WO2007140797A1 - Occlusion instrument for closing a cardiac auricle - Google Patents

Occlusion instrument for closing a cardiac auricle Download PDF

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Publication number
WO2007140797A1
WO2007140797A1 PCT/EP2006/005292 EP2006005292W WO2007140797A1 WO 2007140797 A1 WO2007140797 A1 WO 2007140797A1 EP 2006005292 W EP2006005292 W EP 2006005292W WO 2007140797 A1 WO2007140797 A1 WO 2007140797A1
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WO
WIPO (PCT)
Prior art keywords
occlusion
body
occlusion device
occlusion body
atrial appendage
Prior art date
Application number
PCT/EP2006/005292
Other languages
German (de)
French (fr)
Inventor
Hans-Reiner Figulla
Susann Klebon
Katrin Schmidt
Rüdiger OTTMA
Friedrich Moszner
Robert Moszner
Florian Krizanic
Original Assignee
Occlutech Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Occlutech Gmbh filed Critical Occlutech Gmbh
Priority to PCT/EP2006/005292 priority Critical patent/WO2007140797A1/en
Publication of WO2007140797A1 publication Critical patent/WO2007140797A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12195Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices comprising a curable material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • A61B2017/12054Details concerning the detachment of the occluding device from the introduction device

Abstract

The invention relates to an occlusion instrument for closing a cardiac auricle (100), with a self-expanding occlusion body (1) which is composed of a braid (10) of thin wires or filaments and whose braid (10) is given a suitable configuration by means of a shaping and heating method, wherein the occlusion body (1) has a rear proximal retention area (2) and a front distal retention area (3). The ends of the wires or filaments of the braid (10) run together in a holder (4) in the distal retention area (3), and the occlusion body (1) also has a central area (5) between the proximal and distal retention areas (2, 3), wherein the occlusion body (1) in the collapsed state can be introduced minimally invasively into the body of a patient by means of a catheter and can be positioned in the cardiac auricle (100) of the patient. The object of the invention is to make available an occlusion instrument designed in such a way that it can be anchored in a particularly stable and fixed manner in the cardiac auricle (100). The object is achieved, according to the invention, by the fact that the occlusion instrument also comprises a fixing means (20) with a polymer network which is formed by means of a polyreaction mechanism, preferably taking place in the patient's cardiac auricle (100), and which establishes a force-fit connection between the braid (10) of the occlusion body (1) and the wall of the cardiac auricle.

Description

"Occlusion device for closing an atrial appendage"

description

The present invention relates to an occlusion device for occluding an atrial appendage. The occlusion device has a group consisting of a braiding of thin wires or threads, self-expandable occlusion body, the braid is obtained by means of a molding and heat treatment procedure, a suitable shape, wherein in each of the occlusion body has a rear proximal retention area and a front distal retention area, in which the ends the wires or threads of the mesh converge in a socket. Furthermore, the occlusion body between the proximal and distal retention area at a middle portion, the occlusion body is designed such that it is minimally invasive inserted and positioned in the atrial appendage of the patient in its folded state by means of a catheter in a patient's body. The invention further relates to a use of a fixing agent to form a force-fit connection between the braid of an occlusion body and an atrial auricula wall.

Such an occlusion device is at least partially known in principle from medical technology. For example, 10,338,702 known of 22 August 2003 an occlusion device for treating septal defects in the DE, which consists of a braiding of thin wires or threads, and obtains a suitable shape by means of a molding and heat treatment procedure. The known occlusion instrument has a proximal retention area, which is particularly pronounced flat, a distal retention region and a cylindrical web between the proximal and the distal retention region. At the distal retention area, the ends of the braid wires forming converge in a socket. It is provided that the two retention areas of the occlusion device known to come through a mostly intravascular surgical procedure on both sides of a shunt to be occluded in a septum system while the web passes through the shunt.

In Medical technology has long endeavored to septal defects, such as defects in the atrial septum, transvenous means of an interventional access non-surgically, without operation in the actual sense to close katheterinterventionell. Various different occlusion have been proposed with different advantages and disadvantages, without having yet by any one specific occlusion system. The following are the various systems "occluder" or "occlusion device" are called. With all interventional occlusion is introduced transvenously over a present in a septum to be closed defect a self-expanding umbrella system. Such a system could for example consist of two umbrellas, each having on the distal side (ie the side further from the center of the body or from the heart side) or on the proximal side (ie the side disposed closer to the body center side) of the septum are, after which the two shielding prostheses are screwed into the septal defect to a double screen. The closure system is thus then in the assembled state usually consists of two clamped umbrellas, which are connected to each other via a short, passing through the defect pin.

In such known from the prior art occlusion devices, however, it turns out to be disadvantageous that the implant procedure is relatively complicated, difficult and expensive. Apart from the complicated implantation of the comparison circuit system in the vessel to be closed septal defect with the umbrellas utilized are susceptible to material fatigue along with fragment fracture. It is also often expected to thromboembolic complications.

In order to achieve the inventive occlusion device can be inserted by means of an insertion instrument and 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 engagement after positioning the occlusion device in the defect can be easily released. For example is possible to devise the braiding at the end of the distal portion of the occlusion device tion retentate such that in the version of an internal thread is produced, with the passes the introducer into engagement. Of course, other forms from leadership are also conceivable.

In particular, if a patient suffers from a so-called atrial fibrillation of the heart, embolic-related problems can appear. This is from an-frequency excitation of the atria of the heart that results in no contraction of the atria. Consequence of this contraction loss of the atria of the heart is that an effective turbulence and mixing of the blood fails and thrombi can form in the atrium. A considerable risk for the Vorhoftromben- formation due to atrial fibrillation is that such thrombi can be entrained in the bloodstream and enter the arterial circulation. Follow these embolization are particularly strokes that occur in about 5% per year in patients with atrial fibrillation, unless a Gerin- is performed supply inhibition of the blood with so-called Dicumerolen by chronic treatment. However, an effect the inhibition of the blood coagulation ceremony with so-called Dicumerolen is also not without risk. Side effects of treatments with Dicumerolen are increased bleeding, so contraindications for this treatment in about 20% of patients with atrial fibrillation is and the patient haemorrhage / stroke the risk of stroke is accepted thus due to a risk assessment.

