WO2016087061A1

WO2016087061A1 - Multiflexible occluder for closing pfo and ads defects, and production of said occluder

Info

Publication number: WO2016087061A1
Application number: PCT/EP2015/068810
Authority: WO
Inventors: Martin Dauner; Michael Doser; Markus Milwich; Friedrich Moszner; Norbert Moszner; Robert Moszner; Sven Oberhoffner; Susanne Schneider; Dagmar Yilmaz
Original assignee: Acoredis Gmbh
Priority date: 2014-12-04
Filing date: 2015-08-17
Publication date: 2016-06-09
Also published as: DE102014018086A1

Abstract

Medical occlusion instrument 1 for treating defects in the heart of a patient, in particular for closing abnormal tissue openings, wherein the occluder 1 is composed of a multiflexible braid 3 of thin filaments 2 with closed braid segments 4 and open braid segments 5, wherein a distal disc or distal retention area 24 is delimited by a web 26 from a proximal disc or proximal retention area 25, and wherein at least one woven fabric inlay (patch) 45 is in each case present in the discs 24, 25 which are needed to completely close the shunt in the web 26, wherein the two retention areas 24, 25, in most cases in an invasive surgical procedure, come to rest on both sides of a shunt that is to be closed in a septum, while the web 26 extends through the shunt. The filaments 2 of the multiflexible braid 3 can be produced from metal or from metal alloys, for example nitinol, from non-resorbable synthetics chosen from the group of polyesters, polyamides, polyolefins, polyurethanes and polyhalogenated olefins, or from bioresorbable polymers.

Description

Multifunctional occluder for occluding PFO and ASD defects and its

manufacturing

description

The present invention relates to a flexible intravascular occluder for placement in otherwise difficult to reach defect sites in the human heart by minimally invasive treatment methods via the use of catheter technology, such as occluding holes (shunts) in the area of the atrial septum between the two Atria, the atrium-septal defect (ASD), the patent foramen ovale (PFO), and other applications.

State of the art

The previously established occlusion devices for occluding vascular heart defects are usually made of a rotationally symmetrical mesh of one or more thin metal threads / wires.

In this case, such Occluder usually has a predetermined form (permanent output form), which is achieved after the production of Occluders. During insertion of the occluder into the body of a patient by means of a catheter results in a second pre-definable shape (temporary shape), wherein the distal and proximal retention area are formed as discs and in the central region (defect area) has a waist. To seal the blood stream, nonwovens are additionally used in the two discs to seal off the blood stream. In addition, more fleeces can be inserted in the waist for sealing. For such nonwovens (patches), polyesters such as polyethylene terephthalate (PET) and similar polymers have proven successful. When implanted, the occluder should regain its complete, permanent shape. This is not achieved in the practical implementation. All known on the market Occiuder systems stretch in the defect bulge or tilted distally to one side (so-called. "Cobra" effect) which can usually lead to such devices again exploits Need to become.

Such Occluder are z. In WO 2007/140797 A1, EP 2 014 239 A2 and EP 1 955 DE 10 2005 053 958 A1 discloses a bioresorbable medical self-expandable occluder for the treatment of defects in the heart of a patient, the occluder consisting entirely of a shape memory polymer composition. The occluder has a permanent initial shape. During insertion of the occluder into the body of a patient by means of a catheter, a temporary shape results and in the implanted state of the occluder, the occluder tries to reach the permanent initial shape again, which in practice succeeds only incompletely.

DE 10 2011 077 731.8 describes a further bioresorbable occluder in which a variable final shape is to be shaped in accordance with the profile of the defect in the implanted state. However, such a variable final form implies a high risk as far as the firm anchoring in the defect is concerned.

Another bioresorbable occlusive device is known by the term "Chinese lantern" (WO 2011/075088) .This device is also characterized by a double-disc design, in which a bipartite spinal scaffold has been selected, which consists distally of polycaprolactone (PCL) struts and proximally Polylactide-PCL copolymer struts spanned by a PCL membrane.

Also disclosed in 2012 was an ASD occluder made from bioresorbable monofilaments based on poly (dioxanone) (PDO) (WO

2011/096896). Its mesh design is similar to that of the Amplatzer ASD occluder of US Patent 5,725,552.

In analogy to this ASD-Geflechtsoccluder published patent application DE 10 2011 077 731 AI discloses another example of a bioresorbable ASD / PFO Occlusionssystem, which is based on a rotationally symmetric braid body. In the case of this ball mesh with a central trigger mechanism, an accumulation of multiply crossing and overlapping threads occurs at the distal end, which hinders the ability to pass the lock and excludes the use of small-lumen catheters.

