Left atrial appendage closure device

Abstract

To provide an occlusion device for occluding a left atrial appendage.SOLUTION: An occlusion device (210) is provided for occluding a left atrial appendage (LA A), the occlusion device (210) including a compliant balloon (230) defining a fluid-tight balloon chamber (232), and an actuating shaft (234), which is disposed at least partially within the balloon chamber (232) for setting a distance between a distal end portion and a proximal end portion (236) of the balloon (230). A proximal LAA-orifice cover (70) includes a frame (72) and a covering (74) fixed to the frame (72). An orifice- support stent (290) is fixed to the proximal LAA-orifice cover (70) and extends distally from the proximal LAA-orifice cover (70), and is generally cylindrical when in a radially-expanded state. Other embodiments are also described.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 906,393, filed September 26, 2019, which is assigned to the assignee of the present application and incorporated herein by reference.

[0002] The present invention relates generally to a closure device for closing the left atrial appendage. [Background technology]

[0003] The left atrial appendage (LAA) is a cavity located in the left atrium of the heart. In patients with atrial fibrillation, the passage and stability of blood within this cavity can lead to thrombus formation, which increases the risk of stroke. Percutaneous LAA closure is a treatment for preventing stroke in patients with atrial fibrillation. LAA closure is used as an alternative to or in combination with oral anticoagulation therapy. While LAA closure results in favorable clinical outcomes, commercially available devices are typically self-expanding and are not designed to accommodate the anatomy of the LAA, which can lead to complications and suboptimal outcomes. In these environments, some currently available closure devices are limited by poor device adaptability to the defect (lack of fit) and a lack of sealing within the device (due to high-flow environments).

[0004] WO 2019 / 057950 to Maisano et al. describes an occluder device for closing a gap between a cardiovascular anomaly or a medical device and adjacent body tissue, the occluder device including a compliant balloon defining a fluid-tight balloon chamber and provided with a balloon channel forming a longitudinal passageway from a proximal side to a distal side of the balloon; a tip element disposed distal to the balloon; a base element disposed proximal to the balloon; connection means including at least one connecting strut attached to the tip element and the base element, each having a guide opening substantially coaxial with the balloon channel for slidably receiving a guide wire for the device therein; elongate actuation means slidably disposed longitudinally in the balloon channel, releasably connectable to the tip element and longitudinally slidable relative to the base element; locking means for maintaining a predetermined distance between the tip element and the base element; and proximal connector means for releasably connecting the occluder device to a correspondingly configured distal connector means of a catheter device. The balloon includes a fluid port for filling and withdrawing fluid from the balloon chamber.The occluder system includes an occluder device and a catheter device cooperating therewith.

[0005] U.S. Patent No. 6,652,556 to VanTassel et al. describes a device for permanent placement across the ostium of a patient's left atrial appendage, which includes a filtering membrane configured to extend across the ostium of the left atrial appendage. The filtering membrane has a permeable structure that allows blood to flow through it but substantially inhibits thrombus passage therethrough. The device also includes a support structure including a plurality of fingers that are expandable radially outward relative to the longitudinal axis to permanently engage the inner wall of the left atrial appendage. The filtering membrane is attached to the support structure that extends across the ostium of the left atrial appendage. Summary of the Invention

[0006] Some embodiments of the present invention provide a closure device for mechanically closing the left atrial appendage (LAA). The closure device includes a compliant balloon defining a fluid-tight balloon chamber, and an actuation shaft (a) at least partially disposed within the balloon chamber, (b) connected to a distal end portion of the balloon, and (c) longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal and proximal end portions of the balloon. The closure device also includes a valve that can close after inflation of the balloon chamber.

[0007] The shape and compliance of the closure device, optionally including plastic deformation of its struts, allows the closure device to fixate and seal the LAA while also conforming and adapting to the geometric attributes of the LAA, thereby filling the LAA space at least to some extent regardless of the particular morphological type of the LAA.

[0008] Additionally, a delivery system is provided that allows for over-the-wire engagement into the LAA, adjustment of the length and orientation of the closure device during deployment, and inflation of the balloon chamber with saline or another filling fluid.

[0009] The closure devices described herein are designed to be delivered to the LAA in a longitudinally stretched and fully or partially compressed state. After delivery, the closure device is adapted to the anatomical structure of the anchoring zone by inflating the balloon chamber and shortening the longitudinal dimension of the struts arranged between the proximal and distal end portions of the balloon. Under the influence of internal pressure from inflation, the balloon chamber occupies a specific volume, which results in specific transverse or radial dimensions for a specific longitudinal balloon dimension, providing a good seal between the balloon and the adjacent anatomical structures of the LAA. Changing the longitudinal dimension of the balloon by selecting different distances between the distal and proximal end portions of the balloon results in a corresponding change in the radial or transverse extension of the balloon. In other words, shortening the distance between the distal and proximal end portions of the balloon, under otherwise constant conditions, correspondingly increases the radial or transverse extension, improving the seal with the adjacent tissue of the LAA and reducing unwanted blood flow. The lateral extension of the balloon is not necessarily symmetrical because the balloon is not necessarily symmetrical and / or the anatomy through which the balloon is laterally expanded may cause asymmetric balloon expansion. Radial or lateral expansion together include within their scope one or more directions generally perpendicular to the longitudinal axis of the balloon.

[0010] In the context of this disclosure, the terms "distal" and "proximal" are used according to their standard meanings in the field of percutaneous cardiovascular devices. The term "proximal" refers to components of a device assembly that are closer to the end of the catheter configured for manipulation by the user (e.g., the catheter handle manipulated by the physician) when tracking a delivery catheter during percutaneous delivery. The term "distal" is used to refer to components of a device assembly that are further away from the end of the catheter configured for manipulation by the user and / or that are inserted further into the patient's body.

[0011] The term "compliant" as used herein with respect to a balloon or structural component means the ability to deform substantially in response to an applied force. Thus, a "compliant balloon" refers to a balloon that will gradually expand under the effect of increasing radial pressure, provided that a specified burst pressure is not exceeded.

[0012] As used herein, the term "strut" means an elongated structural element that can be formed, for example, of a thin wire, rod, or thick-walled tube, all of which do not necessarily have a circular cross section.

[0013] Thus, in accordance with inventive concept 1 of the present invention, there is provided a closure device for occluding a left atrial appendage (LAA), the closure device being for use with a delivery system, the closure device comprising: a compliant balloon defining a fluid-tight balloon chamber; an actuation shaft (a) at least partially disposed within the balloon chamber, (b) connected to the distal end portion of the balloon, and (c) longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; (a) a proximal LAA-orifice cover configured to occupy a radially compressed state and a radially expanded state; (b) a frame and a cover secured to the frame; and (c) a proximal LAA-orifice cover, when in the radially expanded state, generally perpendicular to the actuation shaft and having a maximum dimension measured perpendicular to the actuation shaft of 10 to 50 mm. A closure device is provided, comprising: (a) an orifice support stent secured to and extending distally from the proximal LAA-orifice cover; (b) configured to occupy a radially compressed state and a radially expanded state; and (c) a generally cylindrical shape when in the radially expanded state.

[0014] Inventive concept 2. The closure device of inventive concept 1, wherein the orifice-supporting stent, when in a radially expanded state, has (i) a maximum dimension measured perpendicular to the actuation shaft of 8 to 50 mm, and (ii) an axial length of 4 to 30 mm.

[0015] Inventive concept 3. The closure device of inventive concept 1, wherein the closure device further comprises a distal tip disposed at a distal end portion of the balloon, the actuation shaft being connected to the distal tip.

[0016] Inventive concept 4. The closure device of inventive concept 1, wherein the actuation shaft is configured to at least partially define a distal tip disposed at the distal end portion of the balloon.

[0017] Inventive concept 5. The closure device of inventive concept 1, wherein the closure device further includes a proximal base disposed at a proximal end portion of the balloon, and wherein the actuation shaft is movable relative to the proximal base.

[0018] Inventive concept 6. A closure device according to inventive concept 1 for use with a guidewire, wherein the actuation shaft is configured to define a guidewire lumen for slidably receiving the guidewire therein.

[0019] Inventive Concept 7. The closure device of Inventive Concept 1, wherein the compliant balloon comprises a compliant material selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and 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).

[0020] Inventive Concept 8. The closure device of any one of Inventive Concepts 1-7, wherein the orifice support stent is not fixed to the balloon such that the shape of the balloon can change independently of the shape of the orifice support stent.

[0021] Inventive Concept 9. The closure device of any one of Inventive Concepts 1-7, wherein the closure device is configured such that inflation of the balloon chamber transitions the orifice-supporting stent from its radially compressed state to its radially expanded state.

[0022] Inventive Concept10. The closure device further includes a proximal tube axially secured to the proximal end portion of the balloon; A closure device according to any one of inventive concepts 1 to 7, wherein the proximal LAA-orifice cover is fixed to the proximal tube so as to radially surround the proximal tube and is indirectly connected to the balloon via the proximal tube, and is not directly connected to the balloon.

[0023] Inventive concept 11. The closure device of inventive concept 10, wherein the actuation shaft is slidably disposed partially within the proximal tube.

[0024] Inventive Concept 12. The closure device of any one of Inventive Concepts 1-7, wherein the closure device further comprises a connecting strut secured to the distal end portion of the balloon and the proximal end portion of the balloon.

[0025] Inventive concept 13. The closure device of inventive concept 12, wherein the closure device is configured such that inflation of the balloon chamber plastically deforms the connecting struts.

[0026] Inventive concept 14. The closure device of inventive concept 12, wherein the closure device is configured such that shortening of the balloon plastically deforms the connecting struts.

[0027] Inventive concept 15. The occlusion device of any one of inventive concepts 1-7, wherein the balloon has an average wall thickness of 100-5000 microns.

[0028] Inventive Concept 16. The occlusion device of any one of Inventive Concepts 1-7, wherein the balloon has a thinnest wall thickness of between 20 and 500 microns at the thinnest portion of the balloon wall.

[0029] Inventive concept 17. A closure system comprising the closure device of any one of inventive concepts 1 to 7, the closure system further comprising an implant catheter, the closure device being releasably disposed within the implant catheter in a radially compressed state, and the maximum distance between the proximal end portion of the balloon and the distal end portion of the balloon being 8 to 80 mm.

[0030] Inventive concept 18. The closure device of any one of inventive concepts 1-7, further comprising a valve.

[0031] Inventive Concept19. the closure device is configured to define a fluid flow path; 19. A closure device according to inventive concept 18, wherein the valve is configured to selectively allow or block fluid flow between the fluid flow path and the balloon chamber when the valve is in an open state and a closed state, respectively.

[0032] Inventive Concept20. the closure device is configured to define a fluid flow path along a portion of the actuation shaft; the closure device further includes a locking mechanism configured to assume a locked state and an unlocked state, and configured, when in the locked state, to maintain a set distance between the distal end portion of the balloon and the proximal end portion of the balloon using an actuation shaft; The closure device is actuated by proximal longitudinal movement of the actuation shaft. (a) a decrease in the distance between the distal end portion and the proximal end portion of the balloon to a first predetermined distance automatically transitions the valve from an open state to a closed state; (b) A closure device as defined in inventive concept 19, configured such that a decrease in the distance between the distal end portion and the proximal end portion of the balloon to a second predetermined distance automatically transitions the locking mechanism from an unlocked state to a locked state.

[0033] Inventive concept 21. The closure device of inventive concept 20, wherein the closure device is configured to be releasably connected to a delivery system, and the closure device is configured such that the fluid flow path is coupled in fluid communication with the delivery system when the closure device is releasably connected to the delivery system.

[0034] Inventive concept 22. The closure device of inventive concept 1, wherein the closure device further includes a proximal connector configured to releasably connect the closure device to a correspondingly configured distal connector of the delivery system.

[0035] Inventive concept 23. The closure device of inventive concept 22, wherein the proximal connector is shaped to define a screw thread.

[0036] Inventive Concept 24. A closure system including a closure device according to any one of Inventive Concepts 22-23, the closure system being for use with a guidewire and further including a delivery system cooperating with the guidewire, the delivery system including an implant catheter connected to an operating handle, the implant catheter including a longitudinal passage for the guidewire and a distal connector for releasably connecting the implant catheter to a correspondingly configured proximal connector of the closure device, and an inflation tube channel releasably connectable to a fluid flow path of the closure device.