Thrombi in the atrium of the heart arise that the vast majority in the so-called atrial appendages. The atrial appendages are protuberances on the courts of the human heart. The right auricle is located next to the ascending aorta, the left next to the large pulmonary artery. Here, the toad heart ear is the common origin of blood clots that can lead to stroke in patients with atrial fibrillation.

in connection with the previously described Vorhoftrombenbildung mentioned risks and problems of the present invention is based on the object due to the to provide an occlusion device, with which the auricle of the left atrium may be closed in order to reduce thrombus formation with the risk of stroke considerably. In particular, an occlusion device is to be specified with which the risk of stroke can also be reduced in those patients in which an anticoagulation Dicumerolen (called Antikoagolation) is indicated due to bleeding tendencies counterproductive. In particular, the occlusion device should be designed such that it is particularly stable and firmly anchored in the atrial appendage. These objects are achieved with a self-expandable occlusion device of the type mentioned in the introduction according to the invention in particular achieved in that the occlusion device in addition to the occlusion body further comprises a fixing means having formed by means of a preferably ablaufbaren in the auricle of the patient Polyreaktionsmechanismus polymer network to form a kraftschlϋssige connection between the braid of the occlusion body and having atrial auricula wall. It is provided that, after the positioning of the occlusion body, the fixing agent described in detail below is filled in particular, as low-viscous liquid which is curable by a cannula be applied and controlled to a flexible insoluble product in the atrial appendage of the patient so that the occlusion body in the auricle can be firmly anchored.

Advantageous further developments of the inventive occlusion device are specified in the dependent claims.

The solution of the invention has a number of significant advantages over the known from the prior art and the above-mentioned occlusion devices. On the one hand it concerns with the occlusion body is a self-expandable body implantable example with a suitable delivery catheter in a particularly simple manner. To this end, it would be conceivable to puncture a vein in the patient's groin and demonstrate the insertion catheter up to the septum of the right atrium. By means of a puncture of the vaginal wall of the atrium, which can for example be a known transseptal puncture, the toad is achieved atrium of the heart, can be such that subsequently introduced from the groin of the insertion catheter in the left atrial appendage. Via the insertion catheter system of self-expandable occlusion body for closing the atrial appendage can be introduced subsequently. Subsequently, ie after the positioning of the occlusion body in the auricle, the fixing agent may be applied by a cannula and placed in the atrial appendage, at least partially. In this case, the fixing means being adapted to cure after application, in particular in a controlled manner to a flexible insoluble product, thereby providing a durable and firm anchorage between the braid of the occlusion body and the atrial auricula wall.

In a further embodiment of the occlusion device according to the invention is also provided that the proximal retention area of ​​the occlusion body has at least one flanged area which comes in the expanded state of the occlusion body in the vessel to be closed atrial appendage on the inner walls of the atrial appendage and with the inner walls of the atrial appendage a non-positive connection forms for such to keep the implanted and expanded occlusion instrument in the atrial appendage, wherein the distal retention area of ​​the occlusion device closes the opening of the atrial appendage. Here, the anchoring function of the fixing agent supports the positive connection between the flanged area and the atrial auricula wall.

The occlusion body, which is present during implantation in the folded state, has, preferably, a diameter 6-10 frenches, so that the engagement for closure of the atrial appendage is minimally invasive.

After the collapsed occlusion body by means for example of the delivery catheter is positioned in the vessel to be closed atrial appendage, the occlusion body is released from the catheter, upon which this unfolds due to its self-expandable nature and assumes the distinct means of employed in Preparation Umformungsund heat treatment process forming. In this expanded state, the rear proximal retention area with the flanged area formed thereon is completely unfolded, and comes to the inner walls of the vessel to be closed atrial appendage. In this case, the proximal retention area is used with the flanged area formed thereon for securing and positioning of the expanded occlusion body in the atrial appendage. The extending from the proximal retention area in the direction of the atrial appendage opening center area, and the provided at the distal end of said central portion distal retention area fill thereby the opening portion of the atrial appendage almost completely, so that the entire expanded occlusion body is in the inserted state as a closing plug for closing the atrial appendage. In this way, in a particularly simple and minimally invasive manner thrombus formation with the risk of stroke can be reduced considerably.

On the other hand, the fixing agent is applied, so as to improve the anchoring of the occlusion body in the atrial appendage after the positioning of the occlusion body in the atrial appendage. After curing of the fixing agent in the atrial appendage of the implementation process of the occlusion is complete.

In particular in that the fixing means is provided in the inventive solution can be dispensed at the occlusion device to fastening hooks or other anchoring means, which are commonly used in such occlusion devices for fixing and positioning of the instrument in the tissue. It should be noted in particular that due to the extremely thin-walled design of the tissue fastening hooks normally used can not provide permanent attachment and positioning of the occlusion device in the vicinity of the atrial appendage. With the inventive solution, and in particular by the provision of the fixing which is preferably applied after positioning the Occlusi- onskörpers in the atrial appendage means, the problem of fastening of Occlu- sion instruments on the extremely thin and easy to infringing atrial appendage tissue can be bypassed by means of hooks. Here, the fixing agent is used to complete and permanent positioning of the occlusion body in the atrial appendage.

In a case where the occlusion body additionally comprises at least one flanged area, may at least partially a positioning and fixing of the occlusion body by means of the achieved on the inner walls of the atrial appendage coming brim portion; This is particularly advantageous in that even before the application of the fixing a relatively secure hold of the occlusion body can be provided in the atrial appendage. After reaching the end position of the occlusion body a fixing agent in the form of a low-viscosity liquid that can be applied using a cannula inserted for fixing the distal retention area, and finally controlled is cured to a flexible, insoluble product in the blind hole of the atrial appendage.

Description will be made on preferred embodiments of the configuration of the occlusion body and the design of the fixing means with reference to the accompanying drawings. Further preferred embodiments of the inventive occlusion device are described.

Show it:

Figure 1 is a mögüche output form for a funnel-shaped hollow braiding of the occlusion body.

Figure 2 shows a possible form of output for a spherical, pear-shaped or teardrop-shaped hollow braiding of the occlusion body.

FIG. 3a shows an embodiment of an occlusion body with funnel-shape of Figure 1 in side view with a half-section. FIG. 3b shows the occlusion body according to Figure 3a in plan view.

FIG. 3c shows the occlusion body of Fig 3a in a spatial representation.

FIG. 4a shows a further embodiment of an occlusion body having a spherical shape as shown in FIG. 2;

FIG. 4b shows the occlusion body according to Figure 4a in a top view.

Fig. 4c the occlusion body shown in FIG 4a in a spatial representation.

FIG. 5a is a further embodiment of an occlusion body with multiple remote brim portions with the basic spherical shape of FIG. 2;

Fig. 5b the occlusion body of Fig 5a in a spatial representation.

Fig. 6 is a spatial representation of a human atrial appendage in the left atrium in a stylized representation;

FIG. 7a is a sectional view, simplified for the left atrial appendage, with an inserted occlusion body according to Fig 3a of the funnel shape.

7b is a sectional view, simplified for the left atrial appendage, with the inserted occlusion body according to Figures 7a and applied with a fixing agent..;

Fig. 8a is a sectional view, simplified for the left atrial appendage, with an inserted occlusion body of FIG 4a of spherical shape.

