direction with respect to the first locking element 31, so that the radial boundary for the proximal end 51 of the functional element 50 is canceled. The proximal end 51 of the functional element 50 is thus free in the radial direction and can expand. The functional element 50 unfolds completely in the following and assumes the implanted state (FIG. 6).

As can further be seen in FIG. 6, it is possible to return the actuating element 20 with the decoupling mechanism 21 completely back into the catheter 10 or the catheter 10 via the actuating element 20 and the catheter 10

Disconnect mechanism 21 to push. In this context, it should be noted that for the release of the implant or functional element 50 is generally a relative movement between the actuator 20 and the

Catheter 10 is appropriate. It is irrelevant in which direction the catheter 10 or the actuator 20 is moved as long as between the catheter 10 and the actuator 20, a relative movement takes place. In concrete terms, it is thus possible, on the one hand, to hold the actuating element 20 stationary and the catheter 10 to move or alternatively to move the actuator 20 and to hold the catheter 10 at the same time stationary.

The triggering portion 23 of the decoupling mechanism 21 is fixedly connected at both ends, on the one hand, with the proximal end 21 of the decoupling mechanism 21 and, on the other hand, with the intermediate piece 40. This results in a special shape of the trigger section 23 in the expanded state. In particular, in the expanded state, as shown in FIG. 5, the trigger portion 23 forms a camber which extends radially outward substantially midway between the proximal end 21a of the decoupling mechanism 21 and the spacer 40. Thus, in the expanded state, the triggering section 23 has essentially a longitudinal sectional contour, which resembles the shape of a Gaussian curve. This results in a substantially oblique surface of rotation on a proximal end 21a of the uncoupling mechanism 21 facing side of the trigger section 23, which facilitates the re-insertion of the trigger section 23 in the catheter 10 and the slipping over of the catheter 10 via the trigger section 23. Thus, by a simple relative movement between the actuator 20 and the catheter 10 of the trigger section 23 can be converted back into the compressed state. The decoupling mechanism 21 may thus be placed back in the catheter 10 to remove the delivery system.

As previously explained, the holding means 30 may comprise different elements. For example, as shown in Fig. 7, the holding means 30 a first

Locking element 31 having a deformable material The deformable material may be elastically and / or plastically deformable. Preferably, the deformable material is adapted such that the structure of the distal end 52 of the functional element 50 cuts into the deformable material and is thus at least partially positively connected to the first locking element 31. The deformable material preferably comprises silicone or

Polyurethane.

Another way, a positive connection between the

Forming functional element 50 and the first locking element 31 is shown in FIGS. 8 and 9. In this case, the first locking element 31 comprises a pin 33 which extends radially from the actuating element 20 or guide wire. The pin 33 is for receiving a loop 53 of the proximal end 51 of the

Functional element 50 adapted. The connection between the first Arretierungselement 31 and the functional element 50 thus takes place by the engagement of the pin 33 in a loop 53 of the functional element 50. In this case, the functional element 50, as shown in Fig. 8, on the circumference of the proximal end 51 a plurality of loops 53 include, wherein at least one Loop 53 cooperates with the pin 33. It is also possible that one or more pins 33 are arranged over the circumference of the actuating element 20 and in one or more

Loops 53 or cells or meshes of the functional element 50, in particular of the proximal end 51, engage. 9, a configuration is shown in which the functional element 50 at the proximal end 51 a single loop 53 or

Includes snare, in which engages the pin 33 and the functional element 50 thus axially locked. Instead of a pin 33, the first locking element 31 may also have a star-like or pin-like or hook-like shape. The first

Locking element 31 can be coupled to both the proximal end 51, and with a central portion of the functional element 50.

The last-mentioned configuration according to FIG. 9 is particularly advantageous in connection with a functional element 50 which has a single loop 53 arranged in a circumferential plane at the proximal end 51. The functional element 50 in this configuration may comprise, for example, a stent or a filter element. Preferably, such a functional element 50 comprises a braided lattice structure, wherein the wire elements which form the lattice mesh are brought together and twisted at the axial proximal end 51 in an oblique circumferential line such that the wire elements unite at a point which lies in the oblique peripheral plane of the functional element 50 is arranged. The wire elements are in each case twisted together and form wire strands, wherein the number of wires per wire strand increases in sections, by the axial proximal end 51 at discrete intervals in each case a further wire element of the grid structure is supplied. In this way, a uniform smooth outer edge or axial edge of the functional element 50 is provided, which completes the grid mesh in the axial direction completely circumferentially. At the same time all wire elements of the

Combined functional element 50 in a common loop 53, located in the

Extends substantially parallel to the longitudinal axis of the functional element 50 in the circumferential plane.

