INTERSEPTAL OCCLUDER DEVICE

Abstract

The present invention relates to an occluder device (1) comprising a supporting structure (2) adapted to anchor the septum (7) of a heart (103) when crossing a septum defect (107); said supporting structure (2) comprising a supporting structure periphery (5) delimiting a structure central opening (6); said occluder device (1) further comprising a membrane (8); said membrane (8) comprises a membrane body (11) having a membrane periphery (12); said membrane (8) has a closed position in which the membrane (8) is in a configuration which provides maximum occlusion to the structure central opening (6); the membrane periphery (12) is fastened to said supporting structure periphery (5) to cover the structure central opening (6); said membrane (8) comprising at least one slit (21); when actively engaged by an external device (108) the membrane (8) deforms the slit (21) which elastically extends, creating a passage lumen (27); in which said membrane (8) comprises at least one permanent passage lumen or shunt lumen (13) which remains open when the membrane (8) is in a closed position; said at least one shunt lumen (13) is smaller with respect to said passage lumen (27).

Claims

1.-84. (canceled)

85. An occluder device comprising: a supporting structure adapted to anchor a septum of a heart of a patient when crossing a septum defect; said supporting structure comprising a supporting structure periphery delimiting a structure central opening; said occluder device further comprising a membrane; said membrane comprises a membrane body having a membrane periphery; said membrane has a closed position in which the membrane is in a configuration which provides maximum occlusion to the structure central opening; the membrane periphery is fastened to said supporting structure periphery to cover the structure central opening; said membrane comprising at least one slit; when actively engaged by an external device the membrane deforms the at least one slit which elastically extends, creating a passage lumen; said membrane comprises at least one shunt lumen which remains open when the membrane is in a closed position; said at least one shunt lumen is smaller with respect to said passage lumen.

86. The occluder device of claim 85, wherein said supporting structure comprises a central supporting structure portion delimiting a lumen, wherein said supporting structure comprises a first anchoring portion and an opposite second anchoring portion, wherein said supporting structure is configured to expand and contract between a compressed tubular configuration for insertion through the patient's vasculature and an expanded configuration in which the first and second anchoring portions extend radially outwards from said central supporting structure portion to compress a septum therebetween by arranging said supporting structure astride said septum through a defect or hole or opening present in the septum.

87. The occluder device of claim 85, wherein said supporting structure is made of a less elastic material with respect to a material of said membrane.

88. The occluder device of claim 86, wherein said first and second anchoring portions comprise a plurality of supporting structure arms made of elastic material adapted to allow expanding and contracting between a compressed tubular configuration and an expanded or extended configuration for anchoring the plurality of supporting structure arms to opposite surfaces of the septum.

89. The occluder device of claim 85, wherein said supporting structure is in a separate piece or pieces with respect to said membrane.

90. The occluder device of claim 85, wherein said at least one slit extends from a first membrane periphery portion placed near the supporting structure to a second membrane periphery portion placed near the supporting structure.

91. The occluder device of claim 85, wherein said at least one slit extends from the membrane periphery placed near the supporting structure to near a center of the membrane.

92. The occluder device of claim 85, wherein said at least one slit is a notch.

93. The occluder device of claim 85, wherein said at least one slit are at least two slits.

94. The occluder device of claim 93, wherein said at least two slits extend parallel to each other.

95. The occluder device of claim 93, wherein said at least two slits delimit a membrane portion forming a bridge connecting two membrane periphery portions separated from each other.

96. The occluder device of claim 95, wherein said bridge comprises an elongated bridge body having opposite bridge connecting portions and opposite bridge edges coinciding with slit edges.

97. The occluder device of claim 96, wherein each of said slit edges delimits at least one slit present in said membrane.

98. The occluder device of claim 96, wherein both said opposite bridge connecting portions are directly or indirectly connected to said supporting structure.

99. The occluder device of claim 95, wherein when said membrane is in a relaxed condition, said membrane is flat in shape and the bridge is lying flat on said supporting structure.