8b is a sectional view, simplified for the left atrial appendage, with the inserted occlusion body according to Figures 8a and applied with a fixing agent..;

9a is a sectional view, simplified for the left atrial appendage, with an inserted occlusion body according to Fig. 5a. 9b is a sectional view, simplified for the left atrial appendage, with the inserted occlusion body according to Figures 8a and applied with a fixing agent..;

10 shows an example of components of a fixing agent on the basis of tailor-made polymer networks.

11 shows an example for the formation of a free radical redox initiator system of DBPO and DEPT.

FIG. 12 is an example of a polymerizable peroxide (a) and a polymerizable amine accelerator (b);

Figure 13 is an example of free-radically polymerizable groups.

14 shows an example for structural variations in dimethacrylates.

Figure 15 is an example of a synthetic scheme for a Ormocer polymer network.

Figure 16 is a representation of a dendrimer, and the hyperbranched oligomer.

FIG. 17 is an example of material monomer for a simple Peptidkleb-;

FIG. 18 is an example of polymer structures of biodegradable poly (lactic acid (PLA), polyglycolic acid (PGA) or Polybersteinsäureanhydrid (PAB);

Figure 19 is an example of the synthesis, the polymerization and the degradation of a DIAC triacrylate reaction resin. and

Fig. 20 is an example of inhibitors of free-radical polymerisation.

Fig. 1 shows a possible embodiment of a funnel-shaped hollow braiding 10, which can serve as base for an occlusion body 1 of the occlusion device. Fig. 2 shows an alternative form fuhrungs From this base body, wherein in this case a spherical or pear-shaped hollow braiding tropfenformiges 10 is used. From the funnel-shaped hollow braiding 10 (Fig. 1) or the spherical or pear-shaped and tropfenformigen hollow braid in FIG. 2 can be prepared, the most important, but also quite specific Occlusionskorper 1 of Occlusionskorpers 1, as described below.

In Fig. 1 it can be seen in particular that the illustrated here, the Occlusionskorper 1 serving as a base body mesh is formed in the shape of an opened at the proximal retention area 2 funnel-shaped braid 10 10, which is provided only on the distal retention area 3 with a socket 4 in which converge the ends of the wires or threads of the mesh 10th Alternatively, however, to the funnel-shaped hollow braiding 10 of FIG. 1, it would also be conceivable, the spherical braid 10 in FIG. 2 to be used as the base body Occlusionskorpers 1. The main difference between the two in Fig. 1 and 2 shown hollow meshes 10 is particularly to see that the proximal retention area 2 of the hollow braid 10 shown in FIG. 2 is a closed surface, whereby the overall braid or in the form of an upwardly closed tubular . saccular mesh is designed.

In FIGS. 3a to 3c, a possible embodiment of a Occlusionskorpers 1 is shown which is formed from a base mesh 10 of FIG. 1. On the other hand, FIGS. 4a to 4c, an alternative embodiment for the Occlusionskorper 1, wherein said Occlusionskorper is formed from a base mesh 10 of FIG. 2.

As already indicated, the Occlusionskorper 1 of the embodiments shown consists of a braiding of thin wires or filament 10 that obtained with a forming and / or heat treatment process, a suitable shaping. In the case of in Figs. 3 and 4 shapes of Occlusionskorpers 1 are in each case about a substantially hantelahnhche molding consisting of a front distal retention area 3, a central portion 5 and a rear proximal retention area 2. In the distal retention area 3, the ends run the wire or thread of the braid 10 in a holder 4 together. The proximal retention area 2 of the Occlusionskorpers 1 of FIG. 3 comprises an open towards the proximal end shape, while the proximal retention area 2 of the Occlusionskorpers 1 according to Fig 4 is closed at the proximal end. In FIGS. 3 and 4 of the occlusion body 1 is shown in its expanded state. As already indicated, the occlusion body 1 comprises a proximal retention area 2, a distal retention area 3, and a waisted cylindrical center portion. 5 As can be seen from the figures, the proximal retention area at least one flanged area 6, which is formed by at least partially evert back of the proximal and / or distal retention area 2, 3 of the respective end. The proximal retention area 2 with the flanged area 6 formed thereon serves primarily for temporarily fixing and holding of the occlusion body used in the implantation procedure to atrial appendage 1. The final fixing of the occlusion body 1 is performed by subsequent application of a fixing agent described below.

In FIGS. 5a and 5b show a further embodiment of an occlusion body 1 is shown having a plurality of turnup portions 6, to ensure a better grip of the occlusion body 1 used in the auricle of a patient.

Fig. 6 shows a spatial representation of a human atrial appendage 100 in the left atrium. Especially here atrial appendage shown in a stylized representation.

Fig. 7a shows a sectional view in which the occlusion body 1 shown in Fig. 3a is inserted into the atrial appendage 100th Fig. 7 shows the occlusion body 1 used in the atrial appendage 100 gem. Fig. 7a, but with already-applied fixative 20th

Similarly, the Figure 8a show., B and 9a, b the occlusion body according to Fig. 4a and Fig. 5a, respectively without and with applied fixer 20. Based on these figures, the operation of the fixing means 20 can be clearly seen. In particular, it can be seen that initially the occlusion body 1 is inserted into the atrial appendage 100 and positioned there. This positioning is carried out advantageously independently during expansion of the collapsed in implanting occlusion body 1. Following the 100 next to the interior wall of the atrial appendage brim portion 6, a provisional fixation of the occlusion body 1 in the atrial appendage 100 is ensured.

After reaching the end position of the occlusion body 1100, the fixing means 20 is introduced into the blind hole of the atrial appendage. The fixing agent 20 is preferably a low-viscous liquid which can be applied using a cannula. By the fixing agent 20 cures controlled and thereby forming a polymer network, a kraftschlüs--fitting connection between the braid 10 of the occlusion body 1 and the atrial auricula wall can be achieved.

in particular, the occlusion body 1 has a flanged area 6, preferably wherein the proximal retention area 2 is designed with its flanged area 6 such that it bulges out upon expansion of the occlusion body 1 outwardly in such a way in the implanted state with the inner walls of the atrial appendage 100 for attachment to come. With this embodiment it is therefore possible that the selbstexpandier- bare occlusion body 1 can be advanced deeply into the auricle to be closed 100 by means of an insertion catheter system. The distal retention area 3 which is formed for example as distal Schirmchen advantageously, is subsequently, ie after the occlusion body 1 by means of the catheter system has been inserted into the vessel to be closed atrial appendage 100, brought to the development and positioned, wherein the umbrella at the edge of opening of the atrial appendage 100 is applied to the input of the atrial appendage 100th At the same time also the proximal portion 2 of the occlusion body 1, ie the proximal screen expands, being drawn further into the atrial appendage 100 during the expansion process of the proximal Occluder in the proximal retention area 2 of the occlusion body 1 and so exerted on the center section 5, a pulling force on the distal Schirmchen becomes. As a direct consequence, the distal umbrella or the distal retention area is held at least temporarily at a constant voltage at the input of the atrial appendage 100, wherein subsequently a firm anchoring of the occlusion body 1 with the fixing means 20 is realized.