Due to the smooth axial edge is achieved that the functional element 50 in

Essentially fully expandable while continuing with the

Feeding system is connected. In combination with the delivery system that allows previously described functional element 50 a particularly accurate observation of the positioning, since the functional element 50 is substantially completely expandable in the blood vessel and further connected to the actuating element 20, so that the functional element 50 is repositioned as needed. At the same time, the effect of the reduction, which occurs due to the functioning of the delivery system at the release of the functional element 50, is supported, since the smooth axial edge extends substantially obliquely with respect to the central axis of the functional element 50 and thus to a time-delayed or progressive widening of the proximal end 51 of the functional element leads. During discharge, the proximal end 51 thus does not expand or expand abruptly, but rather with a time delay.

Moreover, the smooth axial edge of the proximal end 51 of the

Functional element 50, a retraction of the functional element 50 in the catheter 10 and a slipping of the catheter 10 via the functional element 50, so that the functional element 50 can be completely removed after release in the vessel again. For a detailed description of the structural design of the functional element 50 reference is made to the simultaneously filed patent application under the title "Medical device for import into a hollow organ", which dates back to the applicant. Since the functional element 50 in this embodiment has a single proximal loop 53, it is possible to "catch" the functional element 50 again after complete release or implantation, for example with a first locking element 31, which is designed as a hook or catching wire Also, forceps-like elements, such as a forceps-like holding means 30, are used to retract the fully implanted functional element 50 into the catheter 10.

In this context, it should be noted that the delivery system is disclosed and claimed both on its own and in combination with a functional element 50, in particular the functional element 50 described in detail above and described in said parallel patent application.

In Fig. 11 can be clearly seen how the supply system with the special

Functional element 50 cooperates during implantation. The functional element 50 is completely expanded in the vessel and at the same time connected to the actuating element 20, so that a repositioning or retraction of the

Functional element 50 is still possible. The decision to completely dismiss the functional element 50 and leave it in the body as a permanent implant can thus be delayed. In this way, it is possible to make the decision dependent on other factors, such as the effectiveness of a drug at the treatment site.

A variant for the triggering section 23 is shown in FIGS. 12 and 13. It can be seen that the triggering section 23 according to another

Embodiment as a radially expandable spring 24 may be formed. The radially expandable spring 24 is fixed to the proximal end 21 a of

Decoupling mechanism 21, which is formed according to FIG. 12 as a coil, and the intermediate piece 40, which is also formed as a coil connected. The radially expandable spring 24 in this case has at least one, in particular two, helical turns 25 which comprise a larger cross-sectional diameter than the coils which form the proximal end 21a or the intermediate piece 40. In particular, the cross-sectional diameter of the spiral windings 25 is formed larger than the lumen or the inner diameter of the catheter 10. In the compressed state of the trigger section 23, that is in the arrangement within the catheter 10, the radially expandable spring 24 is stretched, wherein the spiral windings 25 by the limitation that the catheter 10 forms are prevented from radial expansion. After removing the radial boundary, i. After removal of the catheter 10 from the region of the trigger portion 23, the biasing force of the radially expandable spring 24 is effective, as shown in Fig. 13. The radially expandable spring 24 acts as a tension spring, since the radial expansion leads to a shortening of the spring 24. By shortening the spring 24 is the

Between spacer 40 moves in the proximal direction and the release force generated by the trigger portion 23 thus on the holding means 30, in particular the second

Locking element 32 transmitted, which is displaced proximally with respect to the first locking element 31. Thus, the radial boundary for the proximal end 51 of the functional element 50 is released, so that the proximal end 51 can expand. The functional element 50 is thus completely released.

