DE102006056283A1 - Occlusion device for closing left heart auricle of patient, has cladding bag provided with fillable opening at its proximal end and partially made of thermoplastic polyurethane, where bag is partially filled with non-degradable plastic - Google Patents

Abstract

The device (10) has a cladding bag (12) provided with a fillable opening (15) at its proximal end (14) and partially made of thermoplastic polyurethane, where the bag has a foil. The cladding bag is partially filled with a non-degradable plastic e.g. thermoplastic polyurethane, where the plastic is foamed. The cladding bag is supported by a lattice structure from metallic material, plastic material or ceramic material, where the cladding bag is tightened inside or outside on the lattice structure, which is made of shape memory material i.e. nitinol. Independent claims are also included for the following: (1) an inserting device for inserting an occlusion device (2) a system comprising an inserting device and an occlusion device.

Description

The The invention relates to an occlusion device, in particular for the Closing the left ear of the heart, with a pouch. The invention also relates an occlusion device, in particular for closing the left atrial appendage, with a foam body. Furthermore, the Invention on an insertion device and for Such a occlusion device and a system of insertion device and occlusion device, wherein the insertion device transport means to lead and placing the occlusion device at the location of the treatment having.

occlusion are usually for that used, openings or lumens of vessels or Close organs.

One frequent Field of application of such occlusion devices or occluders is the closing of the left atrial appendage, LAA, Aurikel) left atrium of the heart between mitral valve and left pulmonary vein is arranged and has the shape of an approximately thumb-shaped extension. The ostium of the left auricle is compared to the right auricle relatively small and elliptical in most cases. at a pathological enlargement of the left atrial or during Atrial fibrillation can cause stagnant blood in the left ear of the heart Collect so that blood clots or thrombi in this bag form. Upon leakage and transport of the blood clot, e.g. strokes can develop in the brain matter because these blood clots can occlude vessels.

investigations have revealed that the ischemic Insult has about 20% cardiogenic causes. 15% of strokes will be caused by absolute arrhythmia in atrial fibrillation, with atrial fibrillation the most frequent Represents cardiac arrhythmia, their prevalence increases with age. Stroke is the third most common Cause of death, worldwide in 2001, about 20.5 million strokes were counted, with The stroke is one of the leading Reasons for a serious long-term disability and thus low quality of life and high Healthcare costs.

to Prevention of stroke are mostly oral agents for anticoagulation used. Because of contraindications to these substances, which affect at least 17.5% of patients, or bleeding complications is one in some cases Application of oral anticoagulation not possible. The drug therapy for prevention of strokes will also not well tolerated by many patients. With a lot of patients In addition, compliance is low. Because the left ear of the heart is one of the common Educational sites for Thrombosis in patients with atrial fibrillation is in these patients the interventional occlusion of the left ear of the ear is an alternative Treatment option.

The particular anatomy of the left atrial appendage, i. his skinny trained Wall, its curved shape, a frequent branching and the strong Trabeculation, the oblique arranged neck of the heart ear and often oval or elliptical shaped Ostium of the left auricular heart make special demands on the for the close of the atrial appendage. It must be ensured in particular be that the occluder used remains in the respective position, as a partial or complete Dislocation of the occluder can have fatal consequences for the patient.

A known occluder (PLAATO ^®) for the left atrial appendage is composed of a self-expanding nitinol cage, which is provided with a PTFE membrane. Through a series of anchors and an overstretch of more than 10%, this occluder is stabilized in the left atrial ear. This occluder has a round cross-section and a high radial rigidity. Furthermore, oversizing of the occluder has a negative effect on its lifetime.

One from the publication US 2005/0113861 A1 Known occlusion device has a flexible rib structure with a central rod arranged along the axis and a circular cross section. At the proximal end of the occluder known is a membrane made of DACRON ^®, Gore-Tex ^® or a foam of high-density polyvinyl alcohol (PVA), particularly IVALON ^® arranged. The membrane completely closes the proximal end of the occluder and is sutured to the ribs of the cage.