The proximal retention area of ​​the occlusion body 2 can 1 comprises a completely closed proximal wall having a continuous surface, which forms the proximal end of the occlusion body. 1 Here, the proximal wall having a curved surface as the continuous surface, for example with the surface of a portion of a spherical, pear-shaped or teardrop-like body coincide.

By the abutment, the at least one brim portion 6 on the inner wall of the atrial appendage 100 can be further achieved in that the occlusion device can be used completely enclosed by the body's own tissues considerably faster than with the known from the prior art closure systems.

From the use of a built up from thin wires or threads braid 10 as the starting material for the occlusion body 1 the further advantage derives in that it comprises eme long-term mechanical stability. In particular, the occurrence of cracks in the structure or other types of material fatigue of the implant used can be largely prevented. Further, the mesh has a sufficient stiffness

In a particularly advantageous realization of the Occlusionskorpers 1 can be provided that the flanged area formed for example at the proximal retention area 2 is formed by 6 Zuruckstulpen of the proximal retention area 2 to the distal end 3. This is a particularly easy to realize and efficient manner thereby to form the brim portion 6 at the Occlusionskorper. 1 In particular, it is thus possible to form the entire Occlusionskorper 1 from a einstucki- gen braid 10 so that on the one hand, no mechanical fasteners between the flanged area 6 and the proximal end 2 are necessary and on the other hand, the dimension of the Occlusionskorpers 1 in the folded state further minimized can be of course, other embodiments of forming the at least one turnup portion 6 are also conceivable.

In order to achieve that the distal retention area 3 of the Occlusionskorpers 1 in the implanted and expanded state at the rim of the Herzohroffnung completely flattens, and indeed, is almost independent of the diameter of the Herzohroffnung may be provided in a further development of Occlusionskorpers 1 that the distal retention area 3 has a recess in which the socket 4 is arranged. By arranging the socket 4 in the manner provided at the distal end 3 of the cavity 1 Occlusionskorpers no components of the Occlusionskorpers 1 via the atrial auricula wall protrude, so that a gallops contact with the blood components of the implant can be prevented. This has the advantage that defense reactions of the body and no thrombebolischen complications are to be feared. In particular in that the Occlusionskorper 1 is expanded selbststandig in the orifice of the atrial appendage 100, positioned and fixed at least temporarily, wherein the distal and proximal retention area 3, 2 are biased in a radial direction, the Occlusionskorper 1 used over a wide range of differently sized Herzohroffnungen become.

In a further development of the last-mentioned embodiment of the Occlusionskorpers 1, wherein the distal retention area 3 has a recess may also be provided that the Occlusionskorpers 1 in the recess further comprises a connecting member disposed at the distal end 3, wherein the connecting member with a catheter in engageable. This connecting element which is preferably arranged at the Occlusionskorper 1 such that it does not protrude beyond the atrial auricula wall, whereby a gallops contact with the blood components of the implant can be prevented, the Occlusionskorper 1 also the functionality of the Ruckhol- bility on. On the other hand, facilitates a connecting element which is engageable with a catheter in engagement, the implanting and positioning of the (folded during implantation process) Occlusionskorpers 1 in the vessel to be closed atrial appendage 100. As connecting elements different devices are suitable conceivable were, for example, latching members or hooks or eyelets that can be connected kraftschlussig with correspondingly complementarily designed connecting elements of a catheter.

In a further development it can be provided that the Occlusionskorper 1 together reversible and is carried unfoldable, so that the body 1 is folded in its expanded state, for example by means of an explantation catheter, wherein the provisional kraftschlussige connection between, for example, at the proximal retention area 2 formed, at least one Krempen- region 6 and the inner walls of the atrial appendage is achieved 100th It is conceivable that engages and explant, a catheter for example, to a space formed at the distal end 3 of the connecting element 1 Occlusionskorpers folding the Occlusionskorpers 1 is caused by an external manipulation by means of the catheter. Thus, the Occlusionskorper 1 is completely reversible zuruckziehbar into the catheter, which enables the complete removal of the body. 1

To achieve that, the braid 10 of the Occlusionskorpers 1 by means of a Umfor- FFM and heat treatment process can maintain its appropriate shaping, it would be conceivable that the braid 10 is formed from a Formgedachtnis-matenal, in particular nitinol or plastic polymer. The use of nitinol in Occlusion- known sinstrumenten. Formgedachtnispolymere belong to the group of smart polymers and polymers which show a Formgedachtniseffekt, ie can the other under the action of an external stimulus such as a change in temperature, their outer shape.

We first made the polymer by conventional processing methods such as extrusion or Spntzguss in its permanent shape. Subsequently, the plastic is deformed and fixed in the desired tempo rare form, which is also called "programming". This process can be carried out with polymers on the one hand so that the sample is heated, deformed, and is then cooled On the other hand, the polymer or the plastic can also. what is called "cold stretching" are deformed at low temperature. Thus, the permanent shape is stored while the temporary shape is actually present. If now the polymer molding to a temperature higher than the switching temperature is heated, it comes for triggering the shape memory effect and thus to restore the saved permanent shape. By cooling the sample, the temporary shape irreversible, which is why we speak of a so-called one-way shape memory effect.

In comparison with the known shape memory materials such as shape memory alloy Nitinol, an equiatomic alloy of nickel and titanium, shape memory polymers with their memory performance by a multiple reflection. In this case, only a small effort (heating or cooling) for programming the temporary shape and the recovery of the permanent shape is necessary. Moreover, in Nitinol the maximum deformation between permanent and temporary shape is only 8%. Shape memory polymers have much higher ductility of up to 1.100%. All of the aforementioned shape memory polymers and materials are claimed by the present invention for biomedical application of Occlusionskör- pers. 1

In a further development of the latter from the guide form Occlusionskör- pers 1, wherein the braid 10 is formed from a shape memory material may be provided in that the material comprises a biodegradable shape memory polymer material. In particular, synthetic, biodegradable implant materials are suitable. Such degradable materials or polymers containing cleavable bonds under physiological conditions. In this case, if the material is degraded with loss of mechanical properties through or into a biological system is called a "Bioabbaubar- ness". The outer shape and the mass of the implant is retained during degradation under certain circumstances. If with respect to degradation without additional quantifying data spoken, so the time is in the complete loss of mechanical properties occurs, meant. biostable materials refers to those that are stable in biological systems and in the long term at least partially dismantled.