The listed bioresorbable Occiusionssystemen has in common that they are initially after their implantation as a closure device for the diagnosed Atriumseptumsdefekt serve. These include self-centering in the defect site and optimal sealing of the shunt. In addition, they form a kind of temporary carrier material bridge for the onset and most extensive tissue attachment. If this endothelialization is largely completed, these temporary implants are completely split by the body's own reactions into their harmless subunits and these in turn degraded by known metabolic processes in the body. As a result, these

Procedure in principle in a natural closure of the vascular

Defect site in the forecourt septum opens, without foreign material must remain permanently in the body.

These bioresorbable Occiuder are usually similar to the metallic Occuuder also listed from a rotationally symmetrical braid body with permanently crossing threads or wires, which leads in part to the fact that these Occiuder more or less in both the PFO slot and ASD defect stretch or bulge and thus causes only insufficient sealing of the defect and on the other hand results from the relatively simple braid structures a poor grip in the defect. As a result, thrombi may form on the edges of the bulging occlusion, triggering strokes and, if necessary, infarcts during embolization. Furthermore, important properties, such as a good lubricity in an adapted lock size, hardly feasible.

task

The object of the invention is therefore to provide a functional Occuder, which forms flat in the defect without side effects, such as bulging, stretching or "Co bra'- effect and thus optimally adapted to the Vorkammerseptum. In addition, the Occiuder should show optimal Schleusängängigkeit. This object of the invention is achieved by an occluder according to claim 1. Advantageous embodiments can be found in the dependent claims.

The present invention according to claim 1 relates to a multifilament or preferably of monofilament thread material, which may be produced either of metallic or polymeric nature and in particular of biodegradable plastics, molded base body which is produced by a multiflexible braid according to the invention, suitable intermediate stages being suitable for forming and heat treatment processes are used in such a way that essentially Chen a suitable final shape is achieved with a rotationally symmetric disc as a proximal retention area, a rotationally symmetrical distal disc and an approximately cylindrical ridge between the two discs. In principle, a step of the deformation and heat treatment process initially comprises the proper feeding of the braid main body into a device which makes up at least part of the later final shape. It is considered that basically the shaping processes starting from the distal end, z. B. shaping of the distal disc, are continued in defined sub-steps to the final shape at the proximal end (proximal disc). The basic endeavor of the braid body to maintain its shape or permanently expand again into this initial form, is exploited accordingly, for example by the braid body is introduced into a tool mold, which is the later form, for. B. that of the distal disc includes. After introduction into the mold, these and the braid body, which consists in a possible embodiment of nitinol or a medical grade stainless steel, at 250 to 600 ° C and a holding time of about 100 minutes to 3 minutes, ie at a higher temperature with a correspondingly lower holding time, tempered. This tool-bound forming and heat treatment process can be realized several times in succession until the device according to the invention is formed. Depending on the shape of the device and the existing technical possibilities for producing corresponding tool shapes, sub-steps can be combined as desired with the aim of minimizing the total number of steps. Currently, with the use of hot air, it is possible to carry out 3 to 6 heat treatment steps using suitable forming and heat treatment processes. when using tempered salt baths 10 to 12 heat treatment steps are possible.

The core of the invention is that the multiflexible braid is not, as before, a fundamentally homogeneously structured braiding, but in certain areas, the braid structure is adapted so that the derived mechanical properties in conjunction with a suitable heat treatment process always exactly the desired final shape, or In effect, the final position is reached, which means that the occlusion device returns to its original initial shape extremely flat in the defect, without stretching and bulging in contrast to the mesh occlusion State of the art. By certain variants of a multiflexible braid is to be achieved in particular that the Occluderendformen as possible for a large number of different defect morphologies similar good and optimal properties with respect to a flat final shape (initial shape) are relevant.

The flexible braid according to the invention differs from known embodiments in particular in that the occluders used do not stretch or bulge in the defect after the interventional implantation procedure has been completed. This also means that in the ASD occluders an occurrence of the so-called "Cobra" effect is not possible The embodiments according to the invention can be made of metallic materials, plastics, including bioresorbable substances.

The present invention also covers in such embodiments with bioresorbable material.

embodiment

Further advantages, features and details of the invention will become apparent from the following description in which, with reference to the drawings, the embodiments are described in detail. The features mentioned in the claims and in the description are each individually or in any combination subject of the invention.

