WO2016087504A1

WO2016087504A1 - Medical closure device

Info

Publication number: WO2016087504A1
Application number: PCT/EP2015/078337
Authority: WO
Inventors: Peter Osypka
Original assignee: Peter Osypka Stiftung
Priority date: 2014-12-03
Filing date: 2015-12-02
Publication date: 2016-06-09

Abstract

A medical closure device (20, 30) that is configured to be inserted into a patient's hollow organ is designed individually for each patient. A method of manufacturing the medical closure device includes the step of forming a model based on computer graphic data of the patient's hollow organ. The model is made by 3-D printing and is an exact reproduction of the patient's hollow organ. The medical closure device is then preformed using the model. The closure device may comprise a braid of a shape memory material and may be self-expanding.

Description

MEDICAL CLOSURE DEVICE

BACKGROUND OF TH E INVENTION

[OOOI J This invention relates to an individually designed medical closure device suitable to be deliverable into a patient's hollow organ, and particularly to a method of manufacturing said closure device. The medical closure device may be configured for a variety of applications such as closure of the left atrial appendage (LAA), closure of undesired openings with a patient's heart, such as an atrial septal defect (ASD), or other applications, such as treatment of obesity by placement of the closure device within a patient's stomach.

[0002] Left atrial appendage closure (LAAC) is a known treatment strategy for reducing the risk of left atrial appendage blood clots entering the bloodstream and causing a stroke in patients with atrial fibrillation (AF). In atrial fibrillation, over 90% of stroke-causing clots are formed in the left atrial appendage (LAA). Due to the extremely complex and heterogeneous morphology of the LAA and the irregular wavy shape of the LAA ostium, the implantation of an LAA closure device is a great challenge requiring an enormous skill.

[0003] Occluders for undesired openings within the heart are known. For example,

European patent EP 2 53 1 1 13 B l discloses an occluder comprising two spaced apart flexible closure discs formed of a braid of metal wires. The connection between the closure discs does not have clamps, fittings or thread bushings because of a special welding.

[0004] Occluders may be used to close an atrial septal defect (ASD) or a defect in the foramen ovale (PFO). Occluders may also be used in ventricular septal defects (VSD). The atrial septal defect (ASD) is a hole in the septum between the atria of the heart. The ASD is the third most congenital heart defect (ca. 7.5% of all congenital heart defects).

[0005] The most frequent kind of the atrial septum defect is the so-called ASD II. The hole (shunt) lies in the center of the atrial septum and depending on the size a certain amount of blood flows from the left atrium to the right atrium, i.e. back into the pulmonary circulation because of the pressure difference between the atria. In the first years of a patient's life a pulmonary hypertension is not to be expected because the pressure difference between the atria is not significant. However, in adolescence or continuing adulthood disorders are likely to occur. Therefore, the opening in the septum is usually closed by means of an occluder. 10006] The second most kind of a septal defect is the ostium primum defect, which is also called ASD 1. The hole lies in the lower part of the atrial septum, reaches the plane of the valve and is often combined with a malfunction of the mitral valve (between the left atrium and left ventricle), less often with a malfunction of the tricuspid valve (between the right atrium and right ventricle). This defect results from an inhibition of forming the endocardial cushions. Currently, the ASD I is surgically closed with a patch of body's own tissue or with synthetic material.

10007] Besides the aforementioned singular occurrences the ASD may also occur in combination with other defects.

[0008] A very rare kind of ASD is the sinus venosus defect. The defect lies in the upper part of the atrial septum. In 90% of all cases one or more pulmonary veins misled into the right atrium or superior vena cava are present. This defect is also surgically closed with a patch and the misled pulmonary veins are displaced so that a normal blood flow is ensured.

[0009] The foramen ovale is a door-like connection between the left and right atria, which allows a blood transfer from right (pulmonary circulation) to left (body circulation) in the prenatal circulation. Normally, the foramen ovale closes in the first days or weeks of life. If this does not happen, this is called persistent or patent foramen ovale (PFO).

[0010] For the treatment of atrial septal defects (ASD), in particular for minimally invasive closure, the AMPLATZER ^I Septal Occluder is used. These double-disc-shaped occluders consist of a wire braid of Nitinol with a polyester mesh. They were constructed to securely abut against the septum from both sides, to close the defect and to provide a platform for tissue ingrowth after implantation. Depending on the anatomy, different models and sizes of the occluder are available. After overgrowth with endocardium the opening is permanently closed. It is required that the opening is not too large, lies centrally and has smooth edges. If these requirements are not met, the opening must be closed surgically. An Amplatzer occluder is also used for closing the PFO.

[001 11 By using modern 3-D echocardiography defects can be illustrated and measured very safely nowadays. As shown for instance in Figs. 7 or 8, the shape and size of the defect may be complex. In order to close such defect, a relatively large closure disc is necessary. [00121 The American federal agency Food and Drug Administration (FDA) reports in the DAIC magazine (Diagnostic and Interventional Cardiology) erosions of heart tissue if using oversized occluders (October 13, 2013 ). The erosion is caused by the fact that the occluder braid rubs against the heart wall or the aorta wall because of the beating heart.

[ 0013 J Another medical application of a medical closure device is the treatment of obesity. Obesity is a medical condition in which excess body fat may have a negative effect on health, leading to reduced life expectancy and/or increased health problems. Obesity increases the likelihood of various diseases, particularly heart disease, type 2 diabetes, obstructive sleep apnea, certain types of cancer, and osteoarthritis. Obesity is most commonly caused by a combination of excessive food energy intake and lack of physical activity.

(0014] Dieting and exercising are the main treatments for obesity. If diet, exercise, and medication are not effective, a medical closure device, such as a gastric balloon may assist with weight loss, or surgery may be performed to reduce stomach volume, leading to feeling full earlier. Surgeries, however, may be difficult due to the large amount of body fat. Closure devices, like balloons, may be difficult to implant or difficult to remove and may lead to unsatisfactory results because they cannot be adapted to an individual patient.

SUMMARY OF THE INVENTION

|0015] The problem to be solved by the present invention is to provide a medical closure device for a hollow organ which is individually designed for each and every patient. The closure device should be sized and shaped according to the patient ^'s hollow organ. The closure device should thus be optimally adapted to the morphology of the hollow organ so that the closure device fits exactly and properly. Furthermore, the closure device should offer safe and easy insertion. After insertion the closure device should be fixable easily and reliably. Depending on the application, however, it may be desirable that the closure device is removable from the patient's hollow organ.

[0016] This problem is solved by an individually designed closure device

manufactured according to the method of independent claim 1 . [0017] A further object, in particular with regards to occluders for treatment of an

ASD, is to provide an improved occluder that allows an adaptation to the anatomical shape of the septal defect to be closed and an adaptation to the position of the defect in the atrium. The occluder should not or only minimally affect the tissue surrounding the defect in particular in the region of the aorta, but should nevertheless securely close the defect. The occluder should allow closure of openings in the atrial septum that are not disposed in the center, do not have smooth edges or that are too large and would have to be closed surgically as described above. Furthermore, the occluder should allow minimally invasive closure of the ASD I.

