Technical Field

The subject of the present invention is an occluder device according to the pream ble of claim 1 , which can be used to repair a Ventricle Septal Defect (VSD). This defect is located in the septum separating the right and the left ventricle of the heart. It is most often single, located in the perimembranous area, which is the up per part of the septum abutted by the tricuspid and aortic valves, hence called a perimembranous VSD. It can however also be a muscular VSD, an outlet VSD, or multiple swiss-cheese muscular VSD depending on their location, margins and the multiplicity. Additionally, VSD may coexist as a part of more complex defects.

Many of these VSD need to be closed, optimally during the first 6 months of life. The longer they are left unattended, the higher is the risk of developing pulmonary hypertension. A stage is reached when left unattended, when the pulmonary hy pertension gets fixed due to sclerosis of the pulmonary vascular bed leading to Ei- senmenger Syndrome: a point when complete VSD closure is prohibited.

Background Art

VSD closure has been successfully performed since 1954, when it was amongst the first intra-cardiac operations performed by Walton Lillehei at University of Min nesota Hospitals, Minneapolis, USA. Since then, the VSD closure with a biologi cal/prosthetic patch using a Heart Lung Machine has become a routine operation with very good results. The operative technique has hardly changed since dec ades.

The present state of the art technique involves supporting the circulation using ex tra-corporeal support (Heart Lung Machine) which needs to be filled with blood to prevent extreme haemodilution and to maintain the natural homeaostasis. The heart needs to be stopped by administering cardioplegia, for a variable duration ranging up to 60 minutes to allow for careful suturing of the patch to the VSD.

The suturing also subjects the heart to a risk of atrioventricular block (due to injury to the bundle of HIS). The bundle of HIS runs within the septum on the postero- inferior margin of the VSD. 1-3% of patients undergoing surgery for VSD closure develop permanent AV Block requiring insertion of a permanent pacemaker which subjects the child to a cycle of repeated reoperations, risk of infection, endocardi tis, etc. A method to close a VSD is using a dumbbell shaped device which is often called ‘Am platzer’ -device delivered transvenously using a catheter. Catheter is maneu vered into the heart using X ray guidance. This method is applicable in a minority of VSD closure ‘especially mid muscular VSD’ and in elderly patients above 10 kg. The majority (> 95%) of VSD closure are therefore performed surgically. The ‘Amplatzer ^’ -device is voluminous and has no elasticity. It is further not possible to close a VSD near the heart valve. A recent development is to use the ‘Amplatzer ^’ device surgically to close the VSD. This technique is being stretched to use in children under 1 year of age; but continues to be propagated only by a few cen ters in China, albeit with good results. Said device in introduced through the ves sels, which is however very complicated or even impossible with infants.

A further device for the closure of a VSD is an occluder provided by the Carag AG. This occluder is also dumbbell-shaped and has no elasticity or flexibility. Therefore, it is similar to the ‘Amplatzer’-device.

A further state of the art is the closure of a VSD by a surgical patch. It involves in serting a textile patch and putting it in place using numerous stitches (each on the septum as well as the patch). The operation has to be done by very experienced and trained surgeons. A patch is a simple way for the closure of a VSD. It is well accepted by the body and can be overgrown with tissue. However surgical patch has no elasticity and can be a hindrance for the movement of the heart. The time of the surgical operation and for the recovery is long. The numerous stitches near the nerve pathway have the danger of an AV-Block. Due to the low elasticity of the patch, the patch does not participate in the growth of the organ. The pressure in the left ventricle is almost 5 times greater than in the right ventricle during sys tole (during contraction). As a consequence, the patch can actually bulge away to wards the right ventricle when the rest of the left ventricular muscle is contracting, thus to a small extent negating the contractile effect at the base of the heart. De pending on the size and site of the VSD, as well as the occurrence of right bundle branch block (often seen after conventional surgical closure), the consequences can become relevant.

Further a Hernia Patch with the trademark name “Ventralex” is reported in the lit erature. This Hernia Patch however is not suited for cardiovascular defects.

US2008015636 A1 discloses an oval closure device for the closure of a defect in a heart tissue. This element works as a flexible plug, which has to be highly flexi ble to be inserted in a tube. The braid of wires forms a circular body at one side of the heart and is held more or less in place with a rear grip anchoring element of two anchoring elements, which pull together the parts of the tissue in order to re duce the diameter of the defect. The construction is highly flexible and will provide a constant restoration force independent of the contraction of the muscle to hold the device in place. The holding in place of this device is mainly due to the con stant plug form of the device while the axis defined by the device has a S-shape.

