Tissue grabber

Abstract

A tissue grabber device, including: an elongated body having a long axis, a proximal section and a distal section shaped and sized to be inserted into a body lumen; an expandable tissue capturing portion at the distal section, shaped and sized to be introduced into the body lumen via the working channel in a collapsed state, and to expand outside the working channel, the expandable capturing portion comprises: an expandable body having a proximal end and a distal end shaped and sized to contact a tissue surface in the body lumen, the body defines at least one internal volume, and comprises at least one distal opening at the expandable body distal end to the internal volume; at least one fastener functionally coupled to the expandable body, wherein the at least one fastener is configured to controllably inwardly collapse into the internal volume a portion of the expandable body.

Description

[0001] TISSUE GRABBER

[0002] RELATED APPLICATIONS

[0003] This application claims the benefit of priority under 35 USC § 119(e) of U.S. Provisional Patent Application No. 63 / 745,355 filed January 15,2025, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to grasping body tissue and, more particularly, but not exclusively, to grasping a body lumen wall.

[0006] International Patent Application Publication No. W02023002482A1, describes, “a method for left atrial appendage (LAA) invagination, including: convexing a portion of the LAA wall into the LAA; grasping the convexed LAA wall portion within the LAA; invaginating the LAA at least partly into the left atria (LA) using the convexed LAA portion” (Abstract).

[0007] SUMMARY OF THE INVENTION

[0008] Some examples of some embodiments of the invention are listed below (it should be noted that one or more features of an example may be used in combination with one or more features of another example):

[0009] Example 1. A tissue grabber device, comprising:

[0010] an elongated body having a long axis, a proximal section and a distal section shaped and sized to be inserted into a body lumen via a working channel of a delivery device;

[0011] an expandable tissue capturing portion at the distal section, shaped and sized to be introduced into the body lumen from outside a subject body via the working channel in a collapsed state, and to expand outside the working channel, the expandable capturing portion comprises:

[0012] an expandable body having a proximal end coupled to the elongated body and a distal end shaped and sized to contact a tissue surface in the body lumen, the body defines at least one internal volume, and comprises at least one distal opening at the expandable body distal end to the internal volume;

[0013] at least one fastener functionally coupled to the expandable body, wherein the at least one fastener is configured to controllably inwardly collapse into the internal volume a portion of the expandable body.

[0014] Example 2. A device according to example 1, wherein the at least one fastener is configured to controllably inwardly collapse into the internal volume up to 90% of the expandable body.Example 3. A device according to any one of examples 1 or 2, wherein the at least one fastener is configured to controllably inwardly collapse into the internal volume up to 50% of the expandable body.

[0015] Example 4. A device according to any one of the previous examples, wherein the at least one fastener is configured to controllably inwardly collapse a portion of the expandable body, while at least 10% of the expandable body remains uncollapsed.

[0016] Example 5. A device according to any one of the previous examples, wherein the elongated body comprises at least one suction channel fluidically interconnecting a vacuum source with the expandable body, and configured to allow application of vacuum through the expandable body distal opening on the tissue surface, with a force sufficient to convex a portion of the tissue surface into the inner volume via the at least one distal opening.

[0017] Example 6. A device according to any one of the previous examples, wherein the at least one fastener is shaped as a loop or a ring, and surrounds the internal volume.

[0018] Example 7. A device according to any one of the previous examples, wherein the expandable body comprises a flexible distal skirt at the expandable body distal end, wherein the flexible distal skirt surrounds the at least one distal opening and extends radially outwardly to form a funnel shape into the internal volume, wherein at least an inner surface of the flexible distal skirt is shaped and sized to contact the tissue surface.

[0019] Example 8. A device according to any one of the previous examples, wherein the expandable body comprises a flexible distal skirt at the expandable body distal end, wherein the flexible distal skirt surrounds the at least one distal opening and extends distally and radially outwardly, to form a cone or a funnel shape, wherein at least an inner surface of the flexible distal skirt is shaped and sized to contact the tissue surface.

[0020] Example 9. A device according to any one of the previous examples, wherein aid at least one fastener is coupled to a portion of the expandable body surrounding the at least one distal opening, and is configured to controllably collapse the portion to narrow or close the at least one distal opening.