From the publication US 2005/023454 A1 It is known to use a stent to dilate the ostium of the left atrial appendage to reduce the risk of blood clots forming. Another way of expanding the ostium, disclosed in this document, is to insert a catheter into the LAA and introduce a foam or other expandable material. This foam is preferably formed from a biodegradable or bioresorbable polymer that completely degrades over time. Thereafter, the shape of the left atrial appendage has changed so that it has a triangular shape in longitudinal section, so that improves the blood flow through the LAA and thereby the formation of blood clots is difficult. As foam material in the document the materials polyvinyl alcohol, silicone or polyurethane (PUR) are disclosed.

Also in other vessels and Organs next to the heart can Diverticula occur, which must be closed. For example For example, aneurysms, especially so-called "saccular" or "ragged" aneurysms, are often treated by they are closed with an occluder. Effective closure of the aneurysm neck Can help reduce the size of the aneurysms and reduce the likelihood that they break.

In the publication DE 696 29 597 T2 an occluder consisting of a bilaterally sealed nitinol mesh is disclosed as an intravascular occlusive device. This known occluder has a body portion, an anchor and an intermediate tubular central portion. Towards the body portion and anchoring, the diameter of the occluder increases with increasing distance from the central portion, so that the central portion of the occluder is received within the neck of the aneurysm. The body portion is picked up by the aneurysm and anchoring remains in the lumen of the affected vessel. Silk or woolen fabric can be attached to the occluder. It is also mentioned in this document that further methods provide for placing a balloon in an aneurysm and filling it by means of biocompatible plastic balls or helical spirals. Possibly. For example, these structures are designed to thrombogenize.

occlusion can also for closing of other diverticas, for example intestinal diverticula or esophageal diverticula serve.

Also for aneurysms and other diverticula become common Occluder with a flexible and flexibly adaptable shape desired.

task Thus, it is the occlusion devices of the present invention to propose, which is a very good adaptation of the occluder to special Shapes of the shootings Organs and vessels, for example the shape of the left atrial appendage. The task exists in addition, that the occlusion devices safely on the desired Place anchored in the organ or vessel are so that a dislocation can be avoided. In addition, should an overstretching of Occlude be avoided. In addition, it is desired, possibly already known locks and transport systems for introduction to use the occlusion devices. With regard to the insertion device the object is to provide a low-cost manufacturable introducer specify with the occluder according to the invention simply to the treating body introduced can be. The same applies to the system of occluder and introducer.

The The above object is achieved by an occlusion device of solved first, above kind, at the envelope bag has at its proximal end a fillable opening and at least partially made of a thermoplastic polyurethane (TPU). Preferably, the opening after placing the occlusion device on the treatment to be treated Filled up become. Such a occlusion device is particularly flexible and lets particularly well suited to the particular specific shape of the lumen to be closed to adjust. The opening at the proximal end of the envelope bag allows the arrangement of filling Materials. An overstretching the occlusion device to adapt this example to the respective form of the left auricle is not necessary.

Especially Preferably, an occlusion device according to the invention has a Foil made of a thermoplastic polyurethane. TPU has a high Wear resistance, size Flexibility over one wider temperature range, high elasticity, i. a good adaptation to the movement of the respective lumen to be closed, a good resistance against the surrounding media and contains no plasticizers. Accordingly, TPU is for the use in an occluder particularly suitable.

In a preferred embodiment the envelope bag at least with a non-degradable plastic, e.g. with a thermoplastic polyurethane, filled. This will enable that the occlusion device maneuvers better and at the to be treated Place the organ or the vessel better can be placed. The occlusion device can be particularly flexible be designed when the filling plastic is foamed.

In a particularly preferred embodiment has the envelope bag a film of a thermoplastic polyurethane. The occlusion device is in this case particularly flexible and also inexpensive to produce.

In the atrial appendage, in aneurysms or other diverticula, the occlusion device can be placed particularly firmly and securely in relation to dislocations if the enveloping sac is supported by a lattice structure made of a metallic material, a plastic material or a ceramic material, the hull sack on the inside or outside of the lattice structure is curious. In a particularly preferred embodiment, the grid structure consists of a shape memory material, esp especially nitinol.