[0018] This object is achieved by a patient specifically shaped occluder made of a shape memory material as defined in the claims, wherein the closure discs of the occluder are individually adapted in size and shape to the outer contour and size of the septal defect of each patient, the occluder thereby corresponding to the anatomy of the septal defect true to scale as described in more detail hereinafter.

|0019] A still further object, in particular with regards to occluders for treatment of obesity, is to provide an occluder that - after insertion into the patient's stomach - reliably fills a desired area within a patient's stomach and does not accidentally change its position.

|0020] This object is achieved by a patient specific medical closure device for treatment of obesity as defined in the claims, wherein the closure device is temporarily inserted into a patient's stomach through the esophagus and causes a feeling of satiety as described in more detail hereinafter.

[0021 ] The medical closure device may have a delivery configuration in which the closure device is compressed inside a delivery device, such as a delivery catheter, and an expanded configuration into which the closure device expands after insertion and retraction of the delivery device.

Material

[0022] The closure device may be made of any material suitable to be implanted in a human or animal body and suitable to be deliverable into a patient's hollow organ, e.g. by means of a catheter or other insertion device. The closure device may be made of metal or of bio-compatible polymers or a combination thereof. [00231 The closure device is preferably made of a material showing shape memory properties. Thus, the closure member can be formed or pre-formed to the desired shape in a thermal tempering treatment.

[0024] The term "shape memory material" is used herein to refer to a material which recovers from a deformed shape to a pre-formed shape. The shape memory material may be a shape memory alloy, a shape memory steel alloy or shape memory polymer. Shape memory materials are known. The most preferred shape memory metal is Nitinol. In one embodiment the closure device is thus formed of Nitinol.

[0025] The shape memory material may be covered with a precious metal like gold or platinum.

[0026] Representative shape-memory polymers are e.g. polyurethanes, polyethylene terephthalate (PET), polyethylene oxides (PEO) or block copolymers containing a silicone segment. The shape memory polymer may be a carrier for magnetic nanoparticles.

Closure device

[0027] An important aspect of the invention resides in the fact that the closure device or occluder is sized according to the patient^'s hollow organ or at least the area to be treated. By using a model of the hollow organ to form the closure device - as outlined below - it was possible for the first time to provide a closure device, which has exactly the same shape as the patient's hollow organ or the area to be treated.

[0028] After the closure device has been inserted into the hollow organ, it adjoins the tissue of each individual hollow organ wall either with direct contact to the tissue or in a non- contact manner. In one embodiment a body of the closure device is identical in shape and size to the patient^'s hollow organ thus being configured to adjoin the tissue of the hollow organ directly.

[0029] The closure device may have any texture or structure. In one embodiment the closure device is a metal braid, preferably a Nitinol braid. The braid may be covered at least partially by a plastic membrane. In one embodiment the closure device is comprised of a metal grid or metal lattice. In one embodiment the closure device comprises a body part in the form of a polymer balloon and a lid part made of polymer or of a metal braid. [0030] By way of a first example and without limiting the structure of the closure device, it is described herein to be a braid. The invention will be explained in a first example using a braid as a closure device.

[0031 ] The braid is preferably made of Nitinol and comprises a multiplicity of wire elements, preferably at least 30 wire elements, more preferably 30 to 100 wire elements having a diameter of about 0.03 to 0. 15 mm. Wire elements may be wires, filaments, threads or the like.

|0032] The ends of the wires of the braid may be brought together and held by a closure assembly, said closure assembly forming the distal end of the closure device. Any closure assembly capable of preventing the wires from escaping may be used. Non-limiting examples are a sleeve or a ring to which the ends are welded or an assembly in which the ends are welded together to form a welded ball.

|0033] The braid may further comprise at least one layer of occluding material in the form of a coating or a patch. The coating or the patch improves the sealing performance. The coating may be on the outside and/or on the inside of the braiding. The coating is suitably made of silicone, polyurethane, polyester such as PET or polytetrafluoroethylene (PTFE).

[0034] The braid may be self-expanding and thus may have a first compressed state or configuration and a second expanded state or configuration. The braid may self-expand from the compressed configuration to the expanded configuration. It may also be possible to compress the braid from the expanded configuration to the compressed configuration, in particular for insertion or removal.

[0035] In the delivery configuration the braid is compressed inside a delivery catheter.

After the delivery catheter is retracted the braid expands radially due to the elasticity of the braid and recovers to its pre-formed state due to its shape memory property.

[0036] After the closure device is manufactured the completed braid may - after being inserted into the hollow organ - be filled with a plastic, e.g. silicone or polyurethane, in order to improve its stability or to provide a drug carrier. The drug carrier allows the release of any drug, e.g. blood thinners. 10037] By way of a second example the closure device is described to be a polymer balloon having a lid. The balloon forming the body of the closure device is preferably made of silicone and can - after being inserted into the hollow organ - be filled with liquid or foam (silicone foam or polyurethane foam). The filling ensures that the balloon is pressed against the tissue of the hollow organ. The lid may be a metal braid or a lid made of a polymer, e.g. made of silicone.

[0038J In the delivery configuration the balloon with the lid is compressed inside a delivery catheter. After the delivery catheter is retracted the balloon expands.

Method for manufacturing the device

|0039] The invention particularly relates to a method for manufacturing the closure device using 3-D computer graphics.

(0040] The method comprises the following steps:

a) generating a three-dimensional computer graphic of a patient ^'s hollow organ based on medical images of the hollow organ,

b) transferring the data of the computer graphic to a 3-D printer device,

c) forming a hollow organ model by 3-D printing, said model being an exact

reconstruction of the patient^'s hollow organ,

d) manufacturing the closure device conforming at least partially in size and shape to the patient^'s hollow organ.

[00 1 ] The term "medical image" refers to images from various sources such as X- ray, CT scans, MR1 scans, ultrasound, etc.

[0042] The three dimensional computer graphic is created using common CAD software. Preferably, the medical images are produced in accordance with a display standard such as the DICOM standard (digital imaging and communication in medicine). The DICOM standard image is then exported to the 3-D printer to form a model which corresponds to the patient ^'s hollow organ. The hollow organ model may be formed of polymer or of metal. Suitable materials for 3-D printing are known.

[0043] In one embodiment the model is made by laser printing and the model is thus made of metal. Any material suitable for laser printing can be used. In one embodiment the model is made of steel. In one embodiment the model is made by selective laser sintering. The material must be heat resistant up to the temperature required for shaping the closure device. In another embodiment the model is made by 3-D polymer printing and the model is thus made of polymer.

[0044] The forming of the closure device according to the hollow organ model and thus corresponding to the patient^'s hollow organ is an important aspect of the process. The basis of the process is always the medical image and the model gained therefrom. The forming step itself depends on the material used for the closure device.

