DE102014018086A1 - Multifunctional occluder for occluding PFO and ASD defects and producing them - Google Patents

Abstract

Medical occlusion device 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 of thin filaments 2 with closed mesh segments 4 and open mesh segments 5, wherein the occlusion instrument 1 is characterized in that distal disc or distal retention area 24 is bounded by a web 26 of a proximal disc or proximal retention area 25, characterized by at least one tissue patches 45 in the discs 24, 25 required to fully close the shunt in the bridge 26 be, with the two retention areas 24, 25 come through a mostly interventional surgical intervention on both sides of a shunt to be closed in a septum to the plant while the web 26 passes through the shunt. The threads 2 of the multiflexible braid 3 can be made of metal or metal alloys such as Nitinol, non-absorbable plastics selected from the group of polyesters, polyamides, polyolefins, polyurethanes and polyhalogenolefins or bioresorbable polymers.

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 occluder systems that have been on the market so far stretch in the defect or lean distally towards one side (so-called "Cobra" effect), which as a rule can lead to such devices having to be explanted again.

Such Occluder are z. In WO 2007/140797 A1 . EP 2 014 239 A2 and EP 1 955 661 A2 disclosed.

Out DE 10 2005 053 958 A1 there is known a bioabsorbable medical self-expandable occluder for treating defects in the heart of a patient, the occluder being 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.

In DE 10 2011 077 731.8 Another bioresorbable occluder is described in which a variable final shape is to be formed according to 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 closure device is known by the term "Chinese lantern" (US Pat. WO2011075088 ). This device is also characterized by a double disc design, in which case a two-part spoke frame was selected. This consists distally of polycaprolactone (PCL) struts and proximally of 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) ( WO2011096896 ). Its mesh design is similar to that of the Amplatzer ASD Occluder from the U.S. Patent 5,725,552 ,

In analogy to this ASD-Geflechtsoccluder discloses the disclosure DE 10 2011 077 731 A1 Another example of a bioresorbable ASD / PFO Occlusionssystem based on a rotationally symmetrical braid body. In this ball mesh with a central trigger mechanism, an accumulation of multiply intersecting and overlapping threads occurs at the distal end, which hinders the ability to pass the tube and precludes the use of small-lumen catheters.

The listed bioresorbable occlusion systems have in common that after their implantation they first serve as a closure device for the diagnosed atrial septal defect. 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. This has the consequence that this procedure opens in principle in a natural closure of the vascular defect site in the atrial septum, without foreign material must remain permanently in the body.

These bioresorbable Occluder consist usually similar to the metallic Occluder also listed from a rotationally symmetrical braid body with permanently intersecting threads or wires, which leads in part to the fact that these occluder 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 also form on the edges of the bulging occluders, triggering strokes and possibly also 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 Occluder, which forms flat in the defect without side effects, such as bulging, stretching or "Cobra" effect and thus optimally adapts to the Vorkammerseptum. In addition, the Occluder should show optimal Schleusengängigkeit. 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 methods are used in such a way that substantially 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 web 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 Final position is reached, which in fact means that the occlusion device reverts extremely flat in defect to its original initial shape without stretching and buckling in contrast to the prior art mesh occluders. 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 completion of the interventional implantation procedure. This also means that the so-called "Cobra" effect is not possible with the ASD occluders. The embodiments of the invention may be made of metallic materials, plastics, including bioresorbable materials.

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:

1 (a) a spatial schematic representation of the side view of a braiding machine for producing the multiflexible braid main body according to the invention consisting of open and closed braid portions;

1 (b) a schematic plan view and partial view of the braiding machine according to 1 (a) ;

2 a schematic plan view of the braiding with representation of the thread pattern for the multiflex braid after 1 (a-b) ;

3 a schematic representation of a preferred further embodiment of a multiflex braid according to the invention with representation of the thread pattern for the multiflex braid in the braiding according to 1 (a-b) however, with two staggered rows of guide pins;

4 Detail view Rotary table with braided bobbin and carrier and drive plate for the braiding machine according to Multiflex braiding 1 (a-b) ;

5 a schematic representation of a preferred further embodiment of the invention of the Multiflex mesh in the braiding head with braided withdrawal threads centered;

6 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 a schematic representation of a preferred first embodiment of a three-dimensional view of the multiflex main body braided with deduction deduction;

8 (a) a schematic view of a preferred first embodiment of a Multiflex uniform Occluders according to the invention with interlaced deduction in plan view;

8 (b) a schematic view of a preferred first embodiment of a Multiflex uniform Occluders invention 8 (a) in the side view;

