WO2007054118A1

WO2007054118A1 - Occlusion device and surgical instrument and method for implanting or explanting the same

Info

Publication number: WO2007054118A1
Application number: PCT/EP2005/012132
Authority: WO
Inventors: Hans-Reiner Figulla; Friedrich Moszner; Robert Moszner; Rüdiger OTTMA
Original assignee: Occlutech Gmbh
Priority date: 2005-11-11
Filing date: 2005-11-11
Publication date: 2007-05-18
Also published as: CN101355906A; JP2009514626A; CA2627412A1; EP1971269A1; DE102005053906A1

Abstract

The invention relates to an occlusion device which consists of an interlaced structure (2) of thin wires or threads (2), the ends of the wires or threads (4) converging in a holder (10). The aim of the invention is to allow the occlusion device to be retrieved or repeatedly coupled to a surgical instrument. For this purpose, the holder (10), on its free end, has a top section (14) with an eyelet (16) in the form of a crossbore which can be received and retained by an implantation or explantation instrument (100, 200) in a form-fit manner. The invention also relates to a surgical instrument (100) for implanting or explanting an implant having said holder (10) . The surgical instrument has gripping pliers (102) the jaws (103, 104, 105) of which can be opened or closed by a push-pull system and the inside of which is configured in such a manner as to encircle the top section (14) of the holder (10) of the implant in a form-fit manner.

Description

Occlusion instrument and surgical instruments as well as procedures for their im- and

Explantation

description

The present invention relates to an occlusion device consisting of a braid of thin wires which is given a suitable final shape by means of a reshaping and heat treatment process and which can be tapered to implant or explant to the diameter of a catheter used for intravascular surgery, with a proximal retention area , a distal retention area, in which the ends of the wires or threads converge in a socket, and with a cylindrical web between the proximal retention area and the distal retention area, the two retention areas after implantation on both sides of a shunt to be closed in a septum Come as the web runs through the shunt. The invention further relates to a surgical set for implanting and explanting an implant, in particular an occlusion device described above. Finally, the present invention relates to a method for the repeatable coupling of an implant, in particular an occlusion instrument described above, to such surgical equipment.

In medical technology, efforts have long been made to non-surgically close septal defects, such as defects in the atrial septum, by means of a transvenous, interventional access, that is to say without surgery in the actual sense. Various occlusion systems with different advantages and disadvantages have been proposed, without which a specific closure system has so far not been used. could put. In the following, the various systems are called "occluder" or "occlusion instruments". In all interventional occlusion systems, a self-expanding screen system is inserted transvenously over a defect to be closed in a septum. Such a system could, for example, consist of two umbrellas, each positioned on the distal side (ie on the side further away from the center or the heart) or on the proximal side (ie on the side closer to the center) of the septum are then screwed into a double umbrella in the septal defect. In the assembled state, the closure system then usually consists of two open umbrellas, which are connected to one another via a short pin running through the defect. In such occlusion instruments known from the prior art, however, it turns out to be disadvantageous that the implantation procedure is relatively complicated, difficult and complex. Apart from the complicated implantation of the closure system in the septum defect to be closed, there is basically a risk of material fatigue with industry fracture in the umbrellas used. Furthermore, thromboembolic complications are often to be expected.

In order to ensure that the occlusion device according to the invention can be inserted by means of an introducer or a guide wire, it is provided that the end of the distal retention area has a socket which can be brought into engagement with the introducer or guide wire. It is provided that the intervention in the defect can be easily released after the positioning of the occlusion device. For example, it is possible to grasp the braid at the end of the distal retention area of the occlusion device in such a way that an internal thread is produced in the holder, with which the introducer comes into engagement. In the previously known occluder made of nitinol wire mesh, for example from AGA or JEN. meditec, the coupling to the insertion wire is designed as a screw thread. The occluder can be pushed forwards or backwards in the catheter tube using the insertion wire. After placement in the cardiac septum, the insertion wire is unscrewed and the occluder is finally released. A correction is then no longer possible.

Since the insertion wire and the coupling are relatively stiff and the catheter hits the cardiac septum at a shallow angle for anatomical reasons during the minimally invasive implantation of the occluder over the leg artery, the occluder is held in a tilted position when it is deployed and the umbrellas cannot be on both sides of the shunt. In this situation, the surgeon cannot recognize whether the occluder will assume its predetermined fit when disconnected. This results in a great deal of uncertainty for the surgeon, in particular because the uncoupled occluder cannot be repositioned minimally invasively. To minimize these decisive disadvantages of the known systems, the claim of the present invention is based, namely to give the occluder after positioning in the cardiac partition and the release from the introducer all freedom of movement for its independent development and adaptation to the cardiac partition defect to be closed, and not to be forced into a position by the introducer that it would not occupy on its own and can still be repositioned if necessary and retrieved via the introducer. Of course, other embodiments are also conceivable here. In another type of occlusion device, the so-called lock glamshell umbrella system, two steel umbrellas, preferably covered with Dacron, are provided, which are stabilized by four arms each. This type of occluder is implanted through the patient's venous access. With the lock clamshell occluder, however, it has proven to be problematic that the introducer required for the implantation must be made relatively large. Another disadvantage is that with other systems, e.g. B. the so-called "anplatzer occluder", many different occluder sizes are required to meet the respective proportions of the septum defect to be closed. It has been found, therefore, that the umbrellas do not flatten completely when inserted, if the length or the diameter of the bar used in the defect does not fit optimally, which leads to incomplete endothelialization, and it has been shown that many of the systems implanted in the patient's body have material fatigue and fractures in the metallic structures over a longer period of time due to the considerable mechanical stress This is particularly the case if there is permanent tension between the implant and the septum.

In order to overcome these disadvantages, self-centering occlusion instruments have been developed, which are inserted into the patient's body using minimally invasive procedures, for example via a catheter and guide wires, and inserted into the septal defect to be closed. The design is based on the principle that the occlusion device can be tapered to the size of the introducer or catheter used for the intravascular operation. Such a tapered occlusion device is then inserted via the catheter into the septal defect to be closed or into the shunt of the septal defect to be closed. The occluder then emerges from the catheter, whereupon the Unfold self-expanding umbrellas or retention discs that line up on both sides of the septum. The screens in turn contain, for example, fabric inserts made of Dacron or are spanned by them, which closes the defect or shunt. The implants remaining in the body are more or less completely enclosed by the body's own tissue after a few weeks to months.