[0037] Further in accordance with inventive concept 25 of the present invention, there is provided a closure device for occluding a left atrial appendage (LAA), the closure device being for use with a delivery system, the closure device comprising: a compliant balloon defining a fluid-tight balloon chamber; an actuation shaft (a) at least partially disposed within the balloon chamber, (b) connected to the distal end portion of the balloon, and (c) longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; a locking mechanism configured to assume a locked state and an unlocked state, and configured, when in the locked state, to maintain a set distance between the distal end portion of the balloon and the proximal end portion of the balloon using an actuation shaft; a valve; the closure device is configured to define a fluid flow path along a portion of the actuation shaft; the valve is configured to selectively permit or block fluid flow between the fluid flow path and the balloon chamber when the valve is in an open state and a closed state, respectively; The closure device is actuated by proximal longitudinal movement of the actuation shaft. (a) a decrease in the distance between the distal end portion and the proximal end portion of the balloon to a first predetermined distance automatically transitions the valve from an open state to a closed state; (b) A closure device is further provided, wherein the closure device is configured such that a decrease in the distance between the distal end portion and the proximal end portion of the balloon to a second predetermined distance automatically transitions the locking mechanism from an unlocked state to a locked state.

[0038] Inventive concept 26. The closure device of inventive concept 25, wherein the first predetermined distance is not equal to the second predetermined distance.

[0039] Inventive concept 27. The closure device of inventive concept 26, wherein the first predetermined distance is less than the second predetermined distance.

[0040] Inventive concept 28. The closure device of inventive concept 25, wherein the first predetermined distance is equal to the second predetermined distance.

[0041] Inventive concept 29. The closure device of inventive concept 25, wherein the closure device is configured to be releasably connected to the delivery system, and the closure device is configured such that the fluid flow path is coupled in fluid communication with the delivery system when the closure device is releasably connected to the delivery system.

[0042] Inventive concept 30. The closure device of inventive concept 25, wherein the closure device further includes a distal tip disposed at a distal end portion of the balloon, the actuation shaft being connected to the distal tip.

[0043] Inventive concept 31. The closure device of inventive concept 25, wherein the actuation shaft is configured to at least partially define a distal tip disposed at the distal end portion of the balloon.

[0044] Inventive concept 32. The closure device of inventive concept 25, wherein the closure device further includes a proximal base disposed at a proximal end portion of the balloon, and wherein the actuation shaft is movable relative to the proximal base.

[0045] Inventive concept 33. The closure device of inventive concept 25 for use with a guidewire, wherein the actuation shaft is configured to define a guidewire lumen for slidably receiving the guidewire therein.

[0046] Inventive concept 34. The occlusion device of inventive concept 25, wherein the compliant balloon comprises a compliant material selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and 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).

[0047] Inventive Concept 35. The closure device of any one of Inventive Concepts 25-34, wherein the closure device is configured to define a fluid flow path along a portion of the actuation shaft.

[0048] Inventive concept 36. A closure device according to any one of inventive concepts 25 to 34, wherein the valve is disposed along the actuation shaft.

[0049] Inventive concept 37. A closure device according to any one of inventive concepts 25-34, wherein the closure device further includes a proximal tube axially fixed relative to the proximal end portion of the balloon, and the actuation shaft is partially slidably disposed within the proximal tube.

[0050] Inventive concept 38. The closure device of inventive concept 37, wherein the closure device is configured to define a fluid flow path along a portion of the actuation shaft in a radial direction between an outer surface of the actuation shaft and an inner surface of the proximal tube.

[0051] Inventive concept 39. The closure device of inventive concept 38, wherein the valve is disposed along the actuation shaft.

[0052] Inventive concept 40. The closure device of inventive concept 39, wherein the valve includes a seal about at least a portion of an outer surface of the actuation shaft, the valve being configured to occupy an open state when the seal is disposed in one or more first axial positions relative to the proximal tube and to occupy a 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.

[0053] Inventive concept 41. The closure device of inventive concept 40, wherein the seal, actuation shaft, and proximal tube are arranged to block fluid flow from the distal end of the proximal tube at least when the seal is disposed in one or more first axial positions relative to the proximal tube.

[0054] Inventive concept 42. A closure device according to inventive concept 38, wherein the wall of the proximal tube is shaped to define one or more tabs passing through the wall, the one or more tabs being biased to flex radially inward, and wherein when the valve is in an open state, a fluid flow path passes through the wall between a proximal end of each of the one or more tabs and a tab-free portion of the wall axially adjacent to the one or more tabs.

[0055] Inventive concept 43. The closure device of inventive concept 42, wherein the tab-free portion of the wall is disposed proximal to one or more tabs.

[0056] Inventive concept 44. A closure device according to inventive concept 42, wherein the outer surface of the actuation shaft is shaped to define one or more protrusions about at least a portion of the actuation shaft, and wherein the proximal ends of the one or more tabs 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 of the one or more tabs, thereby causing the locking mechanism to assume a locked state.

[0057] Inventive concept 45. The closure device of inventive concept 37, wherein the closure device further includes a proximal LAA-orifice cover, the proximal LAA-orifice cover (a) radially surrounding and secured to the proximal tube, (b) configured to occupy a radially compressed state and a radially expanded state, (c) including a frame and a cover secured to the frame, (d) in the radially expanded state, having a maximum dimension measured perpendicular to the proximal tube generally perpendicular to the proximal tube of 10 to 50 mm, and (e) indirectly connected to the balloon via the proximal tube and not directly connected to the balloon.

[0058] Inventive concept 46. The closure device of inventive concept 45, wherein the closure device further comprises an orifice support stent: (a) secured to and extending distally from the proximal LAA-orifice cover; (b) configured to occupy a radially compressed state and a radially expanded state; and (c) generally cylindrical when in the radially expanded state.

[0059] Inventive concept 47. The closure device of inventive concept 46, wherein the orifice-supporting stent, when in a radially expanded state, has (i) a maximum dimension measured perpendicular to the actuation shaft of 8 to 50 mm, and (ii) an axial length of 4 to 30 mm.

[0060] Inventive concept 48. The closure device of any one of inventive concepts 25-34, wherein the closure device further comprises a connecting strut secured to the distal end portion of the balloon and the proximal end portion of the balloon.

[0061] Inventive concept 49. The closure device of inventive concept 48, wherein the closure device is configured such that inflation of the balloon chamber plastically deforms the connecting struts.

[0062] Inventive concept 50. The closure device of inventive concept 48, wherein the closure device is configured such that shortening of the balloon plastically deforms the connecting struts.

[0063] Inventive concept 51. The occlusion device of any one of inventive concepts 25-34, wherein the balloon has an average wall thickness of 100-5000 microns.

[0064] Inventive concept 52. The occlusion device of any one of inventive concepts 25-34, wherein the balloon has a thinnest wall thickness of between 20 and 500 microns at the thinnest portion of the balloon wall.

[0065] Inventive concept 53. A closure system comprising a closure device according to any one of inventive concepts 25-34, the closure system further comprising an implant catheter, the closure device being releasably disposed within the implant catheter in a radially compressed state, and the maximum distance between the proximal end portion of the balloon and the distal end portion of the balloon being 8-80 mm.

[0066] Inventive concept 54. The closure device of any one of inventive concepts 25-34, wherein the closure device further comprises a proximal connector configured to releasably connect the closure device to a correspondingly configured distal connector of the delivery system.

[0067] Inventive concept 55. The closure device of inventive concept 54, wherein the proximal connector is shaped to define a screw thread.

[0068] Inventive Concept 56. A closure system including a closure device according to any one of Inventive Concepts 25-34, the closure system being for use with a guidewire and further including a delivery system cooperating with the guidewire, the delivery system including an implant catheter connected to an operating handle, the implant catheter including a longitudinal passage for the guidewire and a distal connector for releasably connecting the implant catheter to a correspondingly configured proximal connector of the closure device, and an inflation tube channel releasably connectable to a fluid flow path of the closure device.

[0069] Further in accordance with the present inventive concept 57, there is provided a closure device for occluding a left atrial appendage (LAA), the closure device being for use with a delivery system, the closure device comprising: a compliant balloon defining a fluid-tight balloon chamber; an actuation shaft (a) at least partially disposed within the balloon chamber, (b) connected to the distal end portion of the balloon, and (c) longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; a connecting strut secured to the distal end portion of the balloon and the proximal end portion of the balloon, the connecting strut comprising: a first side portion arranged along a side of the balloon; a second distal end portion disposed on the distal surface of the balloon; a third proximal end portion disposed on the proximal surface of the balloon; and A closure device is further provided, comprising: connecting struts each coupling a second distal end portion of the strut to a distal end portion of the balloon, the distal end portion having a serpentine shape, the closure device being configured such that the distal end portions are curved upon inflation of the balloon chamber.

[0070] Inventive concept 58. A closure device according to inventive concept 57, wherein the connecting struts each couple a third proximal end portion of the strut to a proximal end portion of the balloon and include proximal end portions having a serpentine shape, and the closure device is configured such that the proximal end portions are curved upon inflation of the balloon chamber.

[0071] Inventive concept 59. The closure device of inventive concept 57, wherein the connecting struts each join the first lateral portion and the second distal end portion and include a distal interface portion having a serpentine shape, and the closure device is configured such that the distal interface portion is curved upon inflation of the balloon chamber.

[0072] Inventive concept 60. The closure device of inventive concept 57, wherein the connecting struts each join the first lateral portion and the third proximal end portion and include a proximal interface portion having a serpentine shape, and the closure device is configured such that the proximal interface portion is curved upon inflation of the balloon chamber.

[0073] Inventive concept 61. The closure device of inventive concept 57, wherein the first lateral portion of the strut is generally straight.

[0074] Inventive concept 62. The closure device of inventive concept 57, wherein the second distal end portion and the third proximal end portion are generally straight.

[0075] Inventive concept 63. The closure device of inventive concept 57, wherein the first lateral portion of the strut is generally straight, and the second distal end portion and the third proximal end portion are generally straight.

[0076] Inventive concept 64. The closure device of inventive concept 57, wherein the closure device is configured such that inflation of the balloon chamber plastically deforms the connecting struts.

[0077] Inventive concept 65. The closure device of inventive concept 57, wherein the closure device is configured such that shortening of the balloon plastically deforms the connecting struts.

[0078] Inventive Concept66. the distal interface portion is shaped to define respective pairs of parallel serpentine struts defining respective narrow elongated gaps therebetween; The struts are shaped to define a plurality of spikes, the plurality of spikes comprising: each extending from an outer end of the second distal end portion; When the balloons are in an uninflated elongated configuration, they are disposed in respective narrow elongated gaps that are generally axially oriented; A closure device according to any one of inventive concepts 57-65, configured to extend further radially upon inflation of the balloon chamber to function as barbs for engaging tissue.

[0079] Inventive concept 67. The closure device of any one of inventive concepts 57-65, wherein the connecting struts further include closed stent cells connecting adjacent pairs of the first lateral portions.

[0080] Inventive concept 68. The occlusion device of inventive concept 67, wherein two or more closed stent cells arranged in series connect adjacent pairs of the first side portions.

[0081] Inventive concept 69. The occlusion device of inventive concept 67, wherein the closed stent cells are shaped as respective diamonds.

[0082] Inventive concept 70. The closure device of inventive concept 67, wherein the first lateral portion is oriented parallel to a central longitudinal axis of the closure device.

[0083] Inventive concept 71. The occlusion device of inventive concept 67, wherein the average width of the struts of the first lateral portion is equal to at least 200% of the average width of the struts of the closed stent cells.

[0084] Further in accordance with the present inventive concept 72, there is provided a closure device for occluding a left atrial appendage (LAA), the closure device being for use with a delivery system, the closure device comprising: a compliant balloon defining a fluid-tight balloon chamber; an actuation shaft (a) at least partially disposed within the balloon chamber, (b) connected to the distal end portion of the balloon, and (c) longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; a connecting strut secured to the distal end portion of the balloon and the proximal end portion of the balloon, the connecting strut comprising: a first side portion arranged along a side of the balloon; a second distal end portion disposed on the distal surface of the balloon; a third proximal end portion disposed on the proximal surface of the balloon; and and a connecting strut joining the first lateral portion and the second distal end portion, respectively, and including a distal interface portion having a serpentine shape, wherein the closure device is configured such that the distal interface portion curves upon inflation of the balloon chamber.

[0085] Inventive concept 73. The closure device of inventive concept 72, wherein the connecting struts each join the first lateral portion and the third proximal end portion and include a proximal interface portion having a serpentine shape, and the closure device is configured such that the proximal interface portion is curved upon inflation of the balloon chamber.

[0086] Inventive concept 74. The closure device of inventive concept 72, wherein the first lateral portion of the strut is generally straight.

[0087] Inventive concept 75. The closure device of inventive concept 72, wherein the second distal end portion and the third proximal end portion are generally straight.

[0088] Inventive concept 76. The closure device of inventive concept 72, wherein the first lateral portion of the strut is generally straight, and the second distal end portion and the third proximal end portion are generally straight.

[0089] Inventive concept 77. The closure device of inventive concept 72, wherein the closure device is configured such that inflation of the balloon chamber plastically deforms the connecting struts.

[0090] Inventive concept 78. The closure device of inventive concept 72, wherein the closure device is configured such that shortening of the balloon plastically deforms the connecting struts.