W00027292 A1 discloses an occluder device of the closure of a blind hole. This device also works like a plug inside the defect being held by one anchoring seg ment only and might cause irritation when placed near the heart valve. Therefore, the W00027292 A1 is limited to the position of the defect. Said device is radially braced inside the defect with one single axial fixation. A high flexibility for this de vice is not needed.

US2007083230 A1 is an occlude having the Form of an elastic plug, having a pro tuberance in the form of a bag. The use of this occluder device might depend on the anatomical position of the defect. This device is further held in place by merely one anchoring element being a spiral spring.

Object of the invention

Starting from the state of the art mentioned above, it is an object of the current in vention to reduce operation time for the attachment of a patch in order to repair a Ventricle Septal Defect. Further to this it is an object of the current invention to re duce the recovery time of a patient.

The aforementioned occluder devices in the state of the art are either voluminous and shape, have no elasticity and/or are time demanding during the operation. They can also be not suitable or have other disadvantages as the danger of the formation of an AV-block.

It can be a further object of the invention that the patch is applicable by a method, which does not differ substantially from the established methods for the applica tion of patches in the state of the art.

It is a further object of the invention to generate a better tightness of the patch compared to patches mentioned in the state of the art. A further object of the invention is that the application of the patch can be pro vided with high quality and less training for the surgeons.

A further object of the invention is that the supporting structure participates partly in the closure of the defect and likewise provides a centering and holding in place of the occlude device to grant an optimized closure of the defect under contraction and expansion conditions of the heart.

Disclosure of the invention

The current invention overcomes the aforementioned disadvantages with an oc cluder device with the features of claim 1.

An inventive occluder device can be used for the repair of a ventricle septal de fect, especially a through hole.

The occluder device may preferably comprise at least one covering material. Said covering material can partly or completely cover the surface of the defect. When there is a partly covering the covering material should at least cover the majority of the surface, preferably at least 65% of the surface of the defect. The covering can preferably be more than 90% or even more than 95%. Also, a complete cov ering is desired. The free space of less than 35%, preferably less than 30%, can be provided by openings of preferably less than 3 mm diameters. These openings can be covered by natural tissue material.

The occluder device further comprises at least one supporting structure which can for example support a sewing material such as strings for the attachment of said occluder device. The supporting structure may be preferably adapted for support ing the covering material, however the occluder can also be used without said covering material and with said supporting structure only.

The supporting structure can preferably be made of metal material. It can more preferably be made of a metal sheet with less than 1 mm, preferably less than 0.5 mm, more preferably less than 0.3 mm thickness, most preferably between 0.05 and 0.25 mm, especially between 0.08 and 0.25 mm. The material can be a metal, such as Nitinol, spring steel and/or stainless steel. Stainless spring steel or 1.4404-steel is more preferred. Especially thin edges are of advantage for the overgrowth of the occluder by organic tissue. In a preferred embodiment the supporting structure has an average or mean di ameter of less than 15 mm, preferably 6-12 mm, most preferably 9-11 mm. The diameter of a circular disc is normally uniform at all positions. The diameters of a rectangular disc or other disc forms are normally different depending on the posi tion of measurement. Therefore, an arithmetic average has to be calculated from all diameters, which represents the said average diameters. Might be larger than 15 mm if the defect is significantly large, however the occluder device is preferred and especially of advantage for the holding at defects and the repair of these de fects in the range of several millimeters.

The supporting structure comprises circumferentially outer element as a stop against a first side of the organic, especially human, tissue surrounding the hole, wherein said outer circumferential element defines a plane and a central axis per pendicular to said plane. The circumferentially outer element can be an outer ring, wherein the ring is not restricted to a circular shape, but can also have oval, trian gular, rectangular, hexagonal or any other suitable shape. The circumferentially outer element can also have only ring segments, which are connected to one an other by connection segments. The outer circumferential element might also have or comprise a netlike structure, a three-dimensional adjusted structure, spokes like structure, a form-adjusted structure, a spiral structure and/or a labyrinth struc ture.

