Occluder, system comprising occluder and delivery catheter, and method for providing the system

Description

[0001] The invention relates to an occluder for closing the left auricle of a patient. The invention also relates to an associated system for introducing an occluder into a patient and a method for providing the system.

[0002] The atrial appendages, or atrial appendages, are outpouchings of the atria of the heart in mammals. The left atrial appendage, medically known as the left atrial appendage (LAA), lies adjacent to the pulmonary artery and is a common site of blood clot formation, particularly in patients with atrial fibrillation. Preventing thrombi in the left atrial appendage therefore represents effective stroke prophylaxis in patients at risk.

[0003] Implants have been developed for this stroke prevention purpose. These implants are inserted into the outflow tracts and close off the access, for example using a Teflon film. In English-speaking literature, these implants are referred to as LAA (Left Atrial Appendage) occluders. These implants are inserted into the outflow tracts and anchored there, in particular using anchoring elements, so that they seal off the access to the outflow tracts in a fluid-tight manner, particularly via their proximal end region. They are usually inserted using endovascular techniques, i.e., in particular using an insertion catheter through which the implant is delivered to the site of use. The occluders are delivered to the site of use, in particular in a volume-reduced form, and expanded there. Self-expanding materials, such as shape memory alloys, are generally used for the occluders. One such occluder is already known from WO 2015 / 079023 A1.

[0004] Furthermore, DE 10 2015 104 785 A1 discloses a device for closing the protrusions by means of a closure element, wherein two anchoring elements fix the closure element without damaging tissue.

[0005] In addition, US 2018 / 0338832 A1 and WO 2013 / 158608 A1 disclose devices for arranging, inter alia, the mitral valve by means of a minimally invasive procedure in which the valve is replaced by an artificial valve or its function is improved.

[0006] Furthermore, EP 1 729 682 B1 discloses an endoluminal vascular prosthesis which is inserted into the aorta as a stent and, when expanded, repairs an aneurysm (bulge).

[0007] Furthermore, US 2011 / 184439 A1 discloses an occluder for closing a hole in a vessel wall on both sides, wherein the occluder comprises two shields provided with a biological material and a cylindrical central section connecting the two shields. Another occluder for closing a hole in a vessel wall is shown in WO2006 / 036837A2.

[0008] WO 2017 / 157316 A1 discloses an occluder for closing a patient's left auricle. The occluder comprises a self-expanding frame. In the expanded state, the occluder has a substantially spherical outer contour.

[0009] The present invention is based in particular on the object of improving the biocompatibility of the known occluders.

[0010] This object is achieved by an occluder having the features of claim 1. Accordingly, an occluder is proposed, in particular for closing the left auricula cordis sinistra of a patient. The occluder comprises a self-expanding frame, with biological tissue arranged on the frame to cover said frame at least in sections. The biological tissue is arranged in particular on an outer side of the frame. The use of biological tissue serves in particular to increase the biocompatibility of the occluder. The biological tissue can in particular be arranged on the outer side of the frame and thus be in contact with the patient's natural tissue and / or with the patient's circulating blood. In this respect, the biological tissue can in particular serve to close the left auricula cordis sinistra in a fluid-tight manner when the occluder is arranged.It is also conceivable that, after the occluder is positioned in the left ear, a natural cell or skin layer forms on the biological tissue, thus overgrowing the biological tissue. In particular, increased biocompatibility can be achieved by providing the biological tissue. In particular, it can be provided that the biological tissue is used instead of a Teflon covering, as disclosed in WO 2015 / 079023 A1, or a covering made of another synthetic material. This can improve the overall biocompatibility of the occluder.

[0011] The biological tissue is stabilized, in particular, by treatment using a cross-linking method. Cross-linking can preferably be carried out using the cross-linking process, particularly glutaraldehyde and / or alcohol. The biological tissue can also be permanently wetted with a liquid medium for sterilization and / or preservation, or it can be wetted and then dried. It is conceivable that the biological tissue is first sterilized with a liquid medium and then dried, in particular vacuum-dried. The liquid medium is preferably glycerol and / or a monohydric to trihydric alcohol.