[0091] Inventive concept 79. A closure device according to inventive concept 72, wherein the connecting struts each couple a second distal end portion of the strut to a distal end portion of the balloon and include distal end portions having a serpentine shape, and the closure device is configured such that the distal end portions are curved upon inflation of the balloon chamber.

[0092] Inventive concept 80. The closure device of inventive concept 72, wherein the connecting struts each couple a third proximal end portion of the strut to a proximal end portion of the balloon and include proximal end portions having a serpentine shape, and the closure device is configured such that the proximal end portions are curved upon inflation of the balloon chamber.

[0093] Inventive Concept81. the distal interface portion is shaped to define respective pairs of parallel serpentine struts defining respective narrow elongated gaps therebetween; The struts are shaped to define a plurality of spikes, the plurality of spikes comprising: each extending from an outer end of the second distal end portion; When the balloons are in an uninflated elongated configuration, they are disposed in respective narrow elongated gaps that are generally axially oriented; 81. A closure device according to any one of inventive concepts 72-80, configured to extend further radially upon inflation of the balloon chamber to function as tissue-engaging barbs.

[0094] Inventive concept 82. The closure device of any one of inventive concepts 72-80, wherein the connecting struts further include closed stent cells connecting adjacent pairs of the first lateral portions.

[0095] Inventive concept 83. The occlusion device of inventive concept 82, wherein two or more closed stent cells arranged in series connect adjacent pairs of the first side portions.

[0096] Inventive concept 84. The occlusion device of inventive concept 82, wherein the closed stent cells are shaped as respective diamonds.

[0097] Inventive concept 85. The closure device of inventive concept 82, wherein the first lateral portion is oriented parallel to a central longitudinal axis of the closure device.

[0098] Inventive concept 86. The occlusion device of inventive concept 82, wherein the average width of the struts of the first lateral portion is equal to at least 200% of the average width of the struts of the closed stent cells.

[0099] Further in accordance with the present inventive concept 87, there is provided a closure device for occluding a left atrial appendage (LAA), the closure device being for use with a delivery system, the closure device comprising: a compliant balloon defining a fluid-tight balloon chamber; an actuation shaft (a) at least partially disposed within the balloon chamber, (b) connected to the distal end portion of the balloon, and (c) longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; a connecting strut secured to the distal end portion of the balloon and the proximal end portion of the balloon, the connecting strut comprising: a first side portion arranged along a side of the balloon; and and a connecting strut comprising a closed stent cell connecting adjacent pairs of the first side portions.

[0100] Inventive concept 88. The occlusion device of inventive concept 87, wherein two or more closed stent cells arranged in series connect adjacent pairs of the first side portions.

[0101] Inventive concept 89. The occlusion device of inventive concept 87, wherein the closed stent cells are shaped as respective diamonds.

[0102] Inventive concept 90. The closure device of inventive concept 87, wherein the first lateral portion is oriented parallel to a central longitudinal axis of the closure device.

[0103] Inventive concept 91. The occlusion device of inventive concept 87, wherein the average width of the struts of the first lateral portion is equal to at least 200% of the average width of the struts of the closed stent cells.

[0104] In accordance with the present inventive concept 92, there is provided a method for closing a left atrial appendage (LAA) in a patient, the method comprising: Using a delivery system positioning a compliant balloon of a closure device in its longitudinally extended configuration in the LAA; positioning an actuation shaft of a closure device in the LAA, the actuation shaft (a) being at least partially disposed within the balloon chamber, (b) being connected to a distal end portion of the balloon, and (c) being longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; positioning a proximal LAA-orifice cover in the left ventricle outside the LAA against an atrial wall surrounding the orifice of the LAA, the proximal LAA-orifice cover (a) configured to assume a radially compressed state and a radially expanded state, (b) including a frame and a cover secured to the frame, and (c) when in the radially expanded state, generally perpendicular to the actuation shaft and having a maximum dimension measured perpendicular to the actuation shaft of 10 to 50 mm; positioning an orifice-supported stent at least partially in the LAA, the orifice-supported stent (a) secured to and extending distally from the proximal LAA-orifice cover, (b) configured to occupy a radially compressed state and a radially expanded state, and (c) being generally cylindrical when in the radially expanded state; Inflating the compliant balloon by filling the balloon chamber with fluid via a fluid flow path along a portion of the actuation shaft; radially or laterally expanding the balloon by shortening the distance between the distal and proximal end portions of the balloon to a desired distance; Releasing the closure device from the delivery system is also provided.

[0105] Inventive concept 93. The method of inventive concept 92, wherein the orifice support stent is not fixed to the balloon such that the shape of the balloon can change independently of the shape of the orifice support stent.

[0106] Inventive concept 94. A method according to inventive concept 92, wherein the orifice-supporting stent is transitioned from its radially compressed state to its radially expanded state by inflating a compliant balloon.

[0107] In accordance with the present inventive concept 95, there is provided a method for closing a left atrial appendage (LAA) in a patient, the method comprising: positioning a compliant balloon of a closure device in its longitudinally extended configuration in the LAA using a delivery system; inflating a compliant balloon by filling a fluid into a liquid-tight balloon chamber defined by the balloon through a fluid flow path along a portion of an actuation shaft of the closure device when a valve of the closure device is in an open state permitting fluid flow between the fluid flow path and the balloon chamber, the actuation shaft (a) being at least partially disposed within the balloon chamber, (b) being connected to a distal end portion of the balloon, and (c) being longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; The actuation shaft is longitudinally rotated proximally. (a) a first predetermined distance between the distal end portion and the proximal end portion of the balloon that automatically transitions the valve from an open state to a closed state in which the valve blocks fluid flow between the fluid flow path and the balloon chamber; and (b) radially or laterally expanding the balloon by shortening the distance between the distal end portion and the proximal end portion of the balloon to a desired distance by moving the locking mechanism to a second predetermined distance between the distal end portion and the proximal end portion of the balloon, the second predetermined distance automatically transitioning the locking mechanism from an unlocked state to a locked state in which the locking mechanism maintains a distance set using the actuation shaft between the distal end portion of the balloon and the proximal end portion of the balloon; Releasing the closure device from the delivery system is further provided.

[0108] Inventive concept 96. Positioning a balloon in the LAA comprises: advancing a guidewire into a patient using a delivery system; and advancing a closure device over the guidewire.

[0109] Inventive concept 97. The method of inventive concept 95, wherein the first predetermined distance is not equal to the second predetermined distance.

[0110] Inventive concept 98. The method of inventive concept 97, wherein the first predetermined distance is less than the second predetermined distance.

[0111] Inventive concept 99. The method of inventive concept 95, wherein the first predetermined distance is equal to the second predetermined distance.

[0112] Inventive concept 100. The method of inventive concept 95, wherein the closure device is configured to define a fluid flow path along a portion of the actuation shaft.

[0113] Inventive concept 101. The method of inventive concept 95, wherein the valve is disposed along the actuation shaft.

[0114] Inventive concept 102. The method of inventive concept 95, wherein the closure device further includes a proximal tube axially fixed relative to the proximal end portion of the balloon, the actuation shaft being partially slidably disposed within the proximal tube.

[0115] Inventive concept 103. The method of inventive concept 102, wherein the closure device is configured to define a fluid flow path along a portion of the actuation shaft in a radial direction between an outer surface of the actuation shaft and an inner surface of the proximal tube.

[0116] Inventive concept 104. The method of inventive concept 103, wherein the valve is disposed along the actuation shaft.

[0117] Inventive concept 105. A method according to inventive concept 104, wherein the valve includes a seal about at least a portion of an outer surface of the actuation shaft, the valve being configured to occupy an open state when the seal is disposed in one or more first axial positions relative to the proximal tube and to occupy a 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.

[0118] Inventive concept 106. The method of inventive concept 105, wherein the seal, actuation shaft, and proximal tube are arranged to block fluid flow from the distal end of the proximal tube at least when the seal is disposed in one or more first axial positions relative to the proximal tube.

[0119] Inventive concept 107. The method of inventive concept 103, wherein the wall of the proximal tube is shaped to define one or more tabs passing through the wall, the one or more tabs being biased to flex radially inward, and wherein, when the valve is in an open state, a fluid flow path passes through the wall between a proximal end of each of the one or more tabs and a tab-free portion of the wall axially adjacent to the one or more tabs.

[0120] Inventive concept 108. The method of inventive concept 107, wherein the tab-free portion of the wall is positioned proximal to one or more tabs.

[0121] Inventive concept 109. A method according to inventive concept 107, wherein an outer surface of the actuation shaft is shaped to define one or more protrusions about at least a portion of the actuation shaft, and wherein proximal ends of the one or more tabs 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 of the one or more tabs, thereby causing the locking mechanism to assume a locked state.

[0122] Inventive concept 110. The method of inventive concept 102, wherein the closure device further comprises a proximal LAA-orifice cover, the proximal LAA-orifice cover (a) radially surrounding and secured to the proximal tube, (b) configured to occupy a radially compressed state and a radially expanded state, (c) comprising a frame and a cover secured to the frame, (d) in the radially expanded state, having a maximum dimension measured perpendicular to the proximal tube generally perpendicular to the proximal tube of 10 to 50 mm, and (e) indirectly connected to the balloon via the proximal tube and not directly connected to the balloon.

[0123] Inventive concept 111. The method of inventive concept 110, wherein the closure device further comprises an orifice-supporting stent (a) secured to and extending distally from the proximal LAA-orifice cover, (b) configured to occupy a radially compressed state and a radially expanded state, and (c) generally cylindrical when in the radially expanded state.

[0124] Inventive concept 112. The method of inventive concept 111, wherein the orifice-supported stent, when in a radially expanded state, has (i) a maximum dimension measured perpendicular to the actuation shaft of 8 to 50 mm, and (ii) an axial length of 4 to 30 mm.

[0125] Inventive concept 113. The method of inventive concept 95, wherein the closure device further comprises connecting struts fixed to the distal end portion of the balloon and the proximal end portion of the balloon.

[0126] Inventive concept 114. The method of inventive concept 113, wherein the closure device is configured such that inflation of the balloon chamber plastically deforms the connecting struts.

[0127] Inventive concept 115. The method of inventive concept 113, wherein the closure device is configured such that shortening of the balloon plastically deforms the connecting struts.

[0128] In accordance with the present inventive concept 116, there is provided a device for closing the left atrial appendage (LAA), comprising: (i) A closure device, comprising: a compliant balloon defining a fluid-tight balloon chamber; an actuation shaft (a) at least partially disposed within the balloon chamber, (b) connected to the distal end portion of the balloon, and (c) longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; a valve including an elastomeric sleeve surrounding a portion of the actuation shaft; the closure device is configured to define a fluid flow path having one or more fluid flow path openings to the balloon chamber; a closure device, the elastomeric sleeve configured to have a rest state in which the sleeve covers and seals one or more fluid flow openings such that the valve is in a closed state; (ii) a delivery system configured to be releasably connected to a closure device and including a valve-opening strut, the valve-opening strut comprising: (a) bracing open and deforming the elastomeric sleeve such that, when in the braced position, the elastomeric sleeve does not seal one or more fluid flow openings and the valve is in an open state; (b) a delivery system configured to support and not open the elastomeric sleeve when in the unsupported position, such that the elastomeric sleeve is in a resting state and the valve is in a closed state.

[0129] Inventive concept 117. The device of inventive concept 116, wherein the valve-opening strut includes one or more tabs extending radially outward from the axis of the elastomeric sleeve to support the elastomeric sleeve open.

[0130] Inventive concept 118. The apparatus of inventive concept 116, wherein the valve-opening strut is configured such that axial sliding thereof relative to the elastomeric sleeve transitions the valve-opening strut from a supporting position to an unsupported position.

[0131] Inventive concept 119. The apparatus of inventive concept 116, wherein the closure device further includes a locking mechanism configured to occupy a locked state and an unlocked state, and configured, when in the locked state, to maintain a set distance between the distal end portion of the balloon and the proximal end portion of the balloon using the actuation shaft.

[0132] Inventive concept 120. The apparatus of inventive concept 116, wherein the closure device is configured to be releasably connected to the delivery system, and the closure device is configured such that the fluid flow path is coupled in fluid communication with the delivery system when the closure device is releasably connected to the delivery system.

[0133] Inventive concept 121. The apparatus of inventive concept 116, wherein the closure device further includes a distal tip disposed at a distal end portion of the balloon, the actuation shaft being connected to the distal tip.

[0134] Inventive concept 122. The device of inventive concept 116, wherein the actuation shaft is configured to at least partially define a distal tip disposed at the distal end portion of the balloon.

[0135] Inventive concept 123. The apparatus of inventive concept 116, wherein the closure device further includes a proximal base disposed at a proximal end portion of the balloon, and wherein the actuation shaft is longitudinally movable relative to the proximal base.

[0136] Inventive concept 124. The device of inventive concept 116 for use with a guidewire, wherein the actuation shaft is configured to define a guidewire lumen for slidably receiving the guidewire therein.

