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EP-3431022-B1 - LEFT ATRIL APPENDAGE CLOSURE AND DELIVERY SYSTEM THEREOF

EP3431022B1EP 3431022 B1EP3431022 B1EP 3431022B1EP-3431022-B1

Inventors

  • WANG, ZHEN
  • ZHOU, YI
  • YAO, YAO
  • LI, JUNFEI
  • LUO, QIYI
  • HUANG, HAIYONG

Dates

Publication Date
20260506
Application Date
20170316

Claims (15)

  1. A left atrial appendage (LAA) closure (1, 3, 4, 5), comprising a plurality of supporting struts (11, 31, 41) distributed peripherally around a first hub (10, 30, 40) and extending outwardly from the first hub (10, 30, 40), the supporting strut (11, 31, 41) bifurcating at a first position (110, 310, 410) into a left branch (111, 311, 411) and a right branch (112, 312, 412), the left branch (111, 311, 411) of a supporting strut and the right branch (112, 312, 412) of an adjacent supporting strut (11, 31, 41) joining each other at a second position (113, 313, 413) and extending distally to form a distal end, wherein the LAA closure (1, 3, 4, 5) further comprises a plurality of supporting rods (12, 32, 42) each disposed between adjacent supporting struts (11, 31, 41) and bifurcating at a third position (121), the plurality of supporting rods (12, 32, 42) distributed peripherally around the first hub (10, 30, 40) and extending outwardly from the first hub (10, 30, 40), characterized in that : a length of the supporting rod (12, 32, 42) from the first hub (10, 30, 40) to the third position (121) is smaller than a length of the supporting strut (11, 31, 41) from the first hub (10, 30, 40) to the first position (110, 310, 410).
  2. The LAA closure (1, 3, 4, 5) according to claim 1, wherein each of the supporting rods (12, 32, 42) has a first end (120, 320, 420) connected to the outside of the first hub (10, 30, 40), extending outwardly and bifurcating into a second end (122, 322, 422) and a third end (123, 323, 423) at the third position (121); and the second end (122, 322, 422) and the third end (123, 323, 423) are fixed on two adjacent supporting struts (11, 31, 41).
  3. The LAA closure (1, 3, 4, 5) according to claim 2, wherein some or all of the supporting struts (11, 31, 41) comprise a barb (13, 33, 43), and/or some or all of the left and right branches (111, 112) comprise a barb (13, 33, 43).
  4. The LAA closure (1, 3, 4, 5) according to claim 1, wherein the left and right branches (111, 112) of the same supporting strut are connected to each other at the distal ends thereof.
  5. The LAA closure (1, 3, 4, 5) according to claim 4, wherein each of the distal ends is bent toward the proximal end to form an anchor (14, 34, 44).
  6. The LAA closure (1, 3, 4, 5) according to claim 5, wherein a length from the point where the distal end starts bending to a final point (116) of the distal end is greater than a length from a junction of the distal ends to the final point (116).
  7. The LAA closure (1, 3, 4, 5) according to claim 1, wherein the distal ends extend inwardly to form a second hub.
  8. The LAA closure (1, 3, 4, 5) according to claim 1, wherein the distal ends protrude radially to form an anchor (14, 34, 44).
  9. A left atrial appendage (LAA) closure delivery system used for deploying the LAA, the delivery system comprising an LAA closure according to any one of claims 1 to 8, a first delivery member and a second delivery member inside the first delivery member, wherein the first delivery member is adapted to be engaged with or disengaged from the first hub (10, 30, 40) of the closure (1, 3, 4, 5),, the second delivery member is adapted to be engaged with or disengaged from a second hub of the LAA closure (1, 3, 4, 5).
  10. The LAA closure delivery system according to claim 9, wherein the first hub (10, 30, 40) is engaged with the second hub before the LAA closure (1, 3, 4, 5) is released from the system.
  11. The LAA closure delivery system according to claim 9, further comprising a stopper for fixing the first delivery member relative to the second delivery member; and preferably, the stopper comprises a clamping portion and an actuation portion, the clamping portion being configured to partially or wholly pass through slots in the first delivery member to clamp the second delivery member.
  12. The LAA closure delivery system according to claim 9, wherein the LAA closure (1, 3, 4, 5) comprises a first portion and a second portion, the first portion having a first end connected to the first hub (10, 30, 40) and a second end connected to a first end of the second portion, the second portion having a second end connected to the second hub.
  13. The LAA closure delivery system according to claim 12, wherein the second portion is located inside the first portion before the LAA closure (1, 3, 4, 5) is released from the system.
  14. The LAA closure delivery system according to claim 12, wherein the first portion and/or the second portion is/are provided with a plurality of anchors (14, 34, 44).
  15. The LAA closure delivery system according to claim 10, wherein the first hub (10, 30, 40) defines a step at a distal end thereof on which a proximal end of the second hub is located when the first hub (10, 30, 40) is engaged with the second hub; and/or the first hub (10, 30, 40) comprises a groove at a proximal end thereof which is configured to receive a distal end of the first delivery member.