In degradable polymers, one distinguishes between hydrolytically and enzymatically degradable polymers. The hydrolytic degradation has the advantage that the degradation rate is independent of the site of implantation, since water is present everywhere. In contrast, the concentration of enzymes varies locally. In bioabbauba- ren polymers or materials, degradation enzymatically induced reactions, or by the combination thereof can be obtained by mere hydrolysis, take place. Typical hydro- lyzable chemical bonds are amide, ester or acetal bonds. When removing two mechanisms is observed. With surface degradation, the hydrolysis of chemical bonds takes place exclusively on the surface. Due to the hydrophobic character of the Polymerbau is faster than the diffusion of water into the interior of the material. This mechanism is observed especially with poly (anhydrides) or poly (ortho ester) s. For the important mainly for the shape memory effect of poly (hydroxycarboxylic acids), such as poly (lactic acid) or poly (glycosesäure) and corresponding copolymers, polymer degradation takes place in the entire volume. The rate-determining step here is the hydrolytic bond cleavage, as the diffusion of water into the polymer matrix rather hydrophylen is relatively fast. For the application of biodegradable polymers is crucial that degrade one hand with a Kontrollierbzw, adjustable speed and on the other hand, the degradation products are not toxic.

All of the aforementioned biodegradable shape memory polymers are claimed by the invention.

With regard to the shaping of the occlusion body 1 is - as already indicated - more preferably provided that the occlusion body 1 has a sphere-like shape, with the tapered end of the ball-like shape forming the distal retention area. 3 Alternatively, the occlusion body 1 may also have a mushroom-like shape, the cap of the mushroom-like shape forming the proximal or distal retention area 2; 3. It is also conceivable that the occlusion body 1 has a dumbbell-like shape, wherein the center piece of the dumbbell-shape forms the center section 5 between the proximal and distal retention areas 2, 3 of the occlusion body. 1 Of course, other shapes are possible here but to be selected suitable depending on the application.

Particular preference may further be provided that the braiding 10 of the occlusion body 1 can be tapered to the diameter of a catheter used in the minimally invasive surgical procedure. The advantage of this embodiment is the fact that the to be used for implantation and explantation catheter systems may have a significantly reduced internal diameter, which increases the ness of maneuverability of the appliance to be implanted occlusion body 1 considerably. Therefore, the positioning of the instrument in the atrial appendage 100 can be improved. In a Nitinol Occlusionskorper 1, the inner diameter of the catheter used for implantation or explantation of between 8 to 10 frenches, whereas must occur only between 6 to 8 with the use of frenches Occlusionskorpern of polymer plastic, the inner diameter is located.

Finally, it is also conceivable that the Occlusionskorper 1 a (not explicitly shown) having at least fabric insert, which is arranged to complete closure of the atrial appendage 100 in or on the distal retention area 3 or in the middle region 5 of the Occlusionskor- pers. 1 This fabric reinforcement is used to seal the remaining in the central portion 5 and in the expanding diameters of the Occlusionskorpers 1 interstices after the insertion and expansion of the body 1 in the atrial appendage 100th The fabric insert is fixed, for example at the distal retention area 3 on the braid 10 of the Occlusionskorpers 1 such that it can be stretched over the distal retention area 3 such as a cloth. The advantage of this construction, then, that the rim of the distal retention area 3 abuts flush to the Herzohrόffnung and less foreign material is introduced into the body of the patient lies. The fabric inserts can for example be made of Dacron. Of course, other Materiahen and other positions of the fabric insert in or on Occlusionskorper 1 are also conceivable.

Hereinafter briefly to preferred from fuhrungs the design of fixing 20 form is received. Before a detailed description of possible chemical polymer, inventive fixing 20 takes place on the basis of custom polymer networks, however, is to be made to better understand short review of known tissue adhesives.

A per se known tissue adhesive is adhesive of the so-called fibrin which is a 2-component adhesive, one component consists mainly of fibrinogen, and a specific blood clotting factor, and wherein the second component consists of thrombin with addition of CaCl. 2 The Aushartungsmechanismus corresponds to blood clotting, making them more likely can not be applied to the heart.

Further, a known per se tissue adhesive, known as gelatin resorcinol aldehyde adhesive. The base of the gelatin-resorcinol-aldehyde adhesive forms a mixture of gelatin and resorcinol (1, 3-dihydroxybenzene), wherein the curing is carried out by polycondensation with formaldehyde. But formaldehyde is considered to be carcinogenic and mutagenic.

Also, as Gewebekleb fabric of the so-called gelatin-resorcinol-dialdehyde adhesive known, which consists of a mixture of Gelantme and resorcinol. The curing takes place by reaction with the less toxic dialdehydes (glyoxal, glutaraldehyde). It can be reached only a low strength in wet curing.

As Gewebekleb sto ff Cyanaoacrylate also come into question, which are also known as superglue in the art and, for example, cyanoacrylate based on n-butyl-2-cyanoacrylate or ethyl-2-. The disadvantage is its extreme sensitivity to moisture, since it has hardened, in contact with traces of water and its toxicity.

In a peptide glue in natural substances such as carbohydrates, lipids, amino acids or short-chain peptides polymensationsfahige groups are introduced, which can then be cured for outgoing polymer networks. With this group tissue adhesive is good Biokompatibilitaten be achieved so that analog Monomersyste- me find below consideration.

In contrast to the known from the prior art and discussed above tissue adhesives, however, the fixer 20 for the inventive occlusion device meets the following requirements:

(I) In the Fixlermittel 20 for the inventive occlusion device is preferably low-viscosity liquids that can be applied through a cannula and controlled has hardened, to form a flexible, insoluble product.

(Ii) The curing of the Fixiermitteis 20 for the inventive occlusion device is preferably terminated after about 10 minutes (processing width).

(In) The solidification time of the fixing means 20 for the inventive occlusion device preferably amounts to approximately 10 to 20 minutes (Aushartungszeit). (Iv) The Fixiermittcl 20 for the inventive occlusion device preferably has an adhesive property on the occlusion body 1 as well as the tissue of the atrial auricula wall.

(V) In the fixing means 20 for the inventive occlusion device preferably is a choice between a non-degradable or a biodegradable fixative 20th

(Vi) The fixing means 20 for the inventive occlusion device is preferably non-toxic or low toxicological concern and does not cause adverse reactions in contact with blood.

This requirement profile can be achieved in particular through customized network polymers obtained by a controlled polymerization reaction (network formation) of a multicomponent liquid mixture of the selected monomers or oligomeric, an initiator system, and additional additives such as. for example, stabilizers are accessible.

Fig. 10 shows an example of components of a fixing agent 20 for the inventive occlusion device on the basis of tailor-made polymer networks in this context. As shown, thereby the solidification of the applied liquid fixing agent 20 can be selectively achieved by the addition of suitable substances, a so-called. Initiator system, in which, for example, by a chemical reaction of two compounds (the initiator and co-initiator), the polymerization reaction-inducing species is formed. but the question initiator components together can not be stored. So that the desired fixing agent may be prepared only by mixing two liquid compositions prior to application results.