The spring 24 may form both the triggering portion 23 and the proximal end 21a of the decoupling mechanism 21 and the intermediate piece 40. In this case, the region of the spring 24 forming the triggering section 23 is preferably radially expandable. The areas of the spring 24 that surround the proximal end 21a of the

Decoupling mechanism 21 and the intermediate piece 40 form, are preferably rigid in the axial direction. This means that the proximal end 21a of the

Uncoupling mechanism 21 and the intermediate piece 40 is substantially no axial Experience length change. In particular, the intermediate piece 40 has

advantageously in the axial direction of a constant length, so that the

Triggering force as directly as possible to the holding means 30 is transferable. Analogously, it is expedient if the proximal end 21a of the decoupling mechanism 21 has a constant length. This prevents a shortening of the trigger section 23 in a change in length of the proximal end 21 a of

Implementing decoupling mechanism and thus the force acting on the holding means 30 release force is reduced. The fixation or rigidity of the outer regions of the spring 24 can be achieved, for example, by virtue of the fact that the spring 24 is adhesively bonded to the actuating element 20 at different points in the outer regions. The areas of the spring 24, which are arranged between the splices, are in this way in the axial direction against an extension or

Shortening blocked. Alternatively, it is possible that the radially expandable spring 24 extends only over the trigger portion 23. The proximal end 21a of the decoupling mechanism 21 and the intermediate piece 40 may be formed by additional elements. For example, two tubes may be provided, one tube forming the proximal portion 21a of the decoupling mechanism 21 and the intermediate piece 40, respectively.

Alternatively, it can be provided that the spring 24 extends to the holding means 30. The spring 24 can thus form both the trigger section 23 and the intermediate piece 40 and can be radially expandable overall. In other words, in the context of the application also a supply system for a medical

Functional element 50 which comprises a catheter 10, an actuator 20 which is longitudinally displaceable in the catheter 10, and a holding means 30 which is connectable to a proximal end 51 of the functional element 50 such that the functional element 50 in use by the actuating element 20th relative to the catheter 10 is movable. The holding means 30 is proximal with a

Decoupling mechanism 21 is connected, which exerts a release force on the holding means 30 to release the functional element 50, wherein the decoupling mechanism 21 a radially expandable spring 24 or generally a radially expandable, resilient element, in particular a tension spring, which is stretched within the catheter 10 and when released from the catheter 10 by a radial

Expansion is shortened such that the holding means 30 to complete

Releasing the functional element relative to the proximal end 51 of the

Functional element 50 moves. The spring 24, in particular the tension spring, can be connected directly to the sleeve 32, which forms the retaining means 30. One in the axial direction rigid or geometrically defined intermediate piece 40 is not mandatory. It is therefore possible that between the decoupling mechanism 21, in particular the spring 24, and the holding means 30, in particular the sleeve 32, no intermediate piece 40 is provided. An alternative approach of this embodiment is that the spring 24 forms both the decoupling mechanism 21, and the intermediate piece 40, wherein the intermediate piece 40 on the one hand in the radial direction and on the other hand in the axial direction is flexible, in particular expandable. The spring 24 thus has a distal portion which corresponds to the intermediate piece 40 of the further embodiments, wherein the distal portion is expandable and length-changeable in the axial direction. Under this aspect, that belongs

Intermediate piece 40 to the decoupling mechanism 21. The intermediate piece 40 may have the same geometric construction as the decoupling mechanism 21. Also in functional terms, there is no difference between the intermediate piece 40 and the decoupling mechanism 21. The intermediate piece 40 can therefore expand in the same way as the decoupling mechanism. Due to the length of the sleeve 32 is carried out by the sole expansion of the intermediate piece 40 and the distal portion of the spring 24 is not a complete release of

Functional element 50. Rather, the complete release of the

Functional element 50 only by the expansion of the decoupling mechanism 21, that is, a proximal portion of the spring 24 causes.

The release of the functional element 50 takes place in the aforementioned variant substantially the same as in the embodiments with a rigid

Intermediate piece 40. In particular, the functional element 50 is successively exposed and expanded by retracting the catheter 10 in the proximal direction. The expansion of the functional element 50 takes place from distal to proximal. Once the catheter tip 11 has reached the sleeve 32 or generally the holding means 30, this is discharged with the functional element 50 from the catheter 10 or

exposed. During the entire process, the relative movement between the functional element 50 and the catheter 10 takes place by a displacement of the catheter 10. The functional element 50 remains substantially stationary. As soon as the