[0012] The frame can in particular consist of a flexible, self-expanding material or comprise such a material. This material can be a metal or a plastic. Advantageously, however, it is a metal alloy with shape memory properties. Nickel-titanium alloys, for example a nitinol alloy, are particularly preferred. The production of implants from these materials and the forming by tempering have been described many times. Such shape memory metals can be deformed under external force and, when this force is removed, automatically resume an imposed shape. This allows the occluder to be deformed into an insertion position in order to bring it into its intended position using a catheter and then release the occluder, whereby it expands itself and thereby assumes or is forced into its imposed shape.

[0013] An advantageous development of the invention provides that the biological tissue is animal tissue, in particular mammalian tissue. Such tissue is particularly suitable for arrangement on a frame of an occluder. In particular, such tissue exhibits a comparatively high biocompatibility with the tissue of a human patient.

[0014] A further advantageous embodiment of the invention provides for the tissue to be formed as a pericardium membrane. Such a membrane has proven particularly advantageous in terms of biocompatibility and reliable fluid-tight closure of the left auricle. However, any other animal tissue in membrane format would also be conceivable, such as peritoneal tissue, diaphragmatic tissue, submucosa tissue of the small intestine, or pericardium tissue.

[0015] It is also advantageous if the occluder has a substantially spherical outer contour in the expanded state. Such a spherical or ball-shaped outer contour enables particularly advantageous positioning of the occluder in the left auricula cordis in order to close it. This is particularly independent of how precisely the occluder or the introduction catheter for arranging the occluder is positioned relative to the left auricula cordis in the patient during release and in particular independent of the size and contour of the left auricula cordis. Consequently, in this case the self-expanding occluder is particularly shaped such that in the expanded configuration it tends to have a spherical or substantially spherical outer contour and, as the occluder is released, comes into contact with the inner walls of the left auricula cordis.The occluder can, for example, be positioned along a circular line on the inside of the left auricula cordis.

[0016] It is particularly preferred if, in the arranged state of the occluder, the biological tissue covers the proximal hemisphere of the outer side of the frame at least in sections, in particular at least half, further in particular at least two-thirds, further in particular completely or essentially completely. In this way, the left auricula cordis can be closed by means of the biological tissue in order to reduce in particular the risk of thrombus formation in the left auricula cordis and the resulting risk of stroke. It is conceivable that the occluder, in the arranged state, rests along a circular line against the left auricula cordis. Starting from this in the proximal direction, it is particularly conceivable that the outer side of the frame is completely or essentially covered by biological tissue, so that only this is exposed to the blood circulation through the aorta.It is also conceivable that after the occluder has been placed, the patient's body will form a layer of skin on the biological tissue, so that ultimately a newly formed layer of skin will be formed on the biological tissue and the left auricle will be closed.

[0017] It is particularly preferred if the biological tissue is sewn to the frame, especially using PTFE threads. Attachment using other fastening methods is also conceivable. However, sewing it to the frame structure is particularly easy. Surgical sutures, especially PTFE sutures, are suitable for this purpose.

[0018] It is further particularly preferred if the frame for inserting the occluder into a patient can be transferred into an insertion position in which the occluder has a substantially tubular outer contour. In this state, the occluder consequently has, in particular, a reduced outer diameter and can thus be brought to the desired position, in particular by means of an insertion catheter. In particular, starting from a shape imprinted on the occluder, the occluder can thus be transferred into a compressed configuration and, after release from the insertion catheter, strive for its imprinted self-expanding configuration, thereby coming into contact with the inner surface of the left auricle.

