Left atrial appendage occlusion device

Abstract

An occlusion device (210) for occluding a left atrial appendage (LAA) includes a compliant balloon (230) defining a balloon chamber (232) that is fluid tight and an actuation shaft (234) disposed at least partially within the balloon chamber (232) for setting a distance between distal and proximal portions (236, 238) of the balloon (230). A proximal LAA-orifice cover (70) includes a frame (72) and a cover (74) secured to the frame (72). An orifice support stent (290) is secured to the proximal LAA-orifice cover (70) and extends distally therefrom, generally cylindrical when in a radially expanded state. Other embodiments are also described.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 906,393, filed September 26, 2019, which has been assigned to the assignee of this application and is incorporated herein by reference. Technical Field

[0003] The present invention generally relates to an occlusion device for occluding the left atrial appendage. Background Technology

[0004] The left atrial appendage (LAA) is a cavity located in the left atrium of the heart. In patients with atrial fibrillation, the passage and stagnation of blood within this cavity can lead to thrombosis, increasing the risk of stroke. Percutaneous LAA occlusion is a treatment for stroke prevention in patients with atrial fibrillation. LAA occlusion can be used as an alternative to or in combination with oral anticoagulation therapy. LAA occlusion has good clinical efficacy, but commercially available devices are often self-expanding and poorly designed to fit anatomy, sometimes leading to complications or suboptimal outcomes. In these contexts, some currently available occlusion devices are limited by poor adaptability to defects (lack of consistency) and by a lack of internal sealing (due to the high-flow environment).

[0005] PCT publication WO 2019 / 057950 to Maisano et al. describes an occlusion device for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue. The occlusion device includes a compliant capsule defining a fluid-tight capsule chamber and provided with a capsule channel forming a longitudinal passage from a proximal side to a distal side of the capsule; a tip element provided at the distal side of the capsule; a base element provided at the proximal side of the capsule; and a plurality of connection means including at least one connection strut attached to the tip element and to the base element, the tip element and the base element each having a guide opening substantially coaxial with the capsule channel so as to slidingly accommodate a guide wire for the device in the capsule channel; an elongated actuation means provided longitudinally slidable in the capsule channel and releasably connected to the tip element and longitudinally slidable with respect to the base element; locking means for maintaining a predetermined distance between the tip element and the base element; proximal connector means for releasably connecting the occlusion device to a corresponding distal connector means of a catheter device. The capsule includes a fluid port for filling and draining a fluid into and from the capsule chamber. An occlusion system includes an occlusion device and a catheter device cooperating therewith.

[0006] U.S. Patent 6,652,556 to Van Tassel et al. describes a device for permanently disposing across an orifice of a patient's left atrial appendage, which includes a filter membrane configured to extend across the orifice of the left atrial appendage. The filter membrane has a permeable structure that allows blood to flow therethrough but substantially prevents thrombus from passing therethrough. The device also includes a support structure that includes a plurality of fingers that are radially expandable outwardly relative to a longitudinal axis so as to permanently engage an inner wall of the left atrium. The filter membrane is connected to the support structure so as to extend across the orifice of the left atrial appendage. SUMMARY

[0007] Some embodiments of the present invention provide an occlusion device for mechanically occluding a left atrial appendage (LAA). The occlusion device includes a compliant capsule defining a fluid-tight capsule chamber; and an actuation shaft at least partially disposed in the capsule chamber, connected to a distal portion of the capsule, and longitudinally movable relative to a proximal portion of the capsule so as to set a distance between the distal and proximal portions of the capsule. The occlusion device also includes a valve that is closable after inflation of the capsule chamber.

[0008] The shape and compliance of the occlusion device, optionally including plastic deformation of its struts, enables anchoring of the occlusion device and sealing of the LAA while allowing to conform and adapt to the geometric properties of the LAA, thereby at least to some extent filling the space of the LAA regardless of the specific morphological type of the LAA.

[0009] Furthermore, a plurality of delivery systems are provided to enable cross-wire engagement with the LAA, to adjust the length and orientation of the occlusion device during deployment, and to inflate the balloon chamber using saline or other filling liquid.

[0010] The occlusion device described herein is designed to be delivered to the LAA in a longitudinally extended and fully or partially compressed state. Upon delivery, the occlusion device adapts to the landing zone anatomy by inflating the balloon chamber and shortening the longitudinal dimension of the struts disposed between the balloon proximal and distal portions. Under the influence of the internal pressure generated by inflation, the balloon chamber assumes a volume which, for a given longitudinal balloon dimension, results in a certain transverse or radial dimension, thereby providing a good seal between the balloon and the adjacent anatomy of the LAA. By selecting different distances between the balloon distal and proximal portions, the longitudinal dimension of the balloon is changed, resulting in a corresponding change of the radial or transverse extension of the balloon. In other words, for otherwise constant conditions, shortening the distance between the balloon distal and proximal portions results in a corresponding increase of the radial or transverse extension, thereby improving the seal with the adjacent tissue of the LAA and suppressing unwanted blood passage. The transverse extension of the balloon is not necessarily symmetrical, as the balloon is not necessarily symmetrical and / or the anatomy against which the balloon expands transversely can cause asymmetrical balloon expansion. Radial or transverse expansion collectively includes one or more directions within its scope which are generally perpendicular to the longitudinal axis of the balloon.

[0011] In the context of the present disclosure, the terms "distal" and "proximal" are used in the standard meaning as in the field of percutaneous cardiovascular devices. The term "proximal" refers to those components of the device assembly which, when following a delivery catheter during percutaneous delivery, are closer to the end of the catheter configured for user operation (e.g. the catheter handle operated by a physician). The term "distal" is used to refer to those components of the device assembly which are further away from the end of the catheter, configured for user operation and / or insertion further into the patient.

[0012] The term "compliant" as used herein in connection with a balloon or structural component implies a deformability which substantially follows an applied force. Thus, a "compliant balloon" refers to a balloon which gradually expands under the influence of an increasing radial pressure, as long as a certain burst pressure is not exceeded.

[0013] As used herein, the term "strut" refers to an elongated structural element which can be formed, for example, as a thin wire, a rod, or a thick-walled tube, all of which elements do not necessarily have a circular cross-section.

[0014] According to the inventive concept 1 of the present application, therefore, there is provided an occlusion device for occluding a left atrial appendage (LAA) for use with a delivery system, characterized in that the occlusion device comprises:

[0015] a compliant capsule defining a fluid-tight capsule chamber;

[0016] an actuation shaft (a) disposed at least partially within the capsule chamber, (b) connected to a distal portion of the capsule, and (c) longitudinally movable relative to a proximal portion of the capsule so as to set a distance between the distal and proximal portions of the capsule;

[0017] a proximal LAA orifice cover (a) configured to assume a radially compressed state and a radially expanded state, (b) comprising a frame and a cover fixed to the frame, and (c) generally orthogonal to the actuation shaft when in the radially expanded state and having a maximum dimension measured perpendicular to the actuation shaft of between 10 mm and 50 mm; and

[0018] an orifice support stent (a) fixed to the proximal LAA orifice cover and extending distally therefrom, (b) configured to assume a radially compressed state and a radially expanded state, and (c) generally cylindrical when in the radially expanded state.

[0019] Inventive Concept 2. The occlusion device of Inventive Concept 1, wherein the orifice support stent, when in the radially expanded state, has (i) a maximum dimension measured perpendicular to the actuation shaft of between 8 mm and 50 mm, and (ii) an axial length of between 4 mm and 30 mm.

[0020] Inventive Concept 3. The occlusion device of Inventive Concept 1, wherein the occlusion device further comprises a distal tip disposed at the distal portion of the capsule, wherein the actuation shaft is connected to the distal tip.

[0021] Inventive Concept 4. The occlusion device of Inventive Concept 1, wherein the actuation shaft is shaped to at least partially define a distal tip disposed at the distal portion of the capsule.

[0022] Inventive Concept 5. The occlusion device of Inventive Concept 1, further comprising a proximal base disposed at a proximal portion of the capsule, wherein the actuation shaft is movable relative to the proximal base.

[0023] Inventive Concept 6. The occlusion device of Inventive Concept 1, wherein the occlusion device is used with a guidewire, wherein the actuation shaft is shaped to define a guidewire lumen for slidably receiving the guidewire therein.

[0024] Inventive Concept 7. The occlusion device of Inventive Concept 1, wherein the compliant capsule comprises a compliant material selected from the group consisting of: polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethylmethacrylate, polyether ether ketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, and polyether blockamide (PEBA).

[0025] Inventive Concept 8. The occlusion device of any one of Inventive Concepts 1-7, wherein the orifice support stent is not fixed to the capsule, such that a shape of the capsule can be changed independently of a shape of the orifice support stent.

[0026] Inventive Concept 9. The occlusion device of any one of Inventive Concepts 1-7, wherein the occlusion device is configured such that inflation of the capsule chamber transitions the orifice support stent from its radially compressed state to its radially expanded state.

[0027] Inventive Concept 10. The occlusion device of any one of Inventive Concepts 1-7,

[0028] wherein the occlusion device further comprises a proximal tube that is axially fixed relative to the proximal portion of the capsule, and

[0029] wherein the proximal left atrial appendage orifice cover is fixed to the proximal tube, radially surrounds the proximal tube, and is indirectly connected to the capsule via the proximal tube, rather than being directly connected to the capsule.

[0030] Concept 11. The occlusion device of Concept 10, wherein the actuation shaft is slidably disposed within the proximal tube.

[0031] Concept 12. The occlusion device of any one of Concepts 1-7, wherein the occlusion device further comprises a plurality of connecting struts fixed to a distal portion of the capsule and a proximal portion of the capsule.

[0032] Concept 13. The occlusion device of Concept 12, wherein the occlusion device is configured such that inflation of the capsule chamber plastically deforms the plurality of connecting struts.

[0033] Concept 14. The occlusion device of Concept 12, wherein the occlusion device is configured such that foreshortening of the capsule plastically deforms the plurality of connecting struts.

[0034] Concept 15. The occlusion device of any one of Concepts 1-7, wherein the capsule has an average wall thickness of between 100 microns and 5000 microns.

[0035] Concept 16. The occlusion device of any one of Concepts 1-7, wherein the capsule has a thinnest wall thickness of between 20 microns and 500 microns at a thinnest portion of its wall.

[0036] Concept 17. An occlusion system comprising the occlusion device of any one of Concepts 1-7, the occlusion system further comprising an implantation catheter, wherein the occlusion device is releasably disposed in a radially compressed state, wherein a maximum distance between the proximal portion of the capsule and the distal portion of the capsule is between 8 mm and 80 mm.

[0037] Concept 18. The occlusion device of any one of Concepts 1-7, further comprising a valve.

[0038] Concept 19. The occlusion device of Concept 18,

[0039] wherein the occlusion device is shaped to define a fluid flow path, and

[0040] wherein the valve is configured to selectively allow or prevent fluid flow between the fluid flow path and the capsule chamber when the valve is in open and closed states, respectively.

[0041] Inventive Concept 20. An occlusion device according to Inventive Concept 19,

[0042] wherein said occlusion device is shaped to define said fluid flow path along a portion of said actuation shaft,

[0043] wherein said occlusion device further comprises a locking mechanism configured to assume a locked and an unlocked state, and when in said locked state, said locking mechanism is configured to maintain a distance setting between said distal portion of said capsule and said proximal portion of said capsule using said actuation shaft, and

[0044] wherein said occlusion device is configured to cause said distance to decrease by proximal longitudinal movement of said actuation shaft:

[0045] (a) to a first predetermined distance between said distal and proximal portions of said capsule, automatically transition said valve from said open state to said closed state, and

[0046] (b) to a second predetermined distance between said distal and proximal portions of said capsule, automatically transition said locking mechanism from said unlocked state to said locked state.

[0047] Inventive Concept 21. An occlusion device according to Inventive Concept 20, wherein said occlusion device is configured to be releasably connected to said delivery system, and wherein said occlusion device is configured to cause said fluid flow path to be in fluid communication with said delivery system when said occlusion device is releasably connected to said delivery system.

[0048] Inventive Concept 22. An occlusion device according to Inventive Concept 1, wherein said occlusion device further comprises a proximal connector configured to releasably connect said occlusion device to a correspondingly configured distal connector of said delivery system.

[0049] Inventive Concept 23. An occlusion device according to Inventive Concept 22, wherein said proximal connector is shaped to define a thread.

[0050] Inventive Concept 24. An occlusion system comprising an occlusion device according to any one of Inventive Concepts 22-23, said occlusion system for use with a guidewire, and further comprising said delivery system in cooperation therewith, said delivery system comprising an implant catheter connected to an operating handle, said implant catheter comprising a longitudinal channel for said guidewire, a distal connector for releasably connecting said implant catheter to a correspondingly configured proximal connector of said occlusion device, and an inflation tube channel releasably connected to said fluid flow path of said occlusion device.

[0051] According to inventive concept 25 of the present invention, there is also provided an occlusion device for occluding a left atrial appendage (LAA), the occlusion device for use with a delivery system, the occlusion device comprising:

[0052] a compliant capsule defining a fluid-tight capsule chamber;

[0053] an actuation shaft, the actuation shaft (a) being at least partially disposed in the capsule chamber, (b) being connected to a distal portion of the capsule, and (c) being longitudinally movable relative to a proximal portion of the capsule so as to set a distance between the distal and proximal portions of the capsule;

[0054] a locking mechanism, the locking mechanism being configured to assume a locked and an unlocked state, and when in the locked state, the locking mechanism being configured to maintain the distance set using the actuation shaft between the distal portion of the capsule and the proximal portion of the capsule; and

[0055] a valve,

[0056] wherein the occlusion device is shaped to define a fluid flow path along a portion of the actuation shaft,

[0057] wherein the valve is configured to selectively allow or prevent fluid flow between the fluid flow path and the capsule chamber when the valve is in open and closed states, respectively, and

[0058] wherein the occlusion device is configured such that proximal longitudinal movement of the actuation shaft to reduce the distance:

[0059] (a) to a first predetermined distance between the distal and proximal portions of the capsule automatically transitions the valve from the open state to the closed state, and

[0060] (b) to a second predetermined distance between the distal and proximal portions of the capsule automatically transitions the locking mechanism from the unlocked state to the locked state.