The supporting structure provides a support to the covering material, such that the covering material is spread out and held in said plane. The supporting structure can be flexible, so that the occluder device can be bend or folded or otherwise in troduced through the hole to be covered with. Upon bending or other deformation, the supporting structure develops a restoration force, so that it will tend to form back to an initial form, especially by reversible elastic deformation. Elasticity and/or flexibility may have further advantages for the tightness of the occluder. This way the occluder device will be centered in relation to the defect during each deformation. The edge of the disc must finish with the heart wall as flow-optimized as possible.

In a preferred embodiment the center axis of the device is coaxial to the center axis at the average center of the defect.

The element which is positioned closer to the center axis than the circumferen tially outer element can be moved relative to the circumferentially outer element along the center axis preferably between 0.5 - 4 mm, most preferably between 1 mm - 3 mm. The cantilever arm and/or spring arm are preferably designed such that a restora tion force of the supporting structure of at least 0,15 N, preferably between 0,45 and 3 N, is provided when the element is be moved relative to the circumferen tially outer element along the center axis with a deviation of 2 mm from a planar orientation. The design can comprise different data such as the thickness of the disc-shaped support structure, the width of the arm, it’s length, the material and/or the form of the connection between the arm and the circumferential outer ele ment. The design can be adapted by a variation of at least said data. The thick ness is the extension of the support structure in a direction parallel to the center axis

The supporting structure is further designed in the same manner such that it pro vides a clamping force of at least 0,45 N, preferably between 1 ,5 and 9,0 N, when the element is be moved relative to the circumferentially outer element along the center axis with a deviation of 2 mm from a planar orientation. These values are should be considered by a generation of the supporting structure alone, without the blood pressure, which might apply a further clamping force to the occluder de vice when it is mounted inside a body. However, since the blood pressure will fluctuate in pressure pulses, a quantification of the clamping force together with the blood pressure is only possible for each individual defect.

For a good mechanical stabilization of the stop function it is of advantage if the circumferential outer element is a ring of massive materials, such as steel. A mesh or a braid of wires have less mechanical stability to work as a stop, espe cially under the conditions and forces mentioned above.

The occluder device comprises anchoring segments can extend either from the covering material if such a covering material is provided or from the supporting structure such that a connection of the anchoring segments to the tissue can be made either by sewing, stapling and/or more preferably by a rear grip with the tis sue at the opposite side of the organic tissue. To grant an accurate position of the occluder device said occluder device should have at least three anchoring seg ments. Likewise, it is not of advantage to have more than four anchoring seg ments in order to reduce the fixation effort during an operation, in which every second might be decisive.

With the rear grip, the circumferential outer element abuts at the one side of the organic tissue and the anchoring segments are positioned at said opposite side of said organic tissue. For the positioning of said occluder, it is possible that the cir cumferential outer element will be introduced through the hole of said organic tis sue, while the anchoring segments remain mostly outside of said hole.

Because the organ is the heart, the circumferential outer element, which supports the covering material, is positioned at the pressure side of the heart, which means inside the organ, while the anchoring segments are positioned on the other side of the dividing septum.

More preferred from the methods of connection is the sewing. The anchoring seg ments are wires, strings or straps that are connected or guided near the center of the outer circumferential element and are meant to extend along the central axis through the defect, respectively through the hole, bent away from the hole and are then connected at the opposite side of the hole to the tissue. The connection can be either a fixation either by sewing or, less preferred, by stapling. Biodegradable staples and/or sewing yarn are known in the art and can be used for this applica tion.

If the connection is done by sewing, the inventive occluder reduces the amount of stitches to up to less than 30% compared to the patches of the state of the art.

Alternatively, or optionally to the sewing or stapling a fixation of the Occluder de vice can be achieved by rear grip of the tissue by the anchoring elements, such as wire arms that press with a distal end against the tissue.

Other suitable anchoring segments might be strings, yarn or threads, such as yarn threads, clamping legs, a clamping ring, one or more hooks, an umbrella supporting structure, a spiral structure and/or knots.

In addition to the outer circumferential element, the inventive supporting structure comprises at least an element, which is positioned closer to the center axis than the outer circumferential element. Said element can be moved relatively to the outer circumferential element along the center axis by generating a restoration force for holding the outer circumferential element and the covering material in place during a contraction and/or expansion of the organ. In other words said ele ment is provided in a way that in can be moved an while or especially thereby generating a restoration force. This restoration force can be transferred by the an choring segments to the outer circumferential element and/or the covering mate- rial, such that the outer circumferential element, the covering material or prefera bly both are pressed against the hole. This is a further difference to common patches and plasters, such as hernia patches.