An example of a self-centering occlusion device of the type mentioned at the outset and according to the preamble of claim 1 is known from WO 99/12478 A1, which is a further development of the occlusion device known under the name "Amplatzer occluder" according to US Pat. No. 5,725,552 It consists of a braid made from a multitude of fine, braided Nitinol wires in the form of a yo-jos. This braid is made in its original form as a round braid, which is both at the beginning (or at its proximal side) and at the When the round braid is further processed, these loose ends must each be gripped and welded in a sleeve. After this corresponding further processing, both the proximal side and the distal side of the finished occluder have one protruding sleeve each, into the distal and proximal retention umbrella and Dacron patches are sewn into the bridge between them. Due to the "memory effect" of the Nitinol material used, the two retention umbrellas unfold independently when they leave the catheter. This is initially done via a balloon-like intermediate stage, the retention umbrellas ultimately taking on a more or less flattened form on either side of the septum. While the umbrella is centered in the shunt to be closed, the sleeve protruding from the proximal retention area of the occluder can cause the problem that the implant used causes embolism-related problems, especially consecutive embolization it also prevents complete endothelialization of the occlusion implant.

Furthermore, an occlusion instrument consisting of a wire mesh is known from WO 95/27448 A1. However, this instrument does not have a socket, so that this occluder is not controlled or inserted in the same way using an introducer, as is the case with the instruments described above, or - in the case of an incorrect fit - removed again before uncoupling can be. The present invention is therefore based on the problem of further developing such a self-centering occlusion instrument known from medical technology and consisting of a braid in such a way that the disadvantages mentioned above can be overcome. In particular, an occlusion device is to be specified that can be used to close defects of different sizes, the implantation of the occluder being carried out in a simple manner and also an explantation, eg. B. should be possible for seat correction.

On the basis of this problem, the present invention is based on the object of specifying an occlusion instrument which, in the inserted state, is as flat as possible on the proximal side of the septal defect and can be retrieved after uncoupling if a defect is visible.

It is a further object of the present invention to provide a corresponding surgical set and a method for the repeated coupling of an occlusion device to such a surgical set.

This object is achieved according to the invention in an occlusion device of the type mentioned at the outset in that the holder has a head portion with an eyelet in the form of a transverse bore at its free end, which can be gripped and held in a form-fitting manner by an implant or explant set. As an alternative to this, the object is achieved according to the invention in an occlusion device of the type mentioned at the outset in that the mount has a head which is semi-spherically shaped as a centering sleeve in longitudinal section at its free end and has an eyelet in the form of a transverse bore and by means of a fastening loop running through the eyelet can be held in an implant or explant set.

The procedural object on which the present invention is based is alternatively achieved by the method steps of claims 18, 19 or 20.

In the present case, as a solution to the object of the invention, an entire system is disclosed, consisting of an implant in the form of an occlusion device, a matching surgical set, and a corresponding method for using that surgical set.

The advantages of the invention are, in particular, that an intravascular occlusion instrument, in particular for the treatment of septal defects, is specified, which this can be reliably gripped with a correspondingly designed surgical set for implantation surgery and can also be detached from the surgical set for checking the fit of the occlusion device, it being particularly noteworthy that the occlusion instrument has to be gripped again, for example to change its position or immediately Explant is easily possible.

To form the version of the occlusion device, three alternative embodiments are proposed according to the invention.

On the one hand, the head section of the socket can be designed as a spherical head, the inner sides of the jaws of the gripping tongs of the surgical equipment being designed in accordance with the shape of the spherical head in such a way that positive engagement of that ball head with the gripping tongs of the surgical equipment is ensured. So that the ball head can easily be gripped again after the connection between the surgical set and the occlusion device has been released, the surgical set has a guide thread or guidewire which, in the delivery state of the surgical set, has a loop from the gripping pliers of the surgical set at its proximal end protrudes and both of its loose ends are held by the surgeon in the area of the handle of the surgical set or previously attached there. With this guide thread or guide wire, it is easily possible to unerringly connect the gripping pliers of the surgical instruments to the head section of the socket of the occlusion device and thus to grip the occlusion device again - for example for repositioning or explanting.

According to a second embodiment of the version of the occlusion device, the eyelet of the head is slit obliquely from the section to the transverse bore, the ends of the oblique slot overlap with respect to the longitudinal direction of the transverse bore. This makes it possible to hang the guide thread or guide wire, which protrudes in the delivery state of the surgical set at the proximal end in the form of a loop from the gripper, through the oblique slot into the eyelet of the socket of the occlusion device, the overlapping ends of the oblique slot for this ensure that the guide thread or guide wire cannot escape unintentionally from the eyelet, and in particular not after the guide thread or guide wire has been tensioned by the operator, and nevertheless can be intentionally moved out of the eyelet by inclining the loop.

Preferably, the exit cut surfaces of the transverse bore on both sides are designed to converge with the lateral surface of the spherical head toward the free end of the socket. det. This has the advantage that there are no sharp edges that could damage the guide thread or guide wire, and moreover threading the loop of the guide thread or guide wire through the eyelet of the socket of the first exemplary embodiment is easier. Finally, however, the converging design of the exit cut surfaces of the transverse bore saves material and weight.

According to a third embodiment of the version of the occlusion device, the head section is shaped as a centering sleeve which is semispherical in longitudinal section and also has an eyelet in the form of a transverse bore. To connect to the corresponding surgical cutlery, a fastening loop, for example made of surgical suture material, is pulled through the eyelet and, in compliance with a defined width of the securing loop, both ends are knotted and hung on the hook of the corresponding surgical cutlery. While in the first and the second embodiment of the head, the guide thread or guide wire was tensioned manually by the operator by pulling on one or both loose ends of the guide thread or guide wire from the section of the holder, the fastening loop is tensioned in the third embodiment, by pulling the hook back inside the surgical set.

The pushing and pulling system of the surgical kit for the first and second embodiment preferably includes the following components: a spiral spring, through the interior of which an axially sufficiently stiff but nevertheless sufficiently flexible actuating means runs, on the proximal end of which a shaft of the gripping pliers is fastened, and at its distal end a first handle. Furthermore, the push and pull system includes a tapered sleeve, in the proximal end section of which the shaft of the gripping pliers is axially displaceably received, and in the distal end section of which the proximal end of the coil spring is received in abutment against a stop. Finally, a second grip piece is also included, in which the distal end of the coil spring is received abutting against a stop, the gripping jaws closing due to the force of the coil spring by the proximal end face of the conical sleeve and opening by pushing the actuating means open. The advantages of this push and pull system are essentially the simplicity and the associated reliability of its components and the safe gripping and releasing of the socket of the implant. The guide thread or guide wire, which protrudes in the delivery state of the surgical set at its proximal end in the form of a loop from the gripping pliers, and which is guided with both loose ends through the inside of the conical sleeve and the inside of the coil spring to the first handle at the distal end of the surgical set , In the first exemplary embodiment of the holder, its loop is guided through the eyelet of the holder of the implant and attached to the gripping pliers before the implant is implanted. Tensioning the guide thread or guide wire leads to a connection of the surgical set to the socket of the occlusion device, which can be done repeatedly while maintaining the connection. Thus, the connection between the surgical set and the occlusion device can, for example, first be released - apart from the guide thread or guide wire - in order to check the fit of the implant, and can be easily restored with the help of the guide thread or guide wire if the seat of the Changed the implant and thus the version of the implant must be gripped again with the surgical set. In the event that it is necessary to explant the implant again, a simple restoration of the connection between the surgical set and the implant is possible. In contrast, in the second exemplary embodiment, the loop is hooked into the eyelet through the oblique slot and not, as in the first exemplary embodiment, is passed through the eyelet.