[0061] Inventive concept 26. The occlusion device according to inventive concept 25, wherein the first predetermined distance is not equal to the second predetermined distance.

[0062] Inventive concept 27. The occlusion device according to inventive concept 26, wherein the first predetermined distance is less than the second predetermined distance.

[0063] Inventive concept 28. The occlusion device according to inventive concept 25, wherein the first predetermined distance is equal to the second predetermined distance.

[0064] Inventive Concept 29. The occlusion device of Inventive Concept 25, wherein the occlusion device is configured to releasably connect to the delivery system, and wherein the occlusion device is configured to place the fluid flow path in fluid communication with the delivery system when the occlusion device is releasably connected to the delivery system.

[0065] Inventive Concept 30. The occlusion device of Inventive Concept 25, wherein the occlusion device further comprises a distal tip disposed at the distal portion of the capsule, wherein the actuation shaft is connected to the distal tip.

[0066] Inventive Concept 31. The occlusion device of Inventive Concept 25, wherein the actuation shaft is shaped to at least partially define a distal tip disposed at the distal portion of the capsule.

[0067] Inventive Concept 32. The occlusion device of Inventive Concept 25, further comprising a proximal base disposed at a proximal portion of the capsule, wherein the actuation shaft is movable relative to the proximal base.

[0068] Inventive Concept 33. The occlusion device of Inventive Concept 25, for use with a guidewire, wherein the actuation shaft is shaped to define a guidewire lumen for slidably receiving the guidewire therein.

[0069] Inventive Concept 34. The occlusion device of Inventive Concept 25, wherein the compliant capsule comprises a compliant material selected from the group consisting of: polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyether ether ketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide and polyether block amide (PEBA).

[0070] Inventive Concept 35. The occlusion device of any one of Inventive Concepts 25-34, wherein the occlusion device is shaped to define the fluid flow path alongside the portion of the actuation shaft.

[0071] Inventive Concept 36. The occlusion device of any one of Inventive Concepts 25-34, wherein the valve is disposed along the actuation shaft.

[0072] Inventive Concept 37. The occlusion device of any one of Inventive Concepts 25-34, further comprising a proximal tube axially fixed relative to the proximal portion of the capsule, wherein the actuation shaft is slidably disposed within the proximal tube.

[0073] Inventive Concept 38. The occlusion device of Inventive Concept 37, wherein the occlusion device is shaped to define the fluid flow path along the portion of the actuation shaft between an outer surface of the actuation shaft and an inner surface of the proximal tube.

[0074] Inventive Concept 39. The occlusion device of Inventive Concept 38, wherein the valve is disposed along the actuation shaft.

[0075] Inventive Concept 40. The occlusion device of Inventive Concept 39, wherein the valve includes a seal that surrounds at least a portion of the outer surface of the actuation shaft, and wherein the valve is configured to assume the open state when the seal is disposed in one or more first axial positions relative to the proximal tube, and to assume the closed state when the seal is disposed in one or more second axial positions relative to the proximal tube, the one or more second axial positions being proximal to the one or more first axial positions.

[0076] Inventive Concept 41. The occlusion device of Inventive Concept 40, wherein the seal, the actuation shaft, and the proximal tube are configured such that, at least when the seal is disposed in the one or more first axial positions relative to the proximal tube, the seal prevents fluid from exiting a distal end of the proximal tube.

[0077] Inventive Concept 42. The occlusion device of Inventive Concept 38, wherein a wall of the proximal tube is shaped to define one or more protrusions through the wall, wherein the one or more protrusions are angled to bend radially inward, and wherein, when the valve is in the open state, the fluid flow path is through respective proximal ends of the one or more protrusions and the wall between the proximal ends and non-protruding portions of the wall that are axially adjacent to the one or more protrusions.

[0078] Inventive Concept 43. The occlusion device of Inventive Concept 42, wherein the non-protruding portions of the wall are disposed proximal to the one or more protrusions.

[0079] Inventive Concept 44. The occlusion device of Inventive Concept 42, wherein the outer surface of the actuation shaft is shaped to define one or more protrusions around at least a portion of the actuation shaft, and wherein the proximal ends of the one or more protrusions are shaped to prevent distal movement of the one or more protrusions when the one or more protrusions are disposed proximal to the proximal ends, thereby causing the locking mechanism to assume the locked state.

[0080] Inventive Concept 45. The occlusive device of Inventive Concept 37, wherein the occlusive device further comprises a proximal left atrial orifice cover that (a) is fixed to the proximal tube, radially surrounds the proximal tube, (b) is configured to be in a radially compressed state and a radially expanded state, (c) comprises a frame and a cover fixed to the frame, (d) when in the radially expanded state, is generally orthogonal to the actuation axis and has a maximum dimension measured perpendicular to the actuation axis of between 10 mm and 50 mm, and (e) is indirectly connected to the capsule via the proximal tube without being directly connected to the capsule.

[0081] Inventive Concept 46. The occlusive device of Inventive Concept 45, wherein the occlusive device further comprises an orifice support stent that (a) is fixed to the proximal left atrial orifice cover and extends distally therefrom, (b) is configured to be in a radially compressed state and a radially expanded state, and (c) when in the radially expanded state, is generally cylindrical.

[0082] Inventive Concept 47. The occlusive device of Inventive Concept 46, wherein when in the radially expanded state, the orifice support stent has (i) a maximum dimension measured perpendicular to the actuation axis of between 8 mm and 50 mm, and (ii) an axial length of between 4 mm and 30 mm.

[0083] Inventive Concept 48. The occlusive device of any one of Inventive Concepts 25-34, wherein the occlusive device further comprises a plurality of connecting struts that are fixed to a distal portion of the capsule and a proximal portion of the capsule.

[0084] Inventive Concept 49. The occlusive device of Inventive Concept 48, wherein the occlusive device is configured such that inflation of the capsule chamber plastically deforms the plurality of connecting struts.

[0085] Inventive Concept 50. The occlusive device of Inventive Concept 48, wherein the occlusive device is configured such that foreshortening of the capsule plastically deforms the plurality of connecting struts.

[0086] Inventive Concept 51. The occlusive device of any one of Inventive Concepts 25-34, wherein the average wall thickness of the capsule is between 100 microns and 5000 microns.

[0087] Inventive Concept 52. The occlusive device of any one of Inventive Concepts 25-34, wherein the capsule has a thinnest wall thickness of between 20 microns and 500 microns at a thinnest portion of its wall.

[0088] Inventive Concept 53. An occlusion system comprising an occlusion device according to any one of Inventive Concepts 25-34, the occlusion system further comprising an implantation catheter, wherein the occlusion device is releasably disposed in a radially compressed state, wherein a maximum distance between the proximal portion of the capsule and the distal portion of the capsule is between 8 mm to 80 mm.

[0089] Inventive Concept 54. The occlusion device according to any one of Inventive Concepts 25-34, wherein the occlusion device further comprises a proximal connector configured to releasably connect the occlusion device to a correspondingly configured distal connector of the delivery system.

[0090] Inventive Concept 55. The occlusion device according to Inventive Concept 54, wherein the proximal connector is shaped to define a thread.

[0091] Inventive Concept 56. An occlusion system comprising an occlusion device according to any one of Inventive Concepts 25-34, the occlusion system for use with a guidewire, and further comprising the delivery system in cooperation therewith, the delivery system comprising an implantation catheter connected to an operating handle, the implantation catheter comprising a longitudinal channel for the guidewire; a distal connector for releasably connecting the implantation catheter to a correspondingly configured proximal connector of the occlusion device; and an inflation tube channel releasably connected to the fluid flow path of the occlusion device.

[0092] Inventive Concept 57. There is further provided, in accordance with the inventive concepts of the present application, an occlusion device for occluding a left atrial appendage (LAA), the occlusion device for use with a delivery system, the occlusion device comprising:

[0093] a compliant capsule defining a fluid-tight capsule chamber;

[0094] an actuation shaft, the actuation shaft (a) disposed at least partially within the capsule chamber, (b) connected to a distal portion of the capsule, and (c) longitudinally movable relative to a proximal portion of the capsule so as to dispose a distance between the distal and proximal portions of the capsule;

[0095] a plurality of connecting struts fixed to the distal portion of the capsule and to the proximal portion of the capsule, wherein the plurality of connecting struts comprises:

[0096] a plurality of first side portions disposed along a side surface of the capsule,

[0097] a plurality of second distal portions disposed on a distal surface of the capsule,

[0098] a plurality of third proximal portions disposed on a proximal surface of the capsule, and

[0099] a plurality of distal portions connecting the plurality of second distal portions of the struts to the distal portions of the capsule, respectively, and having a serpentine shape, wherein the occlusion device is configured such that the plurality of distal portions bend upon inflation of the capsule chamber.

[0100] Inventive Concept 58. The occlusion device of Inventive Concept 57, wherein the plurality of connecting struts includes a plurality of proximal portions connecting the plurality of third proximal portions of the struts to the proximal portions of the capsule, respectively, and having a serpentine shape, wherein the occlusion device is configured such that the plurality of proximal portions bend upon inflation of the capsule chamber.

[0101] Inventive Concept 59. The occlusion device of Inventive Concept 57, wherein the plurality of connecting struts includes a plurality of distal interface portions connecting the plurality of first side portions and the plurality of second distal portions, respectively, and having a serpentine shape, wherein the occlusion device is configured such that the plurality of distal interface portions bend upon inflation of the capsule chamber.

[0102] Inventive Concept 60. The occlusion device of Inventive Concept 57, wherein the plurality of connecting struts includes a plurality of proximal interface portions connecting the plurality of first side portions and the plurality of third proximal portions, respectively, and having a serpentine shape, wherein the occlusion device is configured such that the plurality of proximal interface portions bend upon inflation of the capsule chamber.

[0103] Inventive Concept 61. The occlusion device of Inventive Concept 57, wherein the plurality of first side portions of the plurality of struts are generally straight.

[0104] Inventive Concept 62. The occlusion device of Inventive Concept 57, wherein the plurality of second distal portions and the plurality of third proximal portions are generally straight.

[0105] Inventive Concept 63. The occlusion device of Inventive Concept 57, wherein the plurality of first side portions of the plurality of struts are generally straight, and the plurality of second distal portions and the plurality of third proximal portions are generally straight.

[0106] Inventive Concept 64. The occlusion device of Inventive Concept 57, wherein the occlusion device is configured such that inflation of the capsule chamber plastically deforms the plurality of connecting struts.

[0107] Inventive Concept 65. The occlusion device of Inventive Concept 57, wherein the occlusion device is configured such that shortening of the capsule plastically deforms the plurality of connecting struts.

[0108] Inventive Concept 66. The occlusion device of any of Inventive Concepts 57-65,

[0109] the plurality of distal interface portions are shaped to define a plurality of respective pairs of parallel serpentine struts defining a plurality of respective elongated gaps therebetween, and

[0110] wherein the plurality of struts are shaped to define a plurality of spikes that:

[0111] extend respectively from a plurality of outer ends of the plurality of second distal portions;

[0112] when the capsule is in an un-inflated elongated configuration, the capsule is disposed in the plurality of respective elongated gaps, generally in an axial orientation, and

[0113] configured to extend more radially when the capsule chamber is inflated to act as tissue engaging barbs.

[0114] Inventive Concept 67. The occlusion device of any of Inventive Concepts 57-65, wherein the plurality of connecting struts further comprise a plurality of closed cell struts cells connecting the first side portions of adjacent pairs.

[0115] Inventive Concept 68. The occlusion device of Inventive Concept 67, wherein two or more of the closed cell struts cells are connected in series to connect the first side portions of adjacent pairs.

[0116] Inventive Concept 69. The occlusion device of Inventive Concept 67, wherein the plurality of closed cell struts cells are shaped as respective diamonds.

[0117] Inventive Concept 70. The occlusion device of Inventive Concept 67, wherein the first side portions are oriented parallel to a central longitudinal axis of the occlusion device.

[0118] Inventive Concept 71. The occlusion device of Inventive Concept 67, wherein an average width of the plurality of struts of the first side portions is at least 200% of an average width of the plurality of struts of the closed cell struts cells.

[0119] Inventive Concept 72. There is also provided, in accordance with the inventive concepts of the present application, an occlusion device for occluding a left atrial appendage (LAA), for use with a delivery system, the occlusion device comprising:

[0120] a compliant capsule defining a fluid-tight capsule chamber;

[0121] an actuation shaft, the actuation shaft (a) disposed at least partially in the balloon chamber, (b) connected to a distal portion of the balloon, and (c) longitudinally movable relative to a proximal portion of the balloon so as to set a distance between the distal and proximal portions of the balloon;

[0122] a plurality of connecting struts fixed to a distal portion of the balloon and to a proximal portion of the balloon, wherein the plurality of connecting struts comprises:

[0123] a plurality of first side portions disposed along a side surface of the balloon,

[0124] a plurality of second distal portions disposed on a distal surface of the balloon,

[0125] a plurality of third proximal portions disposed on a proximal surface of the balloon, and

[0126] a plurality of distal portions connecting the plurality of second distal portions of the struts to the distal portion of the balloon, respectively, and having a serpentine shape, wherein the occlusion device is configured such that the plurality of distal portions bend upon inflation of the balloon chamber.

[0127] Inventive Concept 73. The occlusion device of Inventive Concept 72, wherein the plurality of connecting struts comprises a plurality of proximal portions connecting the plurality of third proximal portions of the struts to the proximal portion of the balloon, respectively, and having a serpentine shape, wherein the occlusion device is configured such that the plurality of proximal portions bend upon inflation of the balloon chamber.