Due to a preferred flexibility of the aforementioned element along the center axis, this element can be positioned inside the hole while the outer circumferential ele ment is positioned next the hole at the surface of the tissue. Thereby the element can be a stop for a horizontal (lateral) movement or displacement of the occluder device to the center axis.

The supporting structure has a disc-shaped form preferably with disc shaped seg ments. It may consist of a flexible material which can develop restoring forces upon complete or partial deformation of said supporting structure. Due to the disc shaped form the inventive occluder device is able to partially cover the defect over the surface of the defect in contrast to devices in the state of the art, which work merely as a plug inside the defect with low restoration forces.

The current occluder device is designed and adapted to be held in place under contraction and with consideration of the difference of the blood pressure gener ated by the heart, which will be applied to the occluder device as pressure pulses. The blood pressure difference between the right heart chamber compared to the atrium might be 1 :2 to 1 :5. The occlude device is adapted to withstand the blood pressure differences without any functional failure.

Further advantageous embodiments of the invention are subject-matter of the sub-claims.

The element of the supporting structure can be formed as a cantilever or spring arm and/or as an inner ring having a smaller diameter of the outer circumferential element. The element can also be a plurality of cantilever or spring arms, prefera bly at least 3 of said arms with or without said inner ring. This inner ring can pref erably have a center, which is also positioned at the center axis defined by the outer circumferential element. The inventive occlude device might preferably have multiple spring arms or cantilever arms, more preferably at least 3 and most pref erably 3-6 cantilever arms. The number of said arms might preferably correspond to the number of anchoring segments.

In a preferred embodiment the average width of the cantilever arm and/or spring arm over its length is bigger, preferably at least 2-times bigger, than the thickness of the supporting structure. The thickness is the extension of the covering material in a direction parallel to the center axis. This way the restoration forces generated by the occlude device are significantly higher than these of a spiral wire spring.

The length of an arm is preferably always bigger than the width of said arm. Said width may extend in radial direction from the center axis of the occlude device.

The cantilever arm can be provided to have a curved, preferably convex or con cave structure, when it is mounted and might be flat in a not mounted situation.

He can preferably decrease in width towards his distal end. Such a decrease in width means that the flexibility of the cantilever arm increases. At the distal end a cantilever arm can preferably be provided with a guiding bar, where an anchoring segment can be guided from a lateral extend towards the direction of the center axis and the defect. An anchoring segment could be laid up at the distal end of the cantilever arm, especially at the guiding bar. By applying a pulling force at the anchoring segment, the cantilever arm can be bend towards the hole. The defect, respectively the hole in the organ can move, increase or decrease in width and length upon expansion or contraction. Therefore, the support structure with the covering material is only pressed against one side of the defect and fixed by an choring elements, so that the occluder device is able to move to a certain amount when a force is applied. The outer circumferential element and the at least one el ement of the supporting structure additional to the outer circumferential element help to compensate and redirect pulling forces applied in lateral direction or paral lel to the center axis.

A compensation of forces can be further achieved when the inner ring is prefera bly connected to the outer circumferential element by spring arms, preferably made of spring steel or nitinol. Said spring arms can preferably also have a curved form, more preferably concave or convex form when mounted and planar form when not mounted.

The occluder device can comprise a disc shaped segment for covering the defect. The anchoring segments can extend from the center of the disc shaped segment. The disc shaped segment can preferably be formed by the supporting structure having a disc shape and covered, especially pocketed, by the covering material.

The supporting structure is pocketed by a mantle or envelope formed by the cov ering material.

The cantilever arm or spring arms are preferably curved. More preferred they can have a concave or convex form. The spring arm can be provided with interstitial space segments in the form of ring segments for the compression in longitudinal direction of the spring arm. The in terstitial space segments can be arranged in line in radial direction towards the center axis defined by the outer circumferential element. The lined-up interstitial space segments can preferably decrease in size towards the center axis.

The supporting structure can preferably made of nitinol-metal, 1 .4404 stainless steel and/or spring steel.

The anchoring segments can preferably made of sewable textile straps, more preferably made of the covering material. The Occluder device can comprise 3 or 4, sewable textile straps as anchoring segments. The provision of anchoring seg ments can reduce significantly the time for the fixation of the Occluder device compared to a circumferential sewing seam for the connection of a textile patch. It can be easily introduced and positioned at the place of the defect.