[0137] Inventive concept 125. The device of inventive concept 116, wherein the compliant balloon comprises a compliant material selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and 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).

[0138] Inventive concept 126. An apparatus according to any one of inventive concepts 116-125, wherein the closure device further comprises a proximal tube axially fixed relative to the proximal end portion of the balloon.

[0139] Inventive concept 127. The device of inventive concept 126, wherein the actuation shaft is slidably disposed partially within the proximal tube.

[0140] Inventive concept 128. The device of inventive concept 118, wherein the valve opening strut comprises a tubular portion disposed at least partially within the proximal tube.

[0141] Inventive concept 129. The device of inventive concept 128, wherein the valve-opening strut includes one or more tabs extending (a) axially away from the tubular portion and (b) radially outward from the proximal tube to support and open the elastomeric sleeve.

[0142] Inventive concept 130. The device of inventive concept 129, wherein the one or more tabs pass through at least a portion of the one or more fluid flow path openings when the valve-opening strut is in the braced position.

[0143] Inventive concept 131. The device of inventive concept 129, wherein the proximal tube is shaped to define one or more access openings through a wall of the proximal tube, and wherein one or more tabs pass through the one or more access openings, at least when the valve-opening strut is in the braced position.

[0144] Inventive concept 132. The apparatus of inventive concept 126, wherein the closure device further comprises a proximal LAA-orifice cover, the proximal LAA-orifice cover (a) radially surrounding and secured to the proximal tube, (b) configured to occupy a radially compressed state and a radially expanded state, (c) comprising a frame and a cover secured to the frame, (d) in the radially expanded state, having a maximum dimension measured perpendicular to the proximal tube generally perpendicular to the proximal tube of 10 to 50 mm, and (e) indirectly connected to the balloon via the proximal tube and not directly connected to the balloon.

[0145] Inventive concept 133. The apparatus of inventive concept 132, wherein the closure device further comprises an orifice support stent (a) secured to and extending distally from the proximal LAA-orifice cover, (b) configured to occupy a radially compressed state and a radially expanded state, and (c) generally cylindrical when in the radially expanded state.

[0146] Inventive concept 134. The device of inventive concept 133, wherein the orifice-support stent, when in a radially expanded state, has (i) a maximum dimension measured perpendicular to the actuation shaft of 8 to 50 mm, and (ii) an axial length of 4 to 30 mm.

[0147] Inventive concept 135. An apparatus according to any one of inventive concepts 116-125, wherein the closure device further comprises a connecting strut secured to the distal end portion of the balloon and the proximal end portion of the balloon.

[0148] Inventive concept 136. The apparatus of inventive concept 135, wherein the closure device is configured such that inflation of the balloon chamber plastically deforms the connecting struts.

[0149] Inventive concept 137. The apparatus of inventive concept 135, wherein the closure device is configured such that shortening of the balloon plastically deforms the connecting struts.

[0150] Inventive concept 138. The device of any one of inventive concepts 116-125, wherein the balloon has an average wall thickness of 100-5000 microns.

[0151] Inventive concept 139. The device of any one of inventive concepts 116-125, wherein the balloon has a thinnest wall thickness of between 20 and 500 microns at the thinnest portion of the balloon wall.

[0152] Inventive concept 140. The apparatus of any one of inventive concepts 116-125, wherein the delivery system further includes an implant catheter, and wherein the closure device is releasably disposed within the implant catheter in a radially compressed state, wherein the maximum distance between the proximal end portion of the balloon and the distal end portion of the balloon is 8-80 mm.

[0153] Inventive concept 141. An apparatus according to any one of inventive concepts 116-125, wherein the closure device further comprises a proximal connector configured to releasably connect the closure device to a correspondingly configured distal connector of the delivery system.

[0154] Inventive concept 142. The device of inventive concept 141, wherein the proximal connector is configured to define a screw thread.

[0155] Inventive concept 143. A device according to any one of inventive concepts 116-125 for use with a guidewire, wherein the delivery system includes an implant catheter connected to an operating handle, the implant catheter including a longitudinal passage for a guidewire, a distal connector for releasably connecting the implant catheter to a correspondingly configured proximal connector of the closure device, and an inflation tube channel releasably connectable to a fluid flow path of the closure device.

[0156] Additionally, in accordance with the present inventive concept 144, there is provided an apparatus for closing a left atrial appendage (LAA), comprising: (i) A closure device, comprising: a compliant balloon defining a fluid-tight balloon chamber; an actuation shaft (a) at least partially disposed within the balloon chamber, (b) connected to the distal end portion of the balloon, and (c) longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; a valve including an elastomeric sleeve surrounding a portion of the actuation shaft; the closure device is configured to define a fluid flow path having one or more fluid flow path openings to the balloon chamber; a closure device, the elastomeric sleeve configured to have a rest state in which the sleeve covers and seals the one or more fluid flow openings such that the valve is in a closed state; (ii) a delivery system configured to be releasably connected to a closure device and including one or more guidewires, wherein the one or more guidewires: (a) bracing open and deforming the elastomeric sleeve such that, when in the braced position, the elastomeric sleeve does not seal one or more fluid flow openings and the valve is in an open state; (b) a delivery system that, when in an unsupported position, does not support the elastomeric sleeve open so that the elastomeric sleeve is at rest and the valve is closed.

[0157] Inventive concept 145. The device of inventive concept 144, wherein the one or more guidewires pass through at least a portion of the one or more fluid flow passage openings when the one or more guidewires are in a braced position.

[0158] Inventive concept 146. An apparatus according to any one of inventive concepts 144-145, wherein the closure device further comprises a proximal tube axially fixed relative to the proximal end portion of the balloon.

[0159] Inventive concept 147. The device of inventive concept 146, wherein the actuation shaft is slidably disposed partially within the proximal tube.

[0160] Inventive concept 148. The apparatus of inventive concept 146, wherein the closure device further comprises a proximal LAA-orifice cover, the proximal LAA-orifice cover (a) radially surrounding and secured to the proximal tube, (b) configured to occupy a radially compressed state and a radially expanded state, (c) comprising a frame and a cover secured to the frame, (d) in the radially expanded state, having a maximum dimension measured perpendicular to the proximal tube generally perpendicular to the proximal tube of 10 to 50 mm, and (e) indirectly connected to the balloon via the proximal tube and not directly connected to the balloon.

[0161] Inventive concept 149. The apparatus of inventive concept 148, wherein the closure device further comprises an orifice support stent (a) secured to and extending distally from the proximal LAA-orifice cover, (b) configured to occupy a radially compressed state and a radially expanded state, and (c) generally cylindrical when in the radially expanded state.

[0162] Inventive concept 150. The device of inventive concept 149, wherein the orifice-support stent, when in a radially expanded state, has (i) a maximum dimension measured perpendicular to the actuation shaft of 8 to 50 mm, and (ii) an axial length of 4 to 30 mm.

[0163] Still additionally, in accordance with the present inventive concept 151, there is provided an apparatus for closing a left atrial appendage (LAA), comprising: (i) A closure device, comprising: a compliant balloon defining a fluid-tight balloon chamber; a proximal tube axially fixed to the proximal end portion of the balloon; a closure device including: (a) a spring at least partially disposed within the balloon chamber; (b) a spring connected to a distal end portion of the balloon and a proximal tube; and (c) a spring having a relaxed length, wherein when the spring has the relaxed length, the distal end portion of the balloon is at a relaxed distance from the proximal end portion of the balloon; (ii) a delivery system configured to be releasably connected to a closure device, the delivery system including a stylet removably disposed within a spring through a proximal tube, the closure device configured such that a degree of distal advancement of the stylet within the spring sets a tensioned length of the spring, which itself sets a tensioned distance between the distal and proximal end portions of the balloon, the tensioned distance being greater than the relaxed distance.

[0164] Inventive concept 152. The apparatus of inventive concept 151, wherein the closure device further comprises a valve.

[0165] Inventive Concept153. the closure device is configured to define a fluid flow path; 153. A device according to inventive concept 152, wherein the valve is configured to selectively allow or block fluid flow between the fluid flow path and the balloon chamber when the valve is in an open state and a closed state, respectively.

[0166] Inventive concept 154. The apparatus of inventive concept 151, wherein the closure device further comprises a distal tip disposed at a distal end portion of the balloon, the spring being connected to the distal tip.

[0167] Inventive concept 155. The device of inventive concept 151, wherein the compliant balloon comprises a compliant material selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and 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).

[0168] Inventive Concept156. the closure device includes a closure device connector connected to a distal end portion of the balloon and configured to define a closure device connection interface; A device described in any one of inventive concepts 151 to 155, wherein the stylet includes a stylet connector disposed at the distal end of the stylet and configured to define a stylet connection interface that is reversibly connectable to the closure device connection interface.

[0169] Inventive concept 157. The apparatus of inventive concept 156, wherein the closure device connection interface and the stylet connection interface are configured to define respective threads.

[0170] Inventive concept 158. The apparatus of any one of inventive concepts 151-155, wherein the closure device further includes a proximal LAA-orifice cover that (a) radially surrounds and is secured to the proximal tube, (b) is configured to occupy a radially compressed state and a radially expanded state, (c) includes a frame and a cover secured to the frame, (d) in the radially expanded state, has a maximum dimension measured perpendicular to the proximal tube generally perpendicular to the proximal tube of 10-50 mm, and (e) is indirectly connected to the balloon via the proximal tube and is not directly connected to the balloon.

[0171] Inventive concept 159. The apparatus of inventive concept 158, wherein the closure device further comprises an orifice support stent (a) secured to and extending distally from the proximal LAA-orifice cover, (b) configured to occupy a radially compressed state and a radially expanded state, and (c) generally cylindrical when in the radially expanded state.

[0172] Inventive concept 160. The device of inventive concept 159, wherein the orifice-supported stent, when in a radially expanded state, has (i) a maximum dimension measured perpendicular to the proximal tube of 8 to 50 mm, and (ii) an axial length of 4 to 30 mm.

[0173] Inventive concept 161. The apparatus of any one of inventive concepts 151-155, wherein the closure device further comprises a connecting strut secured to the distal end portion of the balloon and the proximal end portion of the balloon.

[0174] Inventive concept 162. The apparatus of inventive concept 161, wherein the closure device is configured such that inflation of the balloon chamber plastically deforms the connecting struts.

[0175] Inventive concept 163. The apparatus of inventive concept 161, wherein the closure device is configured such that shortening of the balloon plastically deforms the connecting struts.

[0176] Inventive concept 164. The device of any one of inventive concepts 151-155, wherein the balloon has an average wall thickness of 100-5000 microns.

[0177] Inventive concept 165. The device of any one of inventive concepts 151-155, wherein the balloon has a thinnest wall thickness of between 20 and 500 microns at the thinnest portion of the balloon wall.

[0178] Inventive concept 166. The apparatus of any one of inventive concepts 151-155, wherein the delivery system further includes an implant catheter, and wherein the closure device is releasably disposed within the implant catheter in a radially compressed state, wherein the maximum distance between the proximal end portion of the balloon and the distal end portion of the balloon is 8-80 mm.

[0179] Inventive concept 167. The apparatus of inventive concept 151, wherein the closure device further includes a proximal connector configured to releasably connect the closure device to a correspondingly configured distal connector of the delivery system.

[0180] Inventive concept 168. The device of inventive concept 167, wherein the proximal connector is configured to define a screw thread.

[0181] Inventive concept 169. A device according to any one of inventive concepts 167-168 for use with a guidewire, wherein the delivery system further includes an implant catheter connected to the operating handle, the implant catheter including a longitudinal passage for a guidewire, a distal connector for releasably connecting the implant catheter to a correspondingly configured proximal connector of the closure device, and an inflation tube channel releasably connectable to a fluid flow path of the closure device.

[0182] In accordance with the present inventive concept 170, there is provided a method for closing a left atrial appendage (LAA) in a patient, the method comprising: positioning a compliant balloon of a closure device in its longitudinally extended configuration in the LAA using a delivery system; inflating a compliant balloon by filling a fluid into a liquid-tight balloon chamber defined by the balloon through a fluid flow path having one or more fluid flow path openings to the balloon chamber, when the valve-opening strut of the delivery system is in a bracing position, in which the valve-opening strut braces open and deforms an elastomeric sleeve of a valve of the closure device, so that the elastomeric sleeve does not seal one or more fluid flow path openings, the compliant balloon being in an open state, the elastomeric sleeve surrounding a portion of an actuation shaft of the closure device, the actuation shaft (a) being at least partially disposed within the balloon chamber, (b) being connected to a distal end portion of the balloon, and (c) being longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; transitioning the valve-opening strut to a non-supporting position in which the valve-opening strut does not support the elastomeric sleeve open, causing the elastomeric sleeve to assume a resting state in which the sleeve covers and seals one or more fluid flow openings, thereby causing the valve to be in a closed state; and releasing the closure device from the delivery system.