The The above object is also achieved by an occlusion device of solved second type above, in which the foam body at least partially consists of a thermoplastic polyurethane. Such a foam body is extremely flexible, let yourself during transport to the desired location very small squeeze and adapts to placing it in the desired location, for example in the left auricle, very flexible in the shape of the lumen to be closed at. An overstretching the material of the occlusion device takes place during adaptation to the shape of the to be closed Lumens not. The occlusion device can also be made using conventional Use locks and transport devices as they are small press together leaves.

In a particularly preferred embodiment has the foam body essentially the shape of a truncated cone, which are produced inexpensively leaves. It has also proved to be particularly advantageous if the foam body at least has a radially extending notch, which causes the sections of the occluder separated by the notch are movable to each other. In a particular embodiment is the radial notch about one third of the Height of Truncated cone arranged and preferably extends from the lateral surface the truncated cone in the direction of the central axis of the truncated cone at least to the half of the radius.

In a further preferred embodiment has the foam body an opening extending substantially along the central axis, which preferably passes through the entire truncated cone and for placing the catheter for insertion of the occluder. to Relief of squeezing of the occluder during insertion can in this more openings possibly be provided with different diameters, which by can go through the entire truncated cone. These openings be after placing the occluder at the desired Position of the patient usually in particular at the distal end to mix or can be closed by a frothed, non-degradable Plastic material, for example foamed thermoplastic polyurethane, in the respective opening is arranged and closes this.

When very advantageous proves that on the outer surface of the envelope bag or the foam body a coating, for example a blood-impermeable coating and / or a coating containing a medically active substance, for example with an anticoagulant effect, and / or or a coating containing a radiopaque material (radioopaque material) is applied. As a result, the anticoagulant effect of Occluses are reinforced in the left auricle or a localization of the occluder by means of an X-ray device be relieved. The substance with anticoagulant effect is preferably applied to the proximal end of the occluder.

Especially good the occlusion device on the lumen to be closed fasten when out of the outer surface of the envelope bag or the foam body protrudes at least one hook element, which after placing of the occluder in the lumen to be occluded in its wall hooked as an anchor. The anchor effect is especially good when the from the envelope bag or the foam body protruding ends of the hook member each having a curvature between a bent portion and a main portion are provided, wherein the bent portion and the main portion of the hook member at most an angle of 90 °, more preferably include an angle of at most 45 °.

The The object specified above is further characterized by an insertion device solved the above type, at the insertion device Ausschäummittel to introduce a foamed, not degradable plastic material in at least part of the from the envelope bag or from the foam body having surrounded volume. Preferably, as the foamed, not degradable plastic material thermoplastic polyurethane in the foaming agent intended. This material is particularly suitable for placement in an occlusion device, which for The left ear of the ear is determined suitable. The above task becomes further by a system of such an insertion device and an occlusion device given above. It will by the insertion device according to the invention and the system of the invention from occlusion device and introducer allows the shape of the occluder after placement of the occlusion device in the to be closed Lumen in a simple manner to adapt to the shape of this lumen.

Further Objectives, features, advantages and applications of the invention result from the following description of embodiments with reference to Drawings. In this case, all described and / or illustrated Features for itself or in any combination the subject matter of the present Invention, independent from their summary in the individual claims or their dependency.

It demonstrate:

1 FIG. 2 schematically shows a view of a lattice structure of a first exemplary embodiment of an occlusion device according to the invention from the side of the distal end, FIG.

2 schematically the first embodiment of an occlusion device according to the invention in a view from the side,

3 1 is a schematic view of a second embodiment of a occlusion device according to the invention in a side view;

4 schematically a longitudinal section through an occlusion device of the embodiment according to 3 .

5 and 6 schematically the view of the distal or proximal end of the embodiment according to 3 and

7 schematically the view of an inventive import device from the side.

This in 1 illustrated lattice framework 2 An occluder according to the invention has a substantially hollow, finger-shaped form with a substantially elliptical cross-section. The lattice framework 2 consists of longitudinal struts 4 and from transverse struts 5 , which at the distal end 6 to form a rounded tip. At the proximal end is the lattice framework 2 open design.