Other additives relate, for example stabilizers which prevent premature polymerization reaction and thus uncontrolled curing of polymerizable mixtures. The viscosity of the fixing agent can be adjusted mainly by the specific choice of low-viscosity monomers, by addition of suitable additives also pseudoplastic properties, that is low viscosity when tiles, but stability after leaving the cannula can be achieved. Further be represented by the structure or functionality of the components, the density and polarity of the polymer network formed, and thus affect such properties as elongation, swelling, substrate adhesion.

The biodegradability can be achieved by use of biodegradable monomers. the multifunctional monomer or oligomer should by polymer network formation - provided virtually complete conversion - very likely be incorporated into the network, which contributes to improve biocompatibility.

Finally, the use of non-water soluble or non-polar substances authorizes wide preventing the mixing of the FIE to curing agent with tissue or blood fluid. Likewise is to dispense with the use of hydrolysis-sensitive components or with water-reactive compounds.

Due to contact with blood, the highest demands are to such so-called "Class III materials" which result in a significant limitation of the components in question. Accordingly are described potentially follow suitable fixing means, on the one hand non-biodegradable or biodegradable and are largely in line with the requirements mentioned above.

The following polymer chemical aspects or potentially possible components of non-biodegradable biocompatible fixing will be described on the basis of custom polymer networks. The components or fixing agent described below are claimed as a fixing agent 20 for the inventive occlusion device.

The known Polyreaktionsmechanismen for a polymer network formation are the polycondensation, polyaddition, and polymerization. Since low molecular weight substances are eliminated during polycondensation and usually take this many hours, such polyreactions of fixing are unsuitable. Likewise, the polyadditions frequently used in the art are eliminated, since the monomer used, such as diisocyanates or diepoxides are very toxic. In addition, isocyanates may react with water to produce gaseous CO 2. To ensure that only the polymerization is suitable as a polymerization reaction, in which from unsaturated or cyclic compounds, the so-called monomers, to form polymer chains The polymerization can be triggered by radicals or ions. Due to a possible blood contact is not ionic, but only a radical polymerization in question

The formation of polymer chains will be drawn by free radicals in the free radical polymerization. Radical is highly reactive species that are formed from stable materials, the so-called. Initiators. The formation of free radicals and thus the radikah- specific polymerization can be known, inter alia, by irradiation of light (photoinitiators), by the action of heat (thermal initiators) or be triggered by redox reaction of an oxidizing agent with a reducing agent (redox initiator systems). For radical polymeπsierbare fixing only re- dox initiator systems are, for obvious reasons in question. When redox initiator systems are, for example, combinations of a peroxide such as dibenzoyl peroxide (BPO) and a tertiary amine, eg N, N-diethanol-p-toluidine (DEPT), which at room temperature as a result of a redox reaction, the polymerisationsauslosende radicals form R-

In this connection, 1 1 is also made to Fig. Referred to, where an example of the radical formation of a redox initiator system comprising DBPO and DEPT is shown.

Although redox initiator systems are not non-toxic, but their biocompatibility let significantly improved by using polymeπsationsfahigen initiator components. A polymensationsfahiges DBPO, for example, 4.4 N is further -Divinylbenzoylperoxid In Fig 12 an example of a polymensationsfahiges peroxide (a) and shown a polymensationsfahiges accelerator-amine (b)

The components of the redox initiator systems are common to not be stored and can be brought only before use as a two-component systems in contact. The advantage of such redox initiator systems, however, is that by choosing the concentration of the initiator components, and by varying the ratio of peroxide and amine accelerator, the so-called processing latitude (i.e., the time until the start of the curing of the mixing together of the component) and the Aushartungszeit ( ie the time from the beginning to the end of the cure) as desired can be set within wide limits. Free-radically polymerizable compounds (monomers) contain at least one reactive C = C double bond to which add up the polymerisationsauslosenden radicals. The resulting initiated chain reaction then leads within a short time (seconds to minutes) to the formation of linear polymers with mono-functional monomer or a polymer network in the case of multi-functional monomers, that is monomers containing multiple polymerization capable C = C double bonds. In this case, the reactivity of the monomers, ie, the polymerization or Aushar- processing speed with the Funktionalltat F, d h. the number of groups per polymeπsa- tionsfahigen Monomermolekul to where F is the most varied monomers in commercial between 1 to 4

Typical radically polymeπserbare monomers are styrenes (a), dienes, (b), vinyl monomers mers (c), allyl compounds (d), acrylates (e) or methacrylates (f), as it is shown in the Figure 13, in which examples of radically polymerizable groups are shown

For applications as Fixlermittel mainly methacrylates have maintained, on the one hand styrenes, dienes or allyl compounds are very reactive and also the reactive acrylates show a high cytotoxicity and partly mutagenicity. were extremely different here methacrylates, di-, above all, tri or tetrafunctional nelle methacrylates, leads the radikahsche polymerization to form a polymer network.

Here, the polymer network properties by the structure of methacrylates used can be adjusted So tri- or tetramethacrylates resulting dense polymer networks compared to dimethacrylates. In the dimethacrylates, by the structure of the spacer, that is, the spacer group between the two methacrylates latgruppen, the properties of the polymer networks are specifically influenced For this purpose, reference is made to Figure 14 in which an example of structural variations in dimethacrylates is shown.

For example, arise with long chain spacers (A: decanediol dimethacrylate) more flexible networks, wherein aromatic spacers (B- propoxyhertes bisphenol A dimethacrylate) rigid networks in polar spacers (C Tnethylenglycoldimethacrylat) hydrophilic networks or perfluorinated (D) or dimethyl siloxane-containing spacers (e) water-repellent polymer networks. Furthermore, additional property variations can be obtained by copolymerization with functionalized methacrylates, ie be achieved with methacrylates which in addition to the polymerizable methacrylate group a further functional groups. For example, OH-group-containing methacrylates may improve wetting on wet surfaces, methacrylates, acid groups consider the adhesion to metals or allow CHO or SH-group-containing methacrylates mediate adhesion to biological tissue.

Accordingly, can be implemented, the respective desired property profile of the polymer network which is prepared from the methacrylate by radical polymerization on the one hand by a purposeful selection of various methacrylates, and on the other hand, by optimizing the composition of the corresponding methacrylate mixture.

The fixer 20 for the inventive occlusion device can be classified as medical devices in Class III. These are materials that are in contact with the heart or the circulating blood, and therefore require a much higher degree of biocompatibility, which is hardly possible with technical methacrylates. Reasons for this are, among others, in the inadequate purity of technical chemicals. Furthermore, the structure of the methacrylates of the proposed application should be properly adjusted.