100. The occluder device of claim 95, wherein said bridge is made of deformable elastic material configured so as to extend when an external device passes through the at least one slit.

101. The occluder device of claim 85, wherein the shunt lumen consists of said at least one slit; and said at least one slit comprises slit edges delimiting the shunt lumen, wherein the slit edges are separated creating an opening therebetween when the membrane is in a closed position.

102. The occluder device of claim 85, wherein said shunt lumen substantially maintains a dimension thereof during normal operation of the heart to maintain a defined blood flow when the occluder device is implanted across the septum defect.

103. The occluder device of claim 85, wherein a cross-sectional area of said shunt lumen is an unobstructed lumen.

104. The occluder device of claim 85, wherein said membrane defines an obstructed area of the structure central opening, said obstructed area is defined as the structure central opening minus a cross-sectional area of said shunt lumen.

Description

DRAWINGS

[0042] Further features and advantages of the invention will become apparent from the description provided below of preferred embodiments thereof, given by way of non-limiting examples, with reference to the accompanying drawings, in which:

[0043] FIG. 1 shows in an axonometric view a first embodiment of a membrane of an occlusion device according to the present invention;

[0044] FIG. 2 depicts the front view of the device of FIG. 1;

[0045] FIG. 3 shows the side view of the device of FIG. 1;

[0046] FIG. 4 depicts the cross-section of the device of FIG. 1;

[0047] FIG. 5 shows an axonometric view of a second embodiment of a membrane of a device of the invention;

[0048] FIGS. 6 to 13 show a front view of eight further embodiments of a membrane of an occlusion device according to the present invention;

[0049] FIG. 14 is an axonometric view of a still further embodiment of a membrane of an occlusion device according to the present invention;

[0050] FIG. 15 depicts the front view of the device of FIG. 14;

[0051] FIG. 16 shows the side view of the device of FIG. 14;

[0052] FIG. 17 depicts the cross-section of the device of FIG. 14;

[0053] FIG. 18 depicts the cross-section of a membrane of an occlusion device according to the present invention;

[0054] FIG. 19 depicts the cross-section of the device of FIG. 18, but in a plane transverse to that of the section of FIG. 18;

[0055] FIG. 20 shows a front view of a pair of membranes of an occlusion device according to the present invention;

[0056] FIG. 21 shows the membranes of the device of FIG. 20 in cross-section;

[0057] FIG. 22 shows an axonometric view of a membrane of an occlusion device according to a further embodiment of the present invention;

[0058] FIG. 23 shows a side view of the membrane of the device of FIG. 22;

[0059] FIG. 24 shows an axonometric view of an occlusion device according to an embodiment of the present invention;

[0060] FIG. 25 depicts in section and diagrammatically a heart in which defects or openings are present in the atrial and ventricular septa;

[0061] FIG. 26 diagrammatically shows in an axonometric view a step of the method of an external device crossing the membrane;

[0062] FIG. 27 depicts an axonometric view of a detail of a geometric coupling between two edges of a membrane slit connected with a geometric coupling;

[0063] FIG. 28 shows in an axonometric view an occlusion device according to a further embodiment of the present invention;

[0064] FIG. 29 shows in a front axonometric view an occlusion device according to a still further embodiment of the present invention;

[0065] FIG. 30 shows in a side axonometric view the occlusion device of FIG. 29.

DESCRIPTION OF SOME PREFERRED EMBODIMENTS

[0066] In accordance with a general embodiment, an occlusion device 1 comprises a supporting structure 2 adapted to be anchored to a septum 7 of a heart 103 when crossing a septum defect 107.

[0067] Said supporting structure 2 comprises a supporting structure periphery 5 delimiting a structure central opening 6.

[0068] Said occlusion device 1 further comprising a membrane 8.

[0069] Said membrane 8 comprises a membrane body 11 having a membrane periphery 12.