The grid structure 2 preferably consists of a metallic material of one or more metals from the group iron, magnesium, nickel, tungsten, titanium, zirconium, niobium, tantalum, zinc and silicon and optionally a second component of one or more metals from the group lithium, sodium , Potassium, calcium and manganese, preferably of a zinc-zinc alloy. In a further embodiment, the base body is made of a shape memory material of one or more materials from the group consisting of nickel-titanium alloys and copper-zinc-aluminum alloys, preferably nitinol. In a further preferred embodiment, the main body of the stent made of stainless steel, preferably made of a Cr-Ni-Fe steel - here preferably the alloy 316L - or a Co-Cr steel. Furthermore, the grid structure 2 at least partially made of plastic and / or a ceramic.

2 shows a first embodiment of an occluder according to the invention 10 , This has a flexible envelope bag 12 on, which consists at least partially of a thermoplastic polyurethane. In a preferred embodiment, the envelope bag 12 consist of several layers. In a further preferred embodiment, the envelope bag 12 a film made entirely of thermoplastic polyurethane. The envelope bag 12 is substantially finger-shaped and hollow and has at its proximal end 14 an opening 15 on. At its distal end 17 is the envelope bag 12 closed. The cross section of the envelope bag 12 is designed substantially elliptical, with the cross-sectional area in the direction of the distal end 17 of the envelope bag 12 gets smaller, so that the occluder 10 rejuvenated in this direction. In a further embodiment, the cross section of the enveloping bag may also be formed substantially circular.

To the introduction of the envelope bag For example, in the left ear of the ear, the envelope bag with a non-degradable Plastic, for example with a thermoplastic polyurethane filled out become. Preferably, a foamed plastic is used in this case.

In particular nonabsorbable polymers (ie permanent or non-degradable) polymers can be used as non-degradable plastic, particularly preferably collagens or cholesterols. Particular preference is given to using the following nonabsorbable polymers:
Polypropylene, polyethylene, polyvinyl chloride, polymethyl methacrylate, polymethyl methacrylate, polytetrafluoroethylene, polyvinyl alcohol, polyurethane, polybuthylene terephthalate, silicones, polyphosphazene and their copolymers and blends.

In another embodiment, inside the envelope bag 12 , ie on its inner wall the in 1 illustrated grid structure 2 arranged, which the envelope bag 12 supports. This can also be on the outside of the envelope bag in an alternative embodiment 12 be arranged.

In a further embodiment, the envelope bag 12 (with or without grid structure 2 ) partially, for example at its distal end 17 be filled with a non degradable ble plastic, for example with a thermoplastic polyurethane, preferably with a foamed plastic. For this purpose, preferably, alternatively or additionally, the above-mentioned, non-absorbable polymers can be used. The insertion of the occluder 10 to the desired location of the organ or the vessel is thereby facilitated. After inserting the occluder 10 into the lumen of the body to be closed, in a preferred embodiment, the still unfilled volume of the envelope sack 12 with non-degradable Plastic, for example, with a thermoplastic polyurethane and / or with one or more of the above-mentioned, non-absorbable polymers, preferably filled with a foamed plastic.

On its outer surface has the envelope bag 12 also a variety of hook elements 20 on, which from the outer circumferential surface of the envelope bag 12 protrude. The hook elements 20 serve to the occluder 10 anchor in position after insertion. The exact structure of the hook elements 20 will be explained below with reference to the second embodiment of an occluder according to the invention.

Based on 3 to 6 a second embodiment of a occlusion device according to the invention will be described. The occluder 30 consists of a sponge-like, biocompatible, largely compressible polymeric plastic, which consists at least partially of a thermoplastic polyurethane. In addition, for example, the above-mentioned non-absorbable polymers can be used. The occluder 30 has a foam body 32 on, which is designed substantially as a truncated cone and in a preferred embodiment consists entirely of thermoplastic polyurethane. In the in the 3 to 6 illustrated embodiment, the cross section of the foam body 32 essentially a circular shape. The proximal end 34 of the foam body 32 (Base), for example, has a diameter of about 30 mm.

In a further embodiment can the foam body also have a substantially elliptical cross-section.