[0183] In accordance with the present inventive concept 171, there is provided a method for closing a left atrial appendage (LAA) in a patient, the method comprising: positioning a compliant balloon of a closure device in its longitudinally extended configuration in the LAA using a delivery system; inflating a compliant balloon by filling a fluid into a liquid-tight balloon chamber defined by the balloon through a fluid flow path having one or more fluid flow path openings to the balloon chamber, with one or more guide wires of the delivery system in a bracing position, in which the one or more guide wires brace open and deform an elastomeric sleeve of a valve of the closure device, so that the elastomeric sleeve does not seal the one or more fluid flow path openings, when the valve is in an open state, wherein the elastomeric sleeve surrounds a portion of an actuation shaft, the actuation shaft (a) being at least partially disposed within the balloon chamber, (b) being connected to a distal end portion of the balloon, and (c) being longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; transitioning the one or more guidewires to a non-supporting position, in which the one or more guidewires do not support the elastomeric sleeve, causing the elastomeric sleeve to assume a resting state in which the sleeve covers and seals the one or more fluid flow openings, thereby causing the valve to be in a closed state; Releasing the closure device from the delivery system is further provided.

[0184] The present invention will be more fully understood from the following detailed description of the embodiments thereof taken together with the drawings. [Brief explanation of the drawings]

[0185] [Figure 1] 1 is a schematic diagram of a closure device for closing the left atrial appendage (LAA), in accordance with an application of the present invention. [Figure 2A] 2 is a schematic cross-sectional view of a distal portion of the closure device and delivery system of FIG. 1, in accordance with an application of the present invention. [Figure 2B] 2 is a schematic cross-sectional view of a distal portion of the closure device and delivery system of FIG. 1, in accordance with an application of the present invention. [Figure 3A] 3 is a schematic diagram of method steps for deploying the closure device of FIG. 1 using the delivery system of FIG. 2 in accordance with an application of the present invention. [Figure 3B] 3 is a schematic diagram of method steps for deploying the closure device of FIG. 1 using the delivery system of FIG. 2 in accordance with an application of the present invention. [Figure 3C] 3 is a schematic diagram of method steps for deploying the closure device of FIG. 1 using the delivery system of FIG. 2 in accordance with an application of the present invention. [Figure 3D] 3 is a schematic diagram of method steps for deploying the closure device of FIG. 1 using the delivery system of FIG. 2 in accordance with an application of the present invention. [Figure 3E] 3 is a schematic diagram of method steps for deploying the closure device of FIG. 1 using the delivery system of FIG. 2 in accordance with an application of the present invention. [Figure 3F] 3 is a schematic diagram of method steps for deploying the closure device of FIG. 1 using the delivery system of FIG. 2 in accordance with an application of the present invention. [Figure 4A] 5A-5F are schematic cross-sectional views of portions of the method steps shown in FIGS. 3A-F according to applications of the present invention. [Figure 4B] 5A-5F are schematic cross-sectional views of portions of the method steps shown in FIGS. 3A-F according to applications of the present invention. [Figure 4C] 5A-5F are schematic cross-sectional views of portions of the method steps shown in FIGS. 3A-F according to applications of the present invention. [Figure 5]2 is a schematic diagram of the closure device of FIG. 1 implanted to occlude the LAA, in accordance with an application of the present invention. [Figure 6] 1 is a schematic diagram of another closure device for occluding the LAA, in accordance with applications of the present invention. [Figure 7A] 7 is a schematic cross-sectional view of a distal portion of the closure device and delivery system of FIG. 6, in accordance with an application of the present invention. [Figure 7B] 7 is a schematic cross-sectional view of a distal portion of the closure device and delivery system of FIG. 6, in accordance with an application of the present invention. [Figure 7C] 7 is a schematic cross-sectional view of a distal portion of the closure device and delivery system of FIG. 6, in accordance with an application of the present invention. [Figure 7D] 1 is a schematic diagram of another closure device for occluding the LAA, in accordance with applications of the present invention. [Figure 8] 10 is a schematic diagram of yet another closure device for occluding the LAA, in accordance with applications of the present invention. [Figure 9A] 9 is a schematic cross-sectional view of a distal portion of the closure device and delivery system of FIG. 8, in accordance with an application of the present invention. [Figure 9B] 9 is a schematic cross-sectional view of a distal portion of the closure device and delivery system of FIG. 8, in accordance with an application of the present invention. [Figure 10] 10 is a schematic diagram of yet another closure device for occluding the LAA, in accordance with applications of the present invention. [Figure 11] 11 is a schematic cross-sectional view of a distal portion of the closure device and delivery system of FIG. 10, in accordance with an application of the present invention. [Figure 12A] 10 is a schematic diagram of another closure device for occluding a partially deployed LAA, in accordance with an application of the present invention. [Figure 12B] 10 is a schematic diagram of another closure device for occluding a partially deployed LAA, in accordance with an application of the present invention. [Figure 13A] 12A-B when its balloon chamber is partially inflated, in accordance with an application of the present invention. FIG. [Figure 13B]12A-B when its balloon chamber is partially inflated, in accordance with an application of the present invention. FIG. [Figure 14A] 12A-B upon final inflation of its balloon chamber, in accordance with an application of the present invention. FIG. [Figure 14B] 12A-B upon final inflation of its balloon chamber, in accordance with an application of the present invention. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0186] 1 is a schematic illustration of a closure device 10 for closing the left atrial appendage (LAA), in accordance with applications of the present invention. The closure device 10 is for use with a delivery system 20, which is described in more detail below with reference to FIGS. 3A-F. Delivery system 20 and other delivery systems described herein are typically transcatheter delivery systems that allow for percutaneous deployment of the closure device.

[0187] See also Figures 2A-B, which are schematic cross-sectional views of a distal portion of a closure device 10 and a delivery system 20, according to applications of the present invention. Figure 2A shows the closure device 10 with its locking mechanism 40 in an unlocked state and its valve 42 in an open state, as described below. Figure 2B shows the closure device 10 with its locking mechanism 40 in a locked state and its valve 42 in a closed state, as described below.

[0188] In some applications, the closure device 10 may include: a compliant balloon 30 defining a liquid-tight balloon chamber 32; an actuation shaft 34 (a) at least partially disposed within the balloon chamber 32, (b) connected to the distal end portion 36 of the balloon 30, and (c) longitudinally movable relative to the proximal end portion 38 of the balloon 30 to set the distance between the distal and proximal end portions 36 and 38 of the balloon 30; a locking mechanism 40 configured to occupy a locked state and an unlocked state, as shown in FIGS. 2B and 2A, respectively; and ●Includes valve 42.

[0189] The closure device 10 is configured such that longitudinal movement of the actuation shaft 34 in the proximal direction causes the balloon 30 to expand radially or laterally by shortening the distance between the distal and proximal end portions 36 and 38 of the balloon 30 to a desired distance.

[0190] When in a locked state, the locking mechanism 40 is configured to maintain a distance set using the actuation shaft 34 between the distal end portion 36 of the balloon 30 and the proximal end portion 38 of the balloon 30.

[0191] In some applications, the closure device 10 is configured to define a fluid flow path 44 along a portion of the actuation shaft 34 (e.g., laterally, as shown). When valve 42 is in an open state, it allows fluid flow between fluid flow channel 44 and balloon chamber 32, as shown in FIG. 2A; or As shown in FIG. 2B, when the valve 42 is in a closed state, it is configured to block the flow of fluid between the fluid flow path 44 and the balloon chamber 32.

[0192] In some applications, the closure device 10 is actuated by proximal longitudinal movement of the actuation shaft 34. As shown in the transition from FIG. 2A to FIG. 2B , a decrease in the distance between the distal and proximal end portions 36 and 38 of the balloon 30 to a first predetermined distance automatically transitions the valve 42 from an open state to a closed state; and As also shown in the transition from Figure 2A to Figure 2B, a decrease in the distance between the distal and proximal end portions 36 and 38 of the balloon 30 to a second predetermined distance is configured to automatically transition the locking mechanism 40 from the unlocked state to the locked state.

[0193] In some applications, the first predetermined distance is not equal to the second predetermined distance. For example, the first predetermined distance may be less than the second predetermined distance, such that proximal longitudinal movement of the actuation shaft 34 first automatically transitions the valve 42 from an open state to a closed state, and then automatically transitions the locking mechanism 40 from an unlocked state to a locked state. Alternatively, the first predetermined distance may be greater than the second predetermined distance, such that the order is reversed.

[0194] Further alternatively, in some applications, the first predetermined distance is equal to the second predetermined distance, whereby proximal longitudinal movement of the actuation shaft 34 simultaneously and automatically transitions the valve 42 from an open state to a closed state and the locking mechanism 40 from an unlocked state to a locked state.

[0195] In some applications, to cause the above-described proximal longitudinal movement of the actuation shaft 34, the delivery system 20 includes a pull shaft 46 releasably coupled to the proximal end portion of the actuation shaft 34. For example, the distal portion of the pull shaft 46 may include a pull shaft coupling 48, which may be shaped, for example, to define threads that removably engage with corresponding threads defined by the proximal end portion of the actuation shaft 34. Rotation of the pull shaft 46 disengages the shaft coupling 48 from the corresponding threads defined by the proximal end portion of the actuation shaft 34.

[0196] Typically, the closure device 10 is configured to be releasably connected to the delivery system 20. In some applications, the closure device 10 is configured such that the fluid flow path 44 is coupled in fluid communication with the delivery system 20 when the closure device 10 is releasably connected to the delivery system 20, as shown in Figures 2A-B.

[0197] For some applications, actuation shaft 34 is shaped to at least partially define a distal tip 50 disposed at distal end portion 36 of balloon 30, as shown in Figures 1 and 2A-B.

[0198] In some other applications, the closure device 10 further includes a distal tip disposed at the distal end portion 36 of the balloon 30, with the actuation shaft 34 connected to the distal tip (configuration not shown).

[0199] Alternatively or additionally, in some applications, the closure device 10 further includes a proximal base disposed at the proximal end portion 38 of the balloon 30, and the actuation shaft 34 is movable (e.g., longitudinally or rotationally) relative to the proximal base (configuration not shown).

[0200] In some applications, the valve 42 is positioned along the actuation shaft 34, as shown in Figures 2A-B.

[0201] For some applications, the closure device 10 further includes a proximal tube 52 axially fixed relative to the proximal end portion 38 of the balloon 30. The actuation shaft 34 is slidably disposed partially within the proximal tube 52, e.g., to indirectly connect the actuation shaft 34 to the proximal end portion 38 via the proximal tube 52. For some of these applications, the closure device 10 is shaped to define a fluid flow path 44 radially along a portion of the actuation shaft 34 between an outer surface of the actuation shaft 34 and an inner surface of the proximal tube 52, as shown in FIGS. 2A-B . Optionally, a valve 42 is disposed along the actuation shaft 34.

[0202] In some applications, the valve 42 includes a seal 54 around at least a portion (e.g., the entire circumference) of the outer surface of the actuation shaft 34. The valve 42 is configured to occupy (a) an open state when the seal 54 is disposed in one or more first axial positions 56A relative to the proximal tube 52 (one such first axial position is shown in FIG. 2A ), and (b) a closed state when the seal 54 is disposed in one or more second axial positions 56B relative to the proximal tube 52 (one such second axial position is shown in FIG. 2B ). The one or more second axial positions 56B are proximal to the one or more first axial positions 56A. For example, the seal 54 may include an O-ring, e.g., a single O-ring or a series of O-rings, as shown in FIGS. 2A-B . Optionally, one or more additional seals 19, e.g., one or more O-rings, are provided to further stabilize the alignment of the distal tube within the proximal tube by friction.

[0203] In some applications, the seal 54, actuation shaft 34, and proximal tube 52 are arranged such that the seal 54 blocks fluid flow from the distal end 58 of the proximal tube 52, at least when the seal 54 is disposed in one or more first axial positions 56A relative to the proximal tube 52, as shown in FIG. 2A. Alternatively or additionally, friction between the seal 54 and the inner surface of the proximal tube 52 increases structural stability and / or allows for gradual expansion / embedding.

[0204] In some applications, the wall of the proximal tube 52 is shaped to define one or more tabs 60 through the wall. The one or more tabs 60 are biased to bend radially inward. As shown in FIG. 2A, when the valve 42 is in an open state, the fluid flow path 44 passes through the wall between a proximal end 62 of each of the one or more tabs 60 and a non-tab portion 64 of the wall axially adjacent to the one or more tabs 60, such as proximal to the one or more tabs 60, as shown.

[0205] In some applications, the outer surface of actuation shaft 34 is shaped to define one or more protrusions 66 around at least a portion (e.g., the entire circumference) of actuation shaft 34. Proximal ends 62 of one or more tabs 60 are shaped to prevent distal movement of one or more protrusions 66 when one or more protrusions 66 are disposed proximal to proximal ends 62 of one or more tabs 60, as shown in FIG. 2B , thereby causing locking mechanism 40 to assume a locked state.