[0021] Example 10. A device according to example 8, wherein the at least one fastener is coupled to the expandable body proximally to the flexible distal skirt, and is configured to controllably inwardly collapse a portion of the expandable body located proximally to the flexible distal skirt.

[0022] Example 11. A device according to example 8, wherein the at least one fastener is coupled to the flexible distal skirt, and is configured to controllably inwardly collapse the flexible distal skirt. Example 12. A device according to any one of examples 8 to 11, wherein the flexible distal skirt is flexible enough to bend backwards when pushed against the tissue surface.Example 13. A device according to any one of examples 8 to 12, wherein the flexible distal skirt is configured to contact the tissue surface at angle smaller than 45 degrees.

[0023] Example 14. A device according to any one of examples 8 to 13, wherein the flexible skirt is formed from at least one layer of flexible material configured to bend and conform the flexible skirt to anatomy of the tissue surface being contacted by the flexible skirt.

[0024] Example 15. A device according to example 14, wherein the expandable body comprises an expandable skeleton shaped as a web of wires, coated with at least one layer of coating, wherein the flexible skirt is located distally to the expandable skeleton.

[0025] Example 16. A device according to example 15, wherein the flexible skirt is coupled to the expandable skeleton and / or to the expandable skeleton coating.

[0026] Example 17. A device according to any one of examples 15 or 16, wherein the at least one layer of coating of the expandable skeleton extends distally to the expandable skeleton, forming the flexible skirt.

[0027] Example 18. A device according to example 14, wherein the expandable body comprises an expandable skeleton shaped as a web of wires, coated with at least one layer of coating, and wherein the flexible skirt comprises the expandable skeleton and / or the expandable skeleton coating.

[0028] Example 19. A device according to any one of examples 15 to 18, wherein the expandable skeleton is formed from a shape memory alloy.

[0029] Example 20. A device according to any one of examples 15 to 19, wherein the at least one layer of flexible material and / or the expandable skeleton coating comprises at least one of, Polyurethane, Silicone, Polyethylene Terephthalate (PET), Fluorinated Ethylene Propylene (FEP), Thermoplastic polyurethane (TPU), Poly(ether-block-amide) (PEBA), and Nylon.

[0030] Example 21. A device according to any one of examples 15 to 20, wherein an inner surface of a portion of the expandable body configured to be inwardly collapsed by the at least one fastener, comprises at least one soft section.

[0031] Example 22. A device according to any one of the previous examples, comprising at least one fastener actuator coupled to the at least one fastener and extending between the at least one fastener and the proximal section of the elongated body, wherein application of force on the at least one fastener actuator fastens the at least one fastener and controllably inwardly collapsed the expandable body portion.

[0032] Example 23. A device according to example 22, comprising:

[0033] at least one control unit coupled to the proximal section of the elongated body, wherein the at least one control unit comprises at least one control interface for controlling manually movement of theelongated body distal section and the expandable body, and for controllably apply force on the at least one fastener actuator for controlling fastening of the at least one fastener.

[0034] Example 24. A device according to any one of examples 22 or 23, comprising at least one extendable force limiter in the at last one fastener actuator and / or in the at least one fastener, configured to limit the force applied by the at least one fastener on the expandable body during fastening of the at least one fastener.

[0035] Example 25. A device according to any one of the previous examples, wherein the elongated body comprises an extendable portion positioned between the proximal section and the distal section, and at least two axially spaced apart radiopaque markers in the extendable portion or at opposite ends of the extendable portion, wherein the at least two axially spaced apart radiopaque markers are configured to deliver a visual indication about a force applied on the elongated body according to extension of the extendable portion and a change in distance between the at least two axially spaced apart radiopaque markers.

[0036] Example 26. A device according to any one of examples 1 to 24, wherein the elongated body comprises an extendable portion positioned between the proximal section and the distal section, wherein the device comprising at least one detector functionally coupled to the extendable portion and configured to detect a force applied on the elongated body according to extension of the extendable portion.

[0037] Example 27. A device according to any one of the previous examples, wherein a maximal width of the expandable tissue capturing portion in an expanded state is up to 40 mm.