About one third of the length (height) of the truncated cone, the foam body 32 a radial notch 36 on. The notch 36 extends from the lateral surface of the truncated cone in the direction of the central axis 38 of the truncated cone. Through this notch 36 is achieved that the proximal section 40 of the foam body 32 that extends from the proximal end 34 to the notch 36 extends, movable to the distal portion 41 of the foam body 32 which is different from the notch 36 to the distal end 43 of the foam body 32 extends. This mobility of the foam body 32 causes a better adaptation of the occluder 30 to the shape of each lumen to be closed. It is also achieved that the foam body 32 is easier to compress so that it is easier to insert.

Along the central axis 38 has the foam body 32 of the occluder 30 a substantially cylindrical, continuous opening 45 which serves to receive a guide wire for introducing the occluder to the desired location of the body. After insertion of the occluder, this opening becomes 45 in particular thrombose at its distal end, since the flow rate of the blood in the opening 45 approaches zero, or can be filled by means of a non-degradable plastic, for example a thermoplastic polyurethane, which is preferably foamed.

The face 47 of the proximal end 34 of the foam body 32 is slightly concave (curved inwards) designed to fit as optimally as possible to the inner surface of the left atrium when the foam body 32 is used to separate the left atrial appendage from the bloodstream in the left atrium.

Analogous to that on the basis of 1 and 2 illustrated embodiment protrude from the lateral surface of the in the 3 to 6 illustrated occluder 30 hook elements 50 out. These hook elements 50 serve to anchor the occluder 30 at the vessel or organ wall. They are in the notch 36 pushed in and protrude from the distal section 41 of the foam body 32 out.

In the first embodiment, the hook elements 20 from the inside through the envelope bag 12 led to the outside, the hook elements 20 in the presence of a lattice framework 2 preferably anchored in this with the end, which lies opposite the protruding end.

The hook elements are designed substantially wire-shaped and consist of the same material as the lattice framework 2 , preferably made of 316 L stainless steel. Preferably, the hook elements 50 a diameter of 0.010 "to 0.014" (254 to 356 μm). Each hook element 50 has a first leg 51 and a second leg 52 on which the main portion of the hook element 50 form and in a base area 54 connected to each other. The first leg 51 and the second leg 52 in a preferred embodiment approximately at an angle of 20 °. The base area 54 is curved and has a radius of curvature of about 1.1 mm. After inserting the hook element 50 in the occluder both legs run 51 . 52 approximately parallel to the central axis 38 of the foam body 32 , The from the foam body 32 protruding ends of the thighs 51 . 52 have bent sections 56 . 57 on. With the respectively associated, through the first leg 51 or the second leg 52 formed main section closes the bent section 56 respectively. 57 at most an angle of 90 °, preferably an angle of at most 45 °. Be particularly preferably the sections run 56 . 57 approximately parallel to the central axis 38 of the foam body 32 , The ends of the bent sections 56 . 57 are rounded and their length is about 1.1 mm. The bent sections 56 . 57 the hook elements 20 . 50 cause these during a movement of the occluder 20 . 30 penetrate deeper into the wall of the lumen in a direction out of the closed lumen, for example into the trabecular meshwork, so that a dislocation of the occluder is effectively prevented.

The transition area between the first leg 51 or the second leg 52 and the associated bent portion 56 respectively. 57 is curved, preferably formed with a radius of curvature of about 1.1 mm. The different hook elements 50 , on one and the same foam body 32 are provided have different lengths of the legs 51 . 52 on, so that they do not come to lie one above the other in the import device. The curvature of the bent ends correspond approximately to the outer periphery of the inner part of the insertion device, so that they rest flush against this. Preferably, the occluder has 10 . 30 approx. 12 hook elements 50 on.

Preferably, the occluders 10 . 30 have on their mantle surface or in their volume X-ray opaque materials, so that they can be easily located by means of an X-ray device. For the X-ray opaque material, preferably one or more of the elements from the group gold, platinum, silver, tungsten, tantalum, iodine, yttrium, niobium, molybdenum, ruthenium, rhodium, barium, lanthanum, cerium, praseodymium, neodymium, samarium, europium , Gadolinium, terbium, dysprosium, holmium, erbium, thulium, ytterbium, lutetium, hafnium, rhenium, osmium and ibisutum and / or one or more of the compounds barium sulfate, bismuth trioxide, bromin, iodine, iodide, titania and zirconia.

In another preferred embodiment, the occluder is 10 . 30 , preferably at its proximal end 14 . 34 coated on the mantle surface with a pharmaceutically active substance.