Show it :

Fig. 1 yes) a spatial schematic representation of the side view of a

Braiding machine for producing the inventive multiflexible braid body consisting of open and closed braid portions;

Fig. 1 (b) is a schematic plan view and partial view of the braiding machine of Fig. 1 (a);

Fig. FIG. 2 is a schematic plan view of the braiding head with illustration of the braiding head. FIG

Thread course for the multiflex braid of FIG. 1 (a-b);

Fig. FIG. 3 shows a schematic illustration of a preferred further embodiment of a multiflexed braid according to the invention, showing the thread pattern for the multiflex braiding in the area of the braiding head according to FIG. 1 (ab) but with two staggered rows Guide pins;

4 shows a round table with a braided bobbin and carrier and drive plate for the braiding machine according to the multiflex braiding according to FIG. 1 (a-b);

5 shows a schematic representation of a preferred further embodiment according to the invention of the multiflexed braid in the region of the braiding head with woven-in draw-off threads in the center;

6 is a further schematic representation of a preferred embodiment of a multiflex braid according to the invention in the region of the braiding head with braided withdrawal threads off-center;

7 is a schematic representation of a preferred first embodiment of a three-dimensional view of the multiflex main body with a woven-in trigger;

Fig. 8 (a) is a schematic view of a preferred first embodiment of a multiflexed uniform occluder according to the invention with a woven-in hood in plan view;

Fig. 8 (b) is a schematic side view of a preferred first embodiment of a multiflexed uniform occluder according to the present invention shown in Fig. 8 (a);

9 (a) is a schematic representation of a preferred further embodiment of a Multiflex PFO-Occluders according to the invention in the expanded state with woven-in deduction in plan view,

9 (b) shows a schematic illustration of a preferred further embodiment of a multiflex PFO occluder according to the invention according to FIG. 9 (a) in the expanded state in side view,

10 (a) shows a schematic illustration of a preferred further embodiment of a multiflex ASD occluder according to the invention in the expanded state with a woven-in deduction in plan view,

10 (b) a schematic representation of a preferred further embodiment of a multiflex ASD occluder according to the invention according to FIG. 10 (a) in the expanded state in side view,

11 (a) shows a schematic representation of a preferred further embodiment of a multiflex PFO occluder according to the invention in the expanded state, consisting of a multiflexible braid main body of open and closed braid parts without any deduction in plan view, 11 (b) shows a schematic illustration of a preferred further embodiment of a multiflex PFO occluder according to the invention according to FIG. 11 (a) in the expanded state in side view, FIG.

12 (a) shows a schematic representation of a preferred further embodiment of a multiflex ASD occluder according to the invention in the expanded state, consisting of a multiflexible braid main body of open and closed braid parts without any deduction in plan view,

12 (b) a schematic representation of a preferred further embodiment of a multiflex ASD occluder according to the invention according to FIG. 12 (a) in the expanded state in side view, FIG.

13 (a) is a schematic detail view in section for a subsequently introduced trigger mechanism for a further preferred embodiment of a Multiflex PFO Occluders according to the invention of FIG. 11 (a-b) or ASD occluders according to FIG. 12 (a-b),

Fig. 13 (b) is a schematic detail view in section of a subsequently introduced trigger mechanism according to Fig. 13 (a) in operation; right pull rope to stop in the ball coupling,

Fig. 13 (c) is a schematic detail view in section for a retrofitted trigger mechanism of FIG. 13 (a) with retracted lock and

13 (d) is a schematic detail view in a sectional view of a subsequently introduced trigger mechanism according to FIG. 13 (a) in the end position after uncoupled insertion system.

Fig. 1 (ab) shows a schematic spatial representation of the side view of a rotationally symmetrical braiding machine 35 for producing a first preferred embodiment of Occluders (Occiusionsinstrument) 1 of FIG. 9 (ab), The braiding machine 35 is constructed as follows: On the rotary table 15th For example, 40 circular support and drive plates 7 are mounted on the outer edge. On each carrier and drive plate are four receptacles 6 for each one Flechtblöppel inside 8 and outside 9. On each carrier and drive plate are exactly two braided beaters, one each for inside 8 and outside 9. Above the braiding machine 35 is a braided 10 with a central through hole 12, which is circumferentially equipped with guide pins 11 at the edge. For the production of a braid body 29 with a multiflexible braid portion 3 with open 5 and closed braid segments 4 all threads 2 of the existing braids 8, 9 are included. The procedure is as follows:

Each of a braid and drive plate 7 is stretched by a braided bobbin 8, 9 on the braiding 10 between the guide pins 11 through exactly to the opposite braided bobbin 8, 9 on the associated support plate 7 each have a thread 2. In this case, the thread 2 is guided from the braiding beater inside 8 to the braiding bobbin outside 9 on the opposite side of the braiding machine 35. Between two opposite braiding bobbins 8 on one support plate 7 and the braiding bobbin 9 on the other opposite support plate 7 (see Fig. 1 (b)), the filaments 2 are held on each side by a filament tensioner 23. In an open braid segment 5, the thread 2 is returned from the clapper 8 via a guide pin 11 located at the edge of the braiding head 10 to the clapper 9 of the same carrier and drive plate 7. For a braid body 29 of FIG. 7 now mutually all present clapper 8, 9 are covered with threads, so that in a closed braid 4 each an open braid 5 follows and that except for four clapper 8, 9, which for the trigger mechanism 13th or 14 (here take-off mechanism 13 with four threads 2) are required. In the example according to the invention of FIG. 7, the withdrawal threads 2 are placed after a central deduction 13 as follows:

From a carrier and drive plate 7 is guided by an internal clapper 8 of the thread 2 to gegenüberbehindlichen carrier and drive plate 7 and although there to the outside claw 9. In two offset by 90 ° support plates 7 is analogous procedure. The bobbins 8, 9 not required on the four support plates 7 are occupied for closed braid segments 4.