[0019] Advantageously, at least one, in particular a plurality of, X-ray markers is / are arranged on the frame. This enables particularly precise positioning of the occluder on the left auricula cordis and subsequent release of the occluder. The X-ray markers can in particular be arranged at equal distances along the outer side of the occluder. In particular, they can be arranged along a circumference of the occluder, which is in particular spherical. In this case, the area in which the X-ray markers are arranged can come into contact with the inner wall of the left auricula cordis when the occluder is in the arranged state. The X-ray markers can therefore in particular be intersected by a cutting plane which, when the occluder is in the arranged state, separates the proximal hemisphere from the distal hemisphere. It is conceivable that the biological tissue also covers the X-ray marker.

[0020] The frame preferably comprises a tubular end section at its proximal end. When the occluder is in the arranged state, the tubular end section is therefore located in the region of the proximal end of the frame. In particular, an insertion catheter for arranging the occluder on the left auricula cordis can be inserted into the frame through this tubular end section. It is conceivable that the biological tissue has an opening such that the insertion catheter can be inserted through the opening and then through the tubular end section into the frame. The biological tissue can be designed to be elastically flexible such that after the insertion catheter is removed from the occluder, the opening in the tissue is closed in a fluid-tight or essentially fluid-tight manner, and thus the left auricula cordis can ultimately be closed in a fluid-tight or essentially fluid-tight manner.

[0021] In this context, a particularly preferred development of the invention results from the frame comprising a cup-shaped end section at its distal end. This cup-shaped end section can accordingly have a tubular frame section and an adjoining base section in order to form a cup-shaped distal end section in the region of the distal end of the occluder when arranged on the auricula cordis. A section of an insertion catheter can be arranged in or on this cup-shaped end section in order to guide the occluder to its intended position on the left auricula cordis.

[0022] In this context, a particularly preferred development of the invention further provides that the frame comprises a plurality of branching and converging webs between the tubular end section and the cup-shaped end section to form a net-like frame section. Consequently, a net-like or frame-like frame section can be provided between the proximal and distal end sections of the occluder. This frame section can assume a spherical shape or a substantially spherical shape in the expanded configuration.

[0023] It is particularly preferred if the frame is formed in one piece. The frame can therefore comprise, in particular, a distal and proximal end section as well as a mesh-like frame section located between them. The one-piece frame can be manufactured by laser cutting, using a hydrojet process, or by electrical discharge machining (EDM). Consequently, the plurality of branching and converging webs can be "cut out" of a tubular section. However, it would also be conceivable for the mesh-like frame structure to be manufactured from a braided structure.

[0024] Advantageously, the proximal hemisphere of the occluder comprises first anchoring means. Additionally or alternatively, the distal hemisphere comprises second anchoring means.

[0025] In the deployed state of the occluder, the proximal hemisphere can therefore have first anchoring means. These can, in particular, be designed as hooks and have a curved structure with an end portion pointing in the proximal direction.

[0026] Additionally or alternatively, the distal hemisphere may have second anchoring means. These may, in particular, be designed as hooks (technical term: barbs) and, in particular, comprise a rod-shaped section pointing in the proximal direction.

[0027] Preferably, the biological tissue is stabilized by treatment using a cross-linking method before being arranged on the frame. It is therefore conceivable that the biological tissue is first stabilized using a cross-linking process, for example using glutaraldehyde and / or alcohol. It is conceivable that the biological tissue, particularly after it has been attached to the occluder, is then stored in a liquid medium until the occluder is to be used and is only arranged on the catheter together with the occluder immediately before being arranged in the patient. On the other hand, it would also be conceivable, in particular, for the biological tissue to be dried and thus preserved. It is conceivable that it is first treated with glycerol and a monohydric to trihydric alcohol. The tissue can then be dried and, in particular, vacuum-dried.Any other tissue drying method for preserving the biological tissue would also be conceivable. Tissue dried in this way can then be placed on the frame of the occluder. The occluder can then be placed in or on the delivery catheter in this state. The system comprising the delivery catheter and occluder, including the biological tissue, can then be sterilized, particularly using gaseous ethylene oxide (EtO), and stored in this configuration for the duration of its shelf life.