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

9 (b) a schematic representation of a preferred further embodiment of a Multiflex invention PFO-Occluders according to the invention 9 (a) in the expanded state in the side view,

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

10 (b) a schematic representation of a preferred further embodiment of a multiflex ASD Occluders invention 10 (a) in the expanded state in the side view,

11 (a) a schematic representation of a preferred further embodiment of a Multiflex invention PFO-Occluders in the expanded state consisting of a multiflexible braid body of open and closed braids without deduction in plan view,

11 (b) a schematic representation of a preferred further embodiment of a Multiflex invention PFO-Occluders according to the invention 11 (a) in the expanded state in the side view,

12 (a) 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 deduction in plan view,

12 (b) a schematic representation of a preferred further embodiment of a multiflex ASD Occluders invention 12 (a) in the expanded state in the side view,

13 (a) a schematic detail view in section for a subsequently introduced trigger mechanism for a further preferred Embodiment of a Multiflex PFO Occluders invention 11 (a-b) or ASD Occluders 12 (a-b) .

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

13 (c) a schematic detail view in section for a subsequently introduced trigger mechanism according to 13 (a) with retracted lock and

13 (d) a schematic detail view in section of a subsequently introduced trigger mechanism according to 13 (a) in end position after decoupled insertion system.

1 (a-b) shows a schematic spatial representation of the side view of a rotationally symmetrical braiding machine 35 for producing a first preferred embodiment of an occluder according to the invention (occlusion instrument) 1 to 9 (a-b) , The braiding machine 35 is structured as follows: On the rotary table 15 For example, on the outer edge, there are 40 circular carrier and drive plates 7 assembled. On each carrier and drive plate are four shots each 6 for one braided beater inside each 8th and outside 9 , On each carrier and drive plate are exactly two braided bobbins, one each for inside 8th and outside 9 , Above the braiding machine 35 there is a braided head 10 with a central through-hole 12 , which circumferentially with guide pins 11 is equipped.

For the production of a braid body 29 with a multiflexible mesh content 3 with open 5 and closed braid segments 4 are all threads 2 the existing braids 8th . 9 included. The procedure is as follows:
Each from any carrier and drive plate 7 is made by a braided bobbin 8th . 9 over the braided head 10 between the guide pins 11 through exactly to the opposite braided bobbin 8th . 9 on the associated carrier plate 7 one thread each 2 curious; excited. This is the thread 2 from wickerwork inside 8th to the wickerwork outside 9 on the opposite side of the braiding machine 35 guided. Between two opposite braided bobbins 8th on the one carrier plate 7 and the braided bobbin 9 on the other opposite support plate 7 (please refer 1 (b) ) become the threads 2 on each side each of a filament tensioner 23 held. In this way, a closed braid segment is thus created during the later braiding process 4 , In an open mesh segment 5 becomes the thread 2 from the clapper 8th over one at the edge of the braiding head 10 located guide pin 11 to the clapper 9 same carrier and drive plate 7 recycled. For a mesh body 29 to 7 are now mutually all available clappers 8th . 9 covered with threads, allowing for a closed mesh share 4 one open mesh each 5 follows and except for four clappers 8th . 9 , which is for the trigger mechanism 13 or 14 (here trigger mechanism 13 with four threads 2 ) are needed. In the example according to the invention 7 become the deduction threads 2 after a central withdrawal 13 as follows;
From a carrier and drive plate 7 is from an inside clapper 8th the string 2 to gegenüberbefindlichen carrier and drive plate 7 led and there to the outside clapper 9 , With two support plates offset by 90 ° 7 the procedure is analogous. The on the four support plates 7 not needed clappers 8th . 9 become for closed braid segments 4 busy.

If all threads 2 This results in forty carrier and drive plates 7 a total of forty-four threads 2 because there are four threads 2 about the trigger system 13 be dissipated.

During the subsequent braiding process, all carrier and drive plates rotate around their own axis. To 4 turns the bottom support plate 7 in clockwise direction 21 and the adjacent support plate in the opposite direction 22 , while the clappers wander 8th . 9 from one carrier plate to the other and in rhythm to the outside, inwards, outwards, etc .. Technically, the whole thing is made possible by appropriate recordings 6 for the carrier and drive plates 7 , The number of shots 6 for the carrier and drive plates 7 must be exactly twice as big as eighty times. The braiding process is complete when a braided bobbin 8th or 9 arrived back at its starting point (rotary motion on rotary table braiding machine 360 degrees).