Methacrylates with improved biocompatibility are available with the following strategies:

In the first place with respect to the accessibility of methacrylates having improved biocompatibility, reference is made to 15 Ormocermatrixsysteme with reference to Fig., Wherein an example of a synthetic scheme for a Ormocer polymer network is shown in Fig. 15. The term Ormocer derives from the English. Word combination "organically modified ceramics" from. This is to flowable oligomeric or polymeric polysilane Loxane, starting from methacrylate groups trialkoxysilanes by hydrolytic condensation (FIG. 15, Step A) can be prepared within the framework of the so-called sol-gel process. due to the existing methacrylate (MA) can be the formed Ormocer resin in a second step (step B) with radicals X to a three-dimensional (3D) Ormocer polymer network polymerize, thereby forming a so-called. inorganic-organic hybrid material wird._Die formed advantageous properties of the Ormocer resins especially a large biocompatibility and a low polymerisation shrinkage. in the second place with respect to the accessibility of methacrylates having improved Biokompatibihtat be described with reference to Fig. 16. Hyperbranched or dendritic Ohgomere are referenced, in which Fig. 16 is an illustration of a Dendnmer and hyperbranched Ol igomer is given. Ideal branched Ohgomere called Dendπmere, and more or less regularly built highly branched structures called hyperbranched Ohgomere or polymers are in modern polymer synthesis is a very promising class of materials for the manufacture of biomedical materials. Because of their special Molekularchitektur high molecular weight products can be recovered as liquids there that are characterized among other things by a very good Biokompatibihtat. Thus can be prepared starting from commercial products such as hyperbranched polyglycidols or polypropylenimine Dendnmeren, produced by the chemical modification with polymerisationsfahigen methacrylate groups for the fixing 20 of the inventive occlusion device suitable biocompatible reactive resins.

is in third place in terms of accessibility of methacrylates having improved Biokompatibihtat with reference to Fig. 17 referenced on natural materials resins, where an example of the monomer components for a simple peptide adhesive is shown in Fig. 17. This strategy is derived from the peptide adhesives which are based on the hypothesis that improved Biokompatibihtat of tissue adhesives containing substances can be reached, which also occur in the body. Accordingly, for example, carbohydrates and their blank blocks (ie, monosaccharides) or proteins and their building blocks (amino acids) used for the preparation of polymerization resins having improved Biokompatibihtat. For example, a substituted dipeptide of glycine which contains in each case a radical polymerisationsfahige methacrylic and allyl group in a methacryherten Alanindenvat (B) was obtained as a radical polymerizable resin by solution, which is suitable, after the addition of a radical initiator as a biocompatible tissue adhesive. Analogously may be prepared by introduction of polymerizable metal thacrylgruppen in Ohgopetide having 3 to 5 identical or different natural amino nosaurebausteinen or, for example in natural Disacchande such as sucrose having 7 methacrylates herbaren OH groups, hoherfunktionalisierte and tailored reactive resins on the one hand with improved Biokompatibihtat and on the other hand make the best-fit for the particular application properties. While the matrix systems listed above are not biodegradable, should be dealt with below briefly biodegradable radically polymerizable resin systems.

Biodegradable materials such as biodegradable polymer pitches containing cleavable bonds under physiological conditions. When biodegradable polymers therefore the degradation by hydrolysis pure, enzymatically induced reactions or by a combination thereof can take place. Typical hydrolyzable chemical bonds are amide, ester or acetal bonds.

At this point, reference is made 18, in which an example of polymer structures of biodegradable poly (lactic acid (PLA), polyglycolic acid (PGA) or Polybersteinsäu- anhydride (PAB) shown in Fig..

When removing two mechanisms is observed. With surface degradation, the hydrolysis of chemical bonds takes place exclusively on the surface. Due to the hydrophobic character of the polymer degradation is faster than the diffusion of water into the interior of the material.

This mechanism is observed especially in poly (anhydrides). In contrast, the polymer degradation takes place in the case of poly (hydroxycarboxylic acids), such as poly (lactic acid) or poly (glycolic acid), in the entire volume. For the application of biodegradable polymers is crucial that degrade one hand with a controllable or adjustable speed and on the other hand, the degradation products are not toxic.

For biodegradable polymerization was made for example based on biodegradable hydrogels photopolymerized Polyesterdiacrylat resin. For this purpose, 19 is shown in FIG. An example of the synthesis, the polymerization and the degradation of a diacrylate reaction resin. The synthesis of the polymerisation is carried out in steps: In the first step a biodegradable oligomer produced by ring-opening polymerization of lactide with polyethylene glycol (PEG), transmits the terminal OH groups. In the second step, the OH groups are then converted with acrylic acid chloride in the polymerization capable acrylate groups. The formed diacrylate reaction resin can be polymerized in a third step to a radical polymer network then that biodegrades in a fourth step, under physiological conditions. Analogously, for the inventive occlusion device biodegradable fixing agent produce 20, wherein methacrylate groups are to be preferred instead of the acrylate groups and by selection of appropriate comonomer the desired property profile can be adjusted.

To stabilize Polyreaktionsharzen these liquid mixtures are added substances, so-called inhibitors, which are able to trap radicals spontaneously formed so during storage of the resin that no premature polymerization occurs. Here, two different types of stabilizer can be used: aerobic and anaerobic inhibitors. Aerobic inhibitors are phenols such as BHT (2,6-di-tert-butyl-4-methylphenol) or MEHQ (hydroquinone monomethyl ether) (Fig. 20), the fully effective only in the presence of oxygen, since it is particularly fast only react with peroxide radicals. They are used to the monomer based usually in amounts of about 100 to 1000 ppm. In contrast, the effect of the anaerobic inhibitors such as PTA (phenothiazine) or TEMPO (2,2,6,6-tetramethyl-l- piperidinyloxy free radical) not bound to the simultaneous presence of oxygen and they react very efficiently directly with primary radicals or growing polymer radicals. Accordingly, in most cases 20 to 50 ppm for an adequate stabilization rich. To avoid these stabilizers lead to Biokopmpatibilitätsproblemen, corresponding polymeriserbare methacrylate derivatives would have to be used thereof, such as a methacrylate derivative (BHT from 4-methacryloyloxy-2,6-di-tert-butyl phenol.

In summary, it should be noted that suitable as a potential fixing means 20 for the occlusion device tailor-made mixtures of liquid, free-radically polymerized sierbaren reaction resins of biocompatible Multimethacrylaten based on hyperbranched oligomers, oligopeptides or disaccharides. In the case of biodegradable materials dimethacrylates are to be used with biodegradable oligoester or Oligoanhydrid spacer. The desired processing width and curing time can be adjusted by selecting the concentration and the mixing ratio of the redox initiator system used. Thereby improving the biocompatibility through the use of polymerizable initiator components is mögüch. Furthermore, the adhesion to the substrate (metal or fabrics) can be influenced by the addition of suitably functionalized methacrylates. Finally, 20 polymerizable inhibitors should also be used to stabilize the fixing agent. It should be noted that the embodiment of the invention is not limited to those described in FIGS embodiments but can also be in a variety of versions.