Forming a device of shape memory alloy

(0045J If the closure device is made of a shape memory alloy, e.g. made of Nitinol, the process further comprises the following heat treating step:

e) heat-treating the hollow organ model together with the closure device placed therein to the transformation temperature of the shape memory alloy to obtain a pre-formed closure device conforming at least partially in size and shape to the patient ^'s hollow organ.

|0046] If the shape memory alloy is Nitinol, the heating is up to 400 to 600 °C.

|0047] The closure device may be filled with a heat resistant material such as ceramic wool before pressing the closure device into the model. After heat treating the ceramic wool is removed. Due to the filling material a body part of the closure device is pressed against the wall of the model during the heat treatment leading to a pre-formed body part, pre-formed such that the body part comes to bear against the wall of the hollow organ after the closure device is inserted into the hollow organ and expanded.

|0048] Modified step d) would read:

d) manufacturing the closure device conforming at least partially in size and shape to the patient^'s hollow organ, filling the closure device with a heat resistant material and forming the closure device by placing it into the model obtained in step c) to obtain a pre-formed closure device which at least partially conforms in size and shape to the patient^'s hollow organ.

|0049] Modified step d) will lead to a closure device with improved fitting. [0050] An important aspect of the shaping process is the fact that medical images of the patient's hollow organ are used to shape the closure device.

|0051 J The above-described process of manufacturing a hollow organ model and pressing the closure device into the model is considered to be the best mode for forming an advantageous process for forming a metal braid. However, there are other conceivable operations leading to a shaping of the closure device by using medical images of the hollow organ.

Forming a device of polymer

[0052] If the closure device is made of polymer, e.g. of silicone, the body in the form of a balloon and the lid may be formed separately in a known manner using the model as a basis. The lid may be glued onto the balloon. The closure device may also be braided of polymer filaments and then formed.

Method of implanting the device

|0053] The method of implanting the closure device in the hollow organ may comprise the following steps:

a) providing a delivery catheter having the above-described closure device carried therein,

b) advancing the deliver catheter into the hollow organ and positioning it therein, c) releasing the closure device from the delivery catheter, with the closure device expanding to its pre-fotmed shape,

d) placing the closure device, and

e) removing the delivery catheter.

Examples of medical applications

[0054] The core idea of the invention may serve as a source for many medical applications. Whenever an exact fitting of a medical device is required in a morphologically complex area of the human body, the sizing of the device according to medical images of the area in question would be a huge improvement. [0055] A modified version of the closure device might be used to be inserted in the septum, closing a septal defect in the heart, especially a septal defect located close to large blood vessels.

|0056] Another modified version of the closure device might thus be inserted via the esophagus into the stomach, leading to a stomach reduction. The modified closure device might thus be used for treating obesity.

Treatment of septal defects

[0057] With regards to treatment of septal defects, a patient specifically shaped occluder for closing an undesired opening within the heart is provided. The occluder is transformable from a compact configuration to an expanded configuration. The occluder has a first closure disc and a second closure disc, each of which being configured to be disposed on one side of the opening in the expanded configuration. The occluder further has a coupling portion connecting both closure discs. The outer contour and size of at least one of the closure discs corresponds to the outer contour and size of the septal defect, wherein a patient specifically created model of the septal defect serves for manufacturing and forming of the closure discs.

[0058] As explained above, the model of the septal defect is created individually for each end ever patient based on digital images of the septal defect of each patient. The septal defect differs in size and shape from patient to patient. Thus, for each patient an individual model of the septal defect is created.

[0059] The exact size of the PFO or ASD is determined for instance by ultrasound, transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE), or other known imaging methods as described above. The digital images can be reconstructed from these imaging methods using commercially available CAD and/or imaging software. A three dimensional data set is reconstructed that illustrates the opening in the heart, e.g. the septal defect, true to scale. Advantageously, the geometric information about the heart is saved in a data format that corresponds to the DICOM standard (Digital Imaging and Communication in Medicine). After data segmentation a 3-D object is saved from the 3-D DICOM data set which is converted into a format suitable for manufacturing a 3-D model. Preferably, a STL format is used. From the STL format a model of the septal defect is gained by manufacturing a real model based on the computer generated model. For example the data are transferred to a 3-D printer and the model of the septal defect is manufactured by selective laser sintering. The thus created model serves for forming and shaping the braid of the closure discs as well as for manufacturing the occluder.

|0060] The model can be made of any temperature resistant materials that are suitable for laser sintering. In one embodiment, the model is made of steel. In another embodiment, as described above, the model may be made by polymer printing and may thus be made of polymer. It will be appreciated that other methods for manufacturing a 3-D model may be applied.

[00611 The expression "the outer contour and size of at least one of the closure discs corresponds to the outer contour and size of the septal defect" means that the size and shape of the septal defect as well as its position in the atrial septum is taken into account. The closure disc is formed according to the boundary of the septal defect but protrudes beyond the boundary of the defect, which is necessary for a secure seat of the occluder.

[0062] The first closure disc may be positioned in the left atrium when implanted. The second closure disc may be positioned in the right atrium when implanted. The left atrial and right atrial closure discs may be formed equally or may have different shapes. Preferably, the right atrially positioned closure disc is a little bit larger, which may improve the seat of the occluder. The expression "a little bit larger" means that the outer contour of the closure disc is approximately 2% to 10% larger than the outer contour of the septal defect. Upon closure of a PFO centrally offset discs are advantageous.

[0063] As described above, a shape memory material, such as Nitinol, may be used. In one embodiment the closure discs are made of braid of a shape memory material, preferably Nitinol. Thus, the metal braid may be self-expanding and may assume a first compressed configuration and a second expanded configuration. For example, the metal braid may comprise at least 30 Nitinol wires, preferably 30 to 100 wires having a diameter of 0.03 to 0. 15 mm.

[0064] The closure discs may be coated with plastic on the inside. A suitable plastic materia! is for instance Polytetrafluorethylen (PTFE), Dacron or Polyester. Both closure discs may be coated or only one of them. [0065] Since the occluder is created based on a patient specific model, the closure discs are very rarely circular. The closure discs have different shapes. The shapes represent the diversity of the heart's anatomy. The braid of a shape memory material is fitted into the model of the septal defect before the heat treatment that is necessary for shaping such that the outer contour and size corresponds to the outer contour and size of the septal defect.

However, in order to ensure a fixed seat, the closure discs have to overlap the edges of the septal defect such that the closure discs abut against the atrial septum.

|0066] As with other medical closure devices, a tube-like mesh or braid is formed for manufacturing the occluder. Then either two closure discs are formed from a single mesh and the end of the mesh is captured by a clamp or the like, or two tube-like meshes are braided from each of which a closure discs is formed, the ends of which are connected to each other, e.g. by welding as described in EP 2 53 1 1 1 3 B 1 . It is also possible to capture the ends of the tube-like meshes and to connect the fittings. Such occluder is disclosed in EP 2 1 1 6 190 A 1 .