[0206] In some applications, the closure device 10 further includes a proximal LAA-orifice cover 70, which - fixed to the proximal tube 52 so as to radially surround the proximal tube 52; configured to occupy a radially compressed state as shown in FIG. 3A, described below, and a radially expanded state as shown in FIGS. 1 and 2A-B; - includes a frame 72 and a cover 74 fixed to the frame 72; when in a radially expanded state, has a maximum dimension, measured generally perpendicular to and perpendicular to the proximal tube 52, of at least 10 mm (e.g., at least 20 mm), 50 mm or less (e.g., 30 mm or less), and / or 10-50 mm (e.g., 20-30 mm); and • Typically, it is indirectly connected to the balloon 30 via the proximal tube 52 and is not directly connected to the balloon 30.

[0207] This indirect connection of the proximal LAA-orifice cover 70 to the balloon 30 generally prevents anodic reaction between the typically superelastic (e.g., nitinol) material of the frame 72 of the proximal LAA-orifice cover 70 and the typically plastically deformable (e.g., stainless steel) material of the struts 80, described below. Such a reaction could occur if the two elements were instead welded or otherwise bonded in contact with each other. (Connection of the elements via a separate, passive element, such as an internal tube or shaft, also does not result in such a reaction.) Instead, the proximal LAA-orifice cover 70 is directly connected to the balloon 30, such as when the frame 72 comprises a different plastically deformable material, such as titanium.

[0208] For some applications, the closure device 10 further includes an orifice support stent 290, described below with reference to Figures 8 and 9A-B.

[0209] In some applications, the actuation shaft 34 is shaped to define a guidewire lumen 76 for slidably receiving a guidewire therein and / or a passage for a fluid injected under pressure, such as a contrast agent injected from the proximal handle of the delivery tool to the distal end of the closure device. Alternatively, for other applications, the actuation shaft 34 is not shaped to define a guidewire lumen.

[0210] In some applications, the compliant balloon 30 comprises a compliant material selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and 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).

[0211] In some applications, the average wall thickness of the balloon 30 is between 100 and 5000 microns. Alternatively or additionally, in some applications, the balloon 30 has a thinnest wall thickness of between 20 and 500 microns at the thinnest portion of the wall of the balloon 30.

[0212] For some applications, the closure device 10 further includes connecting struts 80 secured to the distal end portion 36 of the balloon 30 and the proximal end portion 38 of the balloon 30. The struts 80 may be disposed inside the balloon 30, outside the balloon 30, or partially inside and partially outside the balloon 30. In some applications, the struts 80 are arranged as a frame. In some applications, the struts 80 are arranged in a cage-like arrangement. Typically, the struts 80 comprise a plastically deformable material, such as stainless steel or titanium. Typically, the struts 80 help shape the balloon 30 when the balloon chamber is inflated and / or when the balloon is shortened.

[0213] Typically, the closure device 10 is configured so that inflation of the balloon chamber 32 plastically deforms the connecting struts 80. In some applications, the closure device 10 is configured so that shortening of the balloon 30 plastically deforms the connecting struts 80.

[0214] In some applications, the struts 80 are configured so that inflation of the balloon chamber 32 causes primarily radial deformation of the struts 80, rather than distal or proximal deformation of the struts. To this end, the first lateral portions 81A of the struts 80 arranged along the sides of the balloon 30 may be more compliant than the distal surface of the balloon 30 and / or the second end portions 81B of the struts 80 arranged on the proximal surface of the balloon 30. For example, the first lateral portions 81A may be thinner than the second end portions 81B, as shown in FIG. 1, and / or the first lateral portions 81A may be shaped to be more compliant, for example, having a serpentine (e.g., sinusoidal) shape as shown. Typically, the first lateral portions 81A are oriented parallel to the central longitudinal axis of the closure device 10.

[0215] Reference is now made to Figures 3A-F, which are schematic illustrations of steps in a method of deploying closure device 10 using delivery system 20, in accordance with applications of the present invention.

[0216] Reference is also made to Figures 4A-C, which are schematic cross-sectional views of some of the method steps shown in Figures 3A-F, according to an application of the present invention.

[0217] 3A schematically illustrates closure device 10 releasably positioned in a radially compressed state within sheath 82 of delivery system 20. Typically, the maximum distance between proximal end portion 38 of balloon 30 and distal end portion 36 of balloon 30 is at least 8 mm (e.g., at least 15 mm), 80 mm or less (e.g., 60 mm or less), and / or between 8 and 80 mm (e.g., 15 and 60 mm) when closure device 10 is in this radially compressed state.

[0218] For some applications, the closure device 10 includes a proximal connector 84 configured to releasably connect the closure device 10 to a correspondingly configured distal connector 86 of the delivery system 20 .

[0219] In some applications, distal connector 86 includes one or more legs that engage one or more respective coupling sites (e.g., slots) of proximal connector 84, perhaps best seen in Figures 4A-C. For example, the legs may be configured to be biased radially outward when in an unconstrained, resting state, and may be held radially inward in engagement with coupling sites of proximal connector 84, such as by implant catheter 88, as shown in Figure 4A. Proximal withdrawal of implant catheter 88 relative to closure device 10 releases the legs, as shown in Figure 4B.

[0220] Instead, the proximal connector 84 is shaped to define a screw thread (configuration not shown).

[0221] In some applications, the delivery system 20 includes an implant catheter 88 connected to an operating handle (not shown). The implant catheter 88 includes (a) a longitudinal passage for a guidewire, (b) a distal connector 86 for releasably connecting the implant catheter 88 to a correspondingly configured proximal connector 84 of the closure device 10, and (c) an inflation tube channel releasably connectable to the fluid flow path 44 of the closure device 10. The longitudinal passage may alternatively or additionally be used to inject contrast media from the handle into a distal opening of the inflation tube channel distal to the balloon.

[0222] FIG. 3B shows the closure device 10 after the sheath 82 has been proximally withdrawn, thereby releasing the closure device 10. FIG. 3B also shows the proximal LAA-orifice cover 70 in a radially expanded state. Typically, the frame 72 of the proximal LAA-orifice cover 70 comprises a shape memory, e.g., a superelastic metal, such that the cover 70 automatically transitions to the radially expanded state upon release from the sheath 82. The balloon 30 remains in an uninflated, elongated configuration at this stage of deployment.

[0223] Typically, a medical professional uses delivery system navigation to position the distal end of the closure device 10 within the LAA.

[0224] As shown in Figures 3C-D, the medical professional inflates the balloon chamber 32. Figure 3C shows the closure device 10 upon partial inflation of the balloon chamber 32, and Figure 3D shows the closure device 10 upon full inflation of the balloon chamber 32. The balloon 30 may be inflated by filling the balloon chamber 32 with any fluid, including saline (optionally containing a contrast agent), blood (e.g., autologous blood), foam, and / or adhesive (e.g., a gel, a liquid polymer that can change properties to become rigid, or a hydrogel that remains a gel or self-hardens at body temperature).

[0225] In some applications, the struts 80 are shaped to define a plurality of spikes 89 that are initially generally axially oriented, as shown in FIG. 3C, and are configured to extend further radially upon expansion of the balloon 30 to act as tissue-engaging barbs, as shown in FIG. 3D.

[0226] 3E and 4A show the closure device 10 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 radially or laterally expand the balloon 30 by shortening the distance between the distal and proximal end portions 36 and 38 of the balloon 30 to a desired distance, and (c) the locking mechanism 40 has transitioned from an unlocked state to a locked state, as described above with reference to FIGS. 2A-B. Typically, after the balloon 30 is finally filled, the actuation shaft 34 is moved longitudinally proximally to radially or laterally expand the balloon 30 by shortening the distance between the distal and proximal end portions 36 and 38 of the balloon 30 to a desired distance. The proximal connector 84 of the closure device 10 remains releasably connected to a correspondingly configured distal connector 86 of the delivery system 20.

[0227] 3F and 4B-C show the closure device 10 after the proximal connector 84 of the closure device 10 has been released from the distal connector 86 of the delivery system 20. FIG.

[0228] FIG. 4C also shows the closure device 10 after the pull shaft 46 has been disconnected from the proximal end portion of the actuation shaft 34, such as by rotating and unscrewing the pull shaft 46, as described above.

[0229] Reference is now made to FIG. 5, which is a schematic illustration of a closure device 10 implanted to close an LAA 100 in accordance with an application of the present invention. As can be seen, the balloon 30 is positioned within the LAA 100, and the proximal LAA-orifice cover 70 is positioned in the left atrium 102 outside the LAA 100 against the atrial wall surrounding the orifice of the LAA 100, thereby creating continuity with the atrium at the LAA level. Typically, the proximal LAA-orifice cover 70 protrudes minimally due to its relatively flat shape, does not obstruct blood flow, and does not cause thrombosis. Typically, the struts 80 provide most of the anchoring for the closure device 10, and the balloon 30 provides most of the sealing of the LAA. Furthermore, in a configuration in which the cover 74 of the proximal LAA-orifice cover 70 is blood-impermeable, the proximal LAA-orifice cover 70 provides additional sealing of the LAA, primarily to inhibit thrombus formation on the balloon surface at the orifice level.

[0230] In some applications, the proximal LAA-orifice cover 70 is asymmetrical with respect to the proximal tube 52, for example, oval or having a larger radius in one direction than in the perpendicular direction.

[0231] In 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 may adjust the maximum dimension.

[0232] In some applications, the cover 74 of the proximal LAA-orifice cover 70 is blood-permeable to act as a filter for the passage of blood into and out of the LAA. In other applications, the cover 74 is not blood-permeable to create a secondary seal of the LAA in addition to the seal provided by the balloon 30.

[0233] In some applications, the proximal LAA-orifice cover 70 is bioabsorbable and / or drug-eluting.

[0234] Reference is now made to FIG. 6, which is a schematic illustration of a closure device 110 for occluding the LAA, in accordance with an application of the present invention. The closure device 110 is for use with a delivery system 120. Except as noted below, the closure device 110 is similar to the closure device 10 described above with reference to FIGS. 1-5 and may embody any of the features thereof, mutatis mutandis. Similarly, except as noted below, the delivery system 120 is similar to the delivery system 20 described above with reference to FIGS. 1-5 and may embody any of the features thereof, mutatis mutandis. Like reference numbers refer to like parts.

[0235] See also Figures 7A-C, which are schematic cross-sectional views of a distal portion of a closure device 110 and a delivery system 120, according to applications of the present invention. Figures 7A-B show the closure device 110 connected to a delivery system 120, with the valve 142 of the closure device 110 in an open state, as described below. Figure 7A shows the closure device 110 with its balloon 130 in an extended state, while Figures 7B-C show the closure device 110 with the balloon 130 in a shortened state. Figure 7C shows the closure device 110 connected to a delivery system 120 with the valve 142 in a closed state.

[0236] In some applications, the closure device 110 may include: a compliant balloon 130 defining a liquid-tight balloon chamber 132, the balloon 130 may have any of the characteristics of the balloon 30 described above with reference to FIGS. 1-5; and an actuation shaft 134 that is (a) at least partially disposed within the balloon chamber 132, (b) connected to the distal end portion 136 of the balloon 130, and (c) longitudinally movable relative to the proximal end portion 138 of the balloon 130 to set the distance between the distal and proximal end portions 136 and 138 of the balloon 130; and a valve 142 including an elastomeric sleeve 143 surrounding a portion of the actuation shaft 134.

[0237] The closure device 110 is shaped to define a fluid flow path 144 having one or more fluid flow path openings 145 to the balloon chamber 132. Typically, the closure device 110 is configured such that the fluid flow path 144 is coupled in fluid communication with the delivery system 120 when the closure device 110 is releasably connected to the delivery system 120.

[0238] For example, the elastomeric sleeve 143 may include silicone.

[0239] The elastomeric sleeve 143 is configured to have a rest state in which the sleeve covers and seals one or more fluid flow openings 145 such that the valve 142 is in a closed state, as shown in FIG. 7C.

[0240] The delivery system 120 is configured to be releasably connected to the closure device 110. The delivery system 120 includes a valve-opening strut 147, When in the braced position as shown in FIGS. 6 and 7A-B, bracing open and deforming the elastomeric sleeve 143 so that the elastomeric sleeve 143 does not seal one or more fluid flow openings 145 and the valve 142 is open; and • Includes a valve opening strut 147 that is configured to support and not open the elastomeric sleeve 143 when in the non-supporting position as shown in FIG. 7C such that the elastomeric sleeve is at rest and the valve 142 is closed.

[0241] This configuration allows for separate control of the foreshortening of balloon 130 and the closure of valve 142. Instead, valve-opening strut 147 (e.g., its tubular portion 151, described below) is fixed to pull shaft 46.

[0242] In some applications, the valve-opening strut 147 includes one or more tabs 149 extending radially outward from the axis of the elastomeric sleeve 143 to support the elastomeric sleeve 143 open.