A "pharmaceutical active substance "in the sense The invention is a plant, animal or synthesized Active substance, which is used in appropriate dosage as a therapeutic agent for influencing of states or functions of the body, as replacement for Naturally Active substances produced by the human or animal body as well for disposal or rendering harmless of pathogens or foreign body substances Use finds. The release of the substance in the occluder environment has a positive effect on the healing process or has pathological effects changes tissue as a result of the interventional procedure.

According to the invention the pharmaceutically active substances an anticoagulant, antiinflammatory and / or antiproliferative and / or spasmolytic activity, causing the formation of thrombi, inflammation or vasospasm can be avoided. Such substances can in particularly preferred embodiments from one substance or several substances of the active ingredient group the heparin, the calcium channel blocker, the lipid regulators (like fibrates, for example), immunosuppressants, calcineurin inhibitors (such as tacrolimus), antiflogistics (such as Cortisone or diclofenac), the antiinflammatorica (such as Imidazoles), antiallergic agents, oligonucleotides (such as dODN), the estrogen (such as genistein), the endothelial builder (such as Fibrin), steroids, proteins, peptides and vasodilators (such as Sartane) exist.

In 7 is an introducer 60 with a guide wire 61 shown. The insertion device 60 has means of transport 62 for introducing and placing the occlusion device at the place of treatment. In the means of transport 62 is one of the occluders described above 10 . 30 arranged in compressed or collapsed position. The insertion device 60 also indicates the end of the delivery device remaining outside the patient's body during treatment 60 Ausschäummittel 64 for introducing a foamed, non-degradable plastic material into at least a portion of one of the envelope sack 12 or one of the foam body 32 surrounded volume of the occluder 10 . 30 on. In the foaming agent 64 are at least one non-degradable plastic material and a blowing agent, preferably arranged together with a hardener, which can be transported to the place to be filled if necessary. This is the foaming agent 64 along the guidewire 61 with the means of transport 62 connected. The non-degradable plastic material is preferably thermoplastic polyurethane. Additionally or alternatively, the above-mentioned non-absorbable polymers may also be used.

The introduction of the occluder can, for example, by means of in 7 shown insertion device to be performed. First, the femoral vein is punctured, preferably right. Subsequently, a Mullins-Sheath, ie a sluice to create a connection from the outside transcutaneous via the femoral vein through the right atrium and the atrial septum in the left atrium, introduced, preferably in size 8 French (equivalent to a diameter of 2.7 mm). Preferably, the Mullins-Sheath is then stabilized with a dilator. Subsequently, if necessary, the atrial septum is punctured using a Brockenbrough needle under the control of transesophageal echocardiography (TEE). This last step is usually dispensable for an atrial septal defect or a persistent foramen ovale. Heparin is then administered to the left atrium via the Mullins-Sheath so that the ACT is between 300 and 350 seconds. Subsequently, a long and stiff guidewire 61 0.035 "(889 μm) thick into the left ear of the heart, possibly with the aid of a pigtail catheter of size 4 French (corresponding to a diameter of 1.35 mm). Over the guide wire 61 then becomes the occluder 10 or 30 in the introducer through the Mullins-Sheath by means of the transport device 62 advanced into the left ear of the heart. After ensuring the correct position of the occluder is then possibly the foaming agent 64 actuated and filled a foamed, non-degradable plastic material in the areas of the occluder, which are to be closed (for example, the inner volume of Hüllsack 12 ). After that, the means of transport 62 , the guide wire 61 and the Mullins-Sheath withdrew. The puncture site is then closed mechanically.

With The present invention provides low cost occluders and a corresponding import device and a system of these proposed which prophylaxis of a thrombembolic event serve to cause a stroke in paroxysmal or permanent Cause atrial fibrillation especially if there is a contraindication for oral anticoagulation.