If all the threads 2 are placed, this results in forty carrier and drive plates 7 a total of forty-four threads 2, since four threads 2 are removed via the trigger system 13.

During the subsequent braiding process, all carrier and drive plates rotate around their own axis. According to FIG. 4, the lowermost support plate 7 rotates in rotation direction. Clockwise 21 and the adjacent support plate in the opposite direction 22, while the clapper 8, 9 migrate from one carrier plate to the other and in rhythm to the outside, inward, outward, etc .. Technically, the whole is made possible by corresponding receptacles 6 for Carrier and drive plates 7. The number of receptacles 6 for the carrier and drive plates 7 must be exactly twice as large as eighty times. The braiding process is complete when a braided bobbin 8 or 9 has returned to its starting point (rotary motion on rotary table braiding machine 360 degrees).

In Fig. 2 shows the complete coverage of the braiding head 10 for a multifilament braid with open 5 and closed braid portions 4. The threads 2 in the closed cycle 16 pass through the braiding head 10 and the threads 2 in the open cycle 17 are each returned to a guide pin 11 to the respective support plate 7. In such a braid body 29 after completion of the braiding process, a flattening at the distal end 27, which in turn allows improved sliding properties in the lock 20 occurs.

According to FIG. 3 are equipped with a corresponding braiding 10, two concentric circles with corresponding guide pins, resulting in an improvement of the molding properties, eg. B. causes even better flattening of the distal end 27 of the braid body 29 and also significantly improves the sliding properties in the lock. In the braiding main body 29 according to the invention produced according to FIG. 7 was a central trigger of FIG. 5 used.

FIG. 6 shows a schematic illustration of the design of the braiding head 10 for interlaced eccentric withdrawal threads, which can produce a more stable basic shape for an occlusion device 1.

According to Fig. 8 (a-b), Fig. 9 (a-b) and Fig. 10 (a-b) can be used for specially suitable embodiments of metal filaments, such. B. Nitiniol, a highly elastic alloy of titanium and nickel with shape memory function, corresponding uniform Occluder 37, PFO Occluder 38 and ASD Occluder 39 using appropriate tools for the outer contour and heat treatment process finished.

Likewise, such occluders can also be made from suitable bioresorbable materials. In this case, monofilament or multifilament ment threads 2 (as a replacement for the metallic wires) made of bioresorbable polymer and bioresorbable patches (nonwovens) 45 the following specifications:

Absorbable copolymer formed from 70% by weight to 97% by weight L-lactide and 3% by weight to 30% by weight glycolide, preferably 80% by weight to 95% by weight L-lactide and 5% by weight % to 20% by weight of glycolide and particularly preferably 88% to 93% by weight of L-lactide and 7% by weight to 12% by weight of glycolide. The polymer may be a random copolymer or a block copolymer, with a random copolymer being preferred.

The polymer in the untreated state has a residual monomer content of between 3% by weight and 7% by weight of L-lactide. The residual monomer content can be reduced by appropriate processes under reduced pressure with temperature.

The glass transition point of the polymer is between 48 ° C. and 59 ° C. and, in addition to the composition of the polymer, is dependent on the residual monomer content.

In the rapidly cooled from the melt state, the polymer is substantially amorphous (enthalpy of fusion <8 J / g), but crystallizable at temperatures between 80 ° C and 140 ° C and preferably between 100 ° C and 120 ° C and stress-induced above its glass transition point example by hiding a thread-like material.

Filamentary structures 2 and nonwovens 45 can be recovered from the polymer either by melt-making or solution, melt-making being preferred.

The thread-like structures can be either multifilament or monofilament, with monofilament structures preferably being used for the production of the main body 29 of the occluder 1.

The diameter of the monofilaments 2 produced from the polymer is between 0.08 mm and 0.50 mm, preferably between 0.10 mm and 0.40 mm and particularly preferably between 0.12 mm and 0.25 mm. The drawn monofilaments 2 have a linear strength between 300 N / mm ² and 600 N / mm ² .

The drawn monofilaments 2 have a flexural modulus (bending angle 30 °, clamping length 5 mm, 22 ° C) between 4,000 N / mm ² and 10,000 N / mm ² and more preferably between 6,000 N / mm ² and 10,000 N / mm ² , at the use as Occluder body 29 to provide the necessary erection force.