The cover material can comprise polyfluorinated material, preferably PTFE (Poly- tetrafluoroethylene), more preferred ePTFE. PET (Polyethylene terephthalate), PES (Polyethersulfone), Polypropylene, Fiber-Material and/or biological Cell-Ma terial are also possible but less preferred in terms of mechanical stability and flexi bility and handling for this application. Further to this the material should be sewa ble and should be provided with an intrinsic stability for the application being de formed with every heart contraction together with the support element.

The thickness of a layer of covering material covering the supporting structure might be between 0.05 and 0.2 mm, preferably between 0.08 and 0.12 mm.

Which is sufficient stable to withstand the blood pressure, especially in the con text of the design of the supporting structure. Also, the layer is sufficient flexible to work together with the cantilever or spring arms, without generating a further res toration force in addition to the restoration forces generated by the cantilever or spring arms.

The occluder device is provided with a sealing lip, so that a sealing between the tissue and the occluder device, more preferably the disc-shaped segment, can be achieved. Said sealing lip might have a larger thickness than the thickness of a layer of the covering material to have an enhanced sealing function. This might be preferably the case when the covering material is an envelope for example when two layers are welded together to form said envelope. Further to this, it is of advantage is the sealing lip consist of a cuttable material, such that the form of the occlude device can be slightly adapted to the form and/or position of the defect for example during the surgery, to avoid the contact of the occlude device with an obstacle by cutting parts of the sealing lip away.

For a preferred sealing function, the sealing lip may extend radially over the sup porting structure with at least 1 mm, preferably 1-4 mm.

The inner ring can be connected to the outer circumferential element by spring arms, preferably made of spring steel.

Brief Description of the drawings

Some advantageous embodiments for inventive occluder devices are further ex plained in detail below together with drawings. Specific parts of the different em bodiments can be understood as separate features that can also be realized in other embodiments of the invention. The combination of features described by the embodiment shall not be understood as a limitation for the invention:

Fig. 1 a schematic view on parts of a first inventive embodiment of an occluder device;

Fig. 2 a cross-sectional view of the occluder device of Fig. 1 in intended position in a hole of a heart;

Fig. 3 a schematic view of a sixth inventive embodiment of an occluder device;

Fig. 4 a schematic view of a variation of the parts shown in Fig. 1 ; and

Fig. 5 a schematic view of the position of an occluder device at the heart.

Mode for Carrying out the invention

An occluder device 1 according to the invention is shown in Fig. 1 and 2. It com prises a supporting structure 2, a mantle or envelope 3 covering the supporting structure 2 and anchoring segments 4 for the connection to the tissue preferably either by sewing or a rear grip of the organic, especially human, tissue 5 at the opposite side of an organ which can be a heart. Additional to the use for the treat ment of VSD the occluder device can be used for the repair of other organs with similar defects. A defect is in most cases a hole having a longitudinal axis at the center of the hole and defining an axial direction. Said longitudinal axis can be parallel to the insertion direction of the occluder device 1 in the defect, respec tively the hole.

The supporting structure 2 has a disc-shaped form with disc shaped segments 18 and preferably consists of a flexible material which can develop restoring forces upon complete or partial deformation of said supporting structure 2. Such a mate rial can preferably be spring steel. The disc-shaped supporting structure 2 will preferably be made of a material, resistant to millions of heart beats that it will be subjected to during a life-time. The supporting structure 2 of Fig. 1 comprises an outer circumferential element 6 defining a plane and cantilever arms 7 extending in a curved, preferably convex or concave, shape on said plane from the outer cir cumferential element 6 towards the center of the element 6, more specifically to the center axis A which passes through the center of the outer circumferential ele ment 6 and which extends perpendicular to the plane defined by the ring. A guid ing element 10, such as a guiding bar, for interaction with the anchoring segments 4 is provided at the distal end of each cantilever arm 7. The anchoring segments 4 can be redirected from a radial direction towards an axial direction by said guid ing element 10, wherein the cantilever arms 7 will be bend out of plane if a pulling force is applied on the cantilever arms 7. In an installed position of the occluder device, the cantilever arms are always bend out of plane, in order to avoid move ments of the occluder device perpendicular to the axis defined by the defect.

The connection between the outer circumferential element and the cantilever arms can be seamless. The supporting structure can preferably be produced from a sheet, such as a sheet of metal, by Laser-cutting, etching, stamping or stretch ing.