In both the first embodiment and the second embodiment of the socket, a first loose end of the guide thread or guide wire can be fastened in the region of the first handle, while the second loose end of the guide thread or guide wire is provided with a nipple, with the aid of which the Guide thread or wire can either be tensioned when the implant is coupled or can be pulled out of the surgical set after the connection of the first end to the handle has been released. In the second embodiment of the socket, the loop of the guide thread or guide wire can be moved out of the eyelet through the oblique slot after at least one loose end of the guide thread or guide wire has been loosened.

The guide thread or guide wire preferably consists of nitinol wire, from which, for example, the braid of the occlusion device itself can also be made. Nitinol has proven to be a proven material for such procedures.

For the third embodiment of the version of an occlusion device, surgical equipment with a hook is provided, which is axially connected by means of a push and pull system can be moved towards or away from the eyelet, using a fastening loop that runs through the eyelet and can be hooked into the hook, by means of which the implant can be held by tensioning the fastening loop on the surgical equipment when the hook moves away from the eyelet becomes. The advantage of this embodiment of the surgical set is, in particular, that the guide thread or guide wire described in the other two embodiments is replaced by the fastening loop and, as a result, it is no longer necessary to pull the loose ends of the guide thread or guide wire to tension the entire device , but this tensioning is done by pulling back the hook, which can be done by suitable operation of the surgical set.

For the third embodiment of the surgical set, the push and pull system essentially has the following components: A coil spring, through the interior of which an axially sufficiently stiff but nevertheless sufficiently flexible actuating means runs, to the proximal end of which a shaft of the hook is attached is, and at the distal end of a first handle is attached; a cylindrical sleeve, in the distal end portion of which the proximal end of the coil spring is received abutting against a stop and in which the shaft of the hook is received so as to be axially displaceable; and a second handle, in which the distal end of the coil spring is received abutting against a stop, the hook being able to move axially away from the eyelet under the force of the coil spring and being moved towards the eyelet by advancing the actuating means. This push and pull system also enables very easy and reliable handling of the occlusion device before and during the surgical procedure.

In order to further simplify the connection of the fastening loop running through the eyelet of the socket of the occlusion device to the pushing and pulling system, it is preferably provided that the cylindrical sleeve has a continuous first longitudinal groove on the proximal end face, and a one-sided second longitudinal groove in the central area for torsion-proof guidance of the axially movable hook in the sleeve, and at right angles to the one-sided second longitudinal groove, a transverse groove which extends to the longitudinal axis of the sleeve and has an extension in the middle for receiving a knot of the fastening loop. The extension to accommodate the knot of the attachment chimney also ensures, among other things, that the attachment loop has a tight fit within the transverse groove. In order to ensure that the hook is securely gripped by the hook, it is preferably provided that the cross section of the front section of the hook is flattened by approximately one third compared to the cross section of the shaft and fits into the second longitudinal groove of the cylindrical sleeve with play.

A knife edge is provided at the distal end of the window formed behind the hook to separate the connection between the surgical set and the mount of the implant.

A wire rope is advantageously used as the material for the actuating means of the surgical equipment. However, any other material that is axially sufficiently stiff but still sufficiently flexible could also be used.

In the following, the three mentioned exemplary embodiments of an occlusion instrument and correspondingly three exemplary embodiments of an operating set as well as the three different methods for the repeatable coupling of an implant or occlusion instrument to the respective operating set are described in more detail with the aid of a drawing. Embodiment 1 is shown in FIGS. 1 to 7, embodiment 2 in FIGS. 8 to 14, and embodiment 3 in FIGS. 15 to 24.

Show it

1 is a side view of a first embodiment of an occlusion device with a corresponding surgical set according to embodiment 1;

FIG. 2 shows an enlarged sectional illustration of the partial section “A” according to FIG. 1;

3 shows a perspective illustration of an exemplary occlusion device;

Fig. 4 is an enlarged side view of a first embodiment of a

Version of the occlusion device;

FIG. 5 shows a perspective illustration of the holder according to FIG. 4; Fig. 6 is an enlarged detail view of the gripping pliers with guide wire and

Version of an occlusion device;

7 shows a view of the front section of the surgical set and an occlusion instrument with a loop pulled through;

8 is a side view of a surgical set with occlusion device on the guide thread or wire according to a second embodiment;

9 shows a partial sectional illustration of the front section of the surgical set with the occlusion instrument on the guide thread or wire according to FIG. 8;

10 is an enlarged side view of a socket of an occlusion device in accordance with embodiment 2;

FIG. 11 shows a perspective illustration of the holder according to FIG. 10;

12 shows a simplified view of the front section of the surgical set with gripping tongs and guide thread or wire and occlusion instrument;

FIG. 13 shows an enlarged detailed view of section “A” according to FIG. 12;

Fig. 14 is a view of the front section of the surgical set with gripping pliers and Occlusiotisinsttumefit with attached! Guide wire loop;

15 is a shortened sectional view of a surgical set with attached occlusion device according to embodiment 3;

FIG. 16 is a partial sectional view according to “B” in FIG. 15;

Figure 7 shows a section through the front portion of the surgical set with a coupled occlusion device. 18 is an enlarged side view of the socket of an occlusion device according to embodiment 3;

FIG. 19 shows a perspective illustration of the holder according to FIG. 18;

20 is an enlarged perspective view of the cylindrical sleeve according to Embodiment 3;

FIG. 21 is an enlarged perspective view of the hook according to FIG. 17;

22 shows a perspective illustration of the front section of the surgical set according to the third embodiment with a connected socket of an occlusion device;

FIG. 23 is a perspective view similar to FIG. 22; and

24 is an enlarged perspective view of the front section of the surgical set according to embodiment 3 with an occlusion instrument for showing the coupling by means of a fastening loop.