[0128] Inventive Concept 74. The occlusion device of Inventive Concept 72, wherein the plurality of first side portions of the struts are generally straight.

[0129] Inventive Concept 75. The occlusion device of Inventive Concept 72, wherein the plurality of second distal portions and the plurality of third proximal portions are generally straight.

[0130] Inventive Concept 76. The occlusion device of Inventive Concept 72, wherein the plurality of first side portions of the struts are generally straight, the plurality of second distal portions and the plurality of third proximal portions are generally straight.

[0131] Inventive Concept 77. The occlusion device of Inventive Concept 72, wherein the occlusion device is configured such that inflation of the balloon chamber plastically deforms the plurality of connecting struts.

[0132] Inventive Concept 78. The occlusive device of Inventive Concept 72, wherein the occlusive device is configured such that shortening of the capsule causes the plurality of connecting struts to plastically deform.

[0133] Inventive Concept 79. The occlusive device of Inventive Concept 72, wherein the plurality of connecting struts includes a plurality of distal end portions connecting the plurality of second distal end portions of the struts to the distal end portion of the capsule, respectively, and having a serpentine shape, wherein the occlusive device is configured such that the plurality of distal end portions bend upon inflation of the capsule chamber.

[0134] Inventive Concept 80. The occlusive device of Inventive Concept 72, wherein the plurality of connecting struts includes a plurality of proximal end portions connecting the plurality of third proximal end portions of the plurality of struts to the proximal end portion of the capsule, respectively, and having a serpentine shape, wherein the occlusive device is configured such that the plurality of proximal end portions bend upon inflation of the capsule chamber.

[0135] Inventive Concept 81. The occlusive device of any of Inventive Concepts 72-80,

[0136] wherein the plurality of distal interface portions are shaped to define a plurality of respective pairs of parallel serpentine struts defining a plurality of respective elongated gaps therebetween, and

[0137] wherein the plurality of struts are shaped to define a plurality of spikes extending from a plurality of outer ends of the plurality of second distal portions, respectively.

[0138]

[0139] when the capsule is in an uninflated elongated configuration, the capsule is disposed in the plurality of respective elongated gaps, generally in an axial orientation, and

[0140] configured to extend more radially upon inflation of the capsule chamber to act as tissue engaging barbs.

[0141] Inventive Concept 82. The occlusive device of any of Inventive Concepts 72-80, wherein the plurality of connecting struts further includes a plurality of closed cell lattice cells connecting the first side portions of adjacent pairs.

[0142] Inventive Concept 83. The occlusive device of Inventive Concept 82, wherein two or more of the closed cell lattice cells are disposed in series connecting the first side portions of the adjacent pairs.

[0143] Inventive Concept 84. The occlusive device of Inventive Concept 82, wherein the plurality of closed cell lattice cells are shaped as respective diamonds.​

[0144] Inventive Concept 85. The occlusion device of Inventive Concept 82, wherein the first side portion is oriented parallel to a central longitudinal axis of the occlusion device.

[0145] Inventive Concept 86. The occlusion device of Inventive Concept 82, wherein an average width of the plurality of struts of the first side portion is at least 200% of an average width of the plurality of struts of the closed stent cell.

[0146] Inventive Concept 87, according to the present invention, there is additionally provided an occlusion device for occluding a left atrial appendage (LAA), the occlusion device for use with a delivery system, the occlusion device comprising:

[0147] a compliant capsule defining a fluid-tight capsule chamber;

[0148] an actuation shaft, the actuation shaft (a) disposed at least partially within the capsule chamber, (b) connected to a distal portion of the capsule, and (c) longitudinally movable relative to a proximal portion of the capsule so as to set a distance between the distal and proximal portions of the capsule;

[0149] a plurality of connecting struts fixed to the distal portion of the capsule and to the proximal portion of the capsule, wherein the plurality of connecting struts comprises:

[0150] a plurality of first side portions disposed along a lateral surface of the capsule, and

[0151] a plurality of closed stent cells connecting adjacent pairs of the first side portions.

[0152] Inventive Concept 88. The occlusion device of Inventive Concept 87, wherein two or more of the closed stent cells are disposed in series connecting the adjacent pairs of the first side portions.

[0153] Inventive Concept 89. The occlusion device of Inventive Concept 87, wherein the plurality of closed stent cells are shaped as respective diamonds.

[0154] Inventive Concept 90. The occlusion device of Inventive Concept 87, wherein the first side portions are oriented parallel to a central longitudinal axis of the occlusion device.

[0155] Inventive Concept 91. The occlusion device of Inventive Concept 87, wherein an average width of the plurality of struts of the first side portions is at least 200% of an average width of the plurality of struts of the closed stent cells.

[0156] According to the inventive concept 92, there is also provided a method for occluding a left atrial appendage (LAA) of a patient, the method comprising:

[0157] placing, using a delivery system,

[0158] a compliant balloon of an occlusion device in a left atrial appendage in its longitudinally extended form.

[0159] an actuation shaft of the occlusion device in the left atrial appendage, wherein the actuation shaft (a) is at least partially disposed in the balloon chamber, (b) is connected to a distal portion of the balloon, and (c) is longitudinally movable relative to a proximal portion of the balloon so as to set a distance between the distal and proximal portions of the balloon.

[0160] a proximal left atrial appendage orifice cover in the left atrial appendage outside the left atrium, abutting the atrial wall surrounding the left atrial appendage orifice, wherein the proximal left atrial appendage orifice cover (a) is configured in a radially compressed state and a radially expanded state, (b) comprises a frame and a cover fixed to the frame, and (c) when in the radially expanded state, is generally orthogonal to the actuation shaft and has a maximum dimension measured perpendicular to the actuation shaft of between 10 mm and 50 mm, and

[0161] an orifice support stent at least partially in the left atrial appendage, wherein the orifice support stent (a) is fixed to the proximal left atrial appendage orifice cover and extends distally therefrom, (b) is configured in a radially compressed state and a radially expanded state, and (c) when in the radially expanded state, is generally cylindrical;

[0162] inflating the compliant balloon by filling the balloon chamber with fluid along a fluid flow path of a portion of the actuation shaft;

[0163] inflating the balloon in a radial or lateral direction by shortening the distance between the distal and proximal portions of the balloon to a desired distance; and

[0164] releasing the occlusion device from the delivery system.

[0165] Inventive concept 93. The method according to inventive concept 92, wherein the orifice support stent is not fixed to the balloon, such that the shape of the balloon can be changed independently of the shape of the orifice support stent.

[0166] Inventive concept 94. The method according to inventive concept 92, wherein inflating the compliant balloon transitions the orifice support stent from its radially compressed state to its radially expanded state.

[0167] There is also provided, in accordance with the inventive concept 95 of the present application, a method for occluding a left atrial appendage (LAA) of a patient, the method comprising:

[0168] placing a compliant balloon of an occlusion device in its longitudinally extended form in the left atrial appendage using a delivery system;

[0169] inflating the compliant balloon by filling a fluid into a fluid-tight balloon chamber defined by the balloon through a fluid flow path along a portion of an actuation shaft of the occlusion device, while a valve of the occlusion device is in an open state, wherein the valve allows fluid flow between the fluid flow path and the balloon chamber, wherein the actuation shaft (a) is at least partially disposed in the balloon chamber, (b) is connected to a distal portion of the balloon, and (c) is longitudinally movable relative to a proximal portion of the balloon so as to set a distance between the distal and proximal portions of the balloon;

[0170] radially or laterally expanding the balloon by proximally longitudinally moving the actuation shaft to shorten the distance between the distal and proximal portions of the balloon to a desired distance:

[0171] (a) to a first predetermined distance between the distal and proximal portions of the balloon, which automatically transitions the valve from the open state to a closed state, wherein the valve prevents fluid flow between the fluid flow path and the balloon chamber, and

[0172] (b) to a second predetermined distance between the distal and proximal portions of the balloon, which automatically transitions a locking mechanism from an unlocked state to a locked state, wherein the locking mechanism maintains the distance setting of the actuation shaft between the distal portion of the balloon and the proximal portion of the balloon; and

[0173] releasing the occlusion device from the delivery system.

[0174] Inventive Concept 96. The method of inventive concept 95, wherein placing the balloon in the left atrial appendage (LAA) comprises:

[0175] forwardly moving a guidewire into the patient using the delivery system; and

[0176] forwardly advancing the occlusion device over the guidewire.

[0177] Inventive Concept 97. The method of inventive concept 95, wherein the first predetermined distance is not equal to the second predetermined distance.

[0178] Inventive Concept 98. The method of Inventive Concept 97, wherein the first predetermined distance is less than the second predetermined distance.

[0179] Inventive Concept 99. The method of Inventive Concept 95, wherein the first predetermined distance is equal to the second predetermined distance.

[0180] Inventive Concept 100. The method of Inventive Concept 95, wherein the occlusion device is shaped to define the fluid flow path alongside the portion of the actuation shaft.

[0181] Inventive Concept 101. The method of Inventive Concept 95, wherein the valve is disposed along the actuation shaft.

[0182] Inventive Concept 102. The method of Inventive Concept 95, wherein the occlusion device further comprises a proximal tube axially fixed relative to the proximal portion of the capsule, wherein the actuation shaft is slidably disposed within the proximal tube.

[0183] Inventive Concept 103. The method of Inventive Concept 102, wherein the occlusion device is shaped to define the fluid flow path alongside the portion of the actuation shaft, radially between an outer surface of the actuation shaft and an inner surface of the proximal tube.

[0184] Inventive Concept 104. The method of Inventive Concept 103, wherein the valve is disposed along the actuation shaft.

[0185] Inventive Concept 105. The method of Inventive Concept 104, wherein the valve comprises a seal around at least a portion of the outer surface of the actuation shaft, and wherein the valve is configured to assume the open state when the seal is disposed in one or more first axial positions relative to the proximal tube, and to assume the closed state when the seal is disposed in one or more second axial positions relative to the proximal tube, the one or more second axial positions being proximal to the one or more first axial positions.

[0186] Inventive Concept 106. The method of Inventive Concept 105, wherein the seal, the actuation shaft, and the proximal tube are configured such that, at least when the seal is disposed in the one or more first axial positions relative to the proximal tube, the seal prevents fluid from exiting a distal end of the proximal tube.

[0187] Invention Concept 107. The method of Invention Concept 103, wherein a wall of the proximal tube is shaped to define one or more protrusions through the wall, wherein the one or more protrusions are biased to bend radially inward, and wherein, when the valve is in the open state, the fluid flow path is through respective proximal ends of the one or more protrusions and the wall between the one or more protrusions and a non-protruding portion of the wall axially adjacent the one or more protrusions.

[0188] Invention Concept 108. The method of Invention Concept 107, wherein the non- protruding portion of the wall is disposed proximally of the one or more protrusions.

[0189] Invention Concept 109. The method of Invention Concept 107, wherein the outer surface of the actuation shaft is shaped to define one or more protrusions around at least a portion of the actuation shaft, and wherein the proximal ends of the one or more protrusions are shaped to prevent distal movement of the one or more protrusions when the one or more protrusions are disposed proximally of the proximal ends of the one or more protrusions, thereby causing the locking mechanism to assume the locked state.

[0190] Invention Concept 110. The method of Invention Concept 102, wherein the occlusion device further comprises a proximal LAA orifice cover that (a) is fixed to the proximal tube, radially surrounds the proximal tube, (b) is configured to assume a radially compressed state and a radially expanded state, (c) includes a frame and a cover fixed to the frame, (d) when in the radially expanded state, is generally orthogonal to the actuation shaft and has a maximum dimension measured perpendicular to the actuation shaft of between 10 mm and 50 mm, and (e) is indirectly connected to the capsule through the proximal tube without being directly connected to the capsule.

[0191] Invention Concept 111. The method of Invention Concept 110, wherein the occlusion device further comprises an orifice support stent that (a) is fixed to the proximal LAA orifice cover and extends distally therefrom, (b) is configured to assume a radially compressed state and a radially expanded state, and (c) when in the radially expanded state, is generally cylindrical.

[0192] Invention Concept 112. The method of Invention Concept 111, wherein, when in the radially expanded state, the orifice support stent has (i) a maximum dimension measured perpendicular to the actuation shaft of between 8 mm and 50 mm, and (ii) an axial length of between 4 mm and 30 mm.

[0193] Inventive Concept 113. The method of Inventive Concept 95, wherein the occlusion device further comprises a plurality of connecting struts secured to a distal portion of the capsule and a proximal portion of the capsule.

[0194] Inventive Concept 114. The method of Inventive Concept 113, wherein the occlusion device is configured such that inflation of the capsule chamber plastically deforms the plurality of connecting struts.

[0195] Inventive Concept 115. The method of Inventive Concept 113, wherein the occlusion device is configured such that foreshortening of the capsule plastically deforms the plurality of connecting struts.

[0196] Inventive Concept 116. There is also provided, in accordance with the inventive concepts of the present application, a device for occluding a left atrial appendage (LAA), the device comprising:

[0197] (i) an occlusion device, the occlusion device comprising:

[0198] a compliant capsule defining a fluid-tight capsule chamber;

[0199] an actuation shaft, the actuation shaft (a) disposed at least partially within the capsule chamber, (b) connected to a distal portion of the capsule, and (c) longitudinally movable relative to a proximal portion of the capsule so as to set a distance between the distal and proximal portions of the capsule; and

[0200] a valve comprising an elastomeric sleeve surrounding a portion of the actuation shaft,

[0201] wherein the occlusion device is shaped so as to define a fluid flow path having one or more fluid flow path openings leading to the capsule chamber, and

[0202] wherein the elastomeric sleeve is configured to have a resting state in which the sleeve covers and seals the one or more fluid flow path openings, such that the valve is in a closed state; and

[0203] (ii) a delivery system configured to releasably connect to the occlusion device, and comprising a valve-opening prop configured to:

[0204] (a) when in a prop position, prop open and deform the elastomeric sleeve so that the elastomeric sleeve does not seal the one or more fluid flow path openings, and the valve is in an open state, and

[0205] (b) when in the non-supporting position, does not support open the elastomeric sleeve such that the elastomeric sleeve assumes a resting state and the valve is in a closed state.