[0070] Said membrane 8 has a closed position in which the membrane 8 is in a configuration which provides maximum occlusion to the structure central opening 6.

[0071] The membrane periphery 12 is fastened to said supporting structure periphery 5 to cover the structure central opening 6.

[0072] Said membrane 8 comprising at least one slit 21.

[0073] When actively engaged by an external device 108 the membrane 8 deforms the slit 21 which elastically extends, creating a passage lumen 27.

[0074] Advantageously, said membrane 8 comprises at least one permanent passage lumen or shunt lumen 13 which remains open when the membrane 8 is in a closed position.

[0075] Said at least one shunt lumen 13 is smaller with respect to said passage lumen 27.

[0076] In accordance with an alternative embodiment, said at least one slit 21 extends from the membrane periphery 12 placed near the supporting structure 2.

[0077] In accordance with an alternative embodiment, said at least one slit 21 extends with both ends thereof from the membrane periphery 12 placed near the supporting structure 2.

[0078] In accordance with an alternative embodiment, said at least one slit 21 extends from a first membrane periphery portion 12 placed near the supporting structure 2 to a second membrane periphery portion 12 placed near the supporting structure 2.

[0079] In accordance with an alternative embodiment, said at least one slit 21 extends from the membrane periphery 12 placed near the supporting structure 2 up to near the center of the membrane 14.

[0080] In accordance with an alternative embodiment, said at least one slit 21 extends from the membrane periphery 12 near the supporting structure 2.

[0081] In accordance with an alternative embodiment, said at least one slit 21 extends from the membrane periphery 12 near the supporting structure 2 at least to the center of the membrane 14.

[0082] In accordance with an alternative embodiment, said at least one slit 21 is a notch.

[0083] In accordance with an alternative embodiment, said at least one slit 21 are at least two slits 21.

[0084] In accordance with an alternative embodiment, said at least one slit 21 are at least two slits 21 and said at least two slits 21 extend parallel to each other.

[0085] In accordance with an alternative embodiment, said at least one slit 21 are at least two slits 21, said at least two slits 21 delimit a membrane portion forming a bridge 15 connecting two peripheral membrane portions 16, 17 separated from each other.

[0086] In accordance with an alternative embodiment, said at least one slit 21 are cut edges or slotted edges 18 of the membrane 8.

[0087] In accordance with an alternative embodiment, said at least one slit 21 comprises slit edges 18; said slit edges 18 are shaped and coupled, requiring separation force for the separation thereof, to keep the membrane 8 in a closed position during the normal operation thereof.

[0088] In accordance with an alternative embodiment, said at least one slit 21 comprises slit edges 18; said slit edges 18 are geometrically coupled like a jigsaw piece or a dovetail joint 19.

[0089] In accordance with an alternative embodiment, the shunt lumen 13 consists of said at least one slit 21; and said at least one slit 21 comprises slit edges 18 delimiting the shunt lumen 13, in which the slit edges 18 are separated creating an opening therebetween when the membrane 8 is in a closed position.

[0090] In accordance with an alternative embodiment, the membrane 1, when actively engaged by an external device 108, elastically deforms to enlarge said at least one slit 21, obtaining said passage lumen 27.

[0091] In accordance with an alternative embodiment, said shunt lumen 13 substantially maintains the dimension thereof during the normal operation of the heart 103 to maintain a defined blood flow when the occlusion device 1 is implanted through the septum defect 7 107.

[0092] In accordance with an alternative embodiment, the cross-sectional area CSA of said shunt lumen 13 is an unobstructed lumen.

[0093] In accordance with an alternative embodiment, the cross-sectional area CSA of said shunt lumen 13 is between 12 mm {circumflex over ()}2 and 51 mm {circumflex over ()}2.

[0094] In accordance with an alternative embodiment, said membrane 8 defines an obstructed area of the structure central opening 6, said obstructed area is defined as the structure central opening 6 from which the cross-section area CSA of said shunt lumen 13 is subtracted.