1 and 2 show a side view and a partial step of a first exemplary embodiment of a surgical set 100 for implanting and explanting an implant, which is coupled to an occlusion instrument 1 as an example of an implant. The surgical set 100 has gripping tongs 102, the gripping jaws 103, 104, 105 of which can be opened and closed by means of a push and pull system. The inner surfaces of the gripping jaws 103, 104, 105 are designed in such a way that they can positively engage around the spherical head-shaped head section 14 of the socket 10 of the implant. The push and pull system essentially has the following components: A spiral spring 106, by means of which An axially sufficiently stiff but nevertheless sufficiently flexible actuating means 107 runs in the inner axial direction, on the proximal end of which a shaft 111 of the gripping pliers 102 is attached, and on the distal end of which a first connecting piece 108 is attached. Furthermore, the pushing and pulling system has a tapered sleeve 109, in the proximal end section 112 of which the shaft 111 of the gripping pliers 102 is received in an axially displaceable manner, and in the distal end section 113 of which the proximal end of the spiral spring 106 is received abutting a stop 114. Of furthermore, the push and pull system essentially has a second grip piece 110, in which the distal end of the spiral spring 106 is received in abutment against a stop, the gripping jaws 103, 104, 105 passing through the proximal end 115 of the conical sleeve 109 lying on the outside close under the force of the coil spring 106 and open by advancing the actuating means 107. As a particularly essential component, this surgical set 100 has a guide thread or guide wire 116 which, in the delivery state of the surgical set 100, protrudes at the proximal end in the form of a loop 117 from the gripping pliers 102, and which has two loose ends 118, 119 through the inside of the conical sleeve 109 and the inside of the spiral spring 106 is guided to the first grip piece 108 at the distal end of the surgical set 100, the loop 117 being able to be passed through the eyelet 16 of the socket 10 of the implant before the implant is implanted and fastened to the gripping pliers 102 at a fastening point 101 . The guide thread or guide wire 116 has a first loose end 119, which can be fastened in the region of the first handle 108, and a second loose end 118, which is provided with a nipple 120, with the aid of which the guide thread or wire 116 either can be tensioned in the coupled state of the implant or can be pulled out of the surgical set 100 after the connection of the first end 119 to the first grip piece 108 has been released. This pulling out of the guide thread or guide wire from the surgical set 100 only takes place when the implanted occlusion instrument has the seat desired by the surgeon. If this is not the case, the guide thread or guide wire 116 is used so that the surgeon can easily reconnect the gripping tongs 102 of the surgical instruments 100 to the head section 14 of the socket 10 of the occlusion device 1, i.e. the gripping jaws 103, 104, 105 of the gripping tongs 102 can grip the spherical head-shaped head portion 14 of the socket 10 securely and positively.

3 shows an occlusion device, for example, which can be provided with a holder 10 according to the invention. This occlusion instrument essentially consists of a braid 2 of thin wires or threads 4, which is given a suitable final shape by means of a reshaping and heat treatment process and can be tapered to the diameter of a catheter 5 used for an intravascular surgical procedure for implantation or explanting. The occlusion device has a proximal retention area 6, and a distal retention area 8, in which the ends of the wires or threads 4 converge in a socket 10, and a cylindrical web 12 between the proximal retention area 6 and the distal retention area 8, the two retention areas 6, 8 after implantation come to rest on both sides of a shunt to be closed in a septum, while the web 1 runs through the shunt. The occlusion instrument is thus particularly suitable for the treatment of septal defects, the instrument being suitable for delivery via a catheter 5 to the defect to be closed. The fact that the proximal retention area 6 of the braid 2 has a disk-shaped flattening that is single-layered toward the proximal end of the occlusion instrument can be achieved in a particularly advantageous manner that the occlusion instrument is independent of the proportion of the diameter of the defect to be closed and Regardless of the thickness of the septum wall, it adapts itself to the defect in the septum wall in such a way that on the proximal side of the defect no parts of the occlusion device protrude beyond the plane in which the septum wall with the defect lies. The usual complications associated with this no longer occur. In other words, the occlusion instrument used is completely enclosed by the body's own tissue much faster than in the closure systems known from the prior art. The use of a braid made up of thin wires or threads as the starting material for the occlusion device according to the invention leads to the further advantage that it has long-term mechanical stability. This largely prevents the occurrence of breaks in the structure of the implant used. The braid also has sufficient rigidity. The disc-shaped configuration of the braid 2 towards the proximal end without a hub additionally allows the proximal retention area 6 of the occlusion device to flatten completely in the inserted state at the edge of the defect. Accordingly, the occlusion device can be used over a wide range of septum defects of different sizes. Because the braid 2 can be tapered to the diameter of a catheter used in tra vascular surgical interventions, it is possible to insert the occlusion device, for example through a vein, so that an open operation in the actual sense is no longer necessary. Since the braid 2 consists of a material with a shape memory or "memory" effect, the occlusion device can also be referred to as a "self-expanding instrument", which unfolds automatically after it emerges from the catheter, so that the two retirees tion areas 6, 8 corresponding to the proximal or distal defect side.

FIG. 4 shows an enlarged side view of a first exemplary embodiment of a holder 10 of such an occlusion device. This socket 10 has at its free end a head portion 14 with an eyelet 16 in the form of a transverse bore, wherein the head section 14 can be positively gripped and held by the surgical set 100.

FIG. 5 shows a perspective illustration of the socket according to FIG. 4. On the basis of this illustration it can be seen that the exit cut surfaces 18, 20 on both sides of the transverse bore are designed to converge towards the free end of the socket 10 towards the free end of the socket 10.

FIG. 6 shows an enlarged detailed view of the surgical set 100 with the guide wire 116 running through the eyelet 16, which is suspended in the form of a loop 117 on the shaft 111 of the gripping tongs 102 (cf. FIG. 2, attachment point 101). It can be seen from this illustration that the gripping pliers 102 are provided with an outer cone in the front area and are divided into three gripping jaws 103, 104, 105 by means of longitudinal grooves, which closes when the conical shaft rests against the proximal end 115 of the conical sleeve 109. The gripping jaws 103, 104, 105 are turned out in a shell-shaped manner in order to be able to grip the spherical head-shaped head section 14 of the holder 10 in a form-fitting manner. The shaft 111 of the gripping tongs 102 is flattened in order to be able to pass the loop 117 of the guide thread or guide wire 116 inside the conical sleeve 109. The loop 117 is prepared in such a way that it protrudes from the gripping tongs 102 in the delivery state (see FIG. 7). The loose ends 118, 119 of the guide thread or guide wire 116 are guided through the slots of the gripper pliers 102 and through the spiral spring 106 and are fastened to the first handle piece 108 of the handle, the first loose end 118 additionally being provided with a nipple 120 which allows the guide thread or wire to be gripped and tensioned more easily.

