A transcatheter occluder for high venosus atrial septal defects

Abstract

The present disclosure provides a transcatheter occluder device (1) for high venosum atrial septal defects (hv-asds). The device (1) comprises at least one connecting wire (2), a left occluder disk (3), and an asymmetrically designed right occluder disk (4). A first occluder form (A) includes a rear fixation lobe (5), an upper fixation lobe (6), and a lower fixation lobe (7), with the connecting wire (2) connected to the left occluder disk (3) and formed to provide a crown shape. A second occluder form (B) includes a first ring stabilizer (8) as a spiral ring and a second stabilizer (9) at the end of the connecting wire (2) for insertion into the superior vena cava and the inferior vena cava. The connecting wire (2) comprises a mesh wire. The device's (1) asymmetrical design allows secure anchoring to the inferior vena cava rim, addressing the unique challenges of high venosum atrial septal defects.

Description

[0001] A TRANSCATHETER OCCLUDER FOR HIGH VENOSUS ATRIAL SEPTAL DEFECTS

[0002] The present disclosure relates to a transcatheter occluder for atrial septal defects, and more particularly to a transcatheter occluder device and method for closing high venosus atrial septal defects using a novel anchoring system and asymmetrical disk design.

[0003] Atrial septal defects (ASDs) are congenital heart defects characterized by an opening in the wall between the two upper chambers of the heart. These defects allow oxygenated blood to flow from the left atrium to the right atrium, leading to increased blood flow to the lungs and potential complications if left untreated. Among the various types of ASDs, high venosus ASDs are relatively rare, accounting for approximately 5-10% of all ASD cases. High venosus ASDs present unique challenges in both diagnosis and treatment due to their anatomical location near the junction of the superior vena cava (SVC) and the right atrium. The absence of a supportive SVC rim in these defects complicates traditional transcatheter closure techniques, which often rely on the presence of adequate tissue margins for device anchoring. This anatomical feature frequently necessitates more invasive surgical interventions for effective closure.

[0004] Existing transcatheter closure devices, while effective for other types of ASDs, face significant limitations when applied to high venosus defects. The constant blood flow from the SVC into the right atrium can cause device dislodgement or improper seating, potentially leading to residual shunts or embolization. Additionally, the irregular shape and size variability of high venosus ASDs further complicate the selection and placement of appropriate closure devices.

[0005] The lack of specialized devices for high venosus ASDs often results in prolonged procedural times, increased risk of complications, and a higher likelihood of requiring open-heart surgery. This not only impacts patient outcomes but also places a greater burden on healthcare resources and extends recovery periods for affected individuals.

[0006] It has been appreciated that a transcatheter occluder specifically designed for high venosus atrial septal defects is needed that overcomes one or more of these problems. In the state of the art, United States patent document US10531867B2 relates to a sinus venosus atrial septal defect treatment device.

[0007] In the state of the art, International patent document WO2023281525A1 relates to an atrial septal occluder device.

[0008] In the state of the art another Chinese patent document CN115737013A relates to an edge atrial septal defect closure device.

[0009] In a first aspect, a transcatheter occluder device for high venosum atrial septal defects (hv- asds) is provided. The transcatheter occluder device comprises: at least one connecting wire and a left occluder disk or a right occluder disk to which said connecting wire is connected; and a first occluder form configured to include a rear fixation lobe, an upper fixation lobe, a lower fixation lobe, wherein the connecting wire is connected to the left occluder disk and is formed to provide a crown shape coaxially originating from a portion of said connecting wire extending therefrom; and a second occluder form configured to include a first ring stabilizer in the form of a spiral ring and a second stabilizer provided at the end of the connecting wires connected to the left occluder disk for insertion into the superior vena cava and the inferior vena cava.

[0010] This transcatheter occluder device provides a minimally invasive solution for closing high venosum atrial septal defects, addressing the unique anatomical challenges posed by the absence of a supportive superior vena cava rim. The device's design ensures secure placement and effective closure, potentially reducing procedural time and complications associated with traditional surgical interventions.

[0011] The transcatheter occluder device may further comprise a nitinol mesh wire of the connecting wire.

[0012] The use of nitinol mesh wire enhances the device's flexibility and shape memory properties, allowing for improved conformability to the patient's anatomy and facilitating easier deployment and positioning within the defect.