[0095] In accordance with an alternative embodiment, said membrane body 11 comprises a body structure 20 which with the normal operation of the heart 103 remains in a closed position avoiding substantially modifying the width of the shunt lumen 13.

[0096] In accordance with an alternative embodiment, said membrane body 11 comprises a funnel shape.

[0097] In accordance with an alternative embodiment, said membrane body 11 comprises a funnel shape and said at least one shunt lumen 13 is positioned at the vertex 22 of said funnel-shaped membrane body 11.

[0098] In accordance with an alternative embodiment, said at least one slit 21 is a slit which crosses the entire membrane 8 from a portion 16 of the membrane periphery 12 to a different portion 17 of the membrane periphery 12.

[0099] In accordance with an alternative embodiment, said membrane 8 has a circular shape and said at least one slit 21 is a slit which crosses the entire membrane 8 along a membrane diameter.

[0100] In accordance with an alternative embodiment, the membrane body 11 has a membrane thickness 23.

[0101] In accordance with an alternative embodiment, said membrane thickness 23 increases going towards the center of the membrane 8.

[0102] In accordance with an alternative embodiment, said membrane 8 comprises a membrane periphery 12 having a cylindrical portion 24.

[0103] Said cylindrical portion 24 comprising membrane anchoring seats 32.

[0104] Said membrane anchoring seats 32 house clip portions 33 of said supporting structure 2 to connect the membrane 8 to said supporting structure 2.

[0105] In accordance with an alternative embodiment, said membrane 8 comprises a truncated cone membrane portion 25 having a truncated cone shape.

[0106] In accordance with an alternative embodiment, said membrane body 11 defines a membrane angle 26. Said membrane angle 26 is between 0, i.e., the membrane is parallel to the septum 7, 100 or perpendicular to the blood flow, and 45 with respect to the septum 7, 100.

[0107] In accordance with an alternative embodiment, said at least one shunt lumen 13 comprises shunt lumen edges 28. Said shunt lumen edges 28 are more rigid with respect to the remaining portions of the membrane body 11.

[0108] In accordance with an alternative embodiment, said at least one shunt lumen 13 comprises shunt lumen edges 28. Said shunt lumen edges 28 comprise a greater thickness than the remaining portions of the membrane body 11.

[0109] In accordance with an alternative embodiment, said at least one shunt lumen 13 comprises shunt lumen edges 28; said shunt lumen edges 28 are circular in shape.

[0110] In accordance with an alternative embodiment, said membrane body 11 comprises at least one rib 29.

[0111] In accordance with an alternative embodiment, said membrane body 11 comprises at least one rib 29; said at least one rib 29 is arranged next to said at least one shunt lumen 13.

[0112] In accordance with an alternative embodiment, said membrane body 11 comprises at least one rib 29; said at least one rib 29 is arranged radially.

[0113] In accordance with an alternative embodiment, said membrane body 11 comprises at least one rib 29; said at least one rib 29 is arranged circumferentially.

[0114] In accordance with an alternative embodiment, said membrane body 11 comprises additional strips 30 arranged in a radial direction added radially to the membrane.

[0115] In accordance with an alternative embodiment, said membrane 8 comprises magnets 31 embedded in the membrane.

[0116] In accordance with an alternative embodiment, said membrane 8 comprises magnets 31, said magnets 31 are embedded in the membrane body 11 to keep the membrane 8 in a closed position during normal operation.

[0117] In accordance with an alternative embodiment, said membrane 8 comprises magnets 31, said magnets are incorporated in the shunt lumen edges 28 of said shunt lumen 13 to keep the membrane 8 in a closed position during normal operation, leaving the shunt lumen 13 pervious.

[0118] In accordance with an alternative embodiment, said at least one shunt lumen 13 are at least two shunt lumens 13.

[0119] In accordance with an alternative embodiment, the at least one shunt lumen 13 are at least two shunt lumens 13 and said at least two shunt lumens 13 create at least two different openings through said membrane 8 of different size from each other.