[0067) The coupling portion of the occluder may be braided, welded or otherwise coupled, wherein any coupling methods known in the prior art may be used. In one embodiment, the connection of the closure discs comprises an elastic element, which serves as a spring, for example a coil or Si-hose. Such spring element, or tension element, allows secure abutment of the closure discs against the atrial septum from both sides. The spring element pulls the closure discs towards each other. Thus, atrial septums having varying thicknesses can be treated.

|0068] The connection of the closure discs, and the abutment of the closure discs against the atrial septum, may be further enhanced by additional connecting elements, such as magnets or ratchet mechanisms. For example, the closure discs may have respectively aligned magnets such that an attracting force is created between the closure discs. In an embodiment, there may be two magnets in each of the closure discs, in particular in their edge area. It will be appreciated that any other number or arrangement of magnets in the closure discs may be chosen, which is suitable to create an attracting force between the closure discs.

|0069] The occluder may comprise a lumen, such as a central lumen. The lumen may extend through the occluder from one closure disc to the other closure disc through the coupling portion. For this purpose, the braid may have an opening, preferably in the center thereof. Preferably, the opening or lumen is provided with a self-sealing valve to prevent blood from flowing from the left atrium to the right atrium, but on the other hand to allow passage of a catheter or electrode, e.g. for stimulation of the left atrium. This is described e.g. in EP 2 674 189. Self-sealing valves may be pressure valves, such as silicone valves, which are commercially available in a variety of shapes and sizes.

Treatment of obesity

[0070] Another embodiment of a medical closure device which is manufactured according to the aforementioned principles may be used for the treatment of obesity. Such closure device is inserted into a patient's stomach. Thus, the hollow organ in this application is a patient's stomach and the closure device corresponds in size and shape to the size and shape of a stomach of an individual patient. As with the other applications, a patient specific 3-D model based on imaging data of the patient is used for manufacturing the closure device.

|0071 J The closure device for the treatment of obesity may be self-expanding and can be temporarily inserted into the patient's stomach via the patient's esophagus. It can assume a first compressed configuration and a second expanded configuration, wherein the closure device in the expanded configuration fills the patient's stomach at least partially or completely. Preferably, the closure device comprises or is made of a braid of shape memory material, such as Nitinol. Alternatively, the closure device may comprise a braid of plastic fibers.

[0072] The size and shape of the closure device follows the shape of the patient's stomach or at least a portion of the patient's stomach, which means that the size and shape of the stomach as well as the position of the stomach in the abdomen are considered when forming the closure device. The closure device may be flexible to allow an adaptation to changes of the size and shape of the stomach, e.g. when the patient moves or when the stomach contracts. The flexibility can be adjusted by choosing an appropriate number and diameter of the wires of the braid.

[00731 In the compressed configuration, the closure device may be substantially cylindrical such that it can be inserted via an insertion catheter through the patient's esophagus. In the expanded configuration, the closure device corresponds in size and shape to the patient's stomach, or at least the portion of the stomach that is to be covered by the device. In some applications, depending on the medical indication, it might not be necessary to fill the stomach completely, while in other applications the stomach may be completely filled with the closure device. Advantageously, the closure device is sized and configured to be secured in the patient's stomach without further fixation means, i.e. the closure device remains in place in the patient's stomach only because of its size and shape that is individually adapted to each patient, in case the closure device only fills a part of the stomach, fixation devices, such as an inlet or outlet piece, which may be formed as stent-like tubes, can be provided to improve fixation.

[0074] The closure device is made of a braid, which is adapted to the anatomical structures of the stomach. The mesh apertures are chosen such that the inner surface of the stomach wall is sufficiently covered. For example, the metal braid comprises at least 30 Nitinol wires, preferably 30 to 100 wires having a diameter of 0.05 to 0.3 mm, preferably 0. 1 to 0.2 mm. The braid may be at least partially covered or sealed by another material to seal the apertures in the braid. For instance, a plastic membrane or layer of silicone, polyurethane or PTFE may cover at least a portion of the braid, either from the inside or the outside.

|0075] The closure device is manufactured based on 3-D image data of each individual patient as described above. Different imaging methods, such as X-ray, ultrasound, TEE, ICE, MRT or CT are known and may be used. Commercially available CAD software may be used for manufacturing a model, using data sets in the DICOM standard and STL format as explained above. The model may be manufactured by selective laser sintering and may be made of steel.

|0076) The closure device may have a passage extending therethrough for allowing food to flow through the closure device from the patient's esophagus to the intestine. The closure device may have at least one valve for controlling the flow of food. The valve or valves may be placed in the passage. Thus, food is "bypassed" through the stomach and does not contact the inner wall of the stomach which is covered by the closure device. For example at least one valve may be provided to control the inflow and at least one valve may be provided to control the outflow. Preferably, the at least one valve is a one way valve and allows a flow only in a direction from the esophagus to the intestine. The at least one valve may be used to control the speed of the flow of food. [0077| In order to create an additional feeling of satiety, the closure device may comprise at least one electrode for electric stimulation of desired regions of the stomach. The electric stimulation may be controllable and/or programmable from outside the patient's body, e.g. contactless. Data may be telemetrically transmitted from a control unit to the closure device to control a stimulation of the stomach by means of the electrodes. The 3-D model may be used to place the electrodes at desired locations on the braid. The closure device may comprise electrodes on opposing sides of the braid in order to cause a cross-current through the patient's stomach.

|0078] In one embodiment, the closure device may comprise at least one sensor for measuring physical parameters of the patient and/or the closure device. Sensors may be provided for measuring temperature, pH value (stomach acid), pressure, or motion. The at least one sensor may be located at the edge of the closure device to contact the stomach wall.

[0079] In one embodiment, a filling material may be provided to fill at least a portion of the interior or the entire interior of the braid, such as foam (PU or Si). The closure device, in particular the filling material, may include medicaments that can be released into the patient's stomach.

|0080] In order to measure results of the therapy that have been achieved by the closure device placed inside a patient's stomach, a measurement of the filling level of the stomach can be made. For this purpose, a catheter may be inserted into the passage of the closure device and a balloon at its distal end may be inflated to block the exit of the passage. A fluid, such as water, may then be inserted into the stomach to measure the volume of the stomach. Alternatively, a conductive fluid, such as saline, may be inserted into the blocked stomach and an electric resistance between two electrodes, which may be placed on the catheter, can be measured. By measuring the electric resistance of the fluid in the stomach changes of the volume can be detected.

[0081] The braid of the closure device may be coated with a plastics material, such as silicone, or a layer of plastics material may be provided to seal the closure device as described above. The entire braid may be sealed such that food can only pass through the passage.

Alternatively, only a partial sealing may be provided to allow some food to contact the stomach wall. This may also be controlled by the size of the openings in the braid. BRIEF DESCRIPTION OF THE DRAWINGS

{0082 J The invention will be explained further by the drawings showing an illustrative but not limitative example of the invention.

Figs. 1 and 2 show a braided closure device during its manufacturing before forming the braid.

Figs. 3 to 6 show the forming of an exemplary closure device using a 3-D model.

Fig. 7 shows a 3-D computer graphic of a patient's heart with an atrial septal defect.

Fig. 8 shows a 3-D model of the septal defect of the heart shown in Fig. 7.

Fig. 9 shows a cross-sectional view of a 3-D model of a heart with an occluder.

