A transcatheter closure device for secundum atrial septal defects (ASDS) in the absence of posterior inferior rim

Abstract

The invention relates to a transcatheter closure device for secundum atrial septal defects (ASDs) in the absence of posterior inferior rim. The transcatheter closure device (10) comprises fixation wires (12) connected to a left occluder disc (16) and / or a right occluder disc (20). In a first occluder form (A), it comprises a first ring fixator (14) provided at an end of the fixation wire (12) connected to the left occluder disc (16) and a second ring fixator (18) provided at an end of the fixation wire (12) connected to the right occluder disc (20). In a second occluder form (B), it comprises a posterior fixation lobe (24), an anterior fixation lobe (26), a lower fixation lobe (28) provided by coaxially connecting the fixation wires (12) to the left occluder disc (16) to provide a petal shape.

Description

[0001] A TRANSCATHETER CLOSURE DEVICE FOR SECUNDUM ATRIAL SEPTAL DEFECTS (ASDs) IN THE ABSENCE OF POSTERIOR INFERIOR RIM

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a transcatheter closure device for transcatheter closure of secundum atrial septal defects (ASDs) in the absence of posterior inferior rim and includes the fixation wires that are connected at least one occluder disc.

[0004] BACKGROUND OF THE INVENTION

[0005] Atrial septal defects (ASDs) represent a common congenital heart condition, with secundum ASDs being frequently encountered. Traditional surgical closure methods, though effective, involve invasive procedures and extended recovery times. Transcatheter closure emerged as a less invasive alternative, relying on devices anchored by disks on either side of the atrial septum. However, the efficacy of these devices depends on the presence of a sufficient IVC rim for stable anchoring.

[0006] Challenges arise when the IVC rim is absent, compromising the stability and effectiveness of conventional closure devices. Closure becomes difficult due to anchoring concerns, sealing issues, and the increased risk of device embolization. The limitations associated with IVC rim absence may render patients unsuitable for transcatheter closure, necessitating a return to more invasive surgical procedures.

[0007] Closing an ASD with a catheter-based device in the absence of an IVC rim poses significant challenges. The IVC rim, a crucial anchor for traditional devices, is lacking, making it difficult to maintain proper positioning and prevent migration. Achieving a complete seal of the septal defect becomes complex without a stable structure like the IVC rim, leading to potential residual shunting and inefficacious closure.

[0008] The risk of device embolization is heightened in the absence of a secure anchor, increasing the likelihood of serious adverse events. The overall stability of closure devices is compromised, impacting their ability to withstand the dynamic forces within the heart chambers. In the technical field, devices that provide transcatheter closure are known. Accordingly, the invention WO2023281525 relates to an atrial septal occluder device. The invention discloses an atrial septal occluder device for closing holes in the atrial septum between the left and right atria of the heart. The device has a central segment with four discs and is made of flexible metal fabric. It is manufactured in various sizes and is intended to be delivered percutaneously using a catheter. However, the invention does not include a pulmonary vein ring fixator and an inferior vena cava ring fixator for anchor.

[0009] THE OBJECTIVES OF THE INVENTION

[0010] The present invention relates to a transcatheter closure device to eliminate the above- mentioned disadvantages and bring new advantages to the related technical field.

[0011] The main objective of the present invention is to provide a transcatheter closure device for transcatheter closure of secundum atrial septal defects in the absence of a posterior inferior rim.

[0012] Another objective of the present invention is to provide a transcatheter closure device comprising nitinol mesh wires inserted into the atrial septum and complemented by polyester terephthalate (PET) fiber patches sewn to the discs, providing effective closure of secundum ASDs.

[0013] BRIEF DESCRIPTION OF THE INVENTION

[0014] In order to realize all of the abovementioned objectives and those which are to be obtained from the detailed description below, the present invention relates to a transcatheter closure device for secundum atrial septal defects (ASD) in the absence of a posterior inferior rim, comprising multiple fixation wires; a left occluder disc and a right occluder disc to which the fixation wires are connected. In this invention, the device comprises in a first occluder form configured to comprise a first ring fixator provided at the end of the fixation wire connected to the left occluder disc for insertion into the pulmonary vein, and a second ring fixator provided at the end of the fixation wire connected to the right occluder disc for insertion into the vena cava; in a second occluder form configured to comprise a posterior fixation lobe, an anterior fixation lobe, a lower fixation lobe provided by coaxially connecting the fixation wires to the left occluder disc to provide a petal shape. Thus, the transcatheter closure makes transcatheter closure of secundum atrial septal defects in the absence of a posterior inferior rim.