[0028] The object posed at the outset is also achieved by a system for introducing an occluder into a patient and for arranging the occluder on the left auricula cordis of the patient, the system comprising an introduction catheter and an occluder according to the invention arranged thereon, as well as a method for providing the system. By means of the system, the occluder can thus be supplied to the left auricula cordis and then released there. In particular, it is conceivable for the occluder to have a tubular proximal end section through which the introduction catheter is introduced into the occluder. The introduction catheter can in particular have an outer tube and an inner tube. The outer tube can end in the distal direction before the inner tube. The outer tube can be movement-coupled to the proximal end section of the occluder, while the inner tube can be movement-coupled to the distal end section of the occluder.The distal end of the inner tube can be inserted into the distal, cup-shaped end section of the occluder. It is conceivable that the inner tube and outer tube can be displaced relative to each other in order to initially transfer the occluder into an extended state, i.e., an insertion position, in which it can, in particular, have a tubular configuration, and then to move the occluder to its intended location on the left auricula cordis. The occluder can then be released and push into its self-expanding configuration, in particular a spherical one, and thereby come into contact with the left auricula cordis.

[0029] It is also advantageous if the occluder is already positioned within the delivery catheter after the biological tissue has been applied to the frame for storage and / or transport to the operator (pre-loaded system). By sterilizing the system consisting of the delivery catheter and the occluder, in particular using ethylene oxide (ETO), the system can be stored and transported for a long time. This also results in advantages immediately before the system is inserted into the patient, since the occluder is not a separate part from the delivery catheter, meaning the operator does not have to position the occluder on the delivery catheter. This embodiment thus eliminates a work step and consequently reduces the risk of contamination or operating errors.

[0030] The method for providing a system according to the invention provides that biological tissue is first stabilized by a cross-linking method, and then the biological tissue is wetted and / or dried with a liquid medium for sterilization and preservation. The biological tissue can be dried, in particular by vacuum drying, then arranged on the occluder and inserted into the insertion tube (dry state). The entire system with the occluder present in the insertion tube can then be made available to the operator, in particular the physician (pre-loaded system). However, it is also conceivable that the occluder with the biological tissue is made available to the operator in a sterilizing liquid bath, separate from the insertion catheter (wet state), and that the occluder is attached to the insertion catheter immediately before use of the system (user-loaded system).

[0031] Further details and advantageous embodiments of the invention can be found in the following description, on the basis of which the embodiment of the invention shown in the figures is described and explained in more detail.

[0032] They show: Figure 1 schematic top view of an occluder arranged on the left auricle according to an embodiment; Figure 2 schematic perspective view of the occluder according to Figure 1 ; Figure 3 Top view of one half of the occluder according to Figure 2 ; Figure 4 cutaway schematic representation of a frame section of the occluder according to Figure 2 ; Figure 5 perspective schematic representation of an insertion unit according to an embodiment; Figure 6 schematic cross-sectional representation of the insertion unit according to Figure 1 with an occluder arranged in an insertion tube in the insertion position; Figure 7 schematic cross-sectional view according to Figure 6without insertion tube; Figure 8 schematic cross-section of the insertion unit according to Figure 1 with the occluder arranged thereon in a configuration prior to removal of the insertion unit from the occluder. Figure 9 Schematic cross-section of an area around the proximal end of the occluder with the insertion unit arranged thereon; Figure 10 Illustration based on Figure 9 , wherein the inner tube of the insertion unit is removed from the occluder; Figure 11 shows a proximal region of the insertion unit with the Luer connector detached from the insertion unit; and Figure 12 shows method steps for providing a system according to the invention.

[0033] Figure 1 10 schematically shows the left auricula cordis of a patient. To reduce the risk of stroke, an occluder 12 is inserted into the left auricula cordis 10 to close the access to the left auricula cordis 10.