[0206] Concept 117. The device of Concept 116, wherein the valve opening support includes one or more tabs extending radially outward from an axis of the elastomeric sleeve so as to support open the elastomeric sleeve.

[0207] Concept 118. The device of Concept 116, wherein the valve opening support is configured such that axial sliding of the valve opening support relative to the elastomeric sleeve transitions the valve opening support from the supporting position to the non-supporting position.

[0208] Concept 119. The device of Concept 116, wherein the occlusion device further comprises a locking mechanism configured to assume a locked state and an unlocked state, and when in the locked state, the locking mechanism is configured to maintain a distance setting between the distal end portion of the balloon body and the proximal end portion of the balloon body using the actuation shaft.

[0209] Concept 120. The device of Concept 116, wherein the occlusion device is configured to releasably connect to the delivery system, and wherein the occlusion device is configured such that the fluid flow path is in fluid communication with the delivery system when the occlusion device is releasably connected to the delivery system.

[0210] Concept 121. The device of Concept 116, wherein the occlusion device further comprises a distal tip disposed at the distal end portion of the balloon body, wherein the actuation shaft is connected to the distal tip.

[0211] Concept 122. The device of Concept 116, wherein the actuation shaft is shaped to at least partially define a distal tip disposed at the distal end portion of the balloon body.

[0212] Concept 123. The device of Concept 116, wherein the occlusion device further comprises a proximal base disposed at a proximal end portion of the balloon body, wherein the actuation shaft is movable relative to the proximal base.

[0213] Concept 124. The device of Concept 116, wherein the occlusion device is used with a guidewire, wherein the actuation shaft is shaped to define a guidewire lumen for slidably receiving the guidewire therein.

[0214] Inventive Concept 125. The device of Inventive Concept 116, wherein the compliant bladder comprises a compliant material selected from the group consisting of: polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyether ether ketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide and polyether block amide (PEBA).

[0215] Inventive Concept 126. The device of any of Inventive Concepts 116-125, wherein the occlusion device further comprises a proximal tube axially fixed relative to the proximal end portion of the bladder.

[0216] Inventive Concept 127. The device of Inventive Concept 126, wherein the actuation shaft is slidably disposed within the proximal tube.

[0217] Inventive Concept 128. The device of Inventive Concept 118, wherein the valve opening support comprises a tubular portion at least partially disposed within the proximal tube.

[0218] Inventive Concept 129. The device of Inventive Concept 128, wherein the valve opening support comprises one or more projections that (a) extend axially away from the tubular portion and (b) extend radially outward from the proximal tube to support the elastomeric sleeve in an open position.

[0219] Inventive Concept 130. The device of Inventive Concept 129, wherein the one or more projections pass through at least a portion of the one or more fluid flow path openings when the valve opening support is in the support position.

[0220] Inventive Concept 131. The device of Inventive Concept 129, wherein the proximal tube is shaped to define one or more entry openings through a wall of the proximal tube, and wherein the one or more projections pass through the one or more entry openings at least when the valve opening support is in the support position.

[0221] Inventive Concept 132. The device of Inventive Concept 126, wherein the occlusion device further comprises a proximal LAA-orifice cover that (a) is fixed to the proximal tube, radially surrounds the proximal tube, (b) is configured to assume a radially compressed state and a radially expanded state, (c) comprises a frame and a cover fixed to the frame, (d) when in the radially expanded state, is generally orthogonal to the actuation axis and has a maximum dimension measured perpendicular to the actuation axis of between 10 mm and 50 mm, and (e) is indirectly connected to the capsule via the proximal tube, rather than directly connected to the capsule.

[0222] Inventive Concept 133. The device of Inventive Concept 132, wherein the occlusion device further comprises an orifice support stent that (a) is fixed to the proximal LAA-orifice cover and extends distally therefrom, (b) is configured to assume a radially compressed state and a radially expanded state, and (c) when in the radially expanded state, is generally cylindrical.

[0223] Inventive Concept 134. The device of Inventive Concept 133, wherein when in the radially expanded state, the orifice support stent has (i) a maximum dimension measured perpendicular to the actuation axis of between 8 mm and 50 mm, and (ii) an axial length of between 4 mm and 30 mm.

[0224] Inventive Concept 135. The device of any of Inventive Concepts 116-125, wherein the occlusion device further comprises a plurality of connecting struts that are fixed to a distal portion of the capsule and a proximal portion of the capsule.

[0225] Inventive Concept 136. The device of Inventive Concept 135, wherein the occlusion device is configured such that inflation of the capsule chamber plastically deforms the plurality of connecting struts.

[0226] Inventive Concept 137. The device of Inventive Concept 135, wherein the occlusion device is configured such that foreshortening of the capsule plastically deforms the plurality of connecting struts.

[0227] Inventive Concept 138. The device of any of Inventive Concepts 116-125, wherein the capsule has an average wall thickness of between 100 microns and 5000 microns.

[0228] Inventive Concept 139. The device of any of Inventive Concepts 116-125, wherein the capsule has a thinnest wall thickness of between 20 microns and 500 microns at a thinnest portion of its wall.

[0229] Invention Concept 140. The device of any of Invention Concepts 116-125, wherein the occlusion system further comprises an implant catheter, wherein the occlusion device is releasably disposed in a radially compressed state, wherein a maximum distance between the proximal portion of the capsule and the distal portion of the capsule is between 8 mm and 80 mm.

[0230] Invention Concept 141. The device of any of Invention Concepts 116-125, wherein the occlusion device further comprises a proximal connector configured to releasably connect the occlusion device to a correspondingly configured distal connector of the delivery system.

[0231] Invention Concept 142. The device of Invention Concept 141, wherein the proximal connector is shaped to define a thread.

[0232] Invention Concept 143. The device of any of Invention Concepts 116-125 for use with a guidewire, and further comprising the delivery system in cooperation therewith, the delivery system comprising an implant catheter connected to an operating handle, the implant catheter comprising a longitudinal channel for the guidewire, a distal connector for releasably connecting the implant catheter to a correspondingly configured proximal connector of the occlusion device, and an inflation tube channel releasably connected to the fluid flow path of the occlusion device.

[0233] Invention Concept 144. There is also provided, in accordance with the invention, a device for occluding a left atrial appendage (LAA), the device comprising:

[0234] (i) an occlusion device, the occlusion device comprising:

[0235] a compliant capsule defining a fluid-tight capsule chamber;

[0236] an actuation shaft, the actuation shaft being (a) at least partially disposed in the capsule chamber,

[0237] (b) connected to a distal portion of the capsule, and (c) longitudinally movable relative to a proximal portion of the capsule so as to dispose a distance between the distal and proximal portions of the capsule; and

[0238] a valve comprising an elastomeric sleeve surrounding a portion of the actuation shaft.

[0239] wherein the occlusion device is shaped to define a fluid flow path having one or more fluid flow path openings to the capsule chamber, and wherein the elastomeric sleeve is configured to have a resting state in which the sleeve covers and seals the one or more fluid flow path openings such that the valve

[0240] is in a closed state; and

[0241] (ii) a delivery system configured to releasably connect to the occlusion device and comprising one or more guide wires that:

[0242] (a) when in a support position, support opening and deformation of the elastomeric sleeve such that the elastomeric sleeve does not seal the one or more fluid flow path openings and the valve is in an open state, and

[0243] (b) when in a non-support position, do not support opening of the elastomeric sleeve such that the elastomeric sleeve assumes the resting state and the valve is in a closed state.

[0244] Concept 145. The device of Concept 144, wherein the one or more guide wires pass through at least a portion of the one or more fluid flow path openings when the valve opening support is in the support position.

[0245] Concept 146. The device of any one of Concepts 144-145, wherein the occlusion device further comprises a proximal tube axially fixed relative to the proximal end portion of the capsule.

[0246] Concept 147. The device of Concept 146, wherein the actuation shaft is slidably disposed within the proximal tube.

[0247] Concept 148. The device of Concept 146, wherein the occlusion device further comprises a proximal LAA-ostium cover that (a) is fixed to the proximal tube, radially surrounds the proximal tube, (b) is configured to assume a radially compressed state and a radially expanded state, (c) comprises a frame and a cover fixed to the frame, (d) when in the radially expanded state, is generally orthogonal to the actuation shaft and has a maximum dimension measured perpendicular to the actuation shaft of between 10 mm and 50 mm, and (e) is indirectly connected to the capsule via the proximal tube without being directly connected to the capsule.

[0248] Inventive Concept 149. The device of Inventive Concept 148, wherein the occlusion device further comprises an orifice support stent that (a) is fixed to the proximal left atrial appendage-orifice cover and extends distally from the proximal LAA-orifice cover, (b) is configured to be in a radially compressed state and a radially expanded state, and (c) is generally cylindrical when in the radially expanded state.

[0249] Inventive Concept 150. The device of Inventive Concept 149, wherein, when in the radially expanded state, the orifice support stent has (i) a maximum dimension, measured perpendicular to the actuation axis, of between 8 mm and 50 mm, and (ii) an axial length of between 4 mm and 30 mm.

[0250] Inventive Concept 151. A device for occluding a left atrial appendage (LAA), the device comprising:

[0251] (i) an occlusion device comprising:

[0252] a compliant capsule defining a fluid-tight capsule chamber;

[0253] a proximal tube that is axially fixed relative to the proximal portion of the capsule;

[0254] and

[0255] a spring that (a) is at least partially disposed in the capsule chamber, (b) is connected to the distal portion of the capsule and the proximal tube, and (c) has a relaxed length, wherein, when the spring has the relaxed length, the distal portion of the capsule is a relaxed distance from the proximal portion of the capsule; and

[0256] (ii) a delivery system configured to releasably connect to the occlusion device and comprising a stylet that is removably disposed through the tube and within the spring, wherein the occlusion device is configured such that the extent to which the stylet is advanced distally within the spring sets a tensed length of the spring, which in turn sets a tensed distance between the distal and proximal portions of the capsule, the tensed distance being greater than the relaxed distance.

[0257] Inventive Concept 152. The device of Inventive Concept 151, wherein the occlusion device further comprises a valve.

[0258] Invention Concept 153. The device of Invention Concept 152,

[0259] the occlusion device is shaped to define a fluid flow path, and

[0260] wherein the valve is configured to selectively allow or prevent fluid flow between the fluid flow path and the balloon chamber when the valve is in open and closed states, respectively.

[0261] Invention Concept 154. The device of Invention Concept 151, wherein the occlusion device further comprises a distal end tip disposed at the distal portion of the balloon, wherein the spring is connected to the distal end tip.

[0262] Invention Concept 155. The device of Invention Concept 151, wherein the compliant balloon comprises a compliant material selected from the group consisting of: polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyether ether ketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide and polyether block amide (PEBA).

[0263] Invention Concept 156. The device of any one of Invention Concepts 151-155,

[0264] wherein the occlusion device comprises an occlusion device connector connected to the distal portion of the balloon and shaped to define an occlusion device connection interface, and

[0265] wherein the probe comprises a probe connector disposed at a distal end of the probe and shaped to define a probe connection interface that reversibly connects to the occlusion device connection interface.

[0266] Invention Concept 157. The device of Invention Concept 156, wherein the occlusion device connection interface and the probe connection interface are shaped to define respective threads.

[0267] Inventive Concept 158. The apparatus according to any one of Inventive Concepts 151-155, wherein the occlusion device further comprises a proximal LAA-orifice cover that (a) is fixed to the proximal tube, radially surrounds the proximal tube, (b) is configured to be in a radially compressed state and a radially expanded state, (c) comprises a frame and a cover fixed to the frame, (d) when in the radially expanded state, is generally orthogonal to the actuation axis and has a maximum dimension measured perpendicular to the actuation axis of between 10 mm and 50 mm, and (e) is indirectly connected to the capsule via the proximal tube, rather than directly connected to the capsule.

[0268] Inventive Concept 159. The apparatus according to Inventive Concept 158, wherein the occlusion device further comprises an orifice support stent that (a) is fixed to the proximal LAA-orifice cover and extends distally therefrom, (b) is configured to be in a radially compressed state and a radially expanded state, and (c) when in the radially expanded state, is generally cylindrical.

[0269] Inventive Concept 160. The apparatus according to Inventive Concept 159, wherein when in the radially expanded state, the orifice support stent has (i) a maximum dimension measured perpendicular to the actuation axis of between 8 mm and 50 mm, and (ii) an axial length of between 4 mm and 30 mm.

[0270] Inventive Concept 161. The apparatus according to any one of Inventive Concepts 151-155, wherein the occlusion device further comprises a plurality of connecting struts fixed to a distal portion of the capsule and a proximal portion of the capsule.

[0271] Inventive Concept 162. The apparatus according to Inventive Concept 161, wherein the occlusion device is configured such that inflation of the capsule chamber plastically deforms the plurality of connecting struts.

[0272] Inventive Concept 163. The apparatus according to Inventive Concept 161, wherein the occlusion device is configured such that foreshortening of the capsule plastically deforms the plurality of connecting struts.

[0273] Inventive Concept 164. The apparatus according to any one of Inventive Concepts 151-155, wherein the capsule has an average wall thickness of between 100 microns and 5000 microns.

[0274] Inventive Concept 165. The apparatus according to any one of Inventive Concepts 151-155, wherein the capsule has a thinnest wall thickness of between 20 microns and 500 microns at a thinnest portion of a wall thereof.

[0275] Invention Concept 166. The apparatus according to any one of Invention Concepts 151-155, wherein the occlusion system further comprises an implant catheter, wherein the occlusion device is releasably disposed in a radially compressed state, wherein a maximum distance between the proximal portion of the capsule and the distal portion of the capsule is between 8 mm to 80 mm.