[0120] In accordance with an alternative embodiment, said at least one slit 21 opens into said at least one shunt lumen 13.

[0121] In accordance with an alternative embodiment, said occluder device 1 comprises two membranes 8, in which said two membranes 8 are overlapped.

[0122] In accordance with an alternative embodiment, said occluder device 1 comprises two membranes 8, in which said two membranes 8 are overlapped and supported at the same supporting structure 2.

[0123] In accordance with an alternative embodiment, said occluder device 1 comprises two membranes 8, in which said two membranes 8 are overlapped and the at least one slit 21 of a first membrane 8 avoids completely overlapping the at least one slit 21 of the second membrane 8.

[0124] In accordance with an alternative embodiment, said occluder device 1 comprises two membranes 8, in which said two membranes 8 are overlapped and the at least one slit 21 of a first membrane 8 extends along a first slit path, and the at least one slit 21 of a second membrane 8 extends along a second slit path.

[0125] In accordance with an alternative embodiment, said first slit path crosses said second slit path.

[0126] In accordance with an alternative embodiment, said occluder device 1 comprises two membranes 8, in which said two membranes 8 are overlapped and the at least one slit 21 of a first membrane 8 extends along a first slit path, and the at least one slit 8 of a second membrane extends along a second slit path.

[0127] In accordance with an alternative embodiment, said first slit path crosses said second slit path in a region in which the first and second slit paths are orthogonal to each other when observing the membrane 8 from a transverse direction of said slit paths.

[0128] In accordance with an alternative embodiment, said occlusion device 1 is a structure the purpose of which is to occlude a lumen 4, 107 to reduce the flow through said lumen 4, 107.

[0129] In accordance with an alternative embodiment, said supporting structure 2 is a structure which provides the attachment to the anatomy of the heart 103, for example the tissue of a septum 7, 100, 104.

[0130] In accordance with an alternative embodiment, said supporting structure periphery 5 is the peripheral edge of the structure 2 between the structure central opening 6 and the tissue of the septum 4, 100, 104.

[0131] In accordance with an alternative embodiment, said structure central opening 6 is the central lumen of the supporting structure 2.

[0132] In accordance with an alternative embodiment, said membrane 8 is an elastically flexible occlusive sheet.

[0133] In accordance with an alternative embodiment, said membrane 8 is a flexible occlusive sheet with a thickness 23 which is much less than the height and width thereof.

[0134] In accordance with an alternative embodiment, said closed position is the passive configuration of the membrane 8 where said membrane 8 occludes the maximum cross-sectional area of which it is capable.

[0135] In accordance with an alternative embodiment, said membrane periphery 12 is the margin of the membrane 8 which separates the body of the membrane 11 from the supporting structure 2.

[0136] In accordance with an alternative embodiment, said slit 21 is an unsupported edge of the membrane 8.

[0137] In accordance with an alternative embodiment, said slit 21 is an unsupported edge of the membrane 8, or slit edge 18, said slit edge 18 is linear.

[0138] In accordance with an alternative embodiment, said slit 21 is an unsupported edge of the membrane 8, or slit edge 18, said slit edge 18 is curved.

[0139] In accordance with an alternative embodiment, said external device 108 is a medical device actively brought into apposition with the membrane 8, for example a catheter.

[0140] In accordance with an alternative embodiment, said passage lumen 27, is a lumen inside the structure central opening 6 which is smaller than said structure central opening 6 but large enough to allow the passage of an external device 108.

[0141] In accordance with an alternative embodiment, said shunt lumen 13 is a lumen inside the membrane 8 which remains pervious while the membrane 8 is in a closed, i.e., passive, position.

[0142] In accordance with an alternative embodiment, said shunt lumen 13 is a lumen inside the membrane 8 which facilitates the transfer of blood between the heart chambers 9, 10, 101, 2102, 105, 106.