[0013] The transcatheter occluder device may further comprise the left occluder disk and the right occluder disk completed and sewn with Dacron patches. The incorporation of Dacron patches in the occluder disks promotes tissue ingrowth and enhances the long-term stability and effectiveness of the closure, reducing the risk of residual shunts.

[0014] The first occluder form may be a parachute type occluder.

[0015] The parachute type occluder design provides additional stability and anchoring within the left atrium, particularly beneficial for high venosum atrial septal defects where traditional anchoring methods may be challenging.

[0016] The second occluder form may be a PV-IVC fixation type occluder. The PV-IVC fixation type occluder allows for secure anchoring to both the pulmonary vein and inferior vena cava, addressing the unique anatomical considerations of high venosum atrial septal defects and ensuring optimal device placement and stability.

[0017] The left disc of the occluder is designed asymmetrically to close defects that are superiorly localized from the left atrial side. It is stabilized by an anchoring wire, which is positioned in the right upper pulmonary vein to secure the disc effectively. This anchoring wire provides enhanced stability and ensures the left disc remains optimally positioned.

[0018] The right disc of the occluder is also asymmetrically designed, with a wider portion at the inferior vena caval rim to provide support from the right atrial side of the septum. A second anchoring wire is attached to this disc, which further stabilizes the occluder from the right atrial side. Depending on the patient’s anatomical structure, the second anchoring wire can be positioned in either the superior vena cava or the inferior vena cava, offering additional flexibility and stability for the device.

[0019] In the first occluder form, the connecting wire may be connected to the left occluder disk through a hole. This connection method enhances the structural integrity of the device while allowing for optimal positioning and conformability of the left occluder disk within the left atrium. Furthermore, the transcatheter occluder device may comprise a coaxial connecting segment, which connects the left and right occluder disks. This coaxial connecting segment ensures proper alignment and coordination between the two components, facilitating effective closure of the defect from both sides of the atrial septum.

[0020] Brief Description of Figures

[0021] Figure 1- A perspective view of a transcatheter occluder device in first occluder form. Figure 2- A front view of a transcatheter occluder device in first occluder form.

[0022] Figure 3- Another view of a transcatheter occluder device in the form of a first occluder.

[0023] Figure 4- A top view of a transcatheter occluder device in first occluder form.

[0024] Figure 5- Multiple views of a transcatheter occluder device in second occluder form.

[0025] Figure 6- A perspective view of a transcatheter occluder device in second occluder form.

[0026] Figure 7- Perspective view of a transcatheter occluder device in the second occluder form in an alternative embodiment.

[0027] The reference numbers in the figures are as follows:

[0028] 1. Transcatheter occluder device

[0029] 2. Connecting wire

[0030] 3. Left occluder disk

[0031] 4. Right occluder disk

[0032] 5. Rear fixation lobe

[0033] 6. Upper fixation lobe

[0034] 7. Lower fixation lobe

[0035] 8. First ring stabilizer

[0036] 9. Second stabilizer

[0037] A. First occluder form

[0038] B. Second occluder form

[0039] The present disclosure provides a transcatheter occluder device (1) specifically designed for addressing high venosum atrial septal defects (hv-asds). The device (1) is characterized by several unique features that collectively contribute to its effectiveness in closing these specific types of defects.

[0040] One of the key components of the device (1) is a connecting wire (2), which may be made of a nitinol mesh wire. Nitinol, a nickel-titanium alloy, is known for its shape memory and super elastic properties, which can enhance the device's flexibility and adaptability to the patient's anatomy. The nitinol mesh wire can provide the necessary strength and flexibility for the connecting wire (2) to maintain its shape and position during and after the deployment of the device (1). This can be particularly beneficial in the context of high venosum atrial septal defects, where the device needs to adapt to the unique anatomical challenges posed by these types of defects.

[0041] The device (1) also includes a left occluder disk (3) and a right occluder disk (4). The right occluder disk (4) is designed asymmetrically, a feature that allows it to anchor securely to the inferior vena cava rim, a significant challenge in high venosus ASDs due to the absence of a supportive superior vena cava rim.

[0042] The device (1) incorporates a first occluder form (A) or a second occluder form (B). The first occluder form (A) is configured to include a rear fixation lobe (5), an upper fixation lobe (6), and a lower fixation lobe (7). The connecting wire(2) is connected to the left occluder disk (3) and is formed to provide a crown shape coaxially originating from a portion of the connecting wire (2) extending therefrom.