[0276] Invention Concept 167. The apparatus according to Invention Concept 151, wherein the occlusion device further comprises a proximal connector configured to releasably connect the occlusion device to a correspondingly configured distal connector of the delivery system.

[0277] Invention Concept 168. The apparatus according to Invention Concept 167, wherein the proximal connector is shaped to define a thread.

[0278] Invention Concept 169. The apparatus according to any one of Invention Concepts 167-168, for use with a guidewire, the delivery system comprising an implant catheter connected to an operating handle, the implant catheter comprising a longitudinal channel for the guidewire, a distal connector for releasably connecting the implant catheter to a correspondingly configured proximal connector of the occlusion device, and an inflation tube channel releasably connected to the fluid flow path of the occlusion device.

[0279] Invention Concept 170. According to the invention concept, there is also provided a method for occluding a left atrial appendage (LAA) of a patient, the method comprising:

[0280] placing a compliant capsule of an occlusion device in its longitudinally extended form in the LAA using a delivery system;

[0281] inflating the compliant capsule by filling fluid into a fluid-tight capsule chamber defined by the capsule along a fluid flow path having one or more fluid path openings to the capsule chamber, while a valve opening support of the delivery system is in a support position in which the valve opening support supports open and deforms an elastomeric sleeve of a valve of the occlusion device such that the elastomeric sleeve does not seal the one or more fluid flow path openings and such that the valve is in an open state, wherein the elastomeric sleeve encircles a portion of an actuation shaft of the occlusion device, the actuation shaft (a) being at least partially disposed in the capsule chamber, (b) being connected to a distal portion of the capsule, and (c) being longitudinally movable relative to a proximal portion of the capsule so as to provide a distance between the distal and proximal portions of the capsule;

[0282] transitioning the valve opening support to a non-supporting position in which the valve opening support does not support opening the elastomeric sleeve such that the elastomeric sleeve assumes a resting state in which the sleeve covers and seals the one or more fluid flow path openings such that the valve is in a closed state; and

[0283] releasing the occlusive device from the delivery system.

[0284] According to the inventive concept 171 of the present application, there is also provided a method for occluding a patient's left atrial appendage (LAA), the method comprising:

[0285] placing a compliant capsule of an occlusive device in its longitudinally extended form in the LAA using a delivery system;

[0286] inflating the compliant capsule by filling fluid along a fluid flow path having one or more fluid path openings leading to a fluid-tight capsule chamber defined by the capsule into the fluid-tight capsule chamber while one or more guide wires of the delivery system are in a supporting position in which the one or more guide wires support opening and deforming an elastomeric sleeve of a valve of the occlusive device such that the elastomeric sleeve does not seal the one or more fluid flow path openings and such that the valve is in an open state, wherein the elastomeric sleeve surrounds a portion of an actuation shaft of the occlusive device, the actuation shaft being (a) at least partially disposed in the capsule chamber, (b) connected to a distal portion of the capsule, and (c) longitudinally movable relative to a proximal portion of the capsule so as to set a distance between the distal and proximal portions of the capsule;

[0287] transitioning the one or more guide wires to a non-supporting position in which the one or more guide wires do not support opening the elastomeric sleeve such that the elastomeric sleeve assumes a resting state in which the sleeve covers and seals the one or more fluid flow path openings such that the valve is in a closed state; and

[0288] releasing the occlusive device from the delivery system. BRIEF DESCRIPTION OF DRAWINGS

[0289] Figure 1 is a schematic illustration of an occlusive device for occluding a left atrial appendage (LAA) according to an application of the present application;

[0290] Figure 2A -B is a schematic illustration of a distal portion of an occlusive device and delivery system according to an application of the present application, Figure 1 is a schematic cross-sectional view of a distal portion of an occlusive device and delivery system as shown;

[0291] Figure 3A-F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2 Figure 1 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0292] Figure 4A -C is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2 Figure 3A -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0293] Figure 5 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2 Figure 1 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0294] Figure 6 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0295] Figure 7A -C is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2 Figure 6 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0296] Figure 7D -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0297] Figure 8 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0298] Figure 9A -C is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2 Figure 8 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0299] Figure 10 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0300] Figure 11 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2 Figure 10 -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0301] Figure 12A -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0302] Figure 13A -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2 Figure 12A -F is a schematic view of a step of the method of occlusion device placement according to an application of the present application, using the delivery system shown in figure 2

[0303] Figure 14AFigure B is a schematic view of an occlusion device according to an application of the present invention, for occlusion of the left atrial appendage (LAA). Figure 12A Figure B is a schematic view of an occlusion device according to an application of the present invention, for occlusion of the left atrial appendage (LAA). DETAILED DESCRIPTION

[0304] Figure 1 Figure B is a schematic view of an occlusion device according to an application of the present invention, for occlusion of the left atrial appendage (LAA). Figure 3A Figure B is a schematic view of an occlusion device according to an application of the present invention, for occlusion of the left atrial appendage (LAA).

[0305] Reference is made to Figure 2A Figure B is a schematic view of an occlusion device according to an application of the present invention, for occlusion of the left atrial appendage (LAA). Figure 2A Figure B is a schematic view of an occlusion device according to an application of the present invention, for occlusion of the left atrial appendage (LAA). Figure 2B Figure B is a schematic view of an occlusion device according to an application of the present invention, for occlusion of the left atrial appendage (LAA).

[0306] For some applications, the occlusion device 10 comprises:

[0307] • a compliant balloon 30 defining a fluid-tight balloon chamber 32;

[0308] • an actuation shaft 34, said actuation shaft 34 being (a) at least partially disposed in said balloon chamber 32, (b) connected to a distal portion 36 of said balloon 30, and (c) longitudinally movable relative to a proximal portion 38 of said balloon 30 so as to set a distance between the distal portion 36 and the proximal portion 38 of the balloon 30;

[0309] • a locking mechanism 40, said locking mechanism 40 being configured to assume a locked and an unlocked state, respectively as shown in Figure 2B and 2A ; and

[0310] • a valve 42.

[0311] The occlusion device 10 is configured to inflate said balloon 30 in a radial or lateral direction by proximally longitudinally moving the actuation shaft 34 to shorten the distance between the distal portion 36 and the proximal portion 38 of the balloon 30 to a desired distance.

[0312] The locking mechanism 40 is configured to maintain the distance setting between the distal portion 36 of the balloon 30 and the proximal portion 38 of the balloon 30 using the actuation shaft 34 when in the locked state.

[0313] For some applications, the occlusion device 10 is shaped to define a fluid flow path 44 along (e.g., alongside, as shown) a portion of the actuation shaft 34. The valve 42 is configured to selectively:

[0314] • as shown, when the valve 42 is in the open state, to allow fluid flow between the fluid flow path 44 and the capsule chamber 32, or Figure 2A

[0315] • as shown, when the valve 42 is in the closed state, to block fluid flow between the fluid flow path 44 and the capsule chamber 32. Figure 2B

[0316] For some applications, the occlusion device 10 is configured such that proximal longitudinal movement of the actuation shaft 34:

[0317] • to a first predetermined distance between the distal portion 36 and the proximal portion 38 of the capsule 30, automatically transitions the valve 42 from the open state to the closed state, as shown, and Figure 2A to Figure 2B

[0318] • to a second predetermined distance between the distal portion 36 and the proximal portion 38 of the capsule 30, automatically transitions the locking mechanism 40 from the unlocked state to the locked state, as shown. Figure 2A to Figure 2B

[0319] For some applications, the first predetermined distance is not equal to the second predetermined distance. For example, the first predetermined distance can be less than the second predetermined distance, such that proximal longitudinal movement of the actuation shaft 34 first automatically transitions the valve 42 from the open state to the closed state, and subsequently automatically transitions the locking mechanism 40 from the unlocked state to the locked state. Alternatively, the first predetermined distance can be greater than the second predetermined distance, such that the order is reversed.

[0320] Further, optionally, for some applications, the first predetermined distance is equal to the second predetermined distance, such that proximal longitudinal movement of the actuation shaft 34 simultaneously automatically transitions the valve 42 from the open state to the closed state, and automatically transitions the locking mechanism 40 from the unlocked state to the locked state.

[0321] For some applications, to induce the aforementioned proximal longitudinal movement of the actuation shaft 34, the delivery system 20 includes a pull shaft 46 releasably coupled to a proximal portion of the actuation shaft 34. For example, a distal portion of the pull shaft 46 can include a pull shaft connector 48, which can be shaped, for example, to define threads that detachably engage corresponding threads defined by the proximal portion of the actuation shaft 34. Rotation of the pull shaft 46 causes the pull shaft connector 48 to disengage the corresponding threads defined by the proximal portion of the actuation shaft 34.

[0322] ​​​​Generally, the occlusion device 10 is configured to be releasably coupled to the delivery system 20. For some applications, such as, for example, Figure 2A As shown in FIGS. 1-2, the occlusion device 10 is configured such that, when the occlusion device 10 is releasably coupled to the delivery system 20, the fluid flow path 44 is in fluid communication with the delivery system 20.

[0323] For some applications, such as, for example, Figure 1 and 2A As shown in FIGS. 1-2, the actuation shaft 34 is shaped to at least partially define a distal tip 50 disposed at the distal portion 36 of the balloon 30.

[0324] For some other applications, the occlusion device 10 further includes a distal tip disposed at the distal portion 36 of the balloon 30 and to which the actuation shaft 34 is coupled (configuration not shown).

[0325] Alternatively or additionally, for some applications, the occlusion device 10 further includes a proximal base disposed at the proximal portion 38 of the balloon 30, wherein the actuation shaft 34 is movable (e.g., longitudinally or rotationally) relative to the proximal base (configuration not shown).

[0326] For some applications, such as, for example, Figure 2A As shown in FIGS. 1-2, the valve 42 is disposed along the actuation shaft 34.

[0327] For some applications, the occlusion device 10 further includes a proximal tube 52 axially fixed relative to the proximal portion 38 of the balloon 30. The actuation shaft 34 is slidably partially disposed within the proximal tube 52, e.g., so as to indirectly couple the actuation shaft 34 to the proximal portion 38 via the proximal tube 52. For some of these applications, such as, for example, Figure 2A As shown in FIGS. 1-2, the occlusion device 10 is configured to define the fluid flow path 44 along a portion of the actuation shaft 34 radially between an outer surface of the actuation shaft 34 and an inner surface of the proximal tube 52. Optionally, the valve 42 is disposed along the actuation shaft 34.

[0328] For some applications, the valve 42 includes a seal 54 surrounding (e.g., completely surrounding) at least a portion of an outer surface of the actuation shaft 34. The valve 42 is configured to assume an open state when the seal 54 is disposed in one or more first axial positions 56A (one such first axial position is shown in FIG. 2) relative to the proximal tube 52, and to assume a closed state when the seal 54 is disposed in one or more second axial positions 56B (one such second axial position is shown in FIG. 2) relative to the proximal tube 52. Figure 2A Figure 2B ​when the one or more second axial positions 56B are shown in FIG. 6B. The one or more second axial positions 56B are proximal to the one or more first axial positions 56A. For example, as shown in FIG. 6B, the one or more second axial positions 56B are shown in a closed state. The one or more second axial positions 56B are proximal to the one or more first axial positions 56A. For example, as shown in FIG. 6B, the one or more second axial positions 56B are shown in a closed state. The one or more second axial positions 56B are proximal to the one or more first axial positions 56A. For example, as Figure 2A As shown in FIG. 6B, the seal 54 can include an O-ring, such as a single O-ring or a series of O-rings. Optionally, one or more additional seals 19, such as one or more O-rings, are provided to further stabilize the alignment of the distal tube within the proximal tube by friction.

[0329] For some applications, such as when the one or more second axial positions 56B are shown in FIG. 6B, the one or more second axial positions 56B are shown in a closed state. The one or more second axial positions 56B are proximal to the one or more first axial positions 56A. For example, as shown in FIG. 6B, the one or more second axial positions 56B are shown in a closed state. The one or more second axial positions 56B are proximal to the one or more first axial positions 56A. For example, as Figure 2A As shown in FIG. 6B, the seal 54, the actuation shaft 34, and the proximal tube 52 are configured such that the seal prevents fluid from exiting the distal end 58 of the proximal tube 52 at least when the seal 54 is disposed in the one or more first axial positions 56A relative to the proximal tube 52. Alternatively or additionally, the friction between the seal 54 and the inner surface of the proximal tube 52 increases structural stability and / or enables stepwise expansion / implantation.

[0330] For some applications, the wall of the proximal tube 52 is shaped to define one or more protrusions 60 therethrough. The one or more protrusions 60 are biased to bend radially inward. As shown in FIG. 6B, when the one or more second axial positions 56B are shown in FIG. 6B, the one or more protrusions 60 are shown in a radially compressed state. Figure 2A As shown in FIG. 6B, when the valve 42 is in the open state, the fluid flow path 44 is through the wall between the respective proximal ends 62 of the one or more protrusions 60 and the non-protruding portions 64 axially adjacent to the one or more protrusions 60, such as proximate to the one or more protrusions 60 as shown.

[0331] For some applications, the outer surface of the actuation shaft 34 is shaped to define one or more protrusions 66 around at least a portion of the actuation shaft 34, such as completely around. As shown in FIG. 6B, the proximal ends 62 of the one or more protrusions 60 are shaped to prevent distal movement of the one or more protrusions 66 when the one or more protrusions 66 are disposed proximate to the proximal ends 62 of the one or more protrusions 60, thereby causing the locking mechanism 40 to assume the locked state. Figure 2B

[0332] For some applications, the occlusion device 10 further includes a proximal LAA-ostium cover 70, the proximal LAA-ostium cover 70:

[0333] • is secured to the proximal tube 52, radially encircling the proximal tube,

[0334] • is configured to assume a radially compressed state, such as shown in FIG. 6B, as described below; and a radially expanded state, such as shown in FIG. 6A. Figure 3A Figure 1 and 3B

[0335] ​​​• includes a frame 72 and a cover 74 fixed to the frame 72,

[0336] • when in the radially expanded state, is generally orthogonal to the proximal tube 52 and has a maximum dimension measured perpendicular to the proximal tube 52 of at least 10 mm (e.g., at least 20 mm), no more than 50 mm (e.g., no more than 30 mm), and / or between 10 mm and 50 mm (e.g., between 20 mm and 30 mm), and

[0337] • is typically indirectly connected to the capsule 30 via the proximal tube 52, rather than directly connected to the capsule 30.