Fig. 10 shows different views of an occluder inserted in an ASD.

Fig. 1 1 shows different views of another embodiment of an ASD occluder.

Fig. 12 shows different views of still another embodiment of an ASD occluder.

Fig. 13 shows different views of another embodiment of an ASD occluder.

Fig. 14 shows different views of another embodiment of an ASD occluder.

Fig. 1 5 shows different views of another embodiment of an ASD occluder.

Fig. 16 shows a septal defect near a blood vessel closed with different occluders.

Fig. 17 shows an occluder for treatment of a PFO.

Fig. 18 shows a medical closure device inserted in a patient's stomach.

Fig. 19 shows another embodiment of medical closure device inserted in a patient's stomach.

Figs. 20 and 20a show still another embodiment of a medical closure device inserted in a patient's stomach. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0083| With reference to Figs. 1 to 6, different aspects of a manufacturing method for manufacturing a medical closure device or occluder are explained. While these aspects are described with reference to an LAA occluder, it will be appreciated that an analog method may be applied for any other closure device for another hollow organ or area to be treated. As described in the afore-mentioned, depending on the closure device to be manufactured and depending on the application, a 3-D model of the respective hollow organ is manufactured based on 3-D computer graphic data for manufacturing the respective closure device. That means the method described in the following can be applied to other applications to manufacture a patient specific closure device.

{0084) Fig. 1 shows a braided closure member 1 during its manufacturing. The manufacture of the closure member 1 starts by braiding a core. As shown in Fig. 1 a, the manufacture of the closure member 1 may start by braiding a tube-shaped or sleeve-shaped mesh. The ends of the wires of the braided core will then be brought together and connected, for example by a connection part 14, which may be a sleeve or the like. Connection of the wire ends may be achieved without a connection part by directly connecting the wire ends, e.g. by welding, adhesive or other suitable method. As shown in Fig. l b, the wire ends are connected at the distal end of the closure member 1 .

[0085) Fig. 2 shows another braided closure member 1 during its manufacturing. In contrast to Fig. 1 , the wires of the upper part of the braid are drawn inside the braid, brought together and connected, thus forming a closure member 1 with a double braid structure.

[0086] Figs. 3 to 6 illustrate the forming of the closure member 1 using a model of a patient's hollow organ. In this exemplary method, a model of a patient's LAA is illustrated. As mentioned above, it will be appreciated that the method may be carried out using a model of any other hollow organ depending on the application, i.e. the area to be treated.

[0087J Fig. 3 is a photograph of the LAA model 10 with the braided closure member 1 pressed therein. Fig. 3 mainly illustrates how a lid part 3 of the braided closure member 1 with its ring portion 7 is formed by pressing the braid into the LAA model 1 0, followed by a heat treatment. It can be seen that the lid part 3 of the closure member 1 conforms in size and shape to the opening of the LAA model 1 0 and thus to the patient's individual LAA ostium.

[0088] Fig. 4 is a photograph of the LAA model 10 in a side view with the braided closure member 1 having a lid part 3 pressed therein. Fig. 4 shows how the complex morphology of the patient^'s LAA is reproduced by the LAA model 10.

|0089) Fig. 5 is a photograph of the LAA model 10 with the braided closure member 1 pressed therein. The braided closure member 1 is filled with heat-resistant filling material such as ceramic wool 17. Due to the ceramic wool, the body part of the braided closure member 1 is pressed against the inner wall of the LAA model 10 to form the body part according to the LAA cavity.

[0090| Fig. 6 is a photograph of the LAA model 10 illustrating the fixing of the braided closure member 1 in the LAA model before heat treating. The LAA model 10 is equipped with a metal lid 1 1 and at least one metal rod 12 to fix the lid 1 1 . It will be appreciated that other mechanisms for fixing the lid 1 1 are possible. The closed LAA model 10 together with the closure member 1 pressed therein is then heated through the

transformation temperatures of the braiding material to attain the shape memory effect. In the case of Nitinol the heating temperature is 400 to 600°C. The closure device has its final shape pressed into the model after the heat-treatment. The closure device is then removed from the model, e.g. by compressing it.

(0091 J According to an exemplary insertion method a delivery catheter is used with the closure device therein in an initial configuration. In particular, the closure member 1 is in a compressed configuration. The insertion catheter is open at its distal end so that the closure device can be advanced from the catheter by means of a pusher. The closure device is completely pushed out of the insertion catheter by means of the pusher. A thread can be used to reposition the closure device if necessary.

|0092] As mentioned above, the afore-mentioned manufacturing method may be applied for closure devices for other medical applications, such as closure devices for an atrial septal defect or a patient's stomach. Fig. 7 shows a 3-D computer graphic of a patient's heart having a septal defect 1 01 close to a major vessel 102. The septal defect shown in Fig. 7 is a PFO. The 3-D computer graphic is obtained from medical image data of the patient. A real 3- D model is then manufactured based on the 3-D computer graphics, e.g. by laser sintering. In particular, the atrial region including the septal defect 101 (encircled in Fig. 7) is

manufactured as a real 3-D model, i.e. it is not necessary to manufacture a model of the entire heart. The 3-D model is illustrated in Fig. 8. A braid of Nitinol or other suitable shape memory material is then fitted into the model and shaped to conform to the size and shape of the septal defect 101 . In the case of Nitinol, the model together with the braid is then heated up to approximately 500°C to fix the shape of the braid.

10093] Fig. 9 shows a cross-section through a 3-D model of the heart in the area of the atria. The 3-D model is a patient specific model of the septal defect based on 3-D image data of an individual patient. The hole 101 in the atrial septum 100 is relatively large and close to a vessel 102 (e.g. pulmonary artery). The closure disc 2 1 of the occluder is positioned left atrially and corresponds in size and shape to the septal defect. The outer contour of the closure disc 2 1 follows the outer contour of the hole 101 . The edges of the closure disc 2 1 protrude beyond the edge of the defect, which is necessary for a secure seat of the occluder. The closure disc 21 is visible in an elevated view such that the coupling portion 23 appears as a small circle. Various embodiments of occluders are described in the following.

|0094] Fig. 10 shows elevated views as well as a cross-sectional view of an occluder

20 for closing a septal defect 101 in the atrial septum 100. The occluder 20 has first and second closure discs 21 , 22 that are formed as a braid and connected to each other by a coupling portion 23. The closure disc 22 is larger than the closure disc 2 1 because of the anatomical conditions. Both closure discs 21 , 22 correspond to the septal defect 101 with their outer contour. In the position in use illustrated in Fig. 1 0 the closure discs 2 1 , 22 are positionable left atrially and right atrially. The coupling portion 23 extends through the opening 101 in the atrial septum 100. The closure discs 21 , 22 overlap the edges of the opening 101 , i.e. they extend beyond the edges of the opening 101 to abut against the atrial septum 100.

|0095] Fig. 1 1 illustrates the occluder of Fig. 10, having magnets 24, 25, 26, 27 to improve fixation of the closure discs 2 1 , 22. In each closure disc 2 1 , 22 two magnets 24, 25 and 26, 27, respectively, are disposed. In position of use, magnet 24 is aligned with magnet 26, i.e. lies in the respective opposing closure disc. Magnet 25 is aligned with magnet 27. [0096] Fig. 12 also illustrates the left atrially positionable closure disc 2 1 and the right atrially positionable closure disc 22 in elevated views and a cross-sectional view. The reference numbers correspond to those of Fig. 10. In this embodiment, the right atrially positionable closure disc 22 has a different shape than the left atrially positonable closure disc 2 1 . The right closure disc 22 is substantially circular and thus corresponds to common circular closure discs. The left closure disc 21 corresponds with its outer contour to the septal defect 101. Such a combination is possible if the anatomical conditions allow a larger right atrially positionable closure disc 22, i.e. if the right closure disc 22 does not interfere with a blood vessel in the right atrium.