7 shows a simplified view of the front section of the surgical set 100 with the conical sleeve 109, the gripping tongs 102, the spiral spring 106 and the actuating means 107. Front of the gripping tongs 102 and already guided through the eyelet 16 of the head from section 14 of the socket 10 the loop 117 of the guide thread or wire 116 can be seen. The section highlighted by the circle “A” represents the enlarged detailed view according to FIG. 6.

To connect the occlusion device 1, the loop 117 of the guide thread or '. -di-aliis 116 fetched through the eyelet 16 and suspended from the shaft 111 of the gripping tongs 102 at a fastening point 101 (see FIG. 2) provided for this purpose. The thread or wire material of the guide thread or wire 116 forming the loop 117 runs in each case in a slot between the gripping jaws 103, 104 and 105, while rend the trailing ends in the third slot between the jaws 104, 105. If the gripping pliers 102 are pulled back into the conical sleeve 109 by tensioning the guide thread or wire 116, the loop 117 can no longer unhook. The loop 117 is then pulled on the nipple 120 until the spherical head-shaped head section 14 of the holder 10 sinks into the gripping jaws 103, 104, 105 of the gripping pliers 102. The other loose end 119 of the guide thread or wire 116, which is not provided with the nipple 120, is fastened in a suitable manner in the region of the second grip piece 108.

A method for the repeatable coupling of an implant with a socket 10 described above, in particular an occlusion device 1, to the surgical set 100 is described below:

In a first step, the loop 117 of the guide thread or guide wire 116 is guided through the eyelet 16 of the socket 10 of the implant before the start of the intravascular operation and suspended from the gripper pliers 102 at a fastening point 101 provided for this purpose, while the first and second are loose End 119, 118 of the guide thread or guide wire 116 are held or fastened in the area of the first handle 108. In a second step, the head section 14 of the socket 10 of the implant is gripped with the gripping pliers 102. In a third step, the second loose end 118 of the guide thread or guide wire 116 provided with the nipple 120 is stretched until the head section 14 is completely accommodated in the gripping jaws 103, 104, 105. By loosening the second loose end 118 provided with the nipple 120, the gripping pliers 102 can be released again from the head section 14 of the implant and the fit of the implant can be checked. With the help of the guide thread or wire 116, the gripping pliers 102 can be reconnected to the socket 10 of the implant at any time.

8 and 9 show a shortened side view and a partial section of a second embodiment of a surgical set 200 with an occlusion instrument 1 to be coupled, which has a holder 10 of a second embodiment of the present invention. The same components of the surgical set 200 and the occlusion device 100 are again provided with the reference numerals of FIGS. 1 and 2. The difference between this second embodiment of the occlusion device 1 or the second embodiment of the surgical set 200 and the same parts of the first embodiment consists in the design of the head section 14 of the socket 10 of the occlusion device 1 and in the application and Guide of the guide thread or guide wire 116, which is already clear from FIG. 9: There the loop 117 of the guide thread or wire 116 is not guided with both threads or wires through the eyelet 16 of the head from section 14, but rather runs only with a thread through that eyelet 16 and is otherwise guided with its two loose ends 118, 119 through the interior of the conical sleeve 109 and the interior of the spiral spring 106 to the first handle 108 at the distal end of the surgical set 200. The connection of the guide thread or wire 116 to the head section 14 of the socket 10 is described below with reference to FIGS. 10 and 11.

10 and 11 show an enlarged side view (FIG. 10) and a perspective view (FIG. 11) of a second exemplary embodiment of a holder 10 of an occlusion device 1. This second exemplary embodiment differs from the first exemplary embodiment according to FIGS. 4 and 5 in that the eyelet 16 of the head section 14 is slotted obliquely to the transverse bore, the ends 22, 24 of the oblique slot 26 overlapping with respect to the longitudinal direction of the transverse bore. Otherwise, this second exemplary embodiment of the head also has a spherical head shape from section 14, and the mutually exit cut surfaces 18, 20 of the transverse bore with the lateral surface of the spherical head are designed to converge towards the free end of the socket 10. Because the eyelet 16 has an oblique slot 26, the loop 117 of the guide thread or guide wire 116 can be moved into the eyelet 16 without having to thread a loose end 118, 119 of the guide thread through the eyelet 16 or else the entire loop 117 pass through the eyelet 16 and have to hang on the shaft 111 of the gripper 102. The oblique slot 26 thus enables the loop 117 to be attached particularly easily.

The eyelet 16 has the advantage that the loop 117 can be removed at any time in the same way, namely when the operator has determined that the occlusion instrument 1 is correctly seated and the surgical set 200 is to be finally released from the occlusion instrument 1. For this purpose, the loop 117 is withdrawn from the eyelet 16 and from the entire surgical set 200 as in the first exemplary embodiment by pulling on one of the loose ends 118, 119, but preferably on the second loose end 118 provided with the nipple 120.

12 shows a simplified illustration of the front section of the surgical set 200 with the loop 117 protruding from the tip of the gripping tongs 102 and the occlusion instrument 1 to be coupled, all according to the second embodiment. 13 shows an enlarged detailed view of the gripping tongs 102 with the loop 117 of the guide thread or guide wire 116 projecting between the gripping jaws 103, 104, 105 (the gripping jaws 104, 105 are not visible in this illustration).

FIG. 14 shows a representation similar to FIG. 12, with the surgical set 200 already being connected to the occlusion instrument 1 in FIG. 14.

The push or pull system of the second embodiment of the surgical set 200 consists of the same components as described above for the first embodiment.

The method for the repeatable coupling of an implant with a socket 10 of the second exemplary embodiment, in particular an occlusion device 1, to an operating set 200 according to the second exemplary embodiment is described below: In a first step, the loop 117 of the guide thread or guide wire 116 before the start of the intravascular surgical intervention, it is inserted through the slot 26 into the eyelet 16 in the socket 10 of the implant, while the first and second loose ends 119, 118 of the guide thread or guide wire 116 are held or in the area of the first handle 108 are attached. In a next step, the head section 14 of the holder 10 is gripped with the gripping pliers 102. Then the 2 wide loose end 118 of the guide thread or guide wire 116 provided with the nipple 120 is tensioned until the head section 14 is completely accommodated in the gripping jaws 103, 104, 105. By loosening the second loose end 118 provided with the nipple 120, the gripping pliers 102 can be released again from the head section 14 of the implant and the fit of the implant can be checked. With the help of the guide thread or guide wire 116, a re-coupling of the gripping pliers 102 to the socket 10 of the implant is possible at any time. If the occlusion instrument 1 is to be finally separated from the surgical set 200, the guide thread or wire 116 will be pulled out of the surgical set by pulling on the second loose end 118 provided with the nipple 120. When pulling out, it is important that the loop 117 is flexible enough to wind around the narrow radii and the deflection points on the eyelet 16 or the gripping tongs 102 have no sharp edges. With regard to the eyelet 16, this is ensured, as described above, by the fact that the exit cut surfaces 18, 20 of the transverse bore on both sides are designed to converge with the lateral surface of the ball head toward the free end of the socket 10. In addition, the use of thin, super elastic Nitinol wire as a guide tion thread or wire 116 is particularly suitable, although surgical sutures can also be used.