[0338] As described below, this indirect connection of the proximal LAA-ostial cover 70 to the capsule 30 typically prevents anodic reactions between the typically super-elastic (e.g., Nitinol) material of the frame 72 of the proximal LAA-ostial cover 70 and the typically malleable material of the struts 80. Such reactions can occur if the two elements are welded or otherwise joined in contact with one another. (Connection via independent and passive elements, such as an inner tube or shaft, also does not cause such reactions.) Alternatively, the proximal LAA-ostial cover 70 is directly connected to the capsule 30, e.g., if the frame 72 includes a different malleable material, such as titanium.

[0339] For some applications, the occlusion device 10 further includes an ostial support stent 290, described below with reference to Figure 8 and 9A -B.

[0340] For some applications, the actuation shaft 34 is shaped to define a guidewire lumen 76 for slidably receiving a guidewire and / or a passageway for a liquid injected under pressure, such as contrast injected from a proximal handle of a delivery tool to the distal end of the occlusion device. Alternatively, for other applications, the actuation shaft 34 is not shaped to define a guidewire lumen.

[0341] For some applications, the compliant capsule 30 includes a compliant material selected from the group consisting of: polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyether ether ketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide and polyether block amide (PEBA).

[0342] In some applications, the average wall thickness of the capsule 30 is between 100 microns and 5000 microns. Alternatively or additionally, for some applications, the capsule 30 has a thinnest wall thickness of between 20 microns and 500 microns at the thinnest portion of its wall.

[0343] For some applications, the occlusion device 10 further comprises a plurality of connecting struts 80 fixed to the distal portion 36 of the balloon 30 and to the proximal portion 38 of the balloon 30. The struts 80 can be disposed within the balloon 30, outside the balloon 30, or some within the balloon 30 and some outside the balloon 30. In some applications, the struts 80 are disposed as a frame. In some applications, the struts 80 are disposed as a cage. Typically, the struts 80 comprise a plastically deformable material, such as stainless steel or titanium. Typically, the struts 80 assist in shaping the balloon 30 when the balloon chamber is inflated and / or the balloon is shortened.

[0344] Typically, the occlusion device 10 is configured such that inflation of the balloon chamber 32 plastically deforms the plurality of connecting struts 80. For some applications, the occlusion device 10 is configured such that shortening of the balloon 30 plastically deforms the plurality of connecting struts 80.

[0345] For some applications, the struts 80 are configured such that inflation of the balloon chamber 32 primarily causes radial deformation of the struts 80, rather than deformation of the struts in the distal or proximal direction. To this end, a plurality of first side portions 81A of the struts 80 disposed along the side surface of the balloon 30 can be more compliant than a plurality of second distal portions 81B of the struts 80 disposed on the distal side surface of the balloon 30 and / or on the proximal side surface of the balloon 30. For example, as shown in Figure 1 Fig. F, the first side portions 81A can be thinner than the second distal portions 81B, and / or the first side portions 81A can be shaped to be more compliant, such as having a serpentine (e.g., sinusoidal) shape, as shown in Fig. F. Typically, the first side portions 81A are oriented parallel to the central longitudinal axis of the occlusion device 10.

[0346] Reference is now made to Figure 3A Fig. F, which is a schematic illustration of steps of a method of deploying the occlusion device 10 using the delivery system 20, according to an application of the present application.

[0347] Reference is now made to Figure 4A Fig. C, which is a schematic illustration of a portion of a step of the method shown in Figure 3A Fig. F.

[0348] Figure 3A The occlusion device 10 is shown schematically as being releasably disposed within the sheath 82 of the delivery system 20 in a radially compressed state. Typically, the maximum distance between the proximal portion 38 of the balloon 30 and the distal portion 36 of the balloon 30 when the occlusion device 10 is in this radially compressed state is at least 8 mm (e.g., at least 15 mm), no more than 80 mm (e.g., no more than 60 mm), and / or between 8 mm and 80 mm (e.g., between 15 mm and 60 mm).

[0349] For some applications, the occlusion device 10 includes a proximal connector 84 configured to releasably connect the occlusion device 10 to a correspondingly configured distal connector 86 of the delivery system 20.

[0350] For some applications, the distal connector 86 includes one or more legs that engage one or more corresponding connection sites (e.g., slots) of the proximal connector 84, e.g., as best shown in Figure 4A -C. For example, when the legs are in an unconstrained, at-rest state, the legs can be configured to be biased radially outward, and, e.g., as shown in Figure 4A , can be held radially inward by the implant catheter 88, which engages the connection sites of the proximal connector 84. For example, as shown in Figure 4B , proximal withdrawal of the implant catheter 88 relative to the occlusion device 10 releases the legs.

[0351] Alternatively, the proximal connector 84 is shaped to define a thread (configuration not shown).

[0352] For some applications, the delivery system 20 includes an implant catheter 88 connected to an operator handle (not shown). The implant catheter 88 includes: (a) a longitudinal channel for a guidewire; (b) a distal connector 86 for releasably connecting the implant catheter 88 to a correspondingly configured proximal connector 84 of the occlusion device 10; and (c) an inflation tube channel releasably connected to the fluid flow path 44 of the occlusion device 10. Alternatively or additionally, the longitudinal channel is for injecting contrast media from the handle to a distal opening of the inflation tube channel distal of the balloon.

[0353] Figure 3B The occlusion device 10 is shown after the sheath 82 has been proximally withdrawn, thereby releasing the occlusion device 10. Figure 3B The proximal LAA-orifice cover 70 is also shown in its radially expanded state. Typically, the frame 72 of the proximal LAA-orifice cover 70 includes a shape memory storage, e.g., a super-elastic metal, that causes the proximal LAA-orifice cover 70 to automatically transition to the radially expanded state upon release from the sheath 82. At this deployment stage, the balloon 30 remains in the non-inflated, elongated configuration.

[0354] Typically, the medical professional navigates the delivery system to place the distal end of the occlusion device 10 in the LAA.

[0355] As shown in Figure 3C -D, the medical professional inflates the balloon chamber 32. Figure 3C The occlusion device 10 is shown with the balloon chamber 32 partially inflated, Figure 3DThe occlusion device 10 is shown with the capsule chamber 32 fully inflated. The capsule 30 can be inflated by filling the capsule chamber 32 with any fluid, including but not limited to a saline solution (optionally including a contrast agent), blood (e.g., autologous blood), foam, and / or a gel (e.g., a gel, a liquid polymer that can be modified to become rigid, or a hydrogel that remains gelatinous or self-curing at body temperature).

[0356] For some applications, the struts 80 are shaped to define a plurality of spikes 89, which are initially generally axially oriented, as shown, and are configured to extend more radially upon inflation of the capsule 30, to act as tissue-engaging barbs, as shown. Figure 3C Figure 3D

[0357] Figure 3E and 4A The occlusion device 10 is shown after (a) the valve 42 has transitioned from an open state to a closed state, (b) the actuation shaft 34 has been moved longitudinally proximally to inflate the capsule 30 in a radial or lateral direction by shortening the distance between the distal portion 36 and the proximal portion 38 of the capsule 30, and (c) the locking mechanism 40 has transitioned from an unlocked state to a locked state, as described above with reference to Figure 2A Typically, after the capsule 30 is finally filled, the actuation shaft 34 is moved longitudinally proximally to inflate the capsule 30 in a radial or lateral direction by shortening the distance between the distal portion 36 and the proximal portion 38 of the capsule 30 to a desired distance. The proximal connector 84 of the occlusion device 10 is still releasably connected to the corresponding configured distal connector 86 of the delivery system 20.

[0358] Figure 3F and 4B -C shows the occlusion device 10 after the proximal connector 84 of the occlusion device 10 has been released from the distal connector 86 of the delivery system 20.

[0359] Figure 4C The occlusion device 10 is also shown after the pull shaft 46 has been detached from the proximal portion of the actuation shaft 34 (e.g., by unscrewing it by rotating the pull shaft 46, as described above).

[0360] Reference is now made to Figure 5 ​​which is a schematic view of the occlusion device 10 implanted to occlude the LAA 100, according to an application of the present invention. As can be seen, the capsule 30 is disposed within the LAA 100, and the proximal LAA-orifice cover 70 is disposed outside the LAA 100, abutting the atrial wall around the orifice of the LAA 100, thereby forming a continuum between the LAA level and the atrium. Typically, due to the relatively flat shape of the proximal LAA-orifice cover 70, it protrudes very little, and therefore does not interfere with blood flow, nor does it cause thrombosis. Typically, the struts 80 provide most of the anchoring of the occlusion device 10, while the capsule 30 provides most of the sealing of the LAA. In addition, in configurations in which the cover 74 of the proximal LAA-orifice cover 70 is not blood permeable, the proximal LAA-orifice cover 70 provides additional sealing of the LAA, mainly to inhibit thrombus formation on the capsule surface at the orifice level.

[0361] For some applications, the proximal LAA-orifice cover is asymmetric with respect to the proximal tube 52, for example, elliptical or having a radius in one direction that is larger than in a perpendicular direction.

[0362] For some applications, the proximal LAA-orifice cover 70 is configured to have an adjustable maximum dimension, measured perpendicular to the proximal tube 52. For example, rotation of the proximal LAA-orifice cover 70 adjustment mechanism can adjust the maximum dimension.

[0363] For some applications, the cover 74 of the proximal LAA-orifice cover 70 is permeable to blood, to serve as a filter for blood entering and exiting the LAA. For other applications, the cover 74 is not permeable to blood, and thus forms a secondary seal of the LAA in addition to the seal provided by the capsule 30.

[0364] For some applications, the LAA-orifice cover 70 is bioabsorbable and / or drug eluting.

[0365] Reference is now made to Figure 6 which is a schematic view of an occlusion device 110 for occluding the LAA, according to an application of the present invention. The occlusion device 110 is used with a delivery system 120. Except as described below, the occlusion device 110 is similar to the occlusion device 10 described above with reference to Figures 1-5 and can implement any of its features mutatis mutandis. Similarly, except as described below, the delivery system 120 is similar to the delivery system 20 described above with reference to Figures 1-5 and can implement any of its features mutatis mutandis. Like reference numerals refer to like parts.

[0366] Reference is made to Figure 7A -C, which is a schematic cross-sectional view of the distal portion of the occlusion device 110 and the delivery system 120, according to an application of the present invention. Figure 7A-B shows a blocking device 110 connected to the conveying system 120, wherein the valve 142 of the blocking device 110 is in the open state, as described below. Figure 7A A closure device 110 with a bladder 130 in an extended state is shown. Figure 7B -C shows a closure device 110 having a bladder 130 in a shortened state. Figure 7C A blocking device 110 connected to the conveying system 120 is shown, wherein the valve 142 is in the closed state.

[0367] For some applications, the blocking device 110 includes:

[0368] • A compliant capsule 130 defining a fluid-tight capsule chamber 132; the capsule 130 may have the above-mentioned reference. Figures 1-5 Any properties of the described cyst 30;

[0369] • A coaxial shaft 134, which (a) is at least partially disposed within the capsule chamber 132, (b) is connected to the distal portion 136 of the capsule 130, and (c) is longitudinally movable relative to the proximal portion 138 of the capsule 130, so as to establish a distance between the distal portion 136 and the proximal portion 138 of the capsule 130; and

[0370] A valve 142 includes an elastomeric sleeve 143 surrounding a portion of a brake shaft 134.

[0371] The occlusion device 110 is shaped to define a fluid flow path 144 having one or more fluid flow path openings 145 leading to the bladder chamber 132. Typically, the occlusion device 110 is configured such that the fluid flow path 144 is in fluid communication with the delivery system 120 when the occlusion device 110 is releasably connected to the delivery system 120.

[0372] For example, the elastomer sleeve 143 may include silicone resin.

[0373] The elastomer sleeve 143 is configured to have a stationary state, in which the sleeve covers and seals the one or more fluid flow path openings 145, such that the valve 142 is in a closed state, as... Figure 7C As shown.

[0374] The conveying system 120 is configured to be releasably connected to the blocking device 110. The conveying system 120 includes a valve opening support 147, which is configured to:

[0375] • When in a support position, such as Figure 6 and 7A- as shown by B, the support opens and deforms the elastomeric sleeve 143 such that the elastomeric sleeve 143 does not seal the one or more fluid flow path openings 145 and such that the valve 142 is in an open state, and

[0376] • when in the non-supporting position, as shown by A, the non-support opens the elastomeric sleeve 143 such that the elastomeric sleeve 143 assumes a resting state and the valve 142 is in a closed state. Figure 7C

[0377] This configuration enables independent control of the shortening of the capsule 130 and the closing of the valve 142. Alternatively, the valve opening support 147 (e.g., its tubular portion 151, as described below) is fixed to the pull shaft 46.

[0378] For some applications, the valve opening support 147 includes one or more protrusions 149 that extend radially outward from the axis of the elastomeric sleeve 143 so as to support open the elastomeric sleeve 143.

[0379] For some applications, the valve opening support 147 is configured such that axial sliding of the valve opening support 147 relative to the elastomeric sleeve 143 (e.g., in the proximal direction) transitions the valve opening support 147 from the supporting position to the non-supporting position, as shown by Figure 7B and Figure 7C

[0380] For some applications, the occlusion device 110 further includes a proximal tube 152 that is axially fixed relative to the proximal portion 138 of the capsule 130. In some applications, the actuation shaft 134 is slidably disposed within the proximal tube 152.