[0038] Example 28. A device according to any one of the previous examples, wherein a maximal width of the expandable body in a collapsed state is smaller than 10 mm.

[0039] Example 29. A device according to any one of the previous examples, wherein the expandable capturing portion is shaped as a cup, and wherein the at least one distal opening is a front opening. Example 30. A device according to any one of the previous examples, wherein the body lumen is a left atrial appendage (LAA) of a heart, and wherein the tissue surface comprises a wall of the LAA.

[0040] Example 31. A device according to any one of examples 1 to 29, wherein the body lumen comprises a right atrial appendage (RAA), a colon, a large intestine, a small intestine, a stomach, a pharynx, or a throat, and wherein the tissue surface comprises a wall of the body lumen.

[0041] Example 32. A left atrial appendage (LAA) invaginating system, comprising:

[0042] a delivery device having a proximal opening and a distal opening, wherein the delivery device is shaped and sized to be introduced into a left atrium (LA) of a heart in a subject body;

[0043] a tissue grabber device, comprising:an elongated body comprising a suction channel, having a long axis, a proximal section and a distal section shaped and sized to be inserted into the LA via a working channel of the delivery device;

[0044] an expandable tissue capturing portion at the distal section, shaped and sized to be introduced into the LAA and to be placed in contact with a LAA wall, wherein the expandable tissue capturing portion defines an internal volume and comprises at least one distal opening to the internal volume; wherein the tissue grabber device is configured to apply vacuum on the LAA wall via the at least one distal opening with a force sufficient to convex a portion of the LAA wall into the internal volume of the expandable tissue capturing portion;

[0045] wherein the expandable tissue capturing portion is configured to be partially collapsed to capture the convexed portion of the LAA within the internal volume, while the tissue grabber is retracted and invaginates the LAA into the LA.

[0046] Example 33. A system according to example 32, wherein the expandable tissue capturing portion comprises a flexible distal skirt surrounding the at least one distal opening and extends radially outwardly to form a funnel shape into the internal volume, wherein the flexible distal skirt is shaped and sized to contact the LAA prior to and / or during application of vacuum onto the LAA wall.

[0047] Example 34. A system according to example 32, wherein the expandable tissue capturing portion comprises a flexible distal skirt surrounding the at least one distal opening and extends distally and radially outwardly to form a cone or funnel shape, wherein the flexible distal skirt is shaped and sized to contact the LAA prior to and / or during application of vacuum onto the LAA wall. Example 35. A system according to any one of examples 33 or 34, wherein the tissue grabber device comprises at least one fastener functionally coupled to the expandable capturing portion, wherein fastening of the at least one fastener collapses a portion of the tissue capturing portion into the internal volume while at least 10% of the tissue capturing portion remains uncollapsed. Example 36. A system according to example 35, wherein the at least one fastener is functionally coupled to the expandable capturing portion proximally to the flexible distal skirt, and configured to be fastened proximally to the flexible distal skirt.

[0048] Example 37. A system according to example 35, wherein the at least one fastener is functionally coupled to the flexible distal skirt and is configured to collapse the flexible distal skirt.

[0049] Example 38. A system according to any one of examples 32 to 37, comprising a LAA isolator configured to cover a LAA opening within the LA, to prevent flow of particles, debris and / or blood clots from the LAA into the LA.Example 39. A system according to example 38, wherein the LAA isolator comprises a channel terminating with an expandable cover, wherein the expandable cover is configured to be in a collapsed state within the delivery device and to expand within the LA, and wherein retraction of the tissue grabber into the LA while holding the convexed portion of the LAA within the internal volume, invaginates the LAA into the expandable cover.

[0050] Example 40. A system according to example 39, comprising at least one ligator releasably coupled to an inner surface of the expandable cover and is configured to detach from the expandable and to be fastened around the invaginated LAA.

[0051] Example 41. A system according to example 40, wherein the at least one ligator comprises a suture loop or a lasso, coupled to an inner surface of the LAA isolator around a distal opening of the LAA isolator through which the expandable tissue capturing portion holding the convexed LAA portion is retracted into the LAA isolator.