In 2 is the complete assignment of the braiding head 10 for a multiflex mesh with open 5 and closed mesh parts 4 shown. The strings 2 in a closed cycle 16 run over the braided head 10 through and the threads 2 in the open cycle 17 are each about a guide pin 11 to the respective carrier plate 7 recycled. In such a braid body 29 after completion of the braiding process, there is a flattening at the distal end 27 , which in turn improved sliding properties in the lock 20 allows.

To 3 be at a corresponding braiding 10 two concentric circles equipped with corresponding guide pins, which improves the molding properties, eg. B. even better flattening of the distal end 27 of Braided body 29 causes and also significantly improves the sliding properties in the lock. In the braiding basic body produced according to the invention 29 to 7 became a central deduction after 5 used.

6 shows a schematic representation of the design of the braiding 10 for interlaced eccentric withdrawal threads, what an occlusion device 1 can cause a more stable basic form.

To 8 (a-b) . 9 (a-b) and 10 (a-b) can be for specially suitable designs made of metal filaments, such. As nitinol, a highly elastic alloy of titanium and nickel with shape memory function, corresponding uniform Occluder 37 , PFO Occluder 38 and ASD Occluder 39 manufacture using appropriate tools for the outer contour and heat treatment process.

Likewise, such occluders can also be made from suitable bioresorbable materials. In this case apply to monofilament or multifilament threads 2 (as a replacement for metallic wires) made of bioresorbable polymer and bioresorbable patches (nonwovens) 45 the following requirements:
Resorbable copolymer formed from 70 wt .-% to 97 wt .-% L-lactide and 3 wt .-% to 30 wt .-% glycolide, preferably 80 wt .-% to 95 wt .-% L-lactide and 5 wt % to 20% by weight glycolide and more preferably 88% to 93% by weight L-lactide and 7% to 12% by weight glycolide. The polymer may be a random copolymer or a block copolymer, with a random copolymer being preferred.

The polymer has in the untreated state a residual monomer content between 3 wt .-% and 7 wt .-% 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 stretching a thread-like material.

Thread-like structures 2 and nonwovens 45 can be recovered from the polymer either by melt preparation or solution, melt production being preferred.

The thread-like structures may be either multifilament or monofilament nature, with monofilament structures being preferred for the preparation of the body 29 of the occluder 1 be used.

The diameter of monofilaments made from the polymer 2 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 stretched monofilaments 2 have a linear strength between 300 N / mm ² and 600 N / mm ² .

The stretched monofilaments 2 have a flexural modulus (bending angle 30 °, chucking 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 when used as an occluder base 29 to provide the necessary erection force.

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

The monofilaments 2 may be either partially de-monomerized or preferably almost completely demonomerized by a post-treatment step under reduced pressure. Alternatively, the demonomerization can be achieved by means of CO 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 strings 2 the trigger mechanism 44 are made from bioresorbable polymer, but not necessarily from the LG copolymers described herein. Other polymer variants for the tension cables are homopolymers of polylactide (PLLA), PDO and polycaprolactone and their copolymers with glycolide as a comonomer, in addition, polymers of hydroxycarboxylic acids such. As polyhydroxybutyric acid (eg., P3HB and P4HB) 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.

Also conceivable would be the formation of a spherical coupling such that the monofilaments are laser cut after a shaping heat treatment and then the ends either with an amorphous polymer (T _G about 50-60 ° C) by injection molding to the spherical coupling are fixed 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 accomplished by filling the polymer with an X-ray opaque additive (e.g., barium sulfate or bismuth oxide ,. B. can be achieved during extrusion to monofilament, but this requires at least fill levels of about 30 wt .-%. 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 set-up 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 sluice (preferred) or the Occluder 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)) be coated.

To seal the blood stream after implantation of the occluder 1 are in the discs 24 and 25 one layer of patches (nonwovens) 45 ,

The patch or patches can be produced either 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 of the patches to the base 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 prepared from the polymer either by melt-blown technique, by the spunbonding 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 .mu.m and 0.1 .mu.m, preferably between 5 .mu.m and 0.5 .mu.m and particularly preferably between 2 .mu.m and 0.5 .mu.m.