2

lattice framework

4

in longitudinal direction extending strut

5

in Transverse strut

6

distal end of the lattice framework 2

10

occluder

12

envelope bag

14

proximal end of the envelope bag 12

15

opening

17

distal end of the envelope bag 12

20

hook element

30

occluder

32

foam body

34

proximal end of the foam body 32

36

notch

38

central axis

40

proximal portion of the foam body 32

41

distal portion of the foam body 32

43

distal end of the foam body 32

45

opening

47

face

50

hook element

51

first leg

52

second leg

54

base region

56

bent portion of the first leg 51

57

bent portion of the second leg 52

60

introducer

61

guidewire

62

Mode of Transport

64

Ausschäummittel

Claims (17)

Occlusion device ( 10 ), in particular for closing the left atrial appendage, with an envelope bag ( 12 ), characterized in that the envelope bag ( 12 ) at its proximal end ( 14 ) a fillable opening ( 15 ) and at least partially consists of a thermoplastic polyurethane. Occlusion device ( 10 ), according to claim 1, characterized in that the envelope bag ( 12 ) is at least partially filled with a non-degradable plastic, for example with a thermoplastic polyurethane. Occlusion device ( 10 ) according to claim 2, characterized in that the serving for filling plastic is foamed. Occlusion device ( 10 ) according to one of the preceding claims, characterized in that the envelope bag ( 12 ) has a film of a thermoplastic polyurethane. Occlusion device ( 10 ) according to claim 4, characterized in that the envelope bag by a grid structure ( 2 ) is supported from a metallic material, a plastic material or a ceramic material, wherein the envelope bag ( 12 ) is stretched inside or outside on the grid structure. Occlusion device ( 10 ) according to claim 5, characterized in that the grid structure ( 2 ) consists of a shape memory material, in particular nitinol. Occlusion device ( 30 ), in particular for closing the left atrial appendage, with a foam body ( 32 ), characterized in that the foam body ( 32 ) consists at least partially of a thermoplastic polyurethane. Occlusion device ( 30 ) according to claim 7, characterized in that the foam body ( 32 ) substantially the shape of a truncated cone having. Occlusion device ( 30 ) according to claim 7 or 8, characterized in that the foam body ( 32 ) at least one radial notch ( 36 ) having. Occlusion device ( 30 ) according to claim 9, characterized in that the radially extending notch ( 36 ) is arranged approximately to one third of the length of the truncated cone and from the lateral surface of the truncated cone in the direction of the central axis ( 38 ) of the truncated cone extends at least to half of the radius. Occlusion device ( 30 ) according to one of claims 7 to 10, characterized in that the foam body ( 32 ) substantially along the central axis ( 38 ) opening ( 45 ) having. Occlusion device ( 10 . 30 ) according to one of the preceding claims, characterized in that the envelope bag ( 12 ) or the foam body ( 32 ) has on its outer lateral surface a coating, for example a blood-impermeable coating and / or a coating containing a medically active substance, for example having an anticoagulant effect, and / or a coating containing radiopaque material. Occlusion device ( 10 . 30 ) according to one of the preceding claims, characterized in that from the outer surface of the envelope ( 12 ) or the foam body ( 32 ) at least one hook element ( 20 . 50 ) sticks out. Occlusion device ( 10 . 30 ) according to claim 13, characterized in that the of the Hüllsack ( 12 ) or the foam body ( 32 ) protruding ends ( 56 . 57 ) of the hook element ( 20 . 50 ) each with a curvature between a bent portion ( 56 . 57 ) and a main section ( 51 . 52 ), wherein the bent portion ( 56 . 57 ) and the main section ( 51 . 52 ) of the hook element at most an angle of 90 °, preferably include an angle of at most 45 °. Import device ( 60 ) for introducing an occlusion device ( 10 . 30 ) according to one of claims 1 to 14, wherein the import device ( 60 ) Mode of Transport ( 62 ) for introducing and placing the occlusion device ( 10 . 30 ) to the place of treatment, characterized in that the insertion device ( 60 ) Foaming agent ( 64 ) for introducing a foamed, non-degradable plastic material into at least a portion of the of the envelope bag ( 12 ) or of the foam body ( 32 ) surrounded volume. Insertion device ( 60 ) according to claim 15, characterized in that as the foamed, non-degradable plastic material thermoplastic polyurethane in the foaming agent ( 64 ) is provided. System from an insertion device ( 60 ) according to one of claims 15 to 16 and of an occlusion device ( 10 . 30 ) according to one of claims 1 to 14.