[0143] The present invention further relates to a method for crossing an occluder device 1, comprising the following steps [0144] providing an occluder device 1 according to any one of claims 1 to 14; [0145] actively engaging an external device 108, for example a catheter, to the membrane 8; [0146] elastically deforming the at least one slit 21, elastically creating a passage lumen 27; [0147] crossing the occluding device 1 with said external device 108.

[0148] In accordance with a variant of the method, a further step is included of: [0149] retracting the external device (108) allowing the membrane (8) to close in the original condition thereof.

[0150] In accordance with an embodiment, said occluder device 1 comprises a membrane or diaphragm 8.

[0151] Said membrane 8 is a flexible elastic sheet extending over both the structure central opening 6 and over the supporting structure 2 as well.

[0152] In accordance with an embodiment, said membrane 8 extends beyond the supporting structure periphery 5, partially or totally covering at least one side of the supporting structure 2.

[0153] Said supporting structure 2 comprises a central supporting structure portion 3 delimiting a lumen (4).

[0154] Said supporting structure 2 comprises a first anchoring portion 45 and an opposite second anchoring portion (46).

[0155] Said supporting structure 2 is configured to expand and contract between a compressed tubular configuration for the insertion through the patient's vasculature and an expanded configuration in which the first and the second anchoring portions 45, 46 extend radially outward from said central supporting structure portion 3 to compress a septum 100, 104 therebetween by arranging said supporting structure (2) astride said septum 100, 104 through a defect or hole or opening present in the septum 100, 104.

[0156] In accordance with an embodiment, said first and second anchoring portions 45, 46 comprise a plurality of supporting structure arms 47 made of elastic material adapted to allow expanding and contracting between a compressed tubular configuration and an expanded or extended configuration for anchoring the arms to the opposite surfaces of the septum 7, 100, 104.

[0157] In accordance with an embodiment, said supporting structure 2 is made of a less elastic material with respect to the material of said membrane 8. For example, said supporting structure is made of metallic material. For example, said supporting structure is made of metallic superelastic material.

[0158] In accordance with an embodiment, said first and second anchoring portions 45, 46 comprise a plurality of supporting structure arms 47 made of elastic material adapted to allow expanding and contracting between a compressed tubular configuration and an expanded or extended configuration for anchoring the arms to the opposite surfaces of the septum 7, 100, 104.

[0159] In accordance with an embodiment, said supporting structure 2 is in a separate piece or pieces with respect to said membrane 8. In accordance with an embodiment, said membrane 8 is connected to said supporting structure 2, for example said membrane 8 is fastened with sutures or is glued or is welded to said supporting structure 2.

[0160] In accordance with an embodiment, said membrane 8 extends at least in part above one of said first and second anchoring portions 45, 46.

[0161] In accordance with an embodiment, said at least one slit 21 extends at least partially above at least one of said first and second anchoring portions 45, 46.

[0162] In accordance with an embodiment, said at least one slit 21 extends outside said structure central opening 6. This increases the maximum achievable length of the at least one slit 21, or in the case of at least two slits 21 of the bridge 15 present therebetween. By virtue of this embodiment, the stress which the material must undergo for a specific deformation is reduced. I.e., for a diameter of the external device 108, the longer the slit 21, the less stress the membrane 8 will undergo. Further, this embodiment reduces the force required to cross the slits 21 due to the lesser deformation of the membrane 8.

[0163] In accordance with an embodiment, the membrane 8 is attached to a surface of the supporting structure 2 which is much wider with respect to the central supporting structure portion 3. This increases the strength of the bond between the membrane 8 and the supporting structure 3.

[0164] The membrane 8 does not occlude the area delimited by the central supporting structure portion 3 when an external device 108 is pushed therethrough. This allows the external device 108 (e.g., a catheter) to be larger for a given central supporting structure portion 3, since the material of the membrane 8 is not limited during deformation by the central supporting structure portion 3.