[0097] Fig. 13, 14 and 1 5 show further embodiments similar to those of Figs. 10, 1 1 and 12, respectively. Depending on the wall thickness of the atrial septum 1 00 either one of the embodiments of Figs. 10 to 12 or of Figs. 13 to 15 may be chosen. In particular in the embodiments of Figs. 1 3 and 15, two closure discs 2 1 , 22 are connected by means of a coupling portion 23, wherein one of the closure discs 2 1 , 22 is enlarged to form a body portion 22a that extends into the septal defect 101 in order to substantially completely fill the septal defect 101 and a lid portion 22b covering the opening of the defect 101 .

|0098] Similarly, in the embodiment of Fig. 14 both closure discs 21 , 22 may be regarded to have a body portion 21 a, 22a and a lid portion 22b, 22b, wherein the body portion 21 a, 22a extends into the septal defect 1 01 . In other words, the body portion 21 a, 22a contacts the inner surface of the septal defect 101 while the lid portion 2 1 b, 22b covers the opening of the septal defect 101 . The lid portions 21 b, 22b may have a larger diameter than the body portions 2 1 a, 22a such that they extend beyond the edge of the septal defect 101 while the body portion 2 1 a, 22a contacts the inner surface of the septal defect 101 . In the embodiment of Fig. 14, the closure discs 21 , 22 are additionally coupled by magnets included in the body portions of the closure discs 21 , 22. It will be appreciated that any of the embodiments may be provided with magnets for additional fixation. Further, it will be appreciated that also in the embodiments of Figs. 13 and 1 5 both closure discs 21 , 22 may have a body portion and a lid portion similar to the embodiment of Fig. 14, or the other one (compared to the shown embodiment) of the closure discs may have the body portion and lid portion.

|0099] Fig. 16 schematically illustrates the septal defect 1 01 of Fig. 1 0. The septal defect 101 is located close to a blood vessel 102. The closure disc 21 corresponds to the outer contour of the septal defect 101 . Closure disc 28 is part of a commercially available circular occluder known in the prior art. It is apparent from Fig. 16 that the circular closure disc 28 must have a relatively large outer diameter in order to cover the oval or irregularly shaped septal defect 101. The diameter of the occluder must be a little bit larger than the longitudinal axis of the oval defect. This explains the problem with oversized occluders as mentioned above. The edge of the closure disc 28 nearly interferes with the wall of the blood vessel 102 such that the braid rubs against the vessel wall because of the movement of the beating heart which leads to undesired erosion.

[00100] Fig. 17 illustrates an occluder 20' which is particularly suitable for closing a

PFO. The closure discs 2 Γ, 22 ' are connected by means of the coupling portion 23 ^* such that the closure discs 21 ', 22 ' are centrally offset relative to each other. This corresponds to the anatomy of the PFO. The defect in the foramen ovale is a "hole" in the atrial septum 100 which is formed by overlapping fine septums.

[00101 J Figs. 1 8, 1 9 and 20 show medical closure devices 30, 30', 30" for placement in a patient's stomach for the treatment of obesity. The closure devices 30, 30', 30" are manufactured from a shape memory material, such as Nitinol, with the help of a 3-D model of the patient's stomach based on 3-D image date as explained above for other medical applications, such that the closure devices 30, 30', 30" correspond in size and shape to at least a portion of the size and shape of the patient's stomach 103.

[00102] As shown in Fig. 1 8, the closure device 30 substantially completely fills the stomach 103 and only provides a passage 3 1 from the esophagus 104 to the small intestine 105. The passage 3 1 may include at least one valve (see valve 37 in Fig. 19) to control flow of food through the passage 3 1. A catheter 32 extends through the passage 31 . A balloon 33 at the distal end of the catheter 32 may be inflated to block the exit of the passage 31 . A fluid may then be filled into the stomach 1 03 to measure its volume. This fluid may be e.g. water or a conductive fluid such as saline solution, which allows measuring an electric resistance between two electrodes 36. The device 30 allows easy handling because it is inserted and - if necessary - removed through the patient's esophagus 104 without surgery. The closure device 30 creates a feeling of satiety, which may be further supported by electric stimulation of the stomach 103 (see electrode 41 in Fig. 20). 100103] Fig. 19 shows another embodiment of a closure device for the treatment of obesity. The closure device 30' does not completely fill the patient's stomach 103 but only a part adjacent to the esophagus 104, i.e. the upper part, e.g. half of the stomach 103. The closure device 30' comprises an inlet piece 38, which may be a stent-like tube, to improve fixation of the closure device 30'. The passage 3 1 ' includes a valve 37, such as a silicone valve, to prevent food from flowing back to the esophagus 104. There may be more than one valve, such as two, three or four, which may be advantageous in controlling the flow of food, in particular by slowing down the flow of food to increase the feeling of satiety. Sensors 40 are placed on the edge of the closure device 30' to measure parameters, like pH, stomach acid, temperature etc. In an embodiment, the passage 3 1 ' may widen towards the exit to the stomach 103.

(00104) Fig. 20 shows still another embodiment of a closure device for the treatment of obesity, similar to the aforementioned embodiments. The closure device 30" does not completely fill the patient's stomach 103 like the embodiment of Fig. 19, but is placed in a part of the stomach 103 adjacent the intestine 105, i.e. in the lower part of the stomach 103, e.g. the lower half. The closure device 30" includes an outlet piece 39, such as a stent-like tube, which improves fixation of the closure device 30" . The passage 3 1 " includes a funnel- shaped inlet in order to facilitate food to enter the passage 31 " because the inlet of the passage 3 1 " is located in the interior of the stomach 1 03, not at the inlet of the stomach 103.

(001051 One or more electrodes 4 1 are provided to electrically stimulate the stomach 103 in order to create an additional feeling of satiety. Therefore, the electrodes 41 may be referred to as stimulators. As schematically shown in Fig. 20a, a coil antenna 42 that is connected to the electrode 41 may be provided for contactless communication of a control device (not shown) with the electrode 41. The coil antenna 42 may be integrated in the closure device 30" or attached to it, or may be integrally formed with the electrode 41 . A coil antenna may also be used for communication with the sensors 40 in order to receive measurement signals from the sensors 40 and/or to send control signals to the sensors 40.