[0243] In some applications, the valve-opening strut 147 is configured such that its axial sliding relative to the elastomeric sleeve 143 (e.g., in the proximal direction) transitions the valve-opening strut 147 from a supporting position to a non-supporting position, as shown in the transition between Figures 7B and 7C.

[0244] For some applications, the closure device 110 further includes a proximal tube 152 that is axially fixed relative to the proximal end portion 138 of the balloon 130. For some applications, the actuation shaft 134 is slidably disposed partially within the proximal tube 152.

[0245] In some applications, a seal such as an O-ring (as shown) is provided, where friction between the seal and the inner surface of the proximal tube 152 adds structural stability. Alternatively or additionally, the O-ring is positioned proximal to one or more fluid flow passage openings 145 to block additional fluid from passing through the one or more fluid flow passage openings 145 and the elastomeric sleeve 143 once balloon foreshortening is complete.

[0246] In some applications, the valve-opening strut 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 strut 147 includes one or more tabs 149 that extend (a) axially away (e.g., distally) from the tubular portion 151 and (b) radially outward from the proximal tube 152 to brace the elastomeric sleeve 143. In some applications, as shown in FIGS. 6 and 7A-B , when the valve-opening strut 147 is in the braced position, the one or more tabs 149 pass through at least a portion of the one or more fluid flow passage openings 145. Alternatively, in some applications, the proximal tube 152 is shaped to define one or more access openings through a wall of the proximal tube 152, and the one or more tabs 149 pass through the one or more access openings, at least when the valve-opening strut 147 is in the braced position (configuration not shown).

[0247] For some applications, the closure device 110 further includes a proximal LAA-orifice cover 70 secured to the proximal tube 152, radially surrounding the proximal tube 152. The proximal LAA-orifice cover 70 may implement any of the techniques described above and / or below. For some of these applications, the closure device 110 further includes an orifice support stent 290, described below with reference to Figures 8 and 9A-B.

[0248] For some applications, the closure device 110 further includes a locking mechanism configured to assume a locked state and an unlocked state, the locking mechanism being configured, when in the locked state, to maintain a distance between the distal end portion 136 of the balloon 130 and the proximal end portion 138 of the balloon 130 that is set using the actuation shaft 134. The locking mechanism may implement any of the locking mechanisms described herein, mutatis mutandis.

[0249] For some applications, actuation shaft 134 is shaped to at least partially define a distal tip 150 disposed at the distal end portion 136 of balloon 130 .

[0250] For some applications, the closure device 110 further includes connecting struts 180 secured to a distal end portion 136 of the balloon 130 and a proximal end portion 138 of the balloon 130. Typically, the closure device 110 is configured such that inflation of the balloon chamber 132 plastically deforms the connecting struts 180. For some applications, the closure device 110 is configured such that shortening of the balloon 130 plastically deforms the connecting struts 180.

[0251] For some applications, the delivery system 120 further includes an implant catheter 88 as described above with reference to Figures 1-5.

[0252] Reference is now made to FIG. 7D, which is a schematic illustration of a closure device 410 for occluding the LAA, in accordance with an application of the present invention. For clarity of illustration, the balloon is not shown connected to the struts 180 in FIG. 7D, even though it is an actual element of the closure device. The closure device 410 is intended for use with a delivery system. Except as noted below, the closure device 410 is similar to the closure device 110 described above with reference to FIGS. 6 and 7A-C and may embody any of its features, mutatis mutandis. Like reference numerals refer to like parts. Similarly, except as noted below, the delivery system is similar to the delivery system 20 described above with reference to FIGS. 1-5 and may embody any of its features, mutatis mutandis.

[0253] The closure device 410 includes a valve 442 that includes an elastomeric sleeve 143 that surrounds a portion of the actuation shaft 134. The elastomeric sleeve 143 is configured to have a rest state in which the sleeve covers and seals one or more fluid flow path openings 145 such that the valve is in a closed state (not shown in FIG. 7D but similar to the state shown in FIG. 7C for the closure device 110).

[0254] Unlike the delivery system 120 of the closure device 110, the delivery system of this configuration does not include a valve-opening strut 147. Instead, the delivery system includes one or more guidewires 447, which are bracing open and deforming the elastomeric sleeve 143 such that, when in the braced position as shown in FIG. 7D , the elastomeric sleeve 143 does not seal one or more fluid flow openings 145 and the valve 442 is open; and When in the non-supported position (not shown in FIG. 7D, but similar to the state of the closure device 110 shown in FIG. 7C), the elastomeric sleeve 143 is not supported open so that the elastomeric sleeve is in a resting state and the valve 442 is in a closed state.

[0255] In some applications, one or more guidewires 447 pass through at least a portion of one or more fluid flow passage openings 145 when the one or more guidewires are in a resting position.

[0256] Reference is now made to FIG. 8, which is a schematic illustration of a closure device 210 for closing the LAA, in accordance with an application of the present invention. The closure device 210 is for use with a delivery system 220. The closure device 210 may be implemented in combination with any of the other closure devices described herein, including, but not limited to, any of the valves and / or locking mechanisms described herein, mutatis mutandis. Similarly, except as noted below, the delivery system 220 is similar to the other delivery systems described herein and may implement any of the features thereof, mutatis mutandis. Like reference numbers refer to like parts.

[0257] See also Figures 9A-B, which are schematic cross-sectional views of a distal portion of a closure device 210 and a delivery system 220, according to an application of the present invention. Figures 9A-B show the closure device 210 connected to a delivery system 220. Figure 9A shows the closure device 210 with its balloon 230 in an extended state, and Figure 9B shows the closure device 210 with its balloon 230 in a shortened state.

[0258] The closure device 210 includes: a compliant balloon 230 defining a liquid-tight balloon chamber 232, the balloon 230 may have any of the characteristics of the balloon 30 described above with reference to FIGS. 1-5; and an actuation shaft 234 (a) at least partially disposed within the balloon chamber 232, (b) connected to the distal end portion 236 of the balloon 230, and (c) longitudinally movable relative to the proximal end portion 238 of the balloon 230 to set the distance between the distal and proximal end portions 236 and 238 of the balloon 230; • Valve 242, which may implement any of the valve features described herein, as described above.

[0259] The closure device 210 further includes a proximal LAA-orifice cover 70 that (a) is configured to occupy a radially compressed state and a radially expanded state, (b) includes a frame 72 and a cover 74 secured to the frame 72, and (c) when in the radially expanded state, has a maximum dimension, measured generally perpendicular to and perpendicular to the actuation shaft 234, of at least 10 mm (e.g., at least 20 mm), 50 mm or less (e.g., 30 mm or less), and / or 10 to 50 mm (e.g., 20 to 30 mm).

[0260] The closure device 210 further includes an orifice support stent 290 configured to provide additional support at the orifice of the LAA. The orifice support stent 290 is configured to be positioned at least partially within the LAA, such as completely within the LAA. The orifice support stent 290 secured to and extending distally from the proximal LAA-orifice cover 70; configured to assume a radially compressed state (not shown) and a radially expanded state (shown in FIGS. 8 and 9A-B); • Generally cylindrical in its radially expanded state.

[0261] As used in this application, including the claims and inventive concept, the phrase "generally cylindrical" is not limited to generally circular cylinders, but also includes within its scope other generally cylindrical shapes, such as generally oval cylinders.

[0262] In some applications, the orifice support stent 290, when in a radially expanded state, has (i) a maximum dimension, measured perpendicular to the actuation shaft 234, of at least 8 mm, no more than 50 mm, and / or between 8 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 and 30 mm.

[0263] In some applications, the orifice support stent 290 is not fixed to the balloon 230, allowing the shape of the balloon 230 to 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 closure device 210 prevents anodic reaction between the typically superelastic (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 a reaction could occur if the two elements were instead welded or otherwise bonded in contact with each other. (Connection of the elements via a separate, passive element, such as an inner tube or shaft, also does not result in such a reaction.)

[0264] In some applications, the orifice support stent 290 comprises a superelastic or plastically deformable metal.

[0265] Typically, the closure device 210 is configured so that inflation of the balloon chamber 232 transitions the orifice-support stent 290 from its radially compressed state to its radially expanded state. In some applications, the orifice-support stent 290 comprises a superelastic metal, such as Nitinol, so that when the stent is crimped, it has a minimum diameter given by the thickness of its wall struts. Upon release, the stent tends to transition to a relaxed diameter that is larger than the crimped diameter. In a configuration in which the balloon 230 is expanded within the stent, the stent becomes hyperstretched, and its diameter becomes larger than its relaxed diameter, to an extent that depends on the design and ability of the stent struts to hyperexpand.

[0266] In some applications, the closure device 210 further includes a proximal tube 252 that is axially secured to the proximal end portion 238 of the balloon 230. In these applications, the proximal LAA-orifice cover 70 is secured to the proximal tube 252, radially surrounding the proximal tube 252, and is indirectly connected to the balloon 230 via the proximal tube 252, and is not directly connected to the balloon 230.

[0267] Reference is now made to FIG. 10, which is a schematic illustration of a closure device 310 for occluding the LAA, in accordance with an application of the present invention. The closure device 310 is for use with a delivery system 320. Except as noted below, the closure device 310 is similar to the closure device 10 described above with reference to FIGS. 1-5 and may embody any of the features thereof, mutatis mutandis. Similarly, except as noted below, the delivery system 320 is similar to the delivery system 20 described above with reference to FIGS. 1-5 and may embody any of the features thereof, mutatis mutandis. Like reference numbers refer to like parts.

[0268] See also Figure 11, which is a schematic cross-sectional view of a distal portion of a closure device 310 and a delivery system 320, in accordance with applications of the present invention. Both Figures 10 and 11 show the closure device 310 connected to a delivery system 320. As described below, Figure 10 shows the closure device 310 with its balloon 330 in an extended state, and Figure 11 shows the closure device 310 with its balloon 330 in a shortened state.

[0269] The closure device 310 includes: a compliant balloon 330 defining a liquid-tight balloon chamber 332, the balloon 330 may have any of the characteristics of the balloon 30 described above with reference to FIGS. 1-5; and a proximal tube 352 axially fixed to the proximal end portion 338 of the balloon 330; ●Spring 353 and and a valve 342, which may implement any of the valve features described herein.

[0270] Spring 353 is (a) at least partially disposed within balloon chamber 232, (b) connected (directly or indirectly, e.g., via a tube) to distal end portion 336 of balloon 330 and proximal tubing 352, and (c) has a relaxed length, as shown in Figure 11. When spring 353 has its relaxed length, distal end portion 336 of balloon 330 is at a relaxed distance from proximal end portion 338 of balloon 330, as shown in Figure 11.

[0271] Delivery system 320 is configured to be releasably connected to closure device 310. Delivery system 320 includes a stylet 355 that is removably disposed through proximal tubing 352 and within spring 353. Closure device 310 is configured such that the degree of distal advancement of stylet 355 within spring 353 sets the tensioned length of spring 353, which itself sets the tensioned distance between distal and proximal end portions 336 and 338 of balloon 330, the tensioned distance being greater than the relaxed distance. One possible tensioned distance is shown in FIG. 10 .

[0272] Typically, during deployment of the closure device 310 into the LAA, the closure device 310 is advanced into the LAA while the spring 353 is in an extended tension state. The balloon chamber 332 is typically inflated while the spring 353 is in an extended tension state as shown in FIG. 10 , and the valve 342 is transitioned to a closed state, such as using the techniques described herein. The stylet 355 is then partially withdrawn proximally, shortening the spring 353 to its resting state as shown in FIG. 11 .

[0273] In some applications, the distal end portion of the stylet 355 is releasably connected to a closure device connector 357 of the closure device 310, which is connected to the distal end portion 336 of the balloon 330. (The stylet 355 generally remains in place even when not connected to the closure device 310; however, without such connection, the stylet 355 may become misaligned with and entangled with the spring 353 during manipulation of the closure device 310 and inflation of the balloon 330 during deployment.) In these applications, the stylet 355 is disconnected from the closure device connector 357 after the spring 353 is shortened. For example, the end of the stylet 355 and the closure device connector 357 may define respective threads.

[0274] Optionally, stylet 355 is flexible, eg, highly flexible, to accommodate variations in the anatomy of the LAA, including the curvature of the LAA.

[0275] Reference is now made to Figures 12A-B, 13A-B, and 14A-B, which are schematic illustrations of a closure device 510 for occluding the LAA, in accordance with applications of the present invention. Closure device 510 is for use with a delivery system such as delivery system 20 described above with reference to Figures 1-4C, delivery system 120 described above with reference to Figures 6-7C, delivery system 220 described above with reference to Figures 8-9B, or delivery system 320 described above with reference to Figures 10-11, mutatis mutandis. Except as noted below, closure device 510 is similar to closure device 10 described above with reference to Figures 1-5 and may embody any of its features, mutatis mutandis. Like reference numerals refer to like parts. Alternatively or additionally, closure device 510 may optionally embody any of the features of closure device 110 described above with reference to Figures 6 and 7A-C, closure device 210 described above with reference to Figures 8 and 9A-B, closure device 310 described above with reference to Figures 10 and 11, and / or closure device 410 described above with reference to Figure 7D. By way of example and not limitation, closure device 510 may optionally include proximal LAA-orifice cover 70, as shown in the figures. Similarly, these other closure devices described herein may optionally embody any of the features of closure device 510, mutatis mutandis.