[0381] For some applications, a seal, such as an O-ring (as shown), is provided and the friction between the seal and the inner surface of the proximal tube 152 increases the structural stability. Alternatively or additionally, the O-ring is disposed proximally of the one or more fluid flow path openings 145 and prevents additional fluid from passing through the one or more fluid flow path openings 145 and the elastomeric sleeve 143 after the shortening of the capsule is complete.

[0382] For some applications, the valve opening support 147 includes a tubular portion 151 that is at least partially disposed within the proximal tube 152. For some of these applications, the valve opening support 147 includes one or more protrusions 149 that (a) extend axially away from the tubular portion 151 (e.g., in the distal direction) and (b) extend radially outward from the proximal tube 152 so as to support open the elastomeric sleeve 143. For some applications, when the valve opening support 147 is in the supporting position, the one or more protrusions 149 pass through at least a portion of the one or more fluid flow path openings 145, as shown by Figure 6 and​​7A Alternatively, for some applications, the proximal tube 152 is shaped to define one or more entry openings through the wall of the proximal tube 152, and the one or more protrusions 149 pass through the one or more entry openings at least when the valve opening support 147 is in the support position (configuration not shown).

[0383] For some applications, the occlusion device 110 further comprises a proximal LAA-orifice cover 70 fixed to the proximal tube 152, radially surrounding the proximal tube 152. The proximal LAA-orifice cover 70 can implement any of the techniques described above and / or below. For some of these applications, the occlusion device 110 further comprises an orifice support bracket 290 described below with reference to Figure 8 and Figure 9A as described above and / or below.

[0384] For some applications, the occlusion device 110 further comprises a locking mechanism configured to assume a locked state and an unlocked state, and when in the locked state, the locking mechanism is configured to maintain the distance setting between the distal portion 136 of the balloon 130 and the proximal portion 138 of the balloon 130 using the actuation shaft 134. With the necessary modifications, the locking mechanism can implement any of the locking mechanisms described in this application.

[0385] For some applications, the actuation shaft 134 is shaped to at least partially define a distal tip 150 disposed at the distal portion 136 of the balloon 130.

[0386] For some applications, the occlusion device 110 further comprises a connecting strut 180 fixed to the distal portion 136 of the balloon 130 and to the proximal portion 138 of the balloon 130. Typically, the occlusion device 110 is configured such that inflation of the balloon chamber 132 plastically deforms the connecting strut 180. For some applications, the occlusion device 110 is configured such that shortening of the balloon 130 plastically deforms the connecting strut 180.

[0387] For some applications, the delivery system 120 further comprises an implant catheter 88, for example, as described above with reference to Figures 1-5 .

[0388] Reference is now made to Figure 7D which is a schematic illustration of an occlusion device 410 for occluding an LAA, according to an application of the present application. For clarity of presentation, the balloon is not shown attached to the strut 180, even though it is an actual element of the occlusion device. The occlusion device 410 is used with a delivery system. Except as described below, the occlusion device 410 is similar to the occlusion device 10 described above with reference to Figure 7D . Figure 6 7A ​The blocking device 110 shown in -C can be implemented with necessary modifications to achieve any of its features. The same reference numerals denote the same parts. Similarly, except as described below, the conveying system is similar to the one referenced above. Figures 1-5 The described conveyor system 20 can be implemented with necessary modifications to achieve any of its features.

[0389] The blocking device 410 includes a valve 442, which includes an elastomeric sleeve 143 surrounding a portion of an actuation shaft 134. The elastomeric sleeve 143 is configured to have a resting state, wherein the sleeve covers and seals one or more fluid flow path openings 145, such that the valve is in a closed state. Figure 7D Not shown in the image, but similar to Figure 7C (The state of the blocking device 110 shown).

[0390] Unlike the conveying system 120 of the blocking device 110, the conveying system in this configuration does not include the valve opening support 147. Instead, the conveying system includes one or more guide wires 447, which:

[0391] • When in a support position, such as Figure 7D As shown, the support opens and deforms the elastomer sleeve 143, causing the elastomer sleeve 143 to not seal one or more fluid flow path openings 145, and causing the valve 442 to be in the open state.

[0392] • When in a non-supported position ( Figure 7D Not shown, but similar to Figure 7C (As shown in the state of the blocking device 110), the elastic sleeve 143 is not supported to open, so that the elastic sleeve is in a stationary state and the valve 442 is in a closed state.

[0393] In some applications, when one or more guidewires are in the supported position, one or more guidewires 447 pass through at least a portion of one or more fluid flow path openings 145.

[0394] Now refer to Figure 8 This is a schematic diagram of a blocking device 210 for blocking LAA according to one application of the present invention. The blocking device 210 is used in conjunction with a conveying system 220. The blocking device 210 can be implemented in combination with any other blocking device described in this application (with necessary modifications), including but not limited to any valves and / or locking mechanisms described in this application (with necessary modifications). Similarly, except as described below, the conveying system 220 is similar to other conveying systems described in this application and can implement any of its features with necessary modifications. The same reference numerals denote the same components.

[0395] Reference Figure 9A-B, which is a schematic cross-sectional view of the distal portion of the blocking device 210 and the conveying system 220 according to one application of the present invention. Figure 9A -B shows the blocking device 210 connected to the conveying system 220. Figure 9A A closure device 210 with a bladder 130 in an extended state is shown, and Figure 9B A closure device 110 with a bladder 130 in a shortened state is shown.

[0396] The blocking device 210 includes:

[0397] • A compliant capsule 230 defining a fluid-tight capsule chamber 232; the capsule 230 may have the above-mentioned reference Figures 1-5 Any properties of the described cyst 30;

[0398] • A coaxial shaft 234, which (a) is at least partially disposed within the capsule chamber 232, (b) is connected to the distal portion 236 of the capsule 230, and (c) is longitudinally movable relative to the proximal portion 238 of the capsule 230, so as to establish a distance between the distal portion 236 and the proximal portion 238 of the capsule 230; and

[0399] A valve 242, as described above, can implement any of the features of the valve described in this application.

[0400] The closure device 210 also includes a proximal LAA-orifice cap 70, which (a) is configured to present a radially compressed state and a radially expanded state, (b) includes a frame 72 and a cap 74 fixed to the frame 72, and (c) when in the radially expanded state, is substantially orthogonal to the actuation axis 234 and has a maximum dimension measured perpendicular to the actuation axis 234: at least 10 mm (e.g., at least 20 mm), not exceeding 50 mm (e.g., not exceeding 30 mm), and / or between 10 mm and 50 mm (e.g., between 20 mm and 30 mm).

[0401] The blocking device 210 also includes an orifice support bracket 290, configured to enhance support at the LAA orifice. The orifice support bracket 290 is configured to be at least partially disposed within the LAA, for example, completely disposed within the LAA. The orifice support bracket 290 is as follows:

[0402] • Secured to the proximal LAA-orifice cap 70, and extending distally from the proximal left atrial appendage cap.

[0403] • Configured to be in a radially compressed state (not shown) and a radially expanded state (e.g.) Figure 8 and 9A -B as shown), and

[0404] • is generally cylindrical when in a radially expanded state.

[0405] As used in this application, including in the claims and summary, the phrase "generally cylindrical" is not limited to a general cylinder, and other generally cylindrical shapes within its scope are also included, such as a generally elliptical cylinder.

[0406] For some applications, the orifice support stent 290, when in a radially expanded state, has (i) a maximum dimension measured perpendicular to the actuation axis of at least 8 mm, no more than 50 mm, and / or between 8 mm and 50 mm, and / or (ii) an axial length of at least 4 mm (e.g., at least 5 mm), no more than 30 mm, and / or between 4 mm and 30 mm.

[0407] For some applications, the orifice support stent 290 is not fixed to the capsule 230, such that the shape of the capsule 230 can change independently of the shape of the orifice support stent 290. Alternatively or additionally, the lack of direct physical contact between the orifice support stent 290 and the connecting struts 280 of the occlusion device 210 can prevent anodic reactions between the typically super-elastic (e.g., Nitinol) material of the struts 280 and the typically plastically deformable (e.g., stainless steel) material of the orifice support stent 290. Such reactions can occur if the two elements are welded or otherwise joined together in contact with each other. (Connection via independent and passive elements, such as an inner tube or shaft, also does not cause such reactions.)

[0408] For some applications, the orifice support stent 290 comprises a super-elastic or plastically deformable metal.

[0409] Generally, the occlusion device 210 is configured such that inflation of the capsule chamber 232 transitions the orifice support stent 290 from its radially compressed state to its radially expanded state. In some applications, because the orifice support stent 290 comprises a super-elastic metal, such as Nitinol, the minimum diameter of the stent when crimped is dependent on the thickness of its wall struts. When the stent is released, the diameter of the stent tends to transition toward a released diameter that is larger than the crimped diameter. In the configuration in which the capsule 230 is inflated within the stent, the stent will be over-stretched, its diameter will be greater than its released diameter, the extent of which is dependent on the design and ability of the stent struts to over-expand.

[0410] For some applications, the occlusion device 210 further comprises a proximal tube 252 that is axially fixed relative to the proximal portion 238 of the balloon 230. For these applications, the proximal LAA-orifice cover 70 is fixed to the proximal tube, radially surrounds the proximal tube 252, and is indirectly connected to the balloon 230 via the proximal tube 252, rather than being directly connected to the balloon 230.

[0411] Reference is now made to Figure 10 which is a schematic illustration of an occlusion device 310 for occluding an LAA, according to an application of the present application. The occlusion device 310 is used with a delivery system 320. The occlusion device 310 is similar to the occlusion device 10 described above with reference to Figures 1-5 and can implement any of its features mutatis mutandis. Similarly, the delivery system 320 is similar to the delivery system 20 described above with reference to Figures 1-5 and can implement any of its features mutatis mutandis. Like reference numerals refer to like parts.

[0412] Reference is also made to Figure 11 which is a schematic cross-sectional view of a distal portion of the occlusion device 310 and the delivery system 320, according to an application of the present application. Figure 10 and Figure 11 both show the occlusion device 310 in connection with the delivery system 320. Figure 10 shows the occlusion device 310 with the balloon 330 in an elongated state, Figure 11 shows the occlusion device 310 with the balloon 330 in a shortened state, as described below.

[0413] The occlusion device 310 comprises:

[0414] • a compliant balloon 330 that defines a fluid-tight balloon chamber 332; the balloon 330 can have any of the properties of the balloon 30 described above with reference to Figures 1-5 ;

[0415] • a proximal tube 352 that is axially fixed relative to the proximal portion 338 of the balloon 330;

[0416] • a spring 353; and

[0417] • a valve 342 that can implement any of the features of the valves described herein.

[0418] The spring 353 (a) is at least partially disposed within the balloon chamber 232, (b) is connected (directly or indirectly, e.g., via a tube) to the distal portion 336 of the balloon 330 and to the proximal tube 352, and (c) has a relaxed length, as described above with reference to Figure 11as shown. When the spring 353 has a relaxed length, the distal portion 336 of the balloon 330 is a relaxed distance from the proximal portion 338 of the balloon 330, as shown. Figure 11

[0419] The delivery system 320 is configured to releasably connect to the occlusion device 310. The delivery system 320 includes a probe 355 that is removably disposed through the proximal tube 352 and within the spring 353. The occlusion device 310 is configured such that the extent to which the probe 355 is advanced distally within the spring 353 sets the tensioned length of the spring 353, which in turn sets the tensioned distance between the distal portion 336 and the proximal portion 338 of the balloon 330, which is greater than the relaxed distance. One possible tensioned distance is shown in Figure 10

[0420] Generally, during deployment of the occlusion device 310 in the LAA, the occlusion device 310 is advanced into the LAA with the spring 353 in an elongated, tensioned state. The balloon chamber 332 is generally inflated while the spring 353 is in the elongated, tensioned state, e.g., as shown in Figure 10 Figure 11

[0421] For some applications, the distal portion of the probe 355 is releasably connected to an occlusion device connector 357 of the occlusion device 310, which is connected to the distal portion 336 of the balloon 330. (Even though the probe 355 is generally held in place, even if not connected to the occlusion device 310, the probe 355 can come out of the center of the spring 353 and engage the spring 353 during deployment of the occlusion device 310 and inflation of the balloon 330.) For these applications, the probe 355 is disconnected from the occlusion device connector 357 after the spring 353 is allowed to shorten. For example, the ends of the probe 355 and the occlusion device connector 357 can define respective threads.

[0422] Optionally, the probe 355 is flexible, e.g., highly flexible, to accommodate variations in LAA anatomy, including curvature of the LAA.

[0423] Reference is now made to Figure 12A Figs. -B, 13A-B and 14A-B, which are schematic illustrations of an occlusion device 510 for occluding an LAA, in accordance with an application of the present application. The occlusion device 510 is used with a delivery system, e.g., as described above with reference to Figures 1-4C ; and as described above with reference to Figures 6-7C ​​​​As described, for use with conveyor system 120; as referenced above. Figures 8-9B As described, for use with conveyor system 220; or as referenced above. Figures 10-11 As described, it is used with the conveying system 320. Except as described below, the blocking device 510 is similar to the one referenced above. Figures 1-5 The blocking device 10 is described above, and any of its features can be implemented with necessary modifications. The same reference numerals denote the same components. Alternatively or additionally, the blocking device 510 can optionally implement the features described above with necessary modifications. Figure 6 and 7A -C describes any feature of the blocking device 110; see above. Figure 8 and 9A -B describes any feature of the blocking device 210; see above. Figure 10 and 11 Any features of the described blocking device 310; and / or referenced above Figure 7D Any features of the described blocking device 410. By way of example and not limitation, the blocking device 510 may optionally include a proximal left AA-hole cap 70, as shown in the figure. Similarly, these other blocking devices described herein may optionally implement any features of the blocking device 510 with necessary modifications.