FIGS. 15, 16 and 17 show a shortened sectional view (FIG. 15) as well as a perspective detailed view according to circle “B” in FIG. 15 and a sectional view through the front area of an operating set 300 with an occlusion instrument 1, all in the third The surgical set 300 essentially has a hook 302 which can be moved axially towards or away from the eyelet 16 of the head section 14 of the socket 10 of the occlusion device 1 by means of a pushing and pulling system, and a hook which extends through the eyelet 16 and attachment loop 301 which can be hooked into the hook 302 and by means of which the implant can be held by tensioning the attachment loop 301 on the surgical set 300 when the hook 302 is moved away from the eye 16. In this case, the push and pull system essentially has the following components on: First a spiral spring 106, through the inside of which is axially sufficiently steep in the axial direction Firm, but nevertheless sufficiently flexible actuating means 107 extends, on the proximal end of which a shaft 303 of the hook 302 is attached, and on the distal end of which a first grip piece 108 is attached. Furthermore, the push and pull system essentially has a cylindrical sleeve 304, in the distal end section 113 of which the proximal end of the spiral spring 106 is received abutting against a stop 114, and in which the shaft 303 of the hook 302 is received in an axially displaceable manner, and in which the shaft 303 of the hook 302 is received in an axially displaceable manner. Finally, the push and pull system of this third exemplary embodiment also includes a second handle 110, in which the distal end of the spiral spring 106 is received abutting against a stop, the hook 302 moving axially away from the eyelet 16 under the force of the spiral spring 106 and can be moved towards the eyelet 16 by advancing the actuating means 107.

18 and 19 show an enlarged side view and an enlarged perspective view of the third embodiment of a socket 10 of the occlusion device 1. This third exemplary embodiment differs from the other two exemplary embodiments in that the socket 10 is semi-spherical in longitudinal section at its free end has a head section 14 designed as a centering sleeve with an eyelet 16 in the form of a transverse bore and the holder 10 can be held on the surgical set 300 by means of a fastening loop 301 running through the eyelet 16 (cf. FIGS. 16 and 17). 20 shows a perspective view of the cylindrical sleeve 304 of the surgical set 300 according to the third embodiment. The cylindrical sleeve 304 has a continuous first longitudinal groove 306 on the proximal end face 304, and a one-sided second longitudinal groove 307 in the central region for rotation-proof guiding of the axially movable hook 302, and at right angles to the one-sided second longitudinal groove 307, a transverse groove 308 which extends to the longitudinal axis of the sleeve 304 and has an extension 309 in the center for receiving a knot 311 of the fastening loop 301. The second longitudinal groove 307 is designed such that it penetrates the circumference of the sleeve 304 from the outside diameter to the inside diameter.

21 shows a perspective illustration of the hook 302 with its shaft 303. The cross section of the front section of the hook 302 is flattened by approximately one third compared to the cross section of the shaft 303, which is denoted by the reference symbol 314. As a result, that flattened front section of the hook 302 fits into the second longitudinal groove 307 of the cylindrical sleeve 304 with play (FIG. 20). A material-free window 315 is formed behind the tip of the hook 302 and has a knife edge 310 at its distal end.

22 shows a perspective illustration of the front section of the surgical set 300, which is loosely coupled to the holder 10 of the occlusion device 1 by means of the fastening loop 301. For this purpose, the fastening loop 301 is inserted into the transverse groove 308 such that the knot 311 of the fastening loop 301 comes to lie in an extension 309 of the transverse groove 308, while the thread of the fastening loop 301 crosses the cylindrical sleeve 304 in the transverse groove 308 diametrically. The transverse groove 308 is designed such that the knot 311 of the attached fastening loop 301 cannot escape laterally.

FIG. 23 shows a representation similar to FIG. 22, although the hook 302 inserted into the cylindrical sleeve 304 can be seen in broken lines. By defined advancement of the hook 302, the fastening loop 301 slips over the tip of the hook while evading into the second longitudinal groove 307 and remains in the window 315 formed behind it. The knot of the fastening loop 301 is located in one of the lateral chambers which are formed by the flat 314 of the hook 302. By pulling back the hook 302, the occlusion instrument 1 with its holder 10 is pulled onto the front side 305 of the cylindrical sleeve and clamped with the surgical set 300. The fastening loop 301 runs out of the continuous first longitudinal groove 306 on both sides and along the circumference of the sleeve 304 until it is again guided inwards on the transverse groove 308 and behind the hook 302. Thus, the occlusion device 1 is coupled to the pushing and pulling system of the surgical set 300 without play and can be inserted into a catheter 5 (not shown here).

For the final uncoupling of the occlusion device 1 from the surgical set 300, the stops 312, 313 located in the second handle HO are released, the hook 302 being able to be pushed further forward in a defined manner. The knife edge 310 arranged at the distal end of the window 315 behind the tip of the hook 302 is used. When the surgical set is withdrawn, the fastening loop 301 is stretched diametrically within the transverse groove 308 and can thus be severed from the knife edge 310 by advancing the hook 302. As a result, when the surgical equipment 300 is withdrawn, the knotless end of the fastening loop 301 loosens from the eyelet 16 of the socket 10, the other end of the fastening loop 301 with the knot 311 inevitably remaining within the transverse groove 308 and thus on the hook 302.

FIG. 24 shows a representation similar to FIG. 23, the occlusion instrument 1 also being shown on the socket 10, which is suspended in the transverse groove 308 of the sleeve 304 by means of the socket 10 and by means of the fastening loop 301.

