JP-7857150-B2 - Devices and methods for eliminating the left atrial appendage

Inventors

• デイヴィッド・エー・メランソン
• アンディ・エイチ・レヴァイン
• ジェームズ・エイチ・ローパー
• マイケル・ティー・ラドフォード
• キャロル・デヴェリアン
• アーロン・ヴィ・カプラン
• ロナルド・ビー・ランポート

Assignees

• コンフォーマル・メディカル・インコーポレイテッド

Dates

Publication Date

20260512

Application Date

20220506

Priority Date

20161027

Claims (14)

1. A LAA occlusion device configured to fit into the inlet of the left atrial appendage, comprising a compressible tubular foam wall, wherein the foam wall comprises a mesh-like crosslinking matrix having a porosity of at least 90 % , an average bubble size in the range of 250 μm to 500 μm, a wall thickness of at least 2 mm, and a compressive strength of at least 6.895 kPa . LAA occlusion device wherein the compressible tubular foam wall is substantially cylindrical when uncompressed, the compressible tubular foam wall is a side wall of the tubular foam body, and the tubular foam body has a closed proximal end .
2. The LAA occlusion device according to claim 1, wherein the compressive strength is in the range of 6.895 kPa to 13.790 kPa.
3. The LAA occlusion device according to claim 1, further comprising an expandable support configured to compress the compressible tubular foam wall and press it against the wall of the left atrial appendage.
4. The LAA occlusion device according to claim 3, wherein the expandable support is self-expandable.
5. The LAA occlusion device according to claim 1, wherein the porosity is in the range of 90 % to 95 %.
6. The LAA occlusion device according to claim 1, wherein the porosity is at least 9.5%.
7. The LAA occlusion device according to claim 1, wherein the wall thickness is at least 2.5 mm.
8. The LAA occlusion device according to claim 1, wherein the compressible tubular foam wall is provided with an antithrombotic coating.
9. The LAA occlusion device according to claim 1, wherein the compressible tubular foam wall comprises a plurality of interconnected meshes.
10. The LAA occlusion device according to claim 9, further comprising a PTFE coating on at least a portion of the interconnected mesh.
11. The LAA occlusion device according to claim 1, further comprising an anchor for fixing the LAA occlusion device to tissue.
12. The LAA occlusion device according to claim 1, wherein the tubular foam body portion is configured to fit the inlet portion of the left atrial appendage.
13. The LAA occlusion device according to claim 1 , wherein the closed proximal end comprises a foam end wall.
14. The LAA occlusion device according to claim 13 , wherein the foam end wall is provided with a cover.

Description

This achievement generally relates to systems, devices, and methods for eliminating the left atrial appendage (LAA). In particular, systems, devices, and methods for eliminating LAA using an expandable foam implant with a deployable and compliant frame are described herein. Atrial fibrillation (Afib) is a condition in which the normal beating of the left atrium (LA) is disordered and ineffective. The left atrial appendage (LAA) is a necrotic sac separate from the LA. In patients with Afib, blood flow stagnates within the LAA, promoting clot formation. These clots (or clot fragments) tend to either embolize the LAA or detach from the LAA and enter the systemic circulation. A stroke occurs when a clot/clot fragment embolizes and blocks one of the arteries that perfuse the brain. Anticoagulants, such as Coumadin, have been shown to significantly reduce the risk of stroke in Afib patients. While these drugs reduce clot formation, they also increase hemorrhagic complications, including hemorrhagic stroke, subdural hematoma, and gastrointestinal bleeding. There are approximately 8 million AFIB patients in the United States and the EU. Of these patients, about 4.6 million are at high risk of stroke and would benefit from anticoagulants. The majority of these patients are unable to take anticoagulants due to increased bleeding risk, and their stroke risk remains unresolved. The prevalence of AFIB increases with age. Existing devices for occluding the laryngeal aorta (LAA) have drawbacks. They are available in many sizes and must precisely conform to the highly variable anatomical structure of the LAA. This is difficult to achieve using fluoroscopy alone and often requires supplemental imaging in the form of transesophageal echocardiography (TEE), cardiac CT, and MRI, all of which require three-dimensional reconstruction. If the device is significantly too large, the LAA ostium can be stretched and torn, potentially resulting in bleeding into the pericardial cavity. If the device is too small, it may not properly seal the ostium and may be prone to embolization. Even with the correct size, the device often forces its rounded shape into the oval-shaped LAA ostium, resulting in poor sealing and subsequent leakage of residue from the edges. Existing devices require sufficient spring force or rigidity to seal and secure to surrounding tissue. If too rigid, these devices can become a source of blood leakage through tissue into the pericardial cavity, potentially causing cardiac tamponade. Furthermore, the geometric shape of these devices hinders repositioning after the implant has fully expanded. Existing devices also make delivery a cumbersome task by requiring positioning within the LAA to be coaxial with the LAA axis. Therefore, an improved LAA occlusion device is needed. U.S. Patent Application No. 14/203,187U.S. Provisional Application No. 62/240,124U.S. Patent Application No. 15/290,692U.S. Patent Application No. 14/203,187European Patent Application No. EP14779640.3PCT Patent Application No. PCT/US2014/022865U.S. Patent No. 7,803,395U.S. Patent No. 8,337,487 This diagram shows the anatomical structure of the left atrium (LA) and left atrial appendage (LAA).This figure shows an LAA with an embodiment of an LAA occlusion device, which uses an adhesive, implanted within the LAA.This figure shows an X-ray image of one embodiment of an LAA occlusion device.This figure shows one embodiment of a LAA occlusion device and an LAA in which a distal anchor is implanted within the LA.This figure shows one embodiment of a screw anchor that may be used with the various LAA occlusion devices described herein.This is a longitudinal cross-sectional view showing one embodiment of an LAA occlusion device.These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D.These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D.These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D.These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D.These are sequential schematic cross-sectional views showing one embo