After extrusion and drawing, the untreated monofilaments 2 have a residual monomer content between 3% by weight and 7% by weight. The degradation time (Sörensen buffer pH 7.4 / T = 37 ° C), ie the complete loss of mechanical strength of these non-treated monofilaments 2 is between 4 and 12 and preferably between 8 and 12 weeks.

The monofilaments 2 may either be partially de-monomerized or preferably almost completely demonomerized by a post-treatment step under reduced pressure. Alternatively, the demonomerization can be achieved by C0 ₂ extraction. Monofilaments having a monomer content of <0.2% by weight L-lactide have a prolonged degradation period of 8 weeks to 32 weeks, preferably between 12 weeks and 24 weeks and more preferably between 15 and 20 weeks. This allows a complete epithelialization of the skeleton before the occurrence of mechanical fragments on the one hand and avoids an unnecessarily long irritation of the tissue by the device on the other.

The threads 2 of the withdrawal mechanism 44 are made from bioresorbable polymer, but not necessarily from the LG copolymers described herein. Other polymer variants for the Zugseile are homopolymers of polylactide (PLLA), PDO and polycaprolactone and their copolymers with glycolide as a comonomer, moreover, polymers of hydroxycarboxylic acids such. As polyhydroxybutyric acid (eg., P3H B and P4H B) find use.

The pull rope mechanism may consist of several monofilaments, of bundled monofilaments, of bundled monofilaments with enveloping matrix (Pseudomonofil) or of a monofilament. The same applies to an elastic pulling mechanism. The device for grasping the 20-100 monofilaments of the base body at its proximal end and the coupling for coupling to the insertion aid is preferably formed of bioresorbable polymer, but may alternatively be made of resorbable magnesium, zinc or iron alloys that degrade with hydrogen evolution or from be formed of permanent gold / stainless steel. The latter would then simultaneously serve as an X-ray marker at the proximal end. Another metallic X-ray marker on the distal shield could serve to fix the pull rope or the pulling system at this point, if the pull rope is not integrated into the mesh of the main body.

It would also be conceivable to form a spherical coupling in such a way that the monofilaments are laser cut after a shaping heat treatment and then the ends either by means of an amorphous polymer (T _G about 50-60 ° C) are fixed by injection molding to the spherical coupling or the Monofilaments themselves be deformed at their end to the spherical coupling. The coupling itself must be resistant to 25 N tension.

X-ray labeling can also be achieved by filling the polymer with a radiopaque additive (eg, barium sulfate or bismuth oxide), e.g. B. be achieved during the extrusion to monofilament, but this requires at least fill levels of approx. 30% by weight. In addition, the particles of the additive would be released after absorption of the polymer, but this might be justified due to the epithelialization.

An X-ray mark can also be applied by spraying or punctually dripping a liquid phase containing the X-ray marker either dissolved or dispersed.

The bioresorbable occluder is sterilized in its established permanent form (EO, alternatively: gamma or beta irradiation, here shortening of the degradation profile, plasma sterilization) and stored, the introduction into the sluice by means of an auxiliary device to be described directly before implantation.

To minimize the friction in the lock this can be performed slightly grooved. Furthermore, either the inner surface of the lock (be Preferably) or the Occluder- base body with a biocompatible lubricant (eg salts of stearic acid) or a low-viscosity polymer coating (carboxymethylcellulose (CMC), polyethylene oxide (PEO) or polyvinyl alcohol (PVA)) to be coated.

For sealing the blood stream after implantation of Occiuders 1 are located in the discs 24 and 25 each have a layer of patches (nonwovens) 45th

The patch or patches can either be produced separately or preferably directly on the screens of the occluder by means of melt-blow technology or fiber spraying, which has the advantage that the sewing on of the patches to the main body is dispensed with.

The separately produced patches may be attached either to the outside or the inside of the screens, with attachment to the inside being preferred because of the introduction through the sluice. The fixation of the patches on the base body can be done either by a continuous seam with resorbable suture material or by selective gluing or welding to the base body. The resorbable suture advantageously has a degradation time of between 30 and 60 days and is completely absorbed no later than after 180 days, preferably after 90 days (note: if the degradation duration of the monofilament suture is too short, fragments could form before epithelialization takes place).

Nonwovens (patches) 45 can be made from the polymer either by melt-blown technology, by the spunbond process, by the consolidation of staple fibers, or by a combination of these technologies from the melt. Nonwoven fabrics may be made from solution by electrospinning, centrifugal spinning, a fiber spray process, or combinations of these techniques.

The fiber diameter range is preferably between 10 μιτι and 0.1 μιτι, preferably between 5 μιτι and 0.5 μιτι and more preferably between 2 μιτι and 0.5 μιτι.