The method for the repeatable coupling of an implant with a socket 10 of the third embodiment, in particular an occlusion device 1, to a surgical set 300 is described in more detail below:

In a first method step, a fastening loop 301 of a defined length is fastened to the eyelet 16 of the socket 10 of the implant. The fastening loop 301 is then inserted into the transverse groove 308 of the cylindrical sleeve 304 in such a way that the knot 311 of the fastening loop 301 fits centrally through the extension 309 and the section of the fastening loop 301 coming into the transverse groove 308 is held diametrically. By defined advancement of the hook 302, the section of the fastening loop 301 lying in the transverse groove 308 then slips into the second longitudinal groove 307 over the hook 302 and remains anchored there. By pulling back the hook 302, the socket 10 of the Itnphntati is pulled to the proximal face 305 of the sleeve 304 and clamped. By pushing the hook 302 again in a defined manner, the fastening loop 301 becomes loose again and the proximal end face 305 of the sleeve 304 detaches from the holder 10 and the fit of the implant can be checked. With the aid of the attachment loop 301, a reconnection can development of the sleeve 304 to the socket 10 of the implant possible. The following measures prevent inadvertent detachment of the occlusion device 1 from the surgical set 300: First, the fastening loop 301 cannot itself slide off the hook 302 when it is tensioned. Second, the fastening loop 301 cannot slide off the hook 302 even in the loose state, since the hook opening is closed by the sleeve 304 surrounding it. Third, the hook 302 is secured against rotation within the second longitudinal groove 307 of the sleeve 304, so that the hook opening cannot lie in front of the transverse groove 308 either. Fourth, the knife edge 310 remains behind the transverse groove 308 in the state secured by the stops 312, 313 in the second handle 110 and cannot touch or sever both the untensioned and the tensioned fastening loop 301. Finally, the knife edge 310 in the window 315 of the hook 302 can only be guided against the tensioned fastening loop 301 in a conscious and deliberate interaction of the actuating elements of the surgical equipment 300 and by its slight retraction, in order to cut through it. Only when the surgical equipment 300 is slightly withdrawn does the fastening loop 301 tighten diametrically through the transverse groove 308 and only by defined advancement of the hook 302 with its knife edge 310 can the fastening loop 301 be severed.

B e 2 "g s z e i c h e n

1 occlusion device

2 braid

4 wires or threads

5 catheters

6 proximal retention area

8 distal retention area

10 version

12 bridge

14 head section

16 eyelet

18, 20 exit cut surfaces 2, 24 ends of 14 6 oblique slot

100, 200, 300 implantation or explantation set / surgical set

101 attachment point for 117 to 102

102 gripping pliers

103, 104, 105 gripping jaws

106 coil spring 07 actuating medium

108 first grip piece 09 tapered sleeve 10 second grip piece 11 shaft 12 end section 13 end section 14 stop in 109 15 proximal end face v. 109 16 guide thread or guide wire 17 loop 18, 119 ends of 116 20 nipple 01 fastening loop 02 hook 03 shaft of 302 04 sleeve 305 proximal face

306 first longitudinal groove

307 second longitudinal groove

308 transverse groove

309 extension

310 knife edge

311 nodes from 301 312, 313 strokes in 110

314 flattening

315 windows behind 302

Claims

Expectations

1. Occlusion instrument, consisting of a braid (2) of thin wires or threads (4), which is given a suitable final shape by means of a reshaping and heat treatment process and is suitable for implantation or explantation of the diameter of one, inttavascular. Operational intervention used to taper catheter (5), with a proximal retention area (6), a distal retention area (8), in which the ends of the wires or threads (4) converge in a socket (10), and with a cylindrical web (12 ) between the proximal retention area (6) and the distal retention area (8), the two retention areas (6, 8) coming to rest on both sides of a shunt to be closed in a septum after the implantation, while the bar (12) passes through the shunt runs,

characterized by that s

the fit (10) has a head at its free end (14) with an eyelet (16) in the form of a transverse bore, which can be gripped and held in a form-fitting manner by an implant or explant set (100; 200).

2. Occlusion instrument according to claim I ₅

characterized in that s the head section (14) is designed as a spherical head.

3. occlusion device according to claim 1 or 2,

characterized in that s

the mutual exit cut surfaces (18, 20) of the transverse bore with the lateral surface of the ball head are designed to converge towards the free end of the socket (10).

4. occlusion device according to one of claims 1 to 3,

characterized by the fact that s

the eyelet (16) is slotted obliquely to the transverse bore, the ends (22, 24) of the oblique slot (26) overlapping with respect to the longitudinal direction of the transverse bore.

5. Occlusion instrument, consisting of a braid (2) of thin wires or threads (4), which is given a suitable final shape by means of a reshaping and heat treatment process and which can be implanted or explanted to the diameter of a catheter (5) used for an intravascular surgical procedure. tapered, with a proximal retention area (6), a distal retention area (8) in which the ends of the wires or threads (4) converge in a socket (10), and with a cylindrical web (12) between the proximal retention area ( 6) and the distal retention area (8), the two retention areas (6, 8) coming into contact in a septum on both sides of a shunt to be closed after the implantation, while the web (12) runs through the shunt,

characterized by t, the s

the socket (10) has at its free end a longitudinal section semi-spherically designed as a centering head section (14) with an eyelet (16) in the form of a transverse bore and by means of a through the eyelet (16) extending loop (301) on an im or Explantation set (300) can be kept.

6. surgical equipment (100; 200) for implanting and explanting an implant with a holder (10) according to one or more of claims 1 to 5, in particular an occlusion device,

marked by

a gripping pliers (102), the gripping jaws (103, 104, 105) of which can be opened and closed by means of a pushing and pulling system and which are designed on the inside such that they can positively grip around the head section (14) of the socket (10) of the implant.

7. surgical set (100; 200) according to claim 6,

characterized by the fact that s

the push and pull system essentially has the following components: a spiral spring (106), through the interior of which an axially sufficiently stiff but nevertheless sufficiently flexible actuating means (107) runs in the axial direction, at the proximal end of which a shaft (111) of the gripping pliers ( 102), and a first handle (108) is attached to the distal end thereof; a conical sleeve (109), in the proximal end section (112) of which the shaft (111) of the gripping pliers (102) is axially displaceably accommodated, and in the distal end section (113) of which the proximal end of the spiral spring (106) against a stop (114) is received shockingly; and a second handle (HO), in which the distal end of the spiral spring (106) is received abutting against a stop, the gripping jaws (103, 104, 105) passing through the proximal end (115) of the conical sleeve (109 ) close under the force of the spiral spring (106) and open by advancing the actuating means (107).

8. surgical set (100) according to claim 6 or 7,

marked by

a guide thread or guidewire (116) which protrudes from the gripping pliers (102) in the form of a loop (117) at the proximal end when the surgical set is delivered, and which has two loose ends (118, 119) through the interior of the conical sleeve (109 ) and the inside of the spiral spring (106) to the first handle ^' (108) is guided at the distal end of the surgical set, the loop (117) being able to be passed through the eyelet (16) of the holder (10) of the implant and being fastened to the gripping pliers (102) before the implant is implanted.