Catheter tip 11 after further retraction, the holding means 30 has exposed, the first turn of the spring 24 is released from the catheter 10. Since the spring 24 in the discharged state has a larger cross-sectional diameter than inside the catheter, takes place by the release of the first turn of the spring 24 at the same time an expansion of the first turn. In this case, the release force of the first turn, so the spring force of the spring 24 acts on the holding means 30. By with the radial expansion of the spring 24 connected longitudinal contraction of the spring 24, the holding means 30 is moved in the proximal direction relative to the functional element 50. The path length, which covers the sleeve 32 or the holding means 30, corresponds to the travel of the previously released turns of the spring 24. Preferably, the sleeve 32 is adapted such that a complete release of the proximal end 51 of the functional element 50 from the holding means 30 after Release of more than one turn, in particular at least 2 complete turns, the spring takes place. This can be adjusted on the one hand by the pitch angle and the radial expansion, so the degree of expansion of the spring coil and on the other hand by the length of the sleeve 32. For example, the sleeve 32 may be formed so long that the proximal end 51 of the functional element 50 first slides in the sleeve 32 in the distal direction upon release of the first turns of the spring 24 or the sleeve 32 in the proximal direction via the proximal end 51 of the functional element 50 is pulled without completely dismissing the functional element 50. Only after exposing a few turns of the spring 24 from the catheter 10 is such a large spring length or spring shortening adjusted that the sleeve 32 is completely withdrawn from the proximal end 51 of the functional element 50. In this case, the first turn of the spring 24 may be considered as an intermediate piece 40. Although the first turn of the spring 24 expands or expands upon release from the catheter 10. However, the shortening of the first turn caused thereby is not sufficient to completely release the functional element 50. Rather, in the expansion of the intermediate piece 40 is a relative movement of the holding means 30 relative to the proximal end of the functional element 50. The complete

Release of the functional element 50 is effected only by the second or a further turn. The second and possibly the following turn forms the

Decoupling mechanism 21. It is expedient if the proximal end 51 rests against a proximal stop of the holding means 30 within the sleeve 32 or the holding means 30.

The expansion or partial expansion of the functional element 50 causes an increase in the frictional force between the proximal end 51 of the functional element 50 and the sleeve 32. The relative movement between the sleeve 32 and the functional element 50 therefore depends on the proximal end 51 on the interior of the sleeve 32 counteracting frictional force. Therefore, the spring 24, in particular with regard to its spring force, designed or adapted so that the frictional force between the proximal end 51 of the functional element 50 and the sleeve 32 can be overcome. The Spring force of the spring 24 is thus greater than the frictional force between the proximal end 51 of the functional element 50 and the sleeve 32nd

Overall, the spring travel or the degree of shortening of the spring 24 changes gradually when discharging or releasing from the catheter 10. The gradual change of the spring travel can be achieved with different types of spring, in each case in connection with all embodiments or in general in connection with of the invention. The decoupling mechanism or as

Decoupling mechanism suitable spring type, for example, a

expandable tube having longitudinal slots, ie with slots extending in the axial longitudinal direction of the tube and which are arranged distributed on the circumference of the tube. In the relaxed state, the central region of the tube is curved radially outward. In the stretched, d .h. in the prestressed state, the tube is substantially cylindrical. With increasing discharge of the pipe from the supply pipe, the radial expansion of the pipe gradually increases, so that the shortening of the uncoupling mechanism generated by the pipe increases gradually.

In this case, the intermediate piece 40 is formed by a distal portion of the tube, which is connected to the holding member 30. This area is partially expandable, wherein the expansion is not sufficient to fully release the functional element 50. In particular, the tube is adapted so that the

Expansion of the intermediate piece 40 and the distal portion is not sufficient to either a sufficient release force to overcome the frictional force between the holding means 30 and the proximal end 51 of the functional element 50 to apply or to provide sufficient shortening, the complete sliding out of the proximal end 51st of the functional element 50 from the holding means 30, in particular the sleeve 32 causes. Of the

Decoupling mechanism 21 is formed in this case by a proximal portion of the tube, whose expansion to complete release of the

Function element 50 leads.

Another type of spring suitable for forming the decoupling mechanism 21 and, optionally, the intermediate piece 40 may include a spring coil or a partial spring coil. A distal portion of the winding or partial turn connected to the support member 30 forms the

Spacer 40, whose expansion does not lead to a complete release of the Function element 50 leads. In particular, the expansion or expansion of the distal portion is not sufficient to either apply a sufficient release force to overcome the frictional force between the retaining means 30 and the proximal end 51 of the functional element 50 or sufficient

Shortening provide that causes a complete sliding out of the proximal end 51 of the functional element 50 from the holding means 30, in particular the sleeve 32. Only the expansion of a proximal portion of the spring coil leads either to a sufficient release force or to a sufficient spring travel, so that the functional element 50 is completely releasable.