(00106] It will be appreciated that features of the closure devices 30, 30', 30", which are not included in all of the embodiments, may be also included in the other embodiments, such as the electrode 41 , sensors 40, valve 37 and inlet or outlet pieces 38, 39. 100107] Some preferred embodiments of the invention are described in the following enumerated items 1 to 1 9. However, the invention is defined in the appended claims.

1 . A patient specifically shaped occluder for closing an undesired opening within the heart, wherein the occluder is transformable from a compact configuration to an expanded configuration, wherein the occluder has a first closure disc and a second closure disc, each of which being disposed on one side of the opening in the expanded configuration, and wherein the occluder further has a coupling portion connecting both closure discs, wherein the outer contour and size of at least one of the closure discs corresponds to the outer contour and size of the septal defect, wherein a patient specifically created model of the septal defect serves for manufacturing and forming of the closure discs.

2. The occluder of item 1 , wherein the closure discs are made of a braid of a shape memory material.

3. The occluder of item 2, wherein the closure discs are made of Nitinol.

4. The occluder of item 2 or 3, wherein the braid of at least one of the closure discs is covered by a plastic membrane.

5. The occluder of any one of items 1 to 4, wherein the outer contour and size of both closure discs corresponds to the outer contour and size of the septal defect.

6. The occluder of any one of items 1 to 4, wherein the outer contour of one of the closure discs is approximately 2 to 10% larger than the outer contour and size of the septal defect.

7. The occluder of any one of items 1 to 6, wherein the closure discs are welded to each other.

8. The occluder of any one of items 1 to 7, wherein two magnets are arranged in the edge portion of each closure disc.

9. The occluder of any one of items 1 to 8, wherein the occluder has a central lumen and a self-sealing valve. 1 0. A method of manufacturing the occluder of item 1 , the method comprising the following steps: a) generating a computer generated 3-D model of the septal defect based on medical images of the septal defect,

b) transferring the data of the computer generated model to a 3-D printer device, c) manufacturing a real model of the septal defect by selective laser sintering, d) manufacturing a braid of a shape memory material and forming the braid by pressing the braid into the model obtained in step c), wherein the closure discs are created by said pressing, whose shapes corresponds to the anatomy of the septal defect true to scale, e) tempering said braid for fixation of the shape change,

connecting the closure discs.

1 1 . The occluder of item 1 , manufactured according to the method of item 10.

12. A method of manufacturing a closure device that is configured to be inserted into a patient's LAA (left atrial appendage) cavity, the method comprising the following steps: a) providing a computer generated three-dimensional model of the LAA based on medical images of the LAA,

b) transferring the data of the computer generated model to a 3-D printer device, c) manufacturing a real model by selective laser sintering,

d) manufacturing a braid of a shape memory material und shaping the braid by pressing the braid into the model obtained in step c) or a subsequent model, wherein a braid is created by the pressing, which is formed proximally disc-shaped, such that a closure disc is created, which conforms in shape to the anatomy of the ostium in the target LAA true to scale;

e) tempering the braid for fixation of the shape change;

f) capturing the ends of the braid in a sleeve and connecting the braid with the tension spring, which has distally at least one fixation element.

13. A method of manufacturing a closure device that is configured to be inserted into a patient's LAA (left atrial appendage) cavity, the method comprising the following steps: a) generating a three-dimensional computer graphic of the patient ^'s left atrial appendage ( LAA) based on medical images of the LAA,

b) transferring the data of the computer graphic to a 3-D printer device, c) forming an LAA model by 3-D printing, said model being an exact reproduction of the patient^'s LAA,

d) manufacturing the closure device by pre-fabricating a closure member comprising a lid part and a body part one following the other in a proximal-distal direction and prefabricating a fixing member and forming at least the lid part of the closure member according to the LAA model obtained in step c) to obtain a pre-formed closure device with at least the lid part of the closure member conforming in size and shape to the patient^'s LAA ostium; and attaching the fixing member to the closure member either before forming the closure member or thereafter.

14. A method of manufacturing a closure device that is configured to be inserted into a patient's LAA (left atrial appendage) cavity, the method comprising the following steps: a) generating a three-dimensional computer graphic of the patient ^'s left atrial appendage (LAA) based on medical images of the LAA,

b) transferring the data of the computer graphic to a 3-D printer device,

c) forming an LAA model by 3-D printing, said model being an exact reproduction of the patient^'s LAA,

d) manufacturing the closure device by pre-fabricating a closure member comprising a lid part and a body part one following the other in a proximal-distal direction, and prefabricating a fixing member, filling the closure member with a heat-resistant material and forming the closure member by placing it into the LAA model obtained in step c) to obtain a pre-formed closure device which conforms in size and shape to the patient^'s LAA ostium and the LAA cavity; and attaching the fixing member to the closure member either before forming the closure member or thereafter.

15. A method of manufacturing a closure device that is configured to be inserted into a patient's LAA (left atrial appendage) cavity, the method comprising the following steps:

a) generating a three-dimensional computer graphic of the patient^'s left atrial appendage (LAA) based on medical images of the LAA,

b) transferring the data of the computer graphic to a 3-D printer device,

d) manufacturing the closure member and forming the closure member by first forming a metal ring according to the opening of the LAA model and fixing the closure member to the metal ring to shape it.

16. The method according to any one of items 12 to 1 5, wherein the medical image is an X-ray image, a CT scan, an MRI scan, or an ultrasound image.

1 7. The method according to any one of items 13 to 16, wherein 3-D printing is 3-D laser printing and the LAA model is made of metal.

1 8. The method according to any one of items 13 to 16, wherein 3-D printing is 3-D polymer printing and the LAA model is made of polymer.

19. The method according to any one of items 12 to 1 8, wherein the closure device is made of a shape memory alloy, the method further comprising the following step e);

e) heat-treating the LAA model together with the closure member or closure device placed therein to the transformation temperature of the shape memory alloy to obtain a preformed closure device with at least the lid part of the closure member conforming in size and shape to the patient^'s LAA ostium.

[00108] Further preferred embodiments are described in the following enumerated items 20 to 25, wherein the method as defined in the following items does not comprise at least one, any, various or all of the features of the method as defined in the aforementioned items 1 0 or 12 to 19. In a particularly preferred embodiment, in the method defined in the following items the model is not manufactured by selective laser sintering. In a further preferred embodiment, the method is for manufacturing a closure device that is not configured to be inserted into a patient's LAA (left atrial appendage) cavity.

20. A method of manufacturing a closure device that is configured to be inserted into a patient's hollow organ, the method comprising the following steps:

a) generating a three-dimensional computer graphic of the patient^'s hollow organ based on medical images of the hollow organ,

b) transferring the data of the computer graphic to a 3-D printer device,

c) forming a model of the hollow organ by 3-D printing, said model being an exact reproduction of the patient^'s hollow organ,

d) manufacturing the closure device by pre-fabricating at least a portion of the closure device by forming said portion of the closure device according to the model obtained in step c) to obtain a pre-formed closure device with at least said portion of the closure device conforming in size and shape to the patient^'s hollow organ.