The disc-shaped supporting structure might have a preferred thickness of less than 0.5 mm. For this thickness there is an optimal flexibility of the cantilever arms 7 and for the whole supporting structure 2. The width of the cantilever arms can be reduced from the outer circumferential element 6 to the center of the circum ferential element 6.

The mantle or envelope 3 completely or partially covers the supporting structure 2 so that a membrane for covering the defect area is established. It might be suffi cient that the defect is reduced to a certain diameter such that the tissue can grow over the membrane and close the defect. Therefore, the membrane formed by the mantle or envelope 3 might still have pores, minor recesses or the like of less than 3mm. The material of the mantle or envelope can preferably be a sealing material such as polyfluorinated material, especially PTFE (Polytetrafluoroeth- ylene). In a preferred embodiment the PTFE-Material might be an expanded, es pecially stretched, so-called ePTFE, such as Gore- Tex-Material. Additionally, or alternatively the material for the mantle or envelope 3 can be PET (Polyethylene terephthalate), PES (Polyethersulfone), Polypropylene, Fiber-Material and/or bio logical Cell-Material. The material should preferably cause minimum friction or damage to blood elements and will align the left ventricle to the aorta as much as is possible. The material can be provided with functional layers or fibers with growth-promoting compounds for cellular growth, such as magnesium.

The anchoring segments 4 in Fig. 1 can be attached either to the supporting structure 2 or to the cover material, which can be for example a monolayer, a mantle or envelope 3, or cantilever arms 7. The anchoring segments are prefera bly made of sewable material, for example a textile material, such as the material of the mantle or envelope 3 mentioned above. The anchoring segments 4 can be formed as straps, with sufficient length to extend from the supporting structure 2 or from mantle or envelope 3 through the defect such as a hole and laid against the outer side of the organ for sewing. Sewable material might also be a plastic material which is provided with puncture holes where a sewing needle can pass through, such that the anchoring segment 4 and therefore the occluder device 1 can be connected to the organ at this point or area of connection.

An additionally or alternatively to the aforementioned sewing connection the an choring segments 4 might be a rear grip at the opposite outer side of the organ such as the heart. The anchoring segments in this case might be a bendable ma terial such as a wire segment extending preferably from the support element 2. The anchoring segment 4 can form together with the outer circumferential ele ment 6 a u-shaped section such that the outer circumferential element 6 can bear against an inner surface of the organ and the anchoring segment 4 extend through the defect, such as a hole, and bears against the outer surface of the or gan. To provide flexibility for the surgical closure element 2 to pass through the defect of the organ, the anchoring segments 4 can be formed in this case in the form of prongs.

The closure device shown in Fig. 1 and 2 envisage a ‘step-up’-approach to close all types of VSD (congenital as well as acquired, isolated as well as those occur ring as part of complex lesion, single as well as multiple), using the occluder de vice, especially in a semi-automated intelligent manner. The use of the single ultra low-profile disc-shaped closure device, is able to close the VSD from the left ventricular (LV) side. In the case of an application in the heart the occluder can provide an enhanced tightness while blood pressure is ap plied on said occluder.

By sewing 1 - 4 straps to the tissue, these straps can stitched to the safe loca tions on the right ventricular (RV) side of the septum in a stretched position recre ating the diastole. The safe location of the 1-4 straps is meant to reduce the num ber of stitches by 70-95% and to ensure minimizing and/or prevention of heart block and thus the need for permanent pacemaker. Fig. 1 thus shows a connec tion of the straps 4 and the outer side C of the tissue 5 of a heart by sewing yarn 8.

The tension on the straps connected to the tissue is meant to translate the con centric motion of the VSD into an inward ‘give-way’ motion of the cantilever arms 7. This is thought to give little contractile effect to the device. In any case, it would prevent a paradoxical movement present with a flaccid patch.

The procedure for placing and fixing the occluder device 1 can have a significant shortening of time compared to normal operation time. This would naturally lead to a shortened cardiopulmonary bypass time. The use of the occluder device can make the surgery safe and acceptable to the surgical, referral, para-medical and/or patient/family community. Also, the time of recovery is significantly re duced.

The occluder device is deployable trans-ventricular on a beating heart. The ulti mate goal of curing patients born with a VSD would lay in regenerating a contrac tile muscular septum in place of the defect. While it is known that many of the structures taking shape and function during embryogenesis benefit from local sig naling of flows.