[0015] In a preferred embodiment of the invention, the fixation wires are nitinol mesh wires. Thus, a nitinol mesh wire structure is provided, which is inserted into the atrial septum.

[0016] In another preferred embodiment of the invention, the left occluder disc and the right occluder disc complement by polyester terephthalate (PET) fiber patches sew. Thus, complemented by polyester terephthalate (PET) fiber patches sewn into the device's discs, ensuring effective closure of secundum ASDs.

[0017] In another preferred embodiment of the invention, the first occluder form is a PV-IVC fixation type occluder. Thus, transcatheter closure with additional fixation of the PV-IVC anchored occluder is provided. The PV-IVC type is an occluder fixed between two anchors placed in the pulmonary vein and inferior vena cava.

[0018] In another preferred embodiment of the invention, the second occluder form is a parachutetype occluder. Thus, transcatheter closure is provided with additional fixation of the parachute occluder. The parachute type is provided by the petal shape and a folding wire in a loop-shaped

[0019] In another preferred embodiment of the invention, the first ring fixator and the second ring fixator are configured in the anchor forms. Thus, the risk of device embolization is reduced and the probability of adverse events is reduced.

[0020] In another preferred embodiment of the invention, the posterior fixation lobe, the anterior fixation lobe and the lower fixation lobe are connected through a hole in the left occluder disc. Thus, additional fixation of the parachute occluder is provided. Posterior fixation lobe here, located in the posterior part of the left atrium and provides additional fixation. Anterior fixation lobe here, located in the anterior part of the left atrium and provides additional fixation. And lower fixation lobe here, located in the lower part of the left atrium and provides additional fixation.

[0021] In another preferred embodiment of the invention, it comprises a connecting segment that coaxially connects mentioned left occluder disc and the right occluder disc. Thus, additional fixation is provided in which the discs are connected to each other. BRIEF DESCRIPTION OF THE FIGURES

[0022] Figure 1 shows, schematically from the side, the inventive first occluder form of the preferential transcatheter closure device.

[0023] Figure 2 shows, schematically from the front, the inventive first occluder form of the preferential transcatheter closure device.

[0024] Figure 3 shows, schematically from the back, the inventive first occluder form of the preferential transcatheter closure device.

[0025] Figure 4 shows, schematically from the side, the inventive second occluder form of the preferential transcatheter closure device.

[0026] Figure 5 shows, schematically from the front, the inventive second occluder form of the preferential transcatheter closure device.

[0027] Figure 6 shows, schematically from the back, the inventive second occluder form of the preferential transcatheter closure device.

[0028] Figure 7 shows, schematically from another the front, the inventive second occluder form of the preferential transcatheter closure device.

[0029] Figure 8 shows, schematically from another the back, the inventive second occluder form of the preferential transcatheter closure device.

[0030] THE DETAILED DESCRIPTION OF THE INVENTION

[0031] In this detailed description of the invention, a transcatheter closure device, is explained only with examples that will not have any limiting effect on a better understanding of the subject.

[0032] In Figure 1, Figure 2, Figure 3, Figure 4, Figure 5, Figure 6, Figure 7 and Figure 8 schematically representations of the transcatheter closure device that is the subject of the invention are given. A transcatheter closure device (10) for secundum atrial septal defects (ASD) in the absence of a posterior inferior rim comprises fixation wires (12). And in the mentioned transcatheter closure device (10), a left occluder disc (16) and a right occluder disc (20) optionally where a fixation wire (12) is connected to each. The inventive transcatheter closure device (10) comprises in a first occluder form (A) configured to comprise a first ring fixator (14) provided at the end of the fixation wire (12) connected to the left occluder disc (16) for insertion into the pulmonary vein, and a second ring fixator (18) provided at the end of the fixation wire (12) connected to the right occluder disc (20) for insertion into the vena cava. And furthermore, the inventive transcatheter closure device (10) comprises in a second occluder form (B) configured to comprise a posterior fixation lobe (24), an anterior fixation lobe (26), a lower fixation lobe (28) provided by coaxially connecting the fixation wires (12) to the left occluder disc (16) to provide a petal shape.