[0034] The occluder 12 comprises a one-piece frame 14. This comprises a proximal tubular section 16 and a cup-shaped distal end section 18. The cup-shaped distal end section 18 comprises a circular cylindrical shell section 20 and a base section 22 to form a cup-shaped structure. Between the two end sections 16, 18, the occluder has a net-like frame section 24. This net-like frame section 24 is Figure 4 Particularly clearly visible in sectioned form. Starting from the proximal tubular end section 16, the net-like frame section 24 initially has a number of webs 26. These merge into a branching network of webs 25 to form the net structure. Diamond-shaped structures 28 are formed in the process. In the distal direction 29, the webs 25 converge again into individual webs 30, which open into the distal end section 18.

[0035] In the arranged state (cf. Figure 1 ), the occluder 12 has a proximal hemisphere 32 and a distal hemisphere 35. In the region of the proximal hemisphere 32, a number of first anchoring means 34 are provided. These extend along a circular line along the circumference and are hook-shaped with end sections pointing in the proximal direction 27. In the region of the distal hemisphere 35, second anchoring means 36 are formed. These also extend along a circular line along the circumference, have a rod-like shape and protrude obliquely from the circumferential surface in the proximal direction 27. The anchoring means 34, 36 are also formed integrally with the frame 14.

[0036] The frame 14 of the occluder 12 consists of a self-expanding material, for example, a shape memory alloy, in particular a nitinol alloy. The expanded shape imprinted on the occluder 12 is spherical (see FIG. Figure 2 ). The occluder 12 has a longitudinal axis 38 running in the proximal and distal directions through its center point. This longitudinal axis 38 also extends through the central longitudinal axis of the tubular proximal end section 16 and through the central longitudinal axis of the distal end section 18 (cf. Figure 2). The proximal hemisphere 32 is completely covered by a biological tissue 40. This biological tissue 40 is in particular designed as a biological membrane. In particular, it can be the pericardium membrane. The tissue 40 has openings such that the first anchoring means 34 protrude through the openings. Furthermore, the tissue 40 has an insertion opening for inserting an insertion catheter through the proximal tube section 16 into the occluder 12. When the insertion catheter has been removed from the occluder 12 after the occluder 12 has been released, the elastically flexible tissue 40 can contract such that the insertion opening is closed in a substantially fluid-tight manner, so that overall the tissue 40 closes the proximal hemisphere 32 in a substantially fluid-tight manner and thereby substantially covers the frame 14. As schematically indicated by surgical threads 42, the fabric is sewn to the frame 14 by means of PTFE threads.

[0037] Near the dividing plane 44 of the proximal hemisphere 32 and the distal hemisphere 35, a number of X-ray markers 38 are placed circumferentially in the region of the proximal hemisphere 32. These markers enable precise positioning of the occluder 12 in the left auricle. Consequently, a surgeon can place the occluder 12 with particularly precise positioning.

[0038] Overall, by providing the biological tissue 40, an occluder 12 with comparatively high biocompatibility can be provided. After the occluder 12 has been positioned on the left auricula cordis, the biological tissue 40 can be overgrown by the patient's natural tissue. Due to the biological tissue 40 used, there is a high overall biocompatibility and thus an increased probability of a successful surgical procedure to close the left auricula cordis.

[0039] The following is a system for inserting the occluder 12 into a patient and for releasing the occluder 12 in the left auricle 10 of the patient according to one embodiment: Figure 5 shows an overall insertion unit 100. This comprises, on the one hand, a drive unit 102 and, on the other hand, an insertion catheter 104. The insertion catheter 104 comprises an inner tube 108 and an outer tube 110. The inner tube 108 extends through the outer tube 110. Furthermore, the outer tube 110 ends in the distal direction 29 in front of the inner tube 108. The insertion catheter 104 can also, as in Figure 6 shown, have an insertion tube 111 surrounding the outer tube 110. The drive unit 102 comprises a housing 114 which can be held in the hand by an operator, in particular a surgeon, and has an overall elongated shape.