[0043] The second occluder form (B) is configured to include a first ring stabilizer (8) in the form of a spiral ring and a second stabilizer (9) provided at the end of the connecting wire (2) connected to the left occluder disk (3). These stabilizers (8,9) are designed for insertion into the superior vena cava and the inferior vena cava, respectively, providing secure anchoring and ensuring optimal device placement and stability.

[0044] In some embodiments, the left occluder disk (3) and the right occluder disk (4) may be completed and sewn with Dacron patches. The use of Dacron patches can promote tissue ingrowth and enhance the long-term stability and effectiveness of the closure, reducing the risk of residual shunts.

[0045] The device's (1) design and features collectively provide a minimally invasive solution for closing high venosum atrial septal defects, potentially reducing procedural time and complications associated with traditional surgical interventions.

[0046] In some aspects, the transcatheter occluder device (1) may be part of a system designed for closing a high venosum atrial septal defect. This system may also include a delivery catheter. The delivery catheter is configured to deploy the transcatheter occluder device at the site of the high venosum atrial septal defect. The delivery catheter may be designed to navigate through the patient's vasculature, allowing the transcatheter occluder device (1) to be precisely positioned at the defect site.

[0047] In some cases, the delivery catheter may include features that facilitate the deployment of the transcatheter occluder device (1). For instance, the delivery catheter may have a steerable tip, which can be manipulated to guide the transcatheter occluder device (1) to the desired location within the heart. This feature can enhance the precision of the device (1) placement, potentially improving the effectiveness of the defect closure.

[0048] In some embodiments, the system may further include an imaging system. The imaging system may provide real-time visualization of the transcatheter occluder device ( 1 ) during deployment. This can assist the operator in accurately positioning the device (1) and monitoring the deployment process. The imaging system may utilize various imaging modalities, such as fluoroscopy, echocardiography, or intracardiac echocardiography, depending on the specific requirements of the procedure and the patient's condition.

[0049] These features collectively contribute to the system's ability to provide a minimally invasive solution for closing high venosum atrial septal defects, potentially reducing procedural time, enhancing patient recovery, and reducing hospital stays.

[0050] The connecting wire (2) is connected to the left occluder disk (3) and the right occluder disk (4). The connecting wire (2) can provide a structural link between these two disks (3,4), helping to maintain their relative positions during the deployment and operation of the device. This can ensure that the occluder disks (3,4) are properly aligned with the atrial septal defect, thereby enhancing the effectiveness of the defect closure.

[0051] In some embodiments, the connecting wire (2) may be formed to provide a crown shape coaxially originating from a portion of the connecting wire (2) extending from the left occluder disk (3). This crown shape can provide additional support and stability to the device (1), helping to secure its position within the heart. This can be particularly beneficial in the context of high venosum atrial septal defects, where the device (1) needs to anchor securely in the absence of a supportive superior vena cava rim. In some cases, the right occluder disk (4) is located in the right atrium and may be designed to fix in the interatrial septum. This disk (4) may be positioned on the right atrium side of the defect and may be configured to provide additional support to the left occluder disk, thereby enhancing the stability of the device within the heart.

[0052] In some embodiments, the right occluder disk (4) is designed asymmetrically. This asymmetrical design may allow the right occluder disk (4) to anchor securely to the inferior vena cava rim. This can be particularly beneficial in the context of high venosus ASDs, where the absence of a supportive superior vena cava rim can pose challenges for the secure placement of the device. The asymmetrical design of the right occluder disk (4) can help overcome these challenges, thereby enhancing the effectiveness of the defect closure.

[0053] In some aspects, the left occluder disk (3) and the right occluder disk (4) may be completed and sewn with Dacron patches. Dacron, a type of polyester, is known for its durability and biocompatibility, making it suitable for use in medical devices. The Dacron patches can provide a surface that promotes tissue ingrowth, which can enhance the long-term stability and effectiveness of the closure. The use of Dacron patches can also reduce the risk of residual shunts, which are a common complication associated with atrial septal defect closures.

[0054] In some aspects, the first occluder form (A) of the transcatheter occluder device (1) may include a rear fixation lobe (5), an upper fixation lobe (6), and a lower fixation lobe (7). These lobes may be strategically positioned to provide additional fixation to the device (1) within the heart. For instance, the rear fixation lobe (5) may be located in the posterior part of the left atrium. This positioning can provide additional fixation, helping to secure the device within the heart and enhance the effectiveness of the defect closure.