After densification and thus after increasing the mechanical stability of the nonwovens, these have a thickness of between 25 μm and 100 μm and preferably between 40 and 60 μm. The compression 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 also consist of a film or membrane and preferably from 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, which are delimited from each other by narrow webs. 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 according to the invention 29 according to the specifications of the 2 . 3 . 5 , and 6 with open 5 and closed mesh parts 4 can also be completed without deductions 13 or 14 , After prefabrication of Occluderendform here can subsequently ropes or an equivalent train system 44 be introduced ( 13 (a-d) ). The PFO Occluder 38 to 11a-b) and ASD Occluder 39 to 12a-b) differ from the external appearance and the function to be secured then no longer from those in the 9 (a-b) , and 10 (a-b) illustrated PFO Occluder 38 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 train system 44 may be formed from 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 stretch length prior to drawing is time-limited and achievable almost exclusively by block copolymers of the ABA type, 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 is for the trigger system 44 a monofilament of the same material composition as the copolymer for the braid body 29 used. The string 2 for the train system 44 Strength is chosen so that appropriate tensile forces can be absorbed and the interventional implantation procedure is not hindered. In 13 (a) the occlusion device is already in final position. To 13 (b) is already the right-hand thread of the train system 44 solved and with a thickening at the end in the ball coupling 42 firmly anchored. When returning the lock 20 secures the pull rope on the left side of the solid grip in the ball coupling. With uncoupling of the delivery system 43 the pull rope is severed on the left side, wherein a protruding portion of the pull rope is twisted immediately when strain relief; so are both pull ropes of the train system 44 firmly anchored and support a flat end position of the implanted Occluders 1 in the atrial septum.

It is also conceivable in the production of the body of an occluder 1 to produce this 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 form-neutral (eg, tape or wire,), starting components are made by physico-chemical processes. In the case of the widespread additive manufacturing processes, the desired geometry is achieved by joining together Volume elements generated. 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 mono- or polyfunctional acrylates or methacrylates which, when irradiated in the presence of suitable free-radical-forming photoinitiators, such as. Dimethylbenzilketal, acyl or bisacylphosphine oxides or mixtures of camphorquinone and tertiary amines, e.g. Example, such as N, N-dimethyl-p-toluidine, N, N-dihydroxyethyl-p-toluidine, 4-Dimethylaminobenzoesäureethylester, cure rapidly by free-radical polymerization. Examples of mono- 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 Tetraethylenglycoldi (meth) acrylate, trimethylolpropane tri (meth) lat, pentaerythritol tetra (meth) acrylate, and Glycerindi- and tri (meth) acrylate, 1,4-butanediol di (meth) acrylate, 1,10-decanediol di (meth) acrylate (D3MA) or 1,12-dodecanediol di (meth) acrylate. Furthermore, it is also possible to use cationically polymerizable resins. As cationic polymerization resins can be cationically ring-opening polymerizable monomers such. As glycidyl ethers or cycloaliphatic epoxides, cyclic ketene acetals, spiroorthocarbonates, oxetanes or bicyclic Orthoester use. Examples are: 2-methylene-1,4,6-trioxaspiro [2.2] nonane, 3,9-dimethylene-1,5,7,11-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). Cationically polymerizable resins can be treated with known cationic photoinitiators, especially with diaryliodonium or triarylsulfonium salts, if appropriate in the presence of suitable sensitizers, such as. As camphor quinone or thioxanthones cure. Examples of suitable diaryliodonium salts are 4-octyloxyphenyl phenyliodonium hexafluoroantimonate or isopropylphenylmethylphenyliodonium 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. 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

Thread (monofilaments)

3

Multiflexible braid

4

Closed mesh segment

5

Open mesh segment

6

Holder for carrier and drive plate

7

Carrier and drive plate

8th

Wicker bobbins inside

9

Braided beater outside

10

braiding

11

guide pin

12

Through Hole

13

Trigger in the middle

14

Trigger off the front side off-center

15

Round table braiding machine

16

Thread in the closed cycle

17

Thread in the open cycle

18

Thread course for trigger

19

Outer edge round table braiding machine

20

lock

21

Direction of rotation in clockwise direction

22

Counterclockwise rotation

23

Filamentspanner

24

Distal disc (distal retention area)

25

Proximal Disc (Proximal Retention Area)

26

web

27

Distal end

28

Proximal end

29

Braided body

30

Top view

31

sideview

32

Schematic view

33

Spatial view

34

sectional view

35

braiding

36

detailed view

37

Uniform occluders

38

PFO occluders

39

ASD occluder

40

Occluder with trigger

41

Occluder without deduction

42

ball coupling

43

Insertion system Acoredis

44

Pull system (trigger mechanism)

45

Patches (Nonwovens)

QUOTES INCLUDE IN THE DESCRIPTION

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

Cited patent literature

• WO 2007/140797 A1 [0004]
• EP 2014239 A2 [0004]
• EP 1955661 A2 [0004]
• DE 102005053958 A1 [0005]
• DE 102011077731 [0006]
• WO 2011075088 [0007]
• WO 2011096896 [0008]
• US 5725552 [0008]
• DE 102011077731 A1 [0009]

Claims (16)