[0033] Furthermore, in the transcatheter closure device (10), the fixation wires (12) are nitinol mesh wires and the left occluder disc (16) and the right occluder disc (20) complement by polyester terephthalate (PET) fiber patches sew. In the present invention, the first occluder form (A) is a PV-IVC (Pulmonary Vein-Inferior Vena Cava) fixation type occluder and the second occluder form (B) is a parachute-type occluder. Furthermore, the first ring fixator (14) and the second ring fixator are configured in the anchor forms. In the transcatheter closure device (10), the posterior fixation lobe (24), the anterior fixation lobe (26) and the lower fixation lobe (28) are connected through a hole (30) in the left occluder disc (16). In a preferred embodiment, the device (10) comprises a connecting segment (22) that coaxially connects mentioned left occluder disc (16) and the right occluder disc (20).

[0034] Furthermore, PV-IVC occluder type is an occluder fixed between two anchors placed in pulmonary vein and inferior vena cava. In the first occluder form (A), the fixation of the PV- IVC anchored occluder contains following descriptions of additional:

[0035] 1. The first ring fixator (anchor) (14) placed in pulmonary vein.

[0036] 2. Fixation wire (12) between the ring fixator and the left occluder disc (16).

[0037] 3. Left occluder disc (16) closing the ASD from the LA (left atrium) side.

[0038] 4. Right occluder disc (20) closing the ASD from the RA (right atrium) side.

[0039] 5. The second ring fixator (anchor) (18) placed in vena cava.

[0040] In the second occluder form (B), the fixation of the parachute occluder contains following descriptions of additional:

[0041] 1. Posterior fixation lobe (24), located in the posterior part of the left atrium and provides additional fixation

[0042] 2. Anterior fixation lobe (26), located in the anterior part of the left atrium and provides additional fixation. Lower fixation lobe (28), located in the lower part of the left atrium and provides additional fixation. The right occluder disk (20) located in the right atrium and fixes in the interatrial septum. The left occluder disc (16) is designed to close the atrial septal defect.

[0043] REFERENCE NUMBERS

[0044] 10 Transcatheter closure device

[0045] 12 Fixation wire

[0046] 14 First ring fixator

[0047] 16 Left occluder disc

[0048] 18 Second ring fixator

[0049] 20 Right occluder disc

[0050] 22 Connecting segment

[0051] 24 Posterior fixation lobe

[0052] 26 Anterior fixation lobe

[0053] 28 Lower fixation lobe

[0054] 30 Hole

[0055] A First occluder form

[0056] B Second occluder form

Claims

CLAIMS1. A transcatheter closure device for secundum atrial septal defects (ASD) in the absence of posterior inferior rim, characterized in that, it comprises fixation wires (12), a left occluder disc (16) and a right occluder disc (20), in a first occluder form (A) configured to comprise a first ring fixator (14) provided at the end of the fixation wire (12) connected to the left occluder disc (16) for insertion into the pulmonary vein, and a second ring fixator (18) provided at the end of the fixation wire (12) connected to the right occluder disc (20) for insertion into the vena cava, in a second occluder form (B) configured to comprise a posterior fixation lobe (24), an anterior fixation lobe (26), a lower fixation lobe (28) provided by coaxially connecting the fixation wires (12) to the left occluder disc (16) to provide a petal shape.

2. A transcatheter closure device for secundum atrial septal defects (ASDs) in the absence of posterior inferior rim according to claim 1, characterized in that, the fixation wires (12) are nitinol mesh wires.

3. A transcatheter closure device for secundum atrial septal defects (ASDs) in the absence of posterior inferior rim according to claim 1, characterized in that, the left occluder disc (16) and the right occluder disc (20) complement by polyester terephthalate (PET) fiber patches sew.

4. A transcatheter closure device for secundum atrial septal defects (ASDs) in the absence of posterior inferior rim according to claim 1, characterized in that, the first occluder form (A) is a PV-IVC fixation type occluder.

5. A transcatheter closure device for secundum atrial septal defects (ASDs) in the absence of posterior inferior rim according to claim 1, characterized in that, the second occluder form (B) is a parachute-type occluder.

6. A transcatheter closure device for secundum atrial septal defects (ASDs) in the absence of posterior inferior rim according to claim 1-4, characterized in that, the first ring fixator (14) and the second ring fixator are configured in the anchor forms.

7. A transcatheter closure device for secundum atrial septal defects (ASDs) in the absence of posterior inferior rim according to claim 1-5, characterized in that, the posterior fixation lobe (24), the anterior fixation lobe (26) and the lower fixation lobe (28) are connected through a hole (30) in the left occluder disc.

8. A transcatheter closure device for secundum atrial septal defects (ASDs) in the absence of posterior inferior rim according to any one of the preceding claims, characterized in that, it comprises a connecting segment (22) that coaxially connects mentioned left occluder disc (16) and the right occluder disc (20).

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