[0165] In accordance with an embodiment, if the membrane 8 extends beyond the central supporting structure portion 3 it reduces the angles, edges or shapes which could act as sites for thrombus formation or the creation of turbulence in the blood flow.

[0166] In accordance with an embodiment, said membrane 8 comprises at least one bridge or occlusion bridge 15.

[0167] Said at least one bridge 15 comprises an elongated bridge body 50 having opposite bridge connecting portions 16, 17 and opposite bridge edges coinciding with slit edges 18.

[0168] Each of said slit edges 18 delimit at least one slit 21 present in said membrane 8.

[0169] Both of said opposite bridge connecting portions 16, 17 are connected directly or indirectly with said supporting structure 2.

[0170] In accordance with an embodiment, when said membrane 8 is in a relaxed condition, said membrane 8 is flat in shape and the at least one bridge 15 is lying flat on said supporting structure 2.

[0171] In accordance with an embodiment, when said membrane 8 is in a relaxed condition, said membrane 8 is flat in shape and the at least one bridge 15 is lying tensioned on said supporting structure 2.

[0172] In accordance with an embodiment, said at least one bridge 15 is made of deformable elastic material configured so as to extend when an external device 108 passes through the at least one slit 21.

[0173] In accordance with an embodiment, said membrane 8 comprises at least two bridges or occlusion bridges 15.

[0174] Said at least two bridges 15 each comprise an elongated bridge body 50 having opposite bridge connecting portions 16, 17 and opposite bridge edges coinciding with slit edges 18.

[0175] Each of said slit edges 18 delimit with the slit edge 18 of the adjacent bridge at least one slit 21 present in said membrane 8.

[0176] For each bridge 15, both of said opposite bridge connecting portions 16, 17 are directly or indirectly connected with said supporting structure 2.

[0177] In accordance with an embodiment, when said membrane 8 is in a relaxed condition, said membrane 8 is flat in shape and the at least two bridges 15 are lying flat on said supporting structure 2.

[0178] In accordance with an embodiment, when said membrane 8 is in a relaxed condition, said membrane 8 is flat in shape and the at least two bridges 15 are lying tensioned on said supporting structure 2.

[0179] In accordance with an embodiment, said at least two bridges 15 are made of deformable elastic material configured so as to extend when an external device 108 passes through the at least one slit 21.

LIST OF REFERENCES

[0180] 1 occluder device [0181] 2 supporting structure [0182] 3 central supporting structure portion [0183] 4 septum lumen [0184] 5 supporting structure periphery [0185] 6 structure central opening [0186] 7 septum [0187] 8 membrane or diaphragm [0188] 9 first compartment [0189] 10 second compartment [0190] 11 membrane body [0191] 12 membrane periphery [0192] 13 shunt lumen or permanent passage lumen [0193] 14 membrane center [0194] 15 bridge [0195] 16 bridge connecting membrane periphery portion [0196] 17 bridge connecting membrane periphery portion [0197] 18 slit edges [0198] 19 dovetail joint [0199] 20 membrane body structure [0200] 21 membrane slit or cut [0201] 22 membrane vertex [0202] 23 membrane thickness [0203] 24 cylindrical membrane portion [0204] 25 conical membrane portion [0205] 26 membrane angle [0206] 27 passage lumen created with the slit by the elastic extension of the membrane [0207] 28 shunt lumen edges [0208] 29 membrane body rib [0209] 30 membrane strip [0210] 31 membrane magnets [0211] 32 membrane anchoring seats [0212] 33 supporting structure clip portions [0213] 45 supporting structure first anchoring portion [0214] 46 supporting structure second anchoring structure [0215] 47 supporting structure arms [0216] 50 elongated bridge body [0217] 100 atrial septum [0218] 101 right atrium [0219] 102 left atrium [0220] 103 heart [0221] 104 ventricular septum [0222] 105 right ventricle [0223] 106 left ventricle [0224] 107 defect or opening [0225] 108 external device