After densification and thus after increasing the mechanical stability of the nonwovens, these have a thickness between 25 μιτι and 100 μιτι and preferably between 40 and 60 μιτι on. The compaction can be achieved either by calendering, by pressing, by needling or by water jet compression. For densification, it is advantageous to previously convert the nonwoven by means of aftertreatment in a higher crystalline state. This step can be carried out at temperatures between 70 ° C and 140 ° C and preferably between 90 ° C and 125 ° C under reduced pressure. The fleece, like the monofilaments, can be almost completely demonomerized.

The degradation profile of the nonwovens essentially corresponds to that of the monofilaments 2.

Alternatively, the patch 45 may also consist of a film or membrane and preferably of a unidirectionally or bidirectionally stretched film or membrane of the resorbable polymer, wherein in the case of a film by small punched or laser cutting a large number of small breakthroughs arise by narrow webs from each other are delimited. Films can be made by doctoring a polymer solution or by extrusion, membranes can be made from solution by the phase inversion technique.

Furthermore, alternatively, the patch may be a textile and preferably knitted structure of fine threads.

Such preferred embodiments of Multiflex braids 29 according to the invention according to the specifications of FIGS. 2, Fig. 3, Fig. 5 and 6 with open 5 and closed mesh parts 4 can also be finished without any deductions 13 or 14. After prefabrication of the occluder end form, subsequent traction ropes or an equivalent traction system 44 can be introduced here (Figure 13 (ad).) The PFO occluders 38 of FIG. 11 (ab) and ASD Occluder 39 of FIG. 12 (ab) differ from the external appearance and the function to be secured then no longer from the in Figs. 9 (ab) and Fig. 10 (ab) PFO Occluder 38 shown or ASD Occluder 39.

The pull rope mechanism may consist of several monofilaments, of bundled monofilaments, of bundled monofilaments with enveloping matrix (Pseudomonofil) or of a monofilament. The same applies to an elastic pulling mechanism. The traction cable can be provided with barbs whose tips point towards the distal side, in particular in the region near the distal shield, which, after the Occluder has been set up, anchor to the lead-through element at the proximal Occlunder end by pulling the traction cables and thus fix the erected form. Alternatively, the pull cable could also conically thicken to the distal end and be clamped in the proximal feedthrough element. For this purpose, a thickening of resorbable polymer can be attached to or on the pull rope (s), which is configured either annular or conical or spherical.

A traction system 44 may be formed of either an elastomeric resorbable thread or an undrawn thread. When introducing the occluder through the sluice, the elastomeric thread would lengthen and after ejection of the occluder its erect form by contraction. The unstretched thread would stretch during insertion and set up after ejection under shrink the Occluder. Shrinkage to the initial length before stretching is time-limited and can be achieved almost exclusively by means of block copolymers of the type A-B-A, where block B represents the soft segment and block A represents a hard segment. Both variants, however, increase the friction force in the lock, since already here the raising force acts.

In the simplest case, a monofilament of the same material composition as the copolymer for the braid body 29 is used for the withdrawal system 44. The thread 2 for the traction system 44 is selected by the strength so that corresponding tensile forces can be absorbed and the interventional implantation procedure is not hindered. In Fig. 13 (a) the occlusion instrument is already in final position. According to FIG. 13 (b), the right-hand thread of the tensioning system 44 has already been released and firmly anchored in the ball coupling 42 with a thickening at the end. When returning the lock 20, the pull rope on the left side secures the firm hold in the ball coupling. With uncoupling of the insertion 43, the pull rope is severed on the left side, with a projecting portion of the pull rope immediately twisted when strain relief; Thus, both tension cables of the tension system 44 are firmly anchored and support a flat end position of the implanted Occluders 1 in Vorkammerseptum.

It is also conceivable in the production of the basic body of an occluder 1 to produce it by generative methods. The generative manufacturing processes are methods for the rapid and cost-effective production of models, moldings or prototypes, based on the computer-aided 3D data (usually STL files) of informal (eg liquids or powders) or shape-neutral (eg, tape or wire,), starting components are made by physico-chemical processes. In the case of widespread additive manufacturing processes, the desired geometry is produced by joining together volume elements. In the layer method, the shaped body is composed of individual layers. The selected manufacturing process not only produces the geometry but also simultaneously creates the material properties. Accordingly, the generative methods for the production of occlusion instruments are particularly suitable and two methods are particularly suitable: on the one hand stereolithography (SL) and on the other hand printing (2D or 3D).