If the decoupling mechanism is designed as a spiral spring, the rises

Spring force with the release of the first turn to the maximum value. By means of a corresponding pitch, the axial length of the first turn or of the subsequently further proximally arranged turns can be adjusted such that the spring force gradually increases as a result of the release of the coupling-off mechanism. The travel is determined by the number of turns of the coil spring. The larger the number of turns, the longer is the spring travel. The spring force is independent of the number of turns, but increases with the

Discharge rate of a single turn up to the maximum value continuously. For example, the releasable connection between the functional element 30 and the holding means 30, in particular the sleeve 32, a maximum play or a maximum displacement have, corresponding to the travel of at least one turn, so that only when releasing a proximally following turn the functional element 50 completely is exposed from the sleeve 32.

In general, the invention is not limited to a geometrically defined intermediate piece 40 whose cross-sectional diameter remains unchanged after its release from the catheter 10. The intermediate piece 40 can itself, like the

Uncoupling mechanism 21, be radially expandable. This allows that

Intermediate piece 40 a first sliding of the holding means 30 relative to the functional element 50, in particular to the proximal end 51 of the functional element 50, but without causing the complete release of the functional element 50. The expansion of the intermediate piece 40 can exert a first axial force on the holding element 30, wherein this force is insufficient to overcome the frictional force or connecting force between the sleeve 32 and the functional element. Rather, only allows the expansion and associated shortening of the decoupling mechanism 21, the Proximal to the spacer 40, the complete release of the proximal end 51 of the functional element 50 from the sleeve 32nd

It is also generally conceivable that in another variant of the

Feed system, the first locking means 31 with respect to the actuating member 20 longitudinally axially movable and the second locking element 32 with the

Actuator 20 is firmly connected. For example, the second

Locking element 32 comprise radially inwardly directed webs which are fixedly connected to the actuating element 20. The first locking element 31 in this configuration has corresponding fingers that engage in the spaces between the webs of the second locking element 32. The functional element 50 is between the first locking element 31 and the second

Arretierungselement 32 fixed. The release force acts on the first

Arretierungselement 31, whose fingers for releasing the functional element 50 from the spaces between the webs of the second locking element 32nd

slide out.

The delivery system is generally suitable for body implants, such as stents, flow diverters, filters, basket-type temporary implants, or occlusion devices, as well as implants or devices 50, in particular for laser-cut or by combined sputter-etch techniques, in particular for closed-cell functional elements 50. closed-cell structure). Moreover, the delivery system is advantageous in conjunction with covered or coated

Functional elements 50, in particular stents, can be used, wherein the coating or covering can comprise plastics and / or medicaments. The delivery system can be used to treat thrombosis, with the possibility of retractability of the functional element 50 being advantageous. For example, a stent can be used to dilate a thrombus. If the thrombus completely dissolves, for example as a result of drug treatment, the stent can be removed again via the delivery system. If the thrombus does not completely dissolve, it is possible to completely release the stent in the vessel and provide it as a permanent implant.

Preferred materials for the intermediate piece 40, in particular a hose which forms the intermediate piece, are polytetrafluoroethylene (PTFE) or fluoroelastomers, for example FEP. These materials allow high transverse axial flexibility without a pronounced axial stretch. Low axial elongation is preferred because Thus, it is achieved that the release force from the decoupling mechanism 21 is transmitted to the holding means 30 as directly as possible. The trigger section 23 or the radially expandable spring 24 may comprise nitinol or, in general, a nickel-titanium alloy. Such materials are due to the elastic

Properties that are effective in a large deformation range advantageous. The second locking element 32, in particular the sleeve 34 may also preferably comprise a nickel-titanium alloy, in particular nitinol. Alternatively, the sleeve 34 may comprise a steel, in particular medical grade stainless steel, or a radiopaque material. As X-ray visible materials are, for example, platinum, tungsten or tantalum into consideration. Other metals that are approved for use in a body are possible. Alternatively, the sleeve 34 can also be a plastic, for example polytetrafluoroethylene (PTFE), polyimide (PI), polyamide (PA), polyurethane (PU) or a thermoplastic copolyamide,

For example, PEBAX.

LIST OF REFERENCE NUMBERS

10 'catheter

11 'catheter tip

50 'functional element

10 catheters

11 Catheter tip

20 actuator

21 decoupling mechanism

21a proximal end

21b distal end

23 trigger section

24 radially expandable spring

25 spiral turn

30 holding means

31 first locking element

32 second locking element

33 pen

34 sleeve

0 intermediate piece Functional element proximal end distal end loop

Marker element blood vessel

vessel curvature

Claims

claims

A medical function element delivery system (50) comprising a catheter (10), an actuator (20) mounted in the catheter (10).

is longitudinally displaceable, and a holding means (30) which is connectable to a proximal end (51) of the functional element (50) such that the functional element (50) in use by the actuating element (20) relative to the catheter (10) is movable .