Medical occlusion device 1 for the treatment of defects in the heart of a patient, in particular for occluding abnormal tissue openings, the occluder 1 made of a multiflexible mesh 3 thin threads 2 with closed braid segments 4 and open braid segments 5 is composed of the occlusion device 1 characterized in that a distal disc or distal retention area 24 through a footbridge 26 from a proximal disc or proximal retention area 25 is limited, characterized by at least one tissue insert (patches) 45 in the slices 24 . 25 , which completely closes the shunt in the bridge 26 be needed, with the two retention areas 24 . 25 through a mostly interventional surgery on both sides of a shunt to be closed in a septum come to rest, while the bridge 26 passes through the shunt. occlusion device 1 according to claim 1, characterized in that the braid 3 metal or metal alloys such as Nitinol or non-absorbable plastics selected from the group consisting of polyesters, polyamides, polyolefins, polyurethanes and polyhalogenolefins. The medical occlusion device 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 between 4 and 50 weeks, preferably between 6 and 30 weeks and more preferably between 10 and 20 weeks, the threads are present in a stretched form in the braid. Medical occlusion device 1 according to claim 1 and 3, characterized in that the thread-forming bioresorbable polymer has a glass transition point of at least 42 ° C and a fermentatively produced polyhydroxyalkanoate or a synthetically absorbable polymer, optionally formed from the monomer units lactide, glycolide, e-caprolactone, p-dioxanone and Trimethylene carbonate, wherein the resorbable polymer may be either a homopolymer, a random copolymer or a block copolymer, wherein a copolymer is understood to mean a polymer composed of at least two of said monomer units. occlusion device 1 according to claim 1, 3 and 4, characterized in that the resorbable polymer 70 wt .-% to 97 wt .-% L- or DL-lactide, preferably 80 wt .-% to 95 wt .-% L- or DL- Lactide and more preferably contains 88 wt .-% to 93 wt .-% L- or DL-lactide, wherein the remaining amount to 100 wt .-% of glycolide, e-caprolactone, p-dioxanone, trimethylene carbonate or a combination of these monomers formed can be. occlusion device 1 according to one of the preceding claims, characterized in that the portion of the braid body forming threads which completely span the distal disc and the other portion of the filaments which are inverted in a narrow radius at one or more distances from the center of the distal disc, in one In particular, they may be combined in any ratio to achieve, in particular, increased flexibility of the multifilament braid and a smaller radius of curvature of the elongated occluder in the sheath, which in turn may result in the use of smaller sheath diameters in pediatric cardiology applications. occlusion device 1 according to one of the preceding claims, characterized in that in the braiding 10 via a central through-hole 12 at least two or even a multiple of braid threads 2 via a central trigger 13 be dissipated to the occluder 1 to better position in the defect. occlusion device 1 according to claim 1 to 6, characterized in that in the braiding 10 via an off-center frontal deduction 14 with several eccentric through holes 12 at least two or even a multiple of braid threads 2 can be dissipated to the occluder 1 additionally in the distal retention area or distal disc 24 even better to align optimally. 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, thus fixing the Occluders 1 in the defect in the axial direction is independent of all other conditions possible. occlusion device 1 according to claims 7 to 9, characterized in that the trigger system for setting up the occluder 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. occlusion device 1 according to claims 7 to 9, characterized in that the self-anchoring trigger system has at its distal end barbs pointing towards the distal end, or has thickenings or its Increased diameter toward the distal end, so that the exhaust system itself anchored in the full opening of Occluders in the promissory passage opening and thus fixes the fully established Occluderform. occlusion device 1 according to one of the preceding claims, characterized in that the braid 3 to the diameter of a catheter used in the interventional surgical procedure. Method of making an occlusion device 1 , according to one of claims 1 to 12, characterized by the following method steps: a) forming a braid main body 29 by means of the described braiding method for a multiflexible braid 3 consisting of a closed mesh segment 4 and an open mesh segment 5 , where the braid body 29 at the distal end 27 is spherically shaped, and at the proximal end 28 remains open, and b) forming a distal disc 24 and a proximal disc 25 and one between the distal and proximal retention areas 27 . 28 arranged cylindrical web, or waist 26 , A method according to claim 13, characterized by the step of forming a ball coupling 42 at the bundled proximal end 28 of the mesh main body 29 , A method according to claim 13 and 14, characterized in that the method step of forming the retention areas 24 . 25 and the waist 26 contains a transformation and / or heat treatment. Method of making an occlusion device 1 according to claims 1 to 14, characterized in that the Occluder 1 can generally be prepared by generative methods, the use of such generative methods not being limited to such methods as the use of stereolithography or 3-D printing.

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