In SL, layered liquid resin monomers are cured by photopolymerization and hardening is carried out by irradiation by means of a laser (laser scanner method) or high-performance beamer or UV lamp (mask method). In this case, the molding is made by solidification due to photopolymerization of commercially available monomers which may contain other additives and fillers. Suitable polymerizable resin monomers are, in particular, mixtures of monofunctional or polyfunctional acrylates or methacrylates which, when irradiated in the presence of suitable free-radical-forming photoinitiators, such as, for example, Dimethylbenzilketal, acyl or (bisacylphosphine oxides or mixtures of camphorquinone and tertiary amines, for example N, N-dimethyl-p-toluidine, N, N-dihydroxyethyl-p-toluidine, 4-dimethylaminobenzoic acid ethyl ester, rapidly by free-radical polymerization Examples of monofunctional or polyfunctional (meth) acrylates are methyl, butyl, benzyl, tetrahydrofurfuryl or isobornyl (meth) acrylate, bisphenol A di (meth) acrylate, bis-G (M) A ( an addition product of (meth) acrylic acid and bisphenol A diglycidyl ether), ethoxy or propoxylated bisphenol A di (meth) acrylate, 2,2-bis [4- (2- (meth) acryloxypropoxy) phenyl] propane, UD (M) A (an addition product of 2-hydroxyethyl (meth) acrylate and 2,2,4-trimethylhexamethylene diisocyanate), di-, tri- or tetraethylene glycol di (meth) acrylate, trimethylolpropane tri (meth) lat, pentaerythritol tetra (meth) acrylate, and Glycerol di- and tri (meth) acrylate, 1,4-butanediol di (meth) acrylate, l, 10-decanediol di (meth) acrylate (D3MA) or 1,12- Dodecandioldi- (meth) acrylate. Furthermore, it is also possible to use cationically polymerizable resins. As cationic polymerization resins can be cationically ring-opening polymerizable monomers such. For example, glycidyl ethers or cycloaliphatic epoxides, cyclic ketene acetals, spiroorthocarbonates, oxetanes or bicyclic orthoesters. Examples are: 2-methylene-1, 4,6-trioxaspiro [2.2] nonane, 3,9-dimethylene-1, 5,7, 1-tetraoxaspiro [5,5] undecane, 2-methylene-1,3-dioxepane, 2-phenyl-4-methylene-1,3-dioxolane, bisphenol A diglycidyl ether, 3,4- (epoxycyclohexylmethyl-3,4-epoxycyclohexanecarboxylate, bis (3,4-epoxycyclohexylmethyl) adipate, vinylcyclohexene dioxide, 3-ethyl 3-hydroxymethyloxetane, 1, 10-decanediylbis (oxymethylene) bis (3-ethyloxetane) or 3,3- (4-xylylenedioxy) bis (methyl-3-ethyloxetane) Cationic polymerizable resins Examples of suitable diaryliodonium salts are 4-octyloxyphenyl-phenyl-iodonium hexafluoroantimonate or isopropylphenyl-methylphenyl-iodonium tetrakis (pentafluorophenyl) ## STR5 ## Examples of suitable diaryliodonium salts are 4-octyloxyphenyl-phenyl-iodonium hexafluoroantimonate or isopropylphenyl-methylphenyl-iodonium tetrakis (pentafluorophenyl). borate.

During printing, the building material can be applied layer by layer (2D) by means of a print head. When using polymerizable resins, the applied material is polymerized the same (Polymer Printing). When thermoplastic polymers are used, the solidification takes place by cooling the polymer melt. Most commonly used polymers are polyamide, ABS or polycarbonate, which can be filled up with particles or fibers. In so-called 3D printing, solid layers are produced by gluing granules together with a binder.

LIST OF REFERENCE NUMBERS

1 occluder (occlusion device)

2 threads (monofilaments)

3 Multiflexible braid

4 Closed mesh segment

5 open mesh segment

6 Mounting for carrier and drive plate

7 carrier and drive plate

8 braided beaters inside

9 braided beaters outside

10 wicker head guide pin

Through Hole

Trigger in the middle

Trigger off the front side off-center

Round table braiding machine

Thread in the closed cycle

Thread in the open cycle

Thread course for trigger

Outer edge round table braiding machine

lock

Direction of rotation in clockwise direction

Counterclockwise rotation

Filamentspanner

Distal disc (distal retention area) Proximal disc (proximal retention area) Bridge

Distal end

Proximal end

Braided body

Top view

sideview

Schematic view

Spatial view

sectional view

braiding

detailed view

Uniform occluders

PFO occluders

ASD occluder

Occluder with trigger

Occluder without deduction

ball coupling

Insertion system Acoredis

Pull system (trigger mechanism)

Patches (Nonwovens)

Claims

claims

1. A medical Occiusionsinstrument 1 for the treatment of defects in the heart of a patient, in particular for closing abnormal tissue openings, wherein the Occluder 1 is composed of a multiflexible mesh 3 thin threads 2 with closed braid segments 4 and open braid segments 5 wherein the Occiusionsinstrument 1

characterized in that

a distal disc or distal retention area 24 is delimited by a web 26 from a proximal disk or proximal retention area 25, characterized by at least one respective patches 45 in the disks 24, 25 which completely close the shunt in the web 26 be needed, the two retention areas 24, 25 come through a mostly interventional surgical intervention on either side of a shunt to be closed in a septum to the plant while the web 26 passes through the shunt.