[0055] In some aspects, the transcatheter occluder device (1) includes a second occluder form (B). This second occluder form (B) may be configured to include a first ring stabilizer (8) and a second stabilizer (9). The first ring stabilizer (8) may be in the form of a spiral ring, also known as a coil. This spiral ring can provide a secure anchoring point for the device within the superior vena cava. In some cases, the second stabilizer (9) may be provided at the end of the connecting wires (9) that are connected to the left occluder disk (3). This second stabilizer (9) can be designed for insertion into the inferior vena cava. The placement of the second stabilizer (9) in the inferior vena cava can provide an additional anchoring point for the device (1), further enhancing its stability within the heart.

[0056] The first occluder form (A) of the transcatheter occluder device (1) is designed as a parachute type occluder. This design can provide a unique configuration that is particularly beneficial for addressing high venosum ASDs.

[0057] In some cases, the parachute type occluder may include a binding thread for additional fixation. This binding thread may be connected to the lobes of the parachute type occluder and may be used to secure the device within the heart. The use of a binding thread can provide an additional level of security, helping to ensure that the device remains in place during and after the deployment process. This can be particularly beneficial in the context of high venosum atrial septal defects, where the device needs to anchor securely in the absence of a supportive superior vena cava rim. The binding thread can help overcome these challenges, thereby enhancing the effectiveness of the defect closure.

[0058] The second occluder form (B) of the transcatheter occluder device (1) is designed as a PV- IVC fixation type occluder. This design can provide a unique configuration that is particularly beneficial for addressing high venosum ASDs. The PV-IVC fixation type occluder includes a first ring stabilizer (8) and a second stabilizer (9). These stabilizers may be in the form of spiral rings, also known as coils, and may be provided at the end of the connecting wire (2) that are connected to the left occluder disk (3).

Claims

CLAIMS1. A transcatheter occluder device (1) for high venosum atrial septal defects (hv-asds), comprising:- at least one connecting wire (2);- a left occluder disk (3) and a right occluder disk (4), wherein the right occluder disk (4) is asymmetrically designed;- a first occluder form (A) configured to include a rear fixation lobe (5), an upper fixation lobe (6), and a lower fixation lobe (7), wherein the connecting wire (2) is connected to the left occluder disk (3) and is formed to provide a crown shape coaxially originating from a portion of said connecting wire (2) extending therefrom; or- a second occluder form (B) configured to include a first ring stabilizer (8) in the form of a spiral ring and a second stabilizer (9) provided at the end of the connecting wires (2) connected to the left occluder disk (3) for insertion into the superior vena cava and the inferior vena cava;- wherein the connecting wire (2) comprises a mesh wire,- wherein the first occluder form (A) is a parachute type occluder or wherein the second occluder form (B) is a PV-IVC fixation type occluder.

2. The transcatheter occluder device (1) of claim 1, wherein the left occluder disk (3) and the right occluder disk (4) are completed and sewn with Dacron patches.

3. The transcatheter occluder device (1) of claims 1 or 2, wherein in the first occluder form (A), the connecting wire (2) is connected to the left occluder disk (3) through a hole.

4. The transcatheter occluder device (1) of any preceding claim, wherein the second occluder form (B), further comprising a connecting segment which comprising anotherconnection wire (2) and another first ring stabilizer (8) coaxially connecting said left occluder disk (3) with said right occluder disk (4).

5. The transcatheter occluder device (1) of any preceding claim, wherein the first ring stabilizer (8) and the second stabilizer (9) are configured to provide anchoring in the superior vena cava and the inferior vena cava, respectively.

6. The transcatheter occluder device (1) of any preceding claim, wherein the connection wire (2) is made of Nitinol, a nickel-titanium alloy, which has shape memory and super elastic properties and can enhance the device's flexibility and adaptability to the patient's anatomy.

7. A system for closing a high venosum atrial septal defect, comprising:- the transcatheter occluder device (1) of any of claims 1-6 and- a delivery catheter configured to deploy the transcatheter occluder device (1) at the site of the high venosum atrial septal defect.

8. The system of claim 7, wherein the delivery catheter comprises a steerable tip configured to facilitate precise positioning of the transcatheter occluder device (1) within the high venosum atrial septal defect.

9. The system of any of claims 7 or 8, further comprising an imaging system configured to provide real-time visualization of the transcatheter occluder device ( 1 ) during deployment, wherein the imaging system is selected from the group consisting of fluoroscopy, echocardiography, and intracardiac echocardiography.

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