21 . A method of manufacturing a closure device that is configured to be inserted into a patient's hollow organ, the method comprising the following steps:

b) transferring the data of the computer graphic to a 3-D printer device,

d) manufacturing the closure device by pre-fabricating at least a portion of the closure device and filling said portion with a heat-resistant material and forming said portion of the closure device by placing it into the model obtained in step c) to obtain a pre-formed closure device with at least said portion of the closure device conforming in size and shape to the patient ^'s hollow organ.

22. The method according to item 20 or 21 , wherein the medical image is an X-ray image, a CT scan, an MRI scan, or an ultrasound image.

23. The method according to any one of items 20 to 22, wherein 3-D printing is 3-D laser printing and the model is made of metal.

24. The method according to any one of items 20 to 22, wherein 3-D printing is 3-D polymer printing and the model is made of polymer.

25. The method according to any one of items 20 to 24, wherein the closure device is made of a shape memory alloy, the method further comprising the following step e):

e) heat-treating the model together with at least said portion of the closure device placed therein to the transformation temperature of the shape memory alloy to obtain a pre-formed closure device with at least said portion of the closure device conforming in size and shape to the patient ^'s hollow organ.

[001091 Further preferred embodiments of a closure device suitable for treatment of obesity are described in the following enumerated items 26 to 34. 26. A patient specific medical closure device for treatment of obesity, the closure device being configured for placement in a patient's stomach through the patient's esophagus in order to cause a feeling of satiety, wherein the closure device comprises a braid that can assume a compressed configuration and an expanded configuration, wherein the closure device corresponds in size and shape to at least a portion of the patient's stomach in the expanded configuration, wherein a patient specifically created model of the patient's stomach serves for manufacturing and forming of the closure device.

27. The closure device according to item 26, wherein the braid is a metal braid of a shape memory material, preferably Nitinol, or wherein the braid is a braid of plastic fibers.

28. The closure device according to item 26 or 27, wherein the closure device is self- expanding from the compressed configuration to the expanded configuration.

29. The closure device according to any one of items 26 to 28, wherein the braid is at least partially or completely covered by a plastic membrane.

30. The closure device according to any one of items 26 to 29, further comprising a passage extending through the closure device to allow a flow of food from the patient's esophagus to the patient's intestine.

31. The closure device according to item 30, further comprising at least one valve disposed in the passage configured to allow a flow of food from the patient's esophagus to the patient's intestine but to prevent a flow in the opposite direction.

32. The closure device according to any one of items 26 to 3 1 , further comprising at least one electrode for stimulation of the patient's stomach in order to cause an additional feeling of satiety, wherein preferably the at least one electrode is controllable from outside the patient's body.

33. The closure device according to any one of items 26 to 32, further comprising at least one sensor for measuring physical parameters of the patient or the closure device, such as temperature, pH value, pressure or motion. 34. The closure device according to any one of items 26 to 33, further comprising a filling material that occupies at least a portion of an interior of the closure device, wherein preferably the filling material is a foam.

Claims

1 . A method of manufacturing a closure device that is configured to be inserted into a patient's hollow organ, the method comprising the following steps:

b) transferring the data of the computer graphic to a 3-D printer device,

2. A method of manufacturing a closure device that is configured to be inserted into a patient's hollow organ, the method comprising the following steps:

b) transferring the data of the computer graphic to a 3-D printer device,

d) manufacturing the closure device by pre-fabricating at least a portion of the closure device and filling said portion with a heat-resistant material and forming said portion of the closure device by placing it into the model obtained in step c) to obtain a pre-formed closure device with at least said portion of the closure device conforming in size and shape to the patient^'s hollow organ.

3. The method according to claim 1 or 2, wherein the medical image is an X-ray image, a CT scan, an MRI scan, or an ultrasound image.

4. The method according to any one of claims 1 to 3, wherein 3-D printing is 3-D laser printing and the model is made of metal, or wherein 3-D printing is 3-D polymer printing and the model is made of polymer.

5. The method according to any one of claims 1 to 4, wherein the closure device is made of a shape memory alloy, the method further comprising the following step e):

6. The method according to any one of claims 1 to 5, wherein the closure device is an occluder (30) for treatment of obesity, wherein the model is a model of a patient's stomach based on medical images of the patient's stomach.

7. The method according to any one of claims 1 to 5, wherein the closure device is an occluder (20) for treatment of an undesired opening within a patient's heart, wherein the model is a model of a septal defect based on medical images of the septal defect, wherein said portion of the closure device pre-fabricated in step d) comprises two spaced apart closure discs (2 1 , 22) made of a braid of a shape memory material.

8. The method according to claim 7, further comprising the step of connecting the closure discs (21 , 22).

9. The method according to claim 7 or 8, wherein the outer contour and size of at least one of the closure discs (21 , 22) corresponds to the outer contour and size of the septal defect.

10. A patient specifically shaped occluder (20) for closing a septal defect ( 101 ) within the heart, wherein the occluder (20) is transformable from a compact configuration to an expanded configuration, wherein the occluder (20) has a first closure disc (21 ) and a second closure disc (22), each of which being configured to be disposed on one side of the opening in the expanded configuration, and wherein the occluder (20) further has a coupling portion (23) connecting the closure discs (21 , 22), characterized in that the outer contour and size of at least one of the closure discs (21 , 22) corresponds to the outer contour and size of the septal defect ( 101 ) in the heart, wherein a patient specifically created model of the septal defect ( 101 ) serves for manufacturing and forming of the closure discs (2 1 , 22).

1 1 . The occluder of claim 10, wherein the closure discs (21 , 22) are made of a braid of a shape memory material, preferably Nitinol, wherein preferably the braid of at least one of the closure discs (21 , 22) is covered by a plastic membrane.

12. The occluder of claim 10 or 1 1 , wherein the outer contour and size of both closure discs (21 , 22) corresponds to the outer contour and size of the septal defect ( 101 ), or wherein the outer contour of one of the closure discs is approximately 2 to 10% larger than the outer contour and size of the septal defect.

13. A patient specific self-expanding medical closure device (30) for treatment of obesity, the closure device being configured for placement in a patient's stomach ( 103) through the patient's esophagus ( 104) in order to cause a feeling of satiety, wherein the closure device (30) comprises a braid that can assume a compressed configuration and an expanded configuration, wherein the closure device (30) corresponds in size and shape to at least a portion of the patient's stomach ( 103) in the expanded configuration, wherein a patient specifically created model of the patient's stomach ( 103) serves for manufacturing and forming of the closure device (30).

14. The closure device according to claim 13, wherein the braid is a metal braid of a shape memory material, preferably Nitinol, or wherein the braid is a braid of plastic fibers, wherein preferably the braid is at least partially or completely covered by a plastic membrane.

15. The closure device according to claim 13 or 14, further comprising at least one electrode for stimulation of the patient's stomach in order to cause an additional feeling of satiety, wherein preferably the at least one electrode is controllable from outside the patient's body.