[0040] Furthermore, the drive unit 102 comprises an actuating element 116, which is rotatably arranged in the housing 114. The actuating element 116 is hollow and has a first drive thread 118 and a second drive thread 120, wherein the first drive thread 118 is proximal to the second drive thread 120 (see Figure 6 , 7 and 8 ). The actuating element 116 is in particular formed in one piece.

[0041] Furthermore, a first transmission element 122 and a second transmission element 124 are arranged in the housing 114. Both transmission elements 122, 124 have a screw-like shape overall. The first transmission element 122 has a threaded portion 126 and a head portion 128. Accordingly, the second transmission element 124 has a threaded portion 130 and a head portion 132. Both transmission elements 122, 124 can, in particular, each be formed integrally. The first transmission element 122 is motion-coupled to the inner tube 108, while the second transmission element 124 is motion-coupled to the outer tube 110. The head portion 128 of the first transmission element 122 interacts with a Luer connector 134, which is attached to the inner tube 108. The Luer connector 134 is detachably arranged on the head portion 128 of the first transmission element 122.

[0042] The head portion 132 of the second transmission element 124 interacts with the outer tube 110 to couple the movement. The outer tube 110 is detachably arranged on the head portion 132.

[0043] At the distal end of the outer tube 110, this has two Figure 10 particularly clearly visible locking finger-like end sections 136. These are formed integrally with the outer tube 110 and are elastically deformable. Overall, the functionality of the insertion unit 100 is as follows: In order to insert the occluder 12 into the left auricula cordis 10, the insertion catheter 104 is first arranged on the occluder 12 to form a system comprising the insertion unit 100 and the occluder 12, in order to guide the occluder 12 to the left auricula cordis 10 and then release the occluder 12.

[0044] The occluder 12 is initially in its self-expanded form and thus has a spherical outer contour (cf. Figure 2 ). The outer tube 110 is inserted into the occluder 12 through an insertion opening (not shown) in the biological tissue 40 of the occluder 12 and through the tubular proximal tube section 16. The inner tube 108 is then guided through the occluder 12 and the outer tube 110 and arranged on the distal, cup-shaped end section 18 of the occluder 12. The locking finger-like sections 136 of the inner tube 108 are secured against elastic deformation radially inward, so that the locking fingers 136 come into contact with the proximal tubular section 16 in a form-fitting manner.

[0045] Then, an operator, in particular a surgeon, can take the housing 114 in his hand and rotate the actuating element 116. As in Figure 7As shown, the actuating element 116 is first rotated such that the head-like sections 128, 132 of the two transmission elements 122, 124 are moved towards one another. This moves the distal end 137 of the outer tube 110 and the distal end 138 of the inner tube 108 away from one another. This displaces the distal end 140 of the occluder 12 in the distal direction 29, while the proximal end 142 of the occluder is displaced in the proximal direction 27. Overall, the occluder 12 is transferred into an insertion position, so that the occluder 12 as a whole assumes a compressed shape in which it has an elongated outer contour with a reduced diameter d compared to the self-expanded shape (cf. Figure 7 ). The occluder is thus inserted into its insertion position by the operator himself (user-loaded system).

[0046] Alternatively, it is conceivable that the occluder 12 is provided on the insertion catheter 104 as a preconfigured system; the occluder 12 can be protected by the insertion tube 111 and is provided "loaded" in its insertion position (pre-loaded system). The occluder 12 can have the biological tissue in the insertion tube 111, in particular preserved. The biological tissue can be conditioned with a liquid medium, preferably in an alcohol such as glycerol, and then vacuum-dried. Furthermore, the biological tissue can be sterilized using ethylene oxide (EtO) and stored in this configuration in the insertion catheter 104 or its insertion tube 111 in the compressed insertion position.