[0276] 12A-B show the closure device 510 after the sheath 82 shown in FIG. 3A has been proximally withdrawn, thereby releasing the closure device 510 and transitioning the proximal LAA-orifice cover 70 to its radially expanded state, which is similar to the deployed state of the closure device 10 shown in FIG. 3B. The balloon 30 remains in an uninflated, elongated configuration at this stage of deployment.

[0277] 13A-B show the closure device 510 when the balloon chamber 32 is partially inflated.

[0278] 14A-B show the closure device 510 upon final inflation of the balloon chamber 32. The balloon chamber 32 can be inflated to different final inflation levels depending on the degree of radial expansion required for the particular anatomy of the LAA. Typically, the closure device 510 is configured to be radially expandable to a diameter of 20-35 mm, such as 15-40 mm, e.g., 15-35 mm.

[0279] The closure device 510 includes connecting struts 580 secured to the distal end portion 36 and the proximal end portion 38 of the balloon 30. The struts 580 may embody any of the features of the struts 80 described above, mutatis mutandis. A first lateral portion 581A of the struts 580 is arranged along a side of the balloon 30. A second distal end portion 581B of the struts 580 is arranged on the distal surface of the balloon 30. A third proximal end portion 581C of the struts 580 is arranged on the proximal surface of the balloon 30. Typically, the second distal end portion 581B and the third proximal end portion 581C are generally straight. Typically, the first lateral portion 581A is oriented parallel to the central longitudinal axis of the closure device 510.

[0280] In some applications, the distal interface portion 583A of the strut 580 is coupled to the first lateral portion 581A and the second distal end portion 581B, respectively, and / or the proximal interface portion 583B is coupled to the first lateral portion 581A and the third proximal end portion 581C, respectively. The closure device 510 is configured such that, upon inflation of the balloon chamber 32, the distal interface portion 583A and the proximal interface portion 583B curve, as shown in FIGS. 13A-B and 14A-B. (FIGS. 12A-B show the uninflated balloon chamber 32, FIGS. 13A-B show the partially inflated balloon chamber 32, and FIGS. 14A-B show the fully inflated balloon chamber 32.) For some of these applications, the distal interface portion 583A and / or the proximal interface portion 583B have a serpentine (e.g., sinusoidal) shape, as shown. This serpentine shape causes the distal interface portion 583A and / or the proximal interface portion 583B to be more flexible than the first side portion 581A, the second distal end portion 581B, and / or the third proximal end portion 581C. As a result, the closure device 510 assumes a more cylindrical shape than it would otherwise have upon inflation and deflation of the balloon 30. Optionally, the first side portion 581A of the strut 580 is generally straight, which also contributes to the cylindrical shape of the closure device 510.

[0281] In some applications, the distal end portion 585A of the strut 580 connects the second distal end portion 581B of the strut 580 to the distal end portion 36 of the balloon 30, respectively, and / or the proximal end portion 585B of the strut 580 connects the third proximal end portion 581C of the strut 580 to the proximal end portion 38 of the balloon 30, respectively. The closure device 510 is configured such that the distal end portion 585A and the proximal end portion 585B curve upon inflation of the balloon chamber 32. (FIGS. 12A-B show an uninflated balloon chamber 32, FIGS. 13A-B show a partially inflated balloon chamber 32, and FIGS. 14A-B show a final inflated balloon chamber 32.) For some of these applications, the distal end portion 585A and / or the proximal end portion 585B have a serpentine (e.g., sinusoidal) shape, as shown. The serpentine shape allows distal end portion 585A and / or proximal end portion 585B to stretch, thereby allowing closure device 510 to expand radially to a diameter of 20-35 mm, e.g., 15-40 mm, e.g., 15-35 mm. The serpentine shape also allows distal end portion 585A and / or proximal end portion 585B to selectively stretch, thereby accommodating expansion of balloon 30 to different degrees in different radial directions.

[0282] For some applications, struts 580 are shaped to define a plurality of spikes 589 extending from outer ends 599 (labeled in FIGS. 12A and 14A ) of respective second distal end portions 581B and / or respective third proximal end portions 581C. As shown in FIGS. 12A-B , spikes 589 are initially generally axially oriented when balloon 30 is in an uninflated, elongated configuration. Spikes 589 are configured to extend more radially upon inflation of balloon chamber 32 and function as tissue-engaging barbs, as shown in FIGS. 14A-B . The axes of each of spikes 589 may be parallel to or slightly angled relative to the axes of second distal end portion 581B and third proximal end portion 581C.

[0283] In some applications, distal interface portion 583A is shaped to define respective pairs of parallel serpentine (e.g., sinusoidal) struts 591A and 591B that define respective narrow, elongated gaps 593 therebetween. As shown in FIGS. 12A-B , when spikes 589 are initially oriented generally axially, the spikes are disposed in their respective gaps 593. Respective tips 595 of spikes 589 are disposed near respective end faces 597 of gaps 593 at respective junctions between parallel serpentine struts 591A and 591B, such that respective tips 595 of spikes 589 are protected by their respective end faces 597 until the spikes are radially deployed. Alternatively or additionally, proximal interface portions 583B and their corresponding spikes 589 may implement this feature.

[0284] In some applications, the connecting strut 580 further includes a closed stent cell 587 connecting adjacent pairs of the first side portions 581A. Optionally, two or more closed stent cells 587 arranged in series connect adjacent pairs of the first side portions 581A (the figures show just two closed stent cells 587 arranged in series connecting adjacent pairs of the first side portions 581A). Typically, there are no more than four closed stent cells 587 arranged in series, such as exactly two or three closed stent cells 587 arranged in series. These connections by the closed stent cells 587 may help to laterally stabilize the first side portions 581A during inflation of the balloon chamber 32, helping to constrain the shape of the balloon 30 during inflation of the balloon chamber 32 by helping to limit the radial expansion of the balloon from the stent struts. These connections by closed stent cells 587 may alternatively or additionally stabilize the implantation of closure device 510 by friction by providing a sufficiently large contraction surface against the walls of the LAA. Optionally, as shown, a series of two or more closed stent cells 587 connect adjacent pairs of first lateral portions 581A. Alternatively, two or more series (e.g., just two series) of two or more closed stent cells 587 connect adjacent pairs of first lateral portions 581A (configuration not shown).

[0285] Typically, the average width of the struts in first lateral portion 581A is equal to at least 200%, e.g., at least 250%, 300%, or 400%, of the average width of the struts in closed stent cells 587. As noted above, first lateral portion 581A is typically oriented parallel to the central longitudinal axis of closure device 510. The struts in closed stent cells 587 may have these thinner widths to allow for expansion of the closed stent cells upon balloon expansion.

[0286] In some applications, the closed stent cells 587 are shaped as respective rhombus shapes. The rhombus shapes can be radially compressed for delivery, causing them to expand predictably and symmetrically, unlike many other stent shapes, such as S-shapes or serpentine shapes, which tend to expand asymmetrically. The rhombus shapes also generally return to their original shape after being plastically radially compressed for delivery and then plastically expanded for implantation. In some applications, the rhombus shapes may be shaped as squares and / or diamonds at specific levels of radial compression and expansion.

[0287] In one embodiment, the techniques and apparatus described herein are combined with techniques and apparatus described in one or more of the following patent applications, which are assigned to the assignee of the present application and are incorporated herein by reference: European Patent Application Publication No. 3,459,469 A1 to Maisano et al. ● International Publication No. 2019 / 057950 to Maisano et al. WO 2020 / 060587 to Maisano et al., and / or ●U.S. Provisional Application No. 62 / 906,393, filed September 26, 2019.

[0288] It will be appreciated by those skilled in the art that the present invention is not limited to what has been particularly shown and described above, but rather the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as modifications and variations thereof which would occur to those skilled in the art upon reading the foregoing description and which are not in the prior art.

Claims

1. 1. A closure device for closing a left atrial appendage (LAA), said closure device for use with a delivery system, said closure device comprising: a compliant balloon defining a fluid-tight balloon chamber; an actuation shaft (a) at least partially disposed within the balloon chamber, (b) connected to a distal end portion of the balloon, and (c) longitudinally movable relative to the proximal end portion of the balloon to set a distance between the distal end portion and the proximal end portion of the balloon; a locking mechanism configured to assume a locked state and an unlocked state, and configured, when in the locked state, to maintain a distance between the distal end portion of the balloon and the proximal end portion of the balloon that is set using the actuation shaft; a valve; the closure device is configured to define a fluid flow path along a portion of the actuation shaft; the valve is configured to selectively allow or block fluid flow between the fluid flow path and the balloon chamber when the valve is in an open state and a closed state, respectively; The closure device is actuated by proximal longitudinal movement of the actuation shaft. (a) a decrease in the distance between the distal end portion and the proximal end portion of the balloon to a first predetermined distance automatically transitions the valve from the open state to the closed state; (b) a closure device configured such that a decrease in the distance between the distal end portion and the proximal end portion of the balloon to a second predetermined distance automatically transitions the locking mechanism from the unlocked state to the locked state.

2. The closure device of claim 1 , wherein the first predetermined distance is not equal to the second predetermined distance.

3. The closure device of claim 2 , wherein the first predetermined distance is less than the second predetermined distance.

4. The closure device of claim 1 , wherein the first predetermined distance is equal to the second predetermined distance.

5. The closure device of claim 1, wherein the closure device is configured to be releasably connected to the delivery system, and the closure device is configured such that the fluid flow path is coupled in fluid communication with the delivery system when the closure device is releasably connected to the delivery system.

6. The closure device of claim 1 , further comprising a distal tip disposed at the distal end portion of the balloon, the actuation shaft being connected to the distal tip.

7. The closure device of claim 1 , wherein the actuation shaft is shaped to at least partially define a distal tip disposed at the distal end portion of the balloon.

8. The closure device of claim 1 , further comprising a proximal base disposed at the proximal end portion of the balloon, the actuation shaft being movable relative to the proximal base.

9. The closure device of claim 1 for use with a guidewire, wherein the actuation shaft is shaped to define a guidewire lumen for slidably receiving a guidewire therein.

10. The closure device of any one of claims 1 to 9, wherein the closure device is shaped to define the fluid flow path along the portion of the actuation shaft.

11. The closure device according to any one of claims 1 to 9, wherein the valve is disposed along the actuation shaft.

12. The closure device according to any one of claims 1 to 9, further comprising a proximal tube axially fixed to the proximal end portion of the balloon, the actuation shaft being partially slidably disposed within the proximal tube.

13. The closure device of claim 12 , wherein the closure device is shaped to define the fluid flow path radially along the portion of the actuation shaft between an outer surface of the actuation shaft and an inner surface of the proximal tube.

14. The closure device of claim 13 , wherein the valve is disposed along the actuation shaft.

15. 15. The closure device of claim 14, wherein the valve includes a seal around at least a portion of the outer surface of the actuation shaft, the valve being configured to occupy an open state when the seal is disposed in one or more first axial positions relative to the proximal tube and to occupy a 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.

16. 16. The closure device of claim 15, wherein the seal, the actuation shaft, and the proximal tube are arranged to block fluid flow from the distal end of the proximal tube at least when the seal is positioned in the one or more first axial positions relative to the proximal tube.

17. 14. The closure device of claim 13, wherein the wall of the proximal tube is shaped to define one or more tabs that pass through the wall, the one or more tabs being biased to bend radially inward, and when the valve is in the open state, the fluid flow path passes through the wall between a proximal end of each of the one or more tabs and a tab-free portion of the wall axially adjacent to the one or more tabs.

18. The closure device of claim 17 , wherein the tab-free portion of the wall is disposed proximal to the one or more tabs.

19. 18. The closure device of claim 17, 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 the proximal ends of the one or more tabs are shaped to prevent distal movement of the one or more protrusions when the one or more protrusions are positioned proximal to the proximal ends of the one or more tabs, thereby causing the locking mechanism to assume the locked state.

20. The closure device of any one of claims 1 to 9, further comprising a proximal connector configured to releasably connect the closure device to a correspondingly configured distal connector of the delivery system.

21. 10. A closure system including a closure device according to any one of claims 1 to 9, the closure system being for use with a guidewire and further including a delivery system cooperating with the guidewire, the delivery system including an implant catheter connected to an operating handle, the implant catheter including a longitudinal passage for the guidewire, a distal connector for releasably connecting the implant catheter to a correspondingly configured proximal connector of the closure device, and an inflation tube channel releasably connectable to the fluid flow path of the closure device.

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