9. surgical set (100) according to claim 7 or 8,

characterized by the fact that s

a first loose end (119) of the guide thread or the guide wire (116) can be fastened in the region of the first handle (108), while the second loose end (118) of the guide thread or the guide wire (116) with a nipple (120) is provided, with the aid of which the guide thread or wire (116) can either be tensioned when the implant is coupled or can be pulled out of the surgical set after the connection of the first end (119) to the first handle (108) has been released.

10. surgical set (200) according to claim 7 or 8, for implanting and explanting an implant with a holder (10) according to claim 4, in particular an occlusion instrument,

characterized by the fact that s

a first loose end (119) of the guide thread s or the guide wire (116) can be fastened in the region of the first handle (108), while the second loose end (118) of the guide thread or the guide wire (116) with a Nipple (120) is provided, with the aid of which the guide thread or wire (116) can either be tensioned in the coupled state of the implant after the loop (117) has been moved through the oblique slot (26) into the eyelet (16), or for decoupling the implant from the surgical set can be loosened again so far that the loop (117) can be moved out of the eyelet (16) through the oblique slot (26).

11. surgical set (100; 200) according to any one of claims 8-10,

dadutch marked that s

the guide thread or guide wire (116) consists of nithinol wire.

12. surgical set (300) for implanting and explanting an implant with a holder (10) according to claim 5, in particular an occlusion device,

marked by

a hook (302) which can be moved axially towards or away from the eyelet (16) by means of a push and pull system, and by means of a fastening loop (301) which runs through the eyelet (16) and can be suspended in the hook (302) , by means of which the implant can be held on the surgical set (300) by tensioning the fastening loop (301) when the hook (302) is moved away from the eyelet (16).

13. surgical set (300) according to claim 12,

characterized in that s

the push and pull system essentially has the following components: a spiral spring (106), through the interior of which an axially sufficiently stiff but nevertheless sufficiently flexible actuating means (107) extends in the axial direction, at the proximal end of which a shaft (303) of the hook (302) is attached, and at its distal end a first handle (108) is attached; a cylindrical sleeve (304), in the distal end section (113) of which the proximal end of the spiral spring (106) is received abutting against a stop (114) and in which the shaft (303) of the hook (302) is received in an axially displaceable manner; and a second handle (HO) in which the distal end of the coil spring (106) is received abutting against a stop, the hook (302) moving axially away from the eyelet (16) under the force of the coil spring (106) and can be moved towards the eyelet (16) by advancing the actuating means (107).

14. surgical set (300) according to claim 13,

characterized by t, the s

the cylindrical sleeve (304) has a continuous first longitudinal groove (306) on the proximal end face (305), in the central region a unilateral second longitudinal groove (307) for guiding the hook (302) axially movable in the sleeve, and at right angles a transverse groove (308) to the one-sided second longitudinal groove (307), which extends to the longitudinal axis of the sleeve (304) and has an extension (309) in the center for receiving a knot (311) of the fastening loop (301).

15. surgical set (300) according to claim 14,

characterized in that s

the cross section of the front section of the hook (302) is flattened by approximately one third compared to the cross section of the shaft (303) and fits into the second longitudinal groove (307) of the cylindrical sleeve (304) with play.

16. surgical set (300) according to any one of claims 12 to 15,

marked by

a knife edge (310) at the distal end of the window (315) formed behind the hook (302).

17. surgical set (100; 200; 300) according to one of claims 7 to 16,

characterized by the fact that s

the actuating means (107) is a wire rope.

18. A method for the repeatable coupling of an implant with a holder (10) according to one or more of claims 1-3, in particular an occlusion device, to a surgical set (100) according to one or more of claims 6-9 or 17,

characterized by the following procedural steps:

(a) the loop (117) of the guide thread or guide wire (116) is guided through the eyelet (16) of the socket (10) of the implant before the start of the intravascular surgical intervention and at a fastening point (101) provided on the gripping pliers (102 ) suspended while the first and second loose ends (119, 118) of the guide thread or guide wire (116) are held in place or fastened in the region of the first handle (108); (b) the head section (14) of the socket (10) of the implant is gripped with the gripping pliers (102);

(c) the second loose end (118) of the guide thread or guide wire (116) provided with the nipple (120) is tensioned until the head section (14) is received in the gripping jaws (103, 104, 105);

(d) by loosening the second loose end (118) provided with the nipple (120), the gripping pliers (102) can be released again from the head section (14) of the implant and the fit of the implant can be checked;

(e) with the help of the guide thread or guide wire (116), the gripping pliers (102) can be reconnected to the socket (10) of the implant at any time.

19. A method for the repeatable coupling of an implant with a holder (10) according to claim 4, in particular an occlusion device, to an operating set (200) according to one of claims 10 or 17,

characterized by the following process steps:

(a) the loop (117) of the guide thread or guide wire (116) is inserted before the start of the intravascular surgical intervention through the oblique slot (26) into the eyelet (16) of the socket (10) of the implant, while the first and second are loose The end (119, 118) of the guide thread or guide wire (116) is fixed or fastened in the region of the first handle (108);

(b) the head section (14) of the socket (10) of the implant is gripped with the gripping pliers (102);

(d) by loosening the second loose end (118) provided with the nipple (120), the gripping pliers (102) can be released again from the head section (14) of the implant and the The position of the implant can be checked;

20. A method for the repeatable coupling of an implant with a holder (10) according to claim 5, in particular an occlusion device, to an operating set (300) according to one or more of claims 12-17,

characterized by the following procedural steps:

(a) a fastening loop (301) of a defined length is fastened to the eyelet (16) of the socket (10) of the implant;

(b) the fastening loop (301) is inserted into the transverse groove (308) of the cylindrical sleeve (304) in such a way that the knot (311) of the fastening loop (301) fits centrally through the extension (309) and that in the transverse groove (308 ) Coming section of the fastening loop (301) is held diametrically;

(c) by defined advancement of the hook (302), the section of the fastening loop (301) lying in the transverse groove slips over the hook (302) while deflecting into the second longitudinal groove (307) and remains anchored there;

(d) by pulling back the hook (302), the socket (10) of the implant is pulled to the proximal end face (305) of the sleeve (304) and clamped;

(e) by pushing the hook (302) again in a defined manner, the fastening loop (301) becomes loose again and the proximal end face (305) of the sleeve (304) comes loose from the holder (10) and the fit of the implant can be checked;

(f) With the aid of the fastening loop (301), the sleeve (304) can be reconnected to the socket (10) of the implant at any time.