[0424] Figure 12A -B shows the blocking device 510 behind the sheath 82, such as Figure 3A As shown, it is retracted proximally, thereby releasing the occlusion device 510 and allowing the proximal LAA-orifice cap 70 to transition to its radially expanded state. This is consistent with... Figure 3B The arrangement of the occlusion device 10 shown is similar. During this arrangement phase, the capsule 30 maintains a non-expanded, elongated configuration.

[0425] Figure 13A -B shows the occlusion device 510 when the cyst chamber 32 is partially inflated.

[0426] Figure 14A -B illustrates the occlusion device 510 when the cyst chamber 32 is finally inflated. The cyst chamber 32 can inflate at different final inflated levels, depending on the degree of radial expansion required by the specific anatomy of the LAA. Typically, the occlusion device 510 is configured to inflate radially to a diameter between 15 mm and 40 mm, for example, between 20 mm and 35 mm.

[0427] The occlusive device 510 includes a plurality of connecting struts 580 that are secured to the distal end portion 36 of the balloon 30 and to the proximal end portion 38 of the balloon 30. The struts 580 can implement any of the features of the struts 80 described above, mutatis mutandis. A first side portion 581 A of the strut 580 is disposed along a side surface of the balloon 30. A second distal end portion 581 B of the strut 580 is disposed on a distal end surface of the balloon 30. A third proximal end portion 580C of the strut 580 is disposed on a proximal end surface of the balloon 580. Typically, the second distal end portion 581 B and the third proximal end portion 580C are straight. Typically, the first side portion 581 A is oriented parallel to a central longitudinal axis of the occlusive device 510.

[0428] For some applications, distal interface portions 583A of the struts 580 respectively connect the first side portions 581 A and the second distal end portions 581 B, and / or proximal interface portions 583B respectively connect the first side portions 581 A and the third proximal end portions 581 C. The occlusive device 510 is configured such that, upon inflation of the balloon chamber 32, the distal interface portions 583A and the proximal interface portions 583B bend, e.g., as shown in Figure 13A -B and 14A-B. Figure 12A -B shows the balloon chamber 32 uninflated, Figure 13A -B shows the balloon chamber 32 partially inflated, Figure 14A -B shows the balloon chamber 32 fully inflated. For some of these applications, the distal interface portions 583A and / or the proximal interface portions 583B have a serpentine (e.g., sinusoidal) shape, as shown. This serpentine shape causes the distal interface portions 583A and / or the proximal interface portions 583B to be more compliant than the first side portions 581 A, the second distal end portions 581 B, and / or the third proximal end portions 581 C. As a result, the occlusive device 510 assumes a more cylindrical shape upon inflation and shortening of the balloon. Optionally, the first side portions 581 A of the struts 580 are typically straight, which also contributes to the cylindrical shape of the occlusive device 510.

[0429] For some applications, distal portions 585A of the struts 580 respectively connect the second distal end portions 581 B of the struts 580 to the distal end portion 36 of the balloon 30, and / or proximal portions 585B of the struts 580 respectively connect the third proximal end portions 581 C of the struts 580 to the proximal end portion 38 of the balloon 30. The occlusive device 510 is configured such that, upon inflation of the balloon chamber 32, the distal portions 585A and the proximal portions 585B bend. Figure 12A -B shows the balloon chamber 32 uninflated, Figure 13A -B shows the balloon chamber 32 partially inflated, Figure 14A-B shows the capsule chamber 32 in its final inflation. For some of these applications, the distal portion 585A and / or the proximal portion 585B has a serpentine (e.g., sinusoidal) shape, as shown. This serpentine allows the distal portion 585A and / or the proximal portion 585B to elongate, thereby allowing the occlusion device 510 to radially expand to a diameter of, for example, between 15 mm and 40 mm, for example, between 20 mm and 35 mm, for example, between 15 mm and 35 mm. This serpentine shape also allows the distal portion 585A and / or the proximal portion 585B to selectively elongate, thereby accommodating different degrees of inflation of the capsule 30 in different radial directions.

[0430] In some applications, the struts 580 are shaped to define a plurality of spikes 589 extending respectively from a plurality of outer ends 599 of the second distal portion 581B (at Figure 12A and 14A noted in FIGS. 5A-5B). When the capsule is in the non-inflated, elongated configuration, the spikes 589 are initially generally axially oriented, as shown in Figure 12A -B. The spikes 589 are configured to extend more radially upon inflation of the capsule chamber 32 to act as tissue-engaging barbs, as shown in Figure 14A -B. The respective axes of the spikes 589 can be parallel to the axes of the second distal portion 581B and the third proximal portion 581C, or slightly tilted with respect to the axes of the second distal portion 581B and the third proximal portion 581C.

[0431] For some applications, the distal interface portion 583A is shaped to define a plurality of respective pairs of parallel serpentine (e.g., sinusoidal) struts 591A and 591B defining a plurality of respective elongated gaps 593 therebetween. When the spikes 589 are initially generally axially oriented, as shown in Figure 12A -B, the spikes are disposed in the respective gaps 593. The respective tips 595 of the spikes 589 are disposed proximate respective end surfaces 597 of the gaps 593 at the respective junctions between the parallel serpentine struts 591A and 591B, such that the respective tips 595 of the spikes 589 are protected by the respective end surfaces 597 until the spikes are radially deployed. Alternatively or additionally, the proximal interface portion 583B and its corresponding spikes 589 can implement this feature.

[0432] For some applications, the connecting strut 580 also includes closed support cells 587 that connect adjacent pairs of first side portions 581A. Optionally, two or more closed support cells 587 arranged in series connect adjacent pairs of first side portions 581A (in the figures, two closed support cells 587 arranged in series connecting adjacent pairs of first side portions 581A are shown precisely). Typically, no more than four closed support cells 587 arranged in series are used, for example, exactly two or three closed support cells 587 arranged in series. These connections of the closed support cells 587 can help to laterally stabilize the first side portions 581A during cyst chamber expansion and can help to limit the shape of the cyst during cyst chamber expansion by helping to limit the radial expansion of the cyst from the strut. By providing a sufficiently large contraction surface with respect to the LAA wall, these connections of the closed support cells 587 can alternatively or additionally stabilize the insertion of the occlusion device 510 by friction. Optionally, as shown, a single series of two or more closed support cells 587 connects the first side portions 581A of adjacent pairs; or, two or more series (e.g., exactly two series) of two or more closed support cells 587 connect the first side portions 581A of adjacent pairs (configuration not shown).

[0433] Typically, the average width of the struts of the first side portion 581A is at least 200% of the average width of the struts of the closed stent cell 587, for example, at least 250%, 300%, or 400%. As described above, the first side portion 581A is typically oriented parallel to the central longitudinal axis of the occlusion device 510. The struts of the closed stent cell 587 may have these thinner widths to allow the closed stent cell to expand as the bladder expands.

[0434] In some applications, the closed stent cell 587 is shaped into a corresponding rhombus. The rhombuses can be radially compressed for delivery, allowing them to expand symmetrically in a predictable manner, unlike many other stent shapes that tend to expand asymmetrically (e.g., S-shapes and serpentine shapes). The rhombuses typically also return to their original shape after plastic radial compression for implantation. In some applications, the rhombuses can be shaped into squares and / or rhombuses at certain levels of radial compression and expansion.

[0435] In one embodiment, the technology and apparatus described herein are combined with the technology and apparatus described in one or more of the following patent applications, which have been assigned to the assignee of this application and are incorporated herein by reference:

[0436] •Published text of European patent application EP 3459469 A1 by Maisano et al.;

[0437] • PCT publication WO 2019 / 057950 to Maisano et al.;

[0438] • PCT publication WO 2020 / 060587 to Maisano et al.; and / or

[0439] • U.S. Provisional Application No. 62 / 906,393, filed September 26, 2019.

[0440] Those skilled in the art will appreciate that the application is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present application includes both combinations and sub-combinations of the various features described above, as well as variations and modifications not specifically described herein, which would be apparent to one of ordinary skill in the art upon reading the above description.

Claims

1. An occlusion device for occluding the left atrial appendage, said occlusion device being used in conjunction with a delivery system, characterized in that, The blocking device includes: A compliant capsule defines a fluid-sealed capsule chamber; An actuating shaft is provided, wherein (a) it is at least partially disposed in the cyst chamber, (b) it is connected to a distal portion of the cyst, and (c) it is longitudinally movable relative to a proximal portion of the cyst so as to establish a distance between the distal and proximal portions of the cyst. A proximal left atrial appendage orifice cap, said proximal left atrial appendage orifice cap (a) configured in a radially compressed state or a radially expanded state, (b) comprising a frame and a cap body fixed to said frame, and (c) when in the radially expanded state, being substantially orthogonal to said actuation axis and having a maximum dimension between 10 mm and 50 mm perpendicular to said actuation axis; and An orifice support bracket, the orifice support bracket (a) being fixed to the proximal left atrial appendage orifice cover and extending distally from the proximal left atrial appendage orifice cover, (b) being configured to be in a radially compressed state or a radially expanded state, and (c) being cylindrical when in the radially expanded state.

2. The blocking device according to claim 1, characterized in that, When in the radially expanded state, the orifice support has (i) a maximum dimension between 8 mm and 50 mm, measured perpendicular to the actuation shaft, and (ii) an axial length between 4 mm and 30 mm.

3. The blocking device according to claim 1, characterized in that, The occlusion device further includes a distal end disposed at the distal portion of the bladder, wherein the actuation shaft is connected to the distal end.

4. The blocking device according to claim 1, characterized in that, The actuation shaft is shaped to at least partially define a distal end, which is disposed at the distal portion of the bladder.

5. The blocking device according to claim 1, characterized in that, The occlusion device further includes a proximal base disposed at the proximal end of the cyst, wherein the actuation shaft is movable relative to the proximal base.

6. The blocking device according to claim 1, characterized in that, The occlusion device is used with a guidewire, wherein the actuation shaft is shaped to define a guidewire cavity for slidably receiving the guidewire therein.

7. The blocking device according to claim 1, characterized in that, The compliant capsule comprises a compliant material selected from the group consisting of: polycaprolactone, polyglycolic acid, polylactic acid, polydioxane, silicone, polyurethane, polytetrafluoroethylene, polymethyl methacrylate, polyether ether ketone, polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, and polyether block amide.

8. The blocking device according to any one of claims 1-7, characterized in that, The orifice support bracket is not fixed to the bladder body, so that the shape of the bladder body can be changed independently of the shape of the orifice support bracket.

9. The blocking device according to any one of claims 1-7, characterized in that, The occlusion device is configured such that the expansion of the cyst chamber causes the orifice support to change from its radially compressed state to its radially expanded state.

10. The blocking device according to any one of claims 1-7, characterized in that, The occlusion device further includes a proximal tube, which is axially fixed relative to the proximal portion of the capsule, and The proximal left atrial appendage orifice cap is fixed to the proximal tube, radially surrounds the proximal tube, and is indirectly connected to the cyst body via the proximal tube, rather than directly connected to the cyst body.

11. The blocking device according to claim 10, characterized in that, The actuation shaft is slidably disposed within the proximal tube.

12. The blocking device according to any one of claims 1-7, characterized in that, The occlusion device also includes multiple connecting struts fixed to the distal portion and the proximal portion of the bladder.

13. The blocking device according to claim 12, characterized in that, The occlusion device is configured such that the expansion of the bladder chamber causes plastic deformation of the plurality of connecting struts.

14. The blocking device according to claim 12, characterized in that, The occlusion device is configured such that shortening of the bladder causes plastic deformation of the plurality of connecting struts.

15. The blocking device according to any one of claims 1-7, characterized in that, The average wall thickness of the capsule is between 100 micrometers and 5000 micrometers.

16. The blocking device according to any one of claims 1-7, characterized in that, The capsule has a minimum wall thickness between 20 micrometers and 500 micrometers at its thinnest portion.

17. The blocking device according to any one of claims 1-7, characterized in that, The blocking device also includes a valve.

18. The blocking device according to claim 17, characterized in that, The blocking device is shaped to define a fluid flow path, and The valve is configured to selectively allow or block fluid flow between the fluid flow path and the bladder chamber when the valve is in an open and closed state, respectively.

19. The blocking device according to claim 18, characterized in that, The blocking device is shaped to define the fluid flow path along a portion of the actuation shaft. The occlusion device further includes a locking mechanism configured to be in a locked or unlocked state, and when in the locked state, the locking mechanism is configured to maintain a distance between the distal and proximal portions of the capsule. The blocking device is configured to reduce the distance by longitudinally moving the proximal end of the actuation shaft. (a) When the distance decreases to a first predetermined distance between the distal and proximal portions of the capsule, the valve is automatically switched from the open state to the closed state, and (b) When the distance is reduced to a second predetermined distance between the distal end and the proximal end of the capsule, the locking mechanism is automatically switched from the unlocked state to the locked state.

20. The blocking device according to claim 19, characterized in that, The blocking device is configured to be releasably connected to the conveying system, and wherein the blocking device is configured to allow the fluid flow path to be in fluid communication with the conveying system when the blocking device is releasably connected to the conveying system.

21. The blocking device according to claim 1, characterized in that, The closure device also includes a proximal connector configured to releasably connect the closure device to a correspondingly configured distal connector of the delivery system.

22. The blocking device according to claim 21, characterized in that, The near-end connector is shaped to define a thread.

23. A blocking system, characterized in that, The occlusion system includes an occlusion device according to any one of claims 1-7, the occlusion system further includes an implantable catheter, wherein the occlusion device is releasably disposed in a radially compressed state, wherein the maximum distance between the proximal portion of the capsule and the distal portion of the capsule is between 8 mm and 80 mm.

24. A blocking system, characterized in that, The occlusion system includes an occlusion device according to any one of claims 21-22, the occlusion system being used with a guidewire, and further includes the delivery system cooperating therewith, the delivery system including an implantation catheter connected to an operating handle, the implantation catheter including a longitudinal channel; a distal connector for releasably connecting the implantation catheter to a correspondingly configured proximal connector of the occlusion device; and an expansion tube channel releasably connected to a fluid flow path of the occlusion device.

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