Description

Technical Field The present invention relates to the field of medical devices and, in particular, to a left atrial appendage (LAA) closure and a system for the delivery thereof. Background Atrial fibrillation (AF) is the most common arrhythmia seen in clinical practice and has an estimated prevalence of 0.5-1.3% in the general population. Its most significant hazard is that it promotes the formation of blood clots which, when dislodged, tend to be associated with complications that may cause a significant increase in morbidity and mortality, such as stroke and occlusion of peripheral vessels. Stroke is the most common and harmful complication of AF, and there are about 15 million cases of stroke reported globally every year, in which 20% to 25% are attributed to AF. Studies show that 60% of rheumatic AF patients have their cardiogenic clots come from the left atrial appendage (LAA), and over 90% of non-valvular AF patients have their clots formed in the LAA. Therefore, preventing thromboembolism, in particular stroke, in patients with AF by LAA intervention is theoretically well-founded and of clinical significance. Anticoagulation is currently employed as a default approach for lowering the risk of stroke in AF patients, which, however, suffers from a number of limitations. It is thus of great significance to adopt more effective and safer approaches, such as the recently popular LAA closure that is achieved by medical intervention. Commonly used LAA closures are designed either as an insert plug, such as the Watchman device, or as a disc-like plug, such as the Amplatzer Cardiac Plug (ACP). 1. Deficiencies and Disadvantages of the Insert Plug Design A closure of the insert plug design consists of a self-expanding nickel titanium (nitinol) frame, fixation barbs around the perimeter and a polytetrafluoroethylene (PTEF) porous membrane that separates the atrium but allows the entry and exit of blood to and from the LAA. When inserted into the LAA, a closure of this design cannot completely seal off the LAA orifice due to an irregular shape of the LAA orifice and limited deformability of the closure itself, still leaving a channel for the formation of a clot in the LAA due to AF. In addition, the LAA is a multi-lobed structure varying in shape and depth among individuals, and the closure cannot adapt to all possible LAA anatomies. Further, it suffers from insufficient anchoring. 2. Deficiencies and Disadvantages of the Disk-Like Plug Design A closure of the disc-like plug design is a double-disk closure consisting of a lobe that anchors inside the LAA and a disk, the lobe and the disk being connected by a thinner waist. The lobe inside the LAA is configured to avoid dislocation of the device, and the disk is configured to seal off the LAA orifice. The lobe and the disk of this closure are integral with each other and neither of them can deform completely independently of the other. As a result, after the lobe is positioned inside the LAA and the disk is buckled at the LAA orifice, the disk may not satisfactorily seal the LAA orifice under traction from the lobe and may fail to achieve a desired occlusion effect. Moreover, the lobe and the disk are both limited in lengthwise adjustability, and hence difficult to achieve a favorable anchoring and blood flow blockage effect. Again, the disk of this design is also incapable of adapting to various possible LAA anatomies. Furthermore, the insert plug design and the disc-like plug design both suffer from insufficient strength. US 2007/0244518 A1 discloses a device for occluding an anatomical aperture such as an atrial septal defect or a patent foramen ovale. CN 204 147 142 U discloses a combined left auricle closure device which includes a disk face and an anchor. CN 102 895 008 A discloses a degradable medical occluder. US 2014/364941 A1 discloses devices, methods and systems for occluding an opening within the tissue of a body such as a left atrial appendage. CN 204 971 418 U discloses a left auricle closure device. CN 104 905 840 A discloses a left auricle plugger framework. US 2004/093017 A1 discloses a medical device made from a shape memory alloy. US 2011/082495 A1 discloses apparatus and methods for excluding and reducing the volume of the left atrial appendage. US 2012/316584 A1 discloses devices, methods and systems for occluding an opening within the tissue of a body such as a left atrial appendage. US 2015/196300 A1 discloses an occlusive implant system which may include a catheter and a medical implant. US 2008/262518 A1 discloses an implantable device for use in the human and/or animal body. US 2014/074151 discloses an implantable medical device having barbs that may reduce in height and change angle. In this regard, there is an urgent need in the art for a solution capable of better loading or deployment of an LAA closure. Summary of the Invention The invention is set out in the appended set of claims. Brief Description of The Drawings Fig. 1 is a persp