2. Occiusionsinstrument 1 according to claim 1,

characterized in that

the braid 3 of metal or metal alloys such as nitinol or non-absorbable plastics, selected from the group of polyesters, polyamides, polyolefins, polyurethanes and polyhalogenolefins formed.

3. medical Occiusionsinstrument according to claim 1,

characterized in that

the threads of the braid body and the patches are formed from bioresorbable polymers and both the threads and the patches have a degradation time of between 4 and 50 weeks, preferably between 6 and 30 weeks and more preferably between 10 and 20 weeks, the threads being in stretched form present in the network.

4. medical Occiusionsinstrument 1 according to claim 1 and 3,

characterized in that

the fiber-forming bioresorbable polymer has a glass transition point of at least 42 ° C and a fermentatively produced polyhydroxyalkanoate or a synthetically resorbable polymer optionally formed from the monomer building blocks lactide, glycolide, e-caprolactone, p-dioxanone and trimethylene car- wherein the resorbable polymer can be either a homopolymer, a random copolymer or a block copolymer, wherein a copolymer is to be understood as meaning a polymer composed of at least two of the monomeric units mentioned.

5. occlusion device 1 according to claim 1, 3 and 4,

characterized in that

the resorbable polymer comprises from 70% by weight to 97% by weight of L- or DL-lactide, preferably from 80% by weight to 95% by weight of L- or DL-lactide and particularly preferably from 88% by weight to 93% by weight % L or DL lactide, the balance being 100% by weight of glycolide, e-caprolactone, p-dioxanone, trimethylene carbonate or a combination of these monomers.

6. occlusion device 1 according to any one of the preceding claims,

characterized in that

the proportion of the braid body forming threads which completely span the distal disc and the other portion of the filaments which are inverted at one or more distances from the center of the distal disc in a narrow radius can be combined in any ratio, in particular one To achieve increased flexibility of the multiflexible braid and a smaller radius of curvature of the elongated occluder in the lock, which in turn can lead to the use of smaller lock diameter with regard to applications in pediatric cardiology.

7. occlusion device 1 according to any one of the preceding claims,

characterized in that

in the braiding 10 over a central through-hole 12 at least two or a straight multiple of braid threads 2 are removed via a central trigger 13 to better position the Occiuder 1 in the defect.

8. occlusion device 1 according to claim 1 to 6,

characterized in that

in the braiding 10 via an off-center frontal deduction 14 with a plurality of eccentric through holes 12 at least two or a multiple even of braid threads 2 can be dissipated to optimally align the Occiuder 1 in the distal retention area or distal disc 24 even better.

9. occlusion device 1 according to claim 1 to 6,

characterized in that

in the Occluder 1 after completion additionally a trigger system 13 is integrated, so that the fixation of the Occluders 1 in the defect in the axial direction is independent of all other conditions possible.

10. occlusion device 1 according to claims 7 to 9,

characterized in that

the trigger system for deploying the Occluders in the defect in the proximal opening of Occluders under train either anchored itself or clamped or squeezed by a corresponding operable by the surgeon device in the proximal opening.

11. occlusion device 1 according to claims 7 to 9,

characterized in that

the self-anchoring trigger system at its distal end barbs pointing towards the distal end, or has thickening or the diameter increases towards the distal end, so that the trigger system itself anchored in the full Aufsteilen the Occluders in the promissory passage opening and thus the fully erected Occluderform fixed.

12. Occlusionsinstrument 1 according to any one of the preceding claims, characterized in that

the mesh 3 can be tapered to the diameter of a catheter used in the interventional surgical procedure.

13. A method for producing an occlusion device 1, according to one of claims 1 to 12,

characterized by the following process steps:

a) forming a braid main body 29 by means of the described braiding method for a multiflexible braid 3, consisting of a closed braid segment 4 and an open braid segment 5, wherein the braid body 29 is spherically shaped at the distal end 27, and remains open at the proximal end 28, and b) forming a distal disc 24 and a proximal disc 25 and a between the distal and proximal retention portion 27, 28 arranged cylindrical web or waist 26th

14. The method according to claim 13,

marked by

the method step of forming a ball coupling 42 at the bundled proximal end 28 of the braid body 29.

15. The method according to claim 13 and 14,

characterized in that

the step of forming the retention regions 24, 25 and the waist 26 includes a transformation and / or heat treatment.

16. A method for producing a Occiusionsinstrument 1 according to claims 1 to 14,

characterized in that

The occluder 1 can generally be produced by generative methods in its characteristic properties, and the use of such generative methods should not be limited to such methods as the use of stereolithography or 3-D printing.