When the occluder device is used for neonates and young infants, which are sup posed to possess totipotent cells capable of cardiac regeneration in the early weeks and months of life, the occluder device can be grown together or over grown with said cells.

The occluder device can provide a complete closure of shunts in majority of pa tients, as well as no significant distortion of aortic and tricuspid valve morphology and function. It can especially used for realizing a beating heart VSD closure. During a cardiac cycle the blood-pressure varies with the contraction, ejection re laxation and filling of the heart. Since different parts of the heart are contracting and relaxing at different time of a cardiac cycle, contractions may be longitudinal and/or concentric in the region of the defect. Therefore, the current invention pro vides a solution with the disc-shaped supporting structure 2 with cantilever arms 7 having different designs to transform the kinetic energy which is applied during the cardiac cycle to the occluder device into movements that do not affect the sealing of the occluder device or the fixation of said device.

The single disc-shaped supporting structure 2 covered by the mantle or envelope 3 forms a disc-shaped segment 18 of the occluder device. The support structure 2 and the disc-shaped segment 18 are pressed against or abut against the inner side of the tissue 5 when the blood pressure is high. At the edge of the supporting structure 2, the mantle or envelope 3 or the outer circumferential element (6) may have a sealing lip 9. The sealing lip can be provided by two connected layers of the mantle or envelope 3, that are welded together thus forming a thicker layer compared to the layer which covers one side of the supporting structure 2. In the case of a cover instead of a mantle or envelope, where the cover covers the structure from one side only, the sealing lip 9 can also be formed from one single layer. This sealing lip is pressed against the inner side B of the tissue 5 of the or gan, such as the heart, either by the blood pressure or by the restoration force generated by the supporting structure 2.

When the blood pressure is low, the disc-shaped supporting structure 2 is held in place by the anchoring segments 4 connected to the opposite side of the tissue.

Fig. 3 and 4 disclose further embodiments for an inventive occluder device, hav ing to a certain extend the same advantages as the embodiment described in Fig.

1 and 2. Preferred Materials for the different elements of the occluder devices, un less described otherwise, can be considered to be the same as in the embodi ment of Fig. 1 and 2.

Fig. 3 show a second embodiment of a supporting structure 52 which can be ex changed with the supporting structure 2 of Fig. 1. The supporting structure 52 can have an outer circumferential element 56 provided with spring arms 57 extending from the outer circumferential element 56 towards a center axis to an inner ring 60 of the supporting structure 52.

The spring arm 57 is provided with interstitial space segments 58, such as slits, in the form of ring segments for the compression in longitudinal direction of the spring arm 56. The interstitial space segments 58 can be arranged in line in radial direction towards the center axis defined by the outer circumferential element 56. The lined-up interstitial space segments 58 decreases in size towards the center axis, whereas the slit width preferably remains constant.

Fig. 4 discloses a further variation of the supporting structure 62 as a part of an occluder device 61 , wherein the supporting structure 62 can be covered by a mantle or envelope, in the same way as the supporting structure 2 in Fig. 2. In Fig. 4 the anchoring segments 64 are formed as strings, being connected to the guiding element 63 at the end of spring arms 67. In the embodiment of Fig. 12, the supporting structure 66 is provided with three of said planar spring arms 67. The supporting structure 66 has a plane shape and the guiding element 63 are each provided with openings 70 where the string is inserted such that both open ends of the string are oriented in the same side of the supporting structure 66. At the end of the strings needles 65 or connection strings are shown, which can be separate parts or parts of said inventive occluder. Each spring arm 67 comprises at least one, preferably 2-8 arc-shaped spring segments 68 and connected by u- shaped segments 69. The arc-shaped spring segments 68 have preferably the same curvature as the outer circumferential element 66.

As explained before, the restoration force can be generated during a contraction or an expansion depending of the model of the occluder as shown in Fig. 1 -4.

List of references

1 occluder device

2 supporting structure

3 mantle, envelope or cover

4 anchoring segments

5 tissue

6 outer circumferential element

7 cantilever arms

8 yarn

9 sealing lip

10 guiding element

18 disc shaped segment

52 supporting structure

56 outer circumferential element

57 spring arms

58 interstitial space

60 inner ring

61 occluder

62 supporting structure

63 guiding element

64 anchoring element

65 needles

66 outer circumferential element

67 spring arm

68 arc-shaped spring segments

69 u-shaped spring segments

70 openings

B Inner side of the organ C outer side of the organ