[0052] Example 42. A system according to any one of examples 32 to 41, comprising:

[0053] at least two control units configured to be positioned outside the subject body, wherein the at least two control units comprise a first control unit coupled to the delivery device and configured to control axial movement and / or steering of the delivering device within the subject body, and a second control unit functionally coupled to the tissue grabber device and configured to control axial movement of the tissue grabber device within the subject body and partial collapsing of the expandable capturing portion;

[0054] at least one guiding rail defining a movement range, wherein the at least two control units are axially arranged along the at least one guiding rail and are axially movable within the at least one guiding rail relative to each other, wherein the guiding rail comprises at least one movement limiter configured to limit movement of one or more of the at least two control units relative to each other and / or relative to the defined movement range.

[0055] Example 43. A tissue grabber device, comprising:

[0056] an elongated body having a long axis, a proximal section and a distal section shaped and sized to be inserted into a body lumen via a working channel of a delivery device;

[0057] a tissue capturing portion at the distal section, shaped and sized to be introduced into the body lumen from outside a subject body via the working channel in a collapsed state, and to controllably expand outside the working channel in response to a force applied on the tissue capturing portion, the expandable capturing portion comprises:

[0058] a body having a proximal end coupled to the elongated body and a distal end shaped and sized to contact a tissue surface in the body lumen, the body defines at least one internal volume, and comprises at least one distal opening at the body distal end to the inner volume, wherein the bodyis configured to acquire a collapsed state, in rest, and to expand to an expanded state in response to a force applied on the body;

[0059] at least one body expander functionally coupled to the body, wherein the at least one body expander is configured to controllably expand the body in response to a force applied on the at least one body expander from outside the subject body.

[0060] Example 44. A method for invagination of a body lumen, comprising:

[0061] introducing a tissue capturing device from a first body lumen into a second body lumen, the tissue capturing device comprises an internal volume, at least one distal opening to the internal volume, and a flexible distal end surrounding the at least one distal opening;

[0062] contacting a wall of the second body lumen with the flexible distal end;

[0063] convexing a portion of the wall into the internal volume;

[0064] collapsing a portion of the tissue capturing device into the internal volume while the convexed portion is inside the internal volume, to capture the convexed wall portion within the tissue capturing device;

[0065] invaginating at least partly the second body lumen by retracting the tissue capturing device into the first body lumen while the convexed wall portion remains captured within the tissue capturing device.

[0066] Example 45. A method according to example 44, wherein the collapsing comprises collapsing up to 80% of the tissue capturing device while at least 20% of the tissue capturing device remains uncollapsed.

[0067] Example 46. A method according to any one of examples 44 or 45, wherein the collapsing comprises reducing a volume of the internal volume in up to 80% relative to the internal volume of an uncollapsed tissue capturing device.

[0068] Example 47. A method according to any one of examples 44 to 45, wherein the collapsing comprises narrowing the at least one distal opening.

[0069] Example 48. A method according to any one of examples 42 to 45, wherein the convexing comprises applying suction via the at least one distal opening onto the wall during the contacting with a force sufficient convex the portion of the wall into the internal volume.

[0070] Example 49. A method according to any one of examples 44 to 48, wherein a volume of the convexed wall fills at least 30% of the internal volume.

[0071] Example 50. A method according to any one of examples 44 to 49, comprising closing the invaginated second body lumen by positioning and tightening a ligator around the invaginated body lumen following the invaginating.Example 51. A method according to any one of examples 44 to 50, comprising isolating before, during and / or after the invaginating the second body lumen from the first body lumen by positioning a cover over an opening of the second body to prevent release of blood clots and / or debris out from the second body lumen through the first body lumen.

[0072] Example 52. A method according to any one of examples 44 to 51, wherein the method is a method for invaginating a left atrial appendage (LAA), wherein the first body lumen comprises a left atrium (LA), and wherein the second body lumen comprises the LAA.