[0047] In the compressed insertion position, as described above, the occluder 12 can be inserted into a blood vessel together with the insertion catheter 104 and then advanced further to its intended position up to the left auricula cordis. The position of the occluder 12 can be determined using the X-ray markers 38. The occluder 12 should be placed particularly in the central region, i.e., in the area of ​​the X-ray markers 38, on the left auricula cordis.

[0048] In the event that the insertion catheter 104 encompasses the insertion tube 111, the latter is retracted relative to the outer tube 110 when the occluder 12 has reached its position on the left auricle 10, whereby the occluder can be released.

[0049] To fully release the occluder 12, as in Figure 8As shown, the actuating element 116 rotates such that the head-like sections 128, 132 are moved away from each other. As a result, the inner tube 108 is moved in the proximal direction 27, while the outer tube 110 is moved in the distal direction 29. In the course of this relative movement, the proximal end 142 of the occluder 12 and the distal end 140 of the occluder 12 are moved towards each other. As a result, the diameter d of the occluder 12 becomes larger. The occluder 12 thereby pushes into its self-expanded shape so that the proximal end 142 and the distal end 140 of the occluder push towards each other.

[0050] The position of the middle part of the occluder 12 remains unchanged, which is reflected in the Figure 7 and 8 by the center line 144. The center line 144 runs through the center of the occluder 12 between the proximal end 142 and the distal end 140 when the latter, as in Figure 7The center of the occluder 12 therefore remains true to its position and thus unchanged in its position when the occluder, as shown in Figure 8 shown, is released.

[0051] In the Figure 7 In the position shown, the inner tube 108 is held force-fittingly in the proximal direction 27 at the cup-shaped distal end section 18 of the occluder 12. Consequently, upon a proximal movement of the inner tube 108, the distal end section 18 of the occluder 12 is also moved in the proximal direction 27. If the occluder 12 is in a position as shown in Figure 8 shown, the force of the frictional connection is reduced, so that, as shown in Figure 11 shown, the Luer connector 134 can be detached from the head-like section 128 with comparatively little force, so that the Luer connector 134 and thus the inner tube 108 can be pulled off the occluder 12 through the outer tube 110.

[0052] Then, as in Figure 11 As shown, the outer tube 110 can be pulled off the occluder 12, since the locking finger-like sections 136 can now elastically displace radially inward. The occluder 12 can then assume its release position, in which it assumes its self-expanded shape, as shown in Figure 1shown, or at least pushes it into its self-expanded final shape and can thus tightly close the left auricula cordis. When the insertion catheter has been removed from the occluder 12 after the release of the occluder 12, the elastically compliant tissue 40 can contract such that the insertion opening (not shown) in the tissue 40 is closed essentially fluid-tight, so that overall the tissue 40 closes the proximal hemisphere 32 essentially or completely fluid-tight and thereby essentially or completely covers the frame 14. The patient's skin can then grow over the biological tissue 40 so that the left auricula cordis can be permanently and stably closed. Due to the proposed configuration, the insertion catheter 104 can be withdrawn from the occluder 12 particularly easily. This is particularly possible without, or almost without, any torque being exerted on the occluder 12.This reduces the risk that the insertion catheter 104 will be undesirably displaced from its intended position when it is withdrawn from the occluder 12.

[0053] The method for providing a system according to the invention is described in Figure 12 schematically reproduced and provides the following steps: In process step 200, biological material, in particular pericardium, is first provided and in process step 201 is stabilized by a crosslinking method, in particular by means of glutaraldehyde and / or alcohol.