Claims

claims
1. Occlusionsinstfument for closing an atrial appendage, thinner one of a braid (10) wires or threads existing, self-expandable occlusion body (1), the braid (10) given a suitable profile in a molding and heat treatment procedure, wherein said occlusion body (1) a rear proximal retention area (2) and a front distal retention area (3), wherein in the distal retention area (3) run together the ends of the wires or threads of the braid (10) in a socket (4), and wherein said occlusion body (1 ) further comprises a central region (5) between the proximal and (distal retention areas 2, 3), wherein said occlusion body (1) in its folded state by means of a catheter is minimally invasive inserted and positioned in the atrial appendage of the patient into the body of a patient , characterized in that the occlusion device further comprises a fixing means (20) having a space formed by means of a preferably ablaufbaren in the auricle of the patient Polyreaktionsmechanismus polymer network to form a positive connection between the braid (10) of the occlusion body (1) and the atrial auricula wall.
2. The occlusion device of claim 1, wherein in Polyreaktionsmechanismus polymerization of unsaturated and / or cyclic monomers or oligomers expires, are formed in which polymer chains of the polymer network of the fixing means (20).
3. The occlusion device according to claim 1 or 2, wherein a radical polymerization proceeds at Polyreaktionsmechanismus, wherein the formation of polymer chains of the polymer network is initiated by radicals which are formed by the action of an external stimulus to a stable initiator composition.
4. The occlusion device of claim 3, wherein the stable initiator composition include initiators of the redox type, which form due to a redox reaction of an oxidizing agent with a reducing agent, the radicals to initiate the polymer chain formation.
5. The occlusion device of claim 4, wherein the initiators comprise redox type of polymerization initiator components, in particular 4,4 'divinyl.
6. The occlusion device according to any one of claims 2 to 5, wherein the polymerization or curing of the polymer network can be adjusted in particular by suitable choice of monomers used in the polymerization.
7. The occlusion device of claim 6, wherein said monomers are styrenes, dienes, vinyl monomers, allyl compounds, acrylates or methacrylates have.
8. The occlusion device according to any one of the preceding claims, wherein the fixing means (20) comprises a blend of liquid, free-radically polymerizable reactive resins of biocompatible Multimethacrylaten based on hyperbranched oligomers, oligopeptides or disaccharides.
9. The occlusion device according to claim 8, wherein the composition further comprises dimethacrylates with biodegradable oligoester and / or Oligoanhydrid spacers.
10. The occlusion device according to any one of the preceding claims, wherein the fixing means (20) comprises an initiator composition redox type, in particular a combination of a peroxide and a tertiary Armin, wherein said processing width and / or curing of the polymer network by a suitable choice of the concentration and / or the mixing ratio of the components used in the initiator composition is adjustable in advance.
11. The occlusion device according to any one of the preceding claims, wherein the fixing means (20) suitable functionalised methacrylates for influencing the stability of the frictional connection between the braid (10) of the occlusion body (1) and the atrial auricula wall.
12. The occlusion device according to any one of the preceding claims, wherein the fixing means (20) is minimally invasive and can be inserted can be introduced into the heart of the patient's ear is separated from the occlusion body (1) preferably by means of a catheter into the body of the patient.
13. The occlusion device according to any one of the preceding claims, wherein the proximal retention area (2) of the occlusion body (1) at least one flanged area (6) which in the expanded state of the occlusion body (1) in the vessel to be closed atrial appendage on the interior wall of the atrial appendage at least partially comes to rest and forms a frictional connection with the aid of the polymer network of the fixing means (20) with the inner wall of the atrial appendage and therefore holds the implanted and expanded occlusion instrument in the atrial appendage, wherein the distal
Retention area (3) of the occlusion body (1) at least partially closes the atrial appendage.
14. The occlusion device according to any one of the preceding claims, wherein the proximal retention area (2) of the occlusion body (1) is designed with its at least one flanged area (6) such that it upon expansion of the occlusion body itself (1) at least partially, deflect outwards to to come in such a manner with the inner wall of the atrial appendage.
15. The occlusion device according to any one of the preceding claims, wherein the proximal retention area (2) of the occlusion body (1) has a completely closed proximal wall having a continuous surface, which forms the proximal end of the occlusion device.
16th occlusion device of claim 15, wherein the proximal wall having a continuous surface is a curved surface.
17. The occlusion device of claim 16, wherein the curved surface with the surface of a portion of a spherical, pear-shaped or teardrop-like body coincide.
18. The use of a fixing agent (20) according to any one of the preceding claims for forming a frictional connection between the braid (10) of an occlusion body (1) and an atrial auricula wall.
PCT/EP2006/005292 2006-06-02 2006-06-02 Occlusion instrument for closing a cardiac auricle WO2007140797A1 (en)

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Cited By (16)

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EP2074953A1 (en) * 2007-12-28 2009-07-01 AGA Medical Corporation Percutaneous catheter directed intravascular occlusion devices
DE102009036818A1 (en) * 2009-08-10 2011-02-17 Acoredis Gmbh Left atrial appendage occlusion instrument, has distal retention area possessing circular form of lip and changing strong taper in bar, where bar is movable such that distal retention area is bendable until nearly ninety degrees to cover
DE102010021345A1 (en) 2010-05-22 2011-11-24 Acoredis Gmbh Occlusions instrument for closing left atrial auricle of patient, has occluder provided with region that is located from central region to retention region for forming actuated connection between nub region of occluder and auricle wall
DE102011077731A1 (en) 2010-11-12 2012-05-16 Acoredis Gmbh Approximately cylindrical occluder for treating atrial septal defect and patent foramen ovale, comprises elastic-plastic material with base surface, cover surface and skin surface
DE102012003021A1 (en) 2011-02-15 2012-10-11 Acoredis Gmbh Intravascular occlusion device for closing left atrial appendage during treatment of atrial fibrillation, has distal end that is arranged above diaphragms so as to seal atrial appendage entrance
WO2013025511A3 (en) * 2011-08-12 2013-06-06 W. L. Gore & Associates, Inc. Heart occlusion devices
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US9949728B2 (en) 2007-04-05 2018-04-24 W.L. Gore & Associates, Inc. Septal closure device with centering mechanism
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US9808230B2 (en) 2014-06-06 2017-11-07 W. L. Gore & Associates, Inc. Sealing device and delivery system
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WO2016155847A1 (en) 2015-04-02 2016-10-06 Acoredis Gmbh Modular occlusion device for closing the left atrial appendage (laa) and production thereof
DE102015004535A1 (en) 2015-04-02 2016-10-20 Acoredis Gmbh Modular Occlusionsvorrichtung to closure of the left atrial tube (left atrial appendage LAA) and its preparation
WO2017201316A1 (en) * 2016-05-18 2017-11-23 Microvention, Inc. Embolic containment

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