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

the holding means (30) is connected proximally to a decoupling mechanism (21) which, in order to release the functional element (50), exerts a releasing force on the holding means (30), between the

Uncoupling mechanism (21) and the holding means (30) a flexible

Intermediate piece (40) is arranged, which separates the decoupling mechanism (21) and the holding means (30) from each other and the release force from the decoupling mechanism (21) on the holding means (30) transmits to the intermediate piece (40) and the holding means (30) position the fixed proximal end (51) of the functional element (50) outside the catheter (10) before the release force acts on the retaining means (30).

2. Feed system according to claim 1,

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

the retaining means (30) comprises a first locking element (31) connected to the

Actuator (20) is firmly connected, and a second

Locking element (32) which is fixedly connected to the flexible intermediate piece (40).

3. Feed system according to claim 2,

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

the holding means (30) has a holding position and a release position, wherein the second locking element (32) in the holding position in the region of the first locking element (31) and in the release position offset from the first

Arretierungselement (31) is arranged.

4. Feeding system according to claim 2 or 3,

dadu rc hge ke nnzeichnet that the first locking element (31) can be connected to the proximal end (51) of the functional element (30) in a form-fitting and / or frictionally engaged manner.

5. Feed system according to at least one of claims 2 to 4,

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

the first locking element (31) comprises a deformable material.

6. Feeding system according to at least one of claims 2 to 5,

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

the first locking element (31) has a radially outwardly directed projection, in particular a pin (33), a pin or a hook.

7. Feeding system according to at least one of claims 2 to 6,

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

the second locking element (32) has a sleeve (34) which engages around the first locking element (31) in the holding position.

8. Feed system according to at least one of claims 1 to 7,

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

the decoupling mechanism (21) is arranged in the region of a distal end (22) of the actuating element (20).

9. Feed system according to at least one of claims 1 to 8,

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

a proximal end (21a) of the decoupling mechanism (21) is connected to the actuator (20) such that the

Decoupling mechanism (21) with the actuating element (20) is movable together, and a distal end (21b) of the decoupling mechanism (21) with the flexible intermediate piece (40) is connected, wherein between the proximal end (21a) and the distal end (21b ) a release portion (23) is arranged, which is convertible from a radially compressed state to a radially expanded state such that a release force acts on the holding means (30) to the intermediate piece (40) and / or the second locking element (32) relative to the first locking element (31) to move.

10. Feed system according to claim 9,

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

the triggering section (23) comprises a self-expandable structure, in particular a lattice structure or web structure, or a spring (24), at least partially radially expandable, in particular spiral spring.

11. Feed system according to at least one of claims 1 to 10,

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

the intermediate piece (40) and / or the proximal end (21a) of the

Decoupling mechanism (21) comprises a coil or a spring, in particular spiral spring, or a flexible hose.

12. Feed system according to at least one of claims 1 to 11,

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

the holding means (30) is remotely operable by the decoupling mechanism (21).

13. Feed system according to at least one of claims 1 to 12,

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

the release force for releasing the functional element (50) in the axial direction acts on the retaining means (30).

14. Supply system according to at least one of claims 9 to 13,

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

the trigger portion (23) is radially biased in the compressed state to automatically assume the expanded state in a position outside the catheter (10) and to generate the release force for releasing the retaining means (30).

15. Feed system according to at least one of claims 1 to 14,

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

the actuating element (20) and / or the first locking means (21) is adapted to exert a return force on the functional element (50) such that the functional element (50) moves from a position outside the catheter (10) to a position within the catheter (10). 10) is convertible. A medical function element delivery system (50) comprising a catheter (10), an actuator (20) mounted in the catheter (10).

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

the retaining means (30) is connected proximally to a decoupling mechanism (20) which releases a release force on the retaining means (30) to release the functional member (50), the decoupling mechanism (21) comprising a radially expandable spring (24), in particular a tension spring , which is stretched within the catheter (10) and when released from the

Catheter (10) is shortened by a radial expansion such that the holding means (30) for complete release of the functional element relative to the proximal end (51) of the functional element (50) moves.