[0054] In a next process step 210, the cross-linked biological material can then be attached to the occluder or its frame, in particular by sewing it on. In the subsequent process step 211, the occluder and the biological material are preserved in a liquid medium and thus made durable. The liquid medium can be glutaraldehyde and / or an alcohol. In process step 212, the insertion catheter is sterilized independently of the occluder, in particular with gaseous ethylene oxide (EtO). The occluder and the insertion catheter can then be packaged separately and made available to the physician. In process step 213, the moistened occluder is then mounted on the insertion catheter or arranged within it (user-loaded system), usually in the operating room.

[0055] Method steps 220 to 224 can follow process steps 201 instead of process steps 210 to 213. In process step 220, the biological material is dried, in particular using glycerol and / or a mono- to trivalent alcohol, specifically vacuum-dried or air-dried. In process step 221, the biological material is attached, in particular sewn, to the occluder or its frame. In process step 222, the occluder, together with the biological material, is inserted into the delivery catheter. In process step 222, the occluder and the biological material are sterilized within the delivery catheter, in particular with gaseous ethylene oxide (EtO). The thus preassembled system can then be packaged and stored accordingly and, in process step 224, made available to the physician in the operating room as a pre-loaded system. The system is then "ready to use."

Claims

1. Occluder (12) for closing the left atrial appendage (10) of a patient, comprising a self-expandable frame (14), characterized in that, in the expanded state, the occluder (12) has a substantially spherical outer contour, wherein a biological tissue (40) is arranged on the frame (14) that at least partially covers the outside of the proximal hemisphere (32) of the frame (14), in that the biological tissue (40) is configured to close the left atrial appendage (10) in the arranged state of the occluder (12) in a fluid-tight manner, and in that the biological tissue (40) is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried.

2. Occluder (12) according to claim 1, characterized in that the biological tissue (40) is configured as pericardium membrane.

3. Occluder (12) according to any of the preceding claims, characterized in that the reticulation method comprises the crosslinking process using in particular glutaraldehyde and / or alcohol.

4. Occluder (12) according to any of claims 1 to 3, characterized in that the liquid medium with which the biological tissue (40) is wetted is glutaraldehyde and / or alcohol.

5. Occluder (12) according to any of claims 1 to 3, characterized in that the biological tissue (40) is initially wetted with glycerol and / or with a mono- to trihydric alcohol and is then dried.

6. Occluder (12) according to claim 5, characterized in that the biological tissue (40) is vacuum-dried or air-dried.

7. Occluder (12) according to claim 6, characterized in that the dried biological tissue (40) is sterilized with ethylene oxide.

8. Occluder (12) according to any of the preceding claims, characterized in that the occluder (12) comprises a proximal end (142) and a distal end (140), and in that, in an insertion position, the occluder (12) has, by comparison with the self-expanded form, an elongate outer contour in which the proximal end (142) is displaced in the proximal direction and the distal end (140) is displaced in the distal direction and the occluder (12) is stretched.

9. Occluder (12) according to any of the preceding claims, wherein the frame (12) comprises a tubular end portion (16) at its proximal end and / or wherein the frame (12) comprises a pot-shaped end portion (18) at its distal end.

10. Occluder (12) according to any of the preceding claims, wherein the proximal hemisphere (32) has first anchoring means (34), and / or wherein the distal hemisphere (35) has second anchoring means (36).

11. System for inserting an occluder (12) into a patient and for arranging the occluder (12) on the left atrial appendage (10) of the patient, the system comprising an insertion catheter (104) and an occluder (12) comprising biological tissue (40) according to any of the preceding claims.

12. Method for providing a system according to claim 11, wherein biological tissue (40) is first stabilized by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium, or dried.

13. Method according to claim 12, wherein the liquid medium comprises glutaraldehyde and / or alcohol and the occluder (12) comprising the biological tissue (40) is arranged on the insertion catheter (104) immediately before it is inserted into the patient.

14. Method according to claim 12, wherein the biological tissue (40) is vacuum-dried or air-dried, and wherein the occluder (12) comprising the biological tissue (40) is introduced into the insertion catheter (104) and, having been made durable, is made available.