[0073] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0074] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0075] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0076] In the drawings:

[0077] FIG. 1 is a general flow chart of a process for grabbing a portion of a convexed wall of a body lumen, and invaginating the body lumen using the grasped portion, according to some exemplary embodiments of the invention;

[0078] FIG. 2 A is a block diagram of a tissue grabber, according to some exemplary embodiments of the invention;

[0079] FIGs. 2B and 2C are block diagrams of selectively contracted tissue grabbers, according to some exemplary embodiments of the invention;

[0080] FIG. 3 is a flow chart of a general process for controllably capturing and / or manipulating tissue, according to some exemplary embodiments of the invention;

[0081] FIG. 4A is a block diagram of a system for closing a body lumen, for example the LAA, according to some exemplary embodiments of the invention;FIG. 4B is a schematic illustration showing distal and proximal ends of a system for closing a body lumen, for example the LAA, according to some exemplary embodiments of the invention;

[0082] FIG. 4C is an enlarged view of a distal portion of the system shown in fig. 4B, for example the LAA, according to some exemplary embodiments of the invention;

[0083] FIG. 5 is a detailed flow chart of process for closure of a body lumen, for example a LAA, according to some exemplary embodiments of the invention;

[0084] FIGs. 6A-6D are schematic illustrations of a tissue grabber having a capturing cup with a distal flexible edge, according to some exemplary embodiments of the invention;

[0085] FIG. 6E is a schematic illustration showing a tissue capturing portion having a distal skirt, according to some exemplary embodiments of the invention;

[0086] FIGs. 7A-7I are schematic illustrations showing closure of a body lumen, for example a LAA, using a tissue grabber having a capturing cup with a collapsible portion, according to some exemplary embodiments of the invention;

[0087] FIGs. 8A-8E are schematic illustrations showing a tissue grabber having a capturing cup with a collapsible flexible skirt, according to some exemplary embodiments of the invention;

[0088] FIGs. 9A-9B are schematic illustrations showing a tissue grabber having a capturing cup with a collapsible flexible skirt during convexing and invagination, according to some exemplary embodiments of the invention;

[0089] FIGs. 10A and 10B are schematic illustrations of a tissue capturing cup with an expandable opening, in a collapsed closed state (10A), and in an open expanded state (10B), according to some exemplary embodiments of the invention;

[0090] FIG. 11 is a schematic illustration of a tissue grabber having at least one force limiter, according to some exemplary embodiments of the invention;

[0091] FIGs. 12A-12C are schematic illustrations of a tissue grabber having force indicator, according to some exemplary embodiments of the invention;

[0092] FIGs. 12D-12E are schematic illustrations showing generation of force indication during invagination, according to some exemplary embodiments of the invention;

[0093] FIG. 12F is a schematic illustration of a tissue grabber having at least one first detector, according to some exemplary embodiments of the invention; and

[0094] FIGs. 13A-13B are schematic illustrations showing a tissue grabber having a tissue capturing cup with an inner soft layer, according to some exemplary embodiments of the invention.DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0095] The present invention, in some embodiments thereof, relates to grabbing body tissue and, more particularly, but not exclusively, to grabbing a body lumen wall.

[0096] Overview

[0097] An aspect of some embodiments relates to grabbing a small portion of a wall of a body lumen, when invaginating the body lumen. In some embodiments, at least one collapsible portion of a tissue grabber is controllably collapsed on wall tissue, for example to grab the small portion with a force that is sufficient to ensure contact between the body lumen wall and the tissue grabber during body lumen invagination. Alternatively, the at least one collapsible portion controllably collapses inwardly into an inner volume of the tissue grabber comprising the body lumen wall tissue. In some embodiments, the at least one collapsible portion reversibly controllably collapses to capture a portion of a body lumen within an inner volume of the tissue grabber, for example an inner volume of a tissue grabber tissue capturing portion. In some embodiments, the body lumen is partially invaginated, optionally into the body lumen. Alternatively, the body lumen is completely invaginated into a neighboring lumen. For example, a LAA is partially invaginated into the LAA lumen, or is completely invaginated into a left atria (LA) of the heart.

[0098] As used herein, the terms “collapsing” or “collapse” means shrinkage and / or narrowing of a structure, for example reducing a structure width, without causing damage and / or affecting a structural integrity of the structure.

[0099] According to some embodiments, the at least one collapsible portion of a tissue grabber comprises less than 80%, less than 60, less than 50%, less than 25%, or any intermediate, smaller or larger percentage value of the tissue grabber body. In some embodiments, at least one collapsible portion of the tissue grabber is a middle portion of the tissue grabber body, located between a proximal end and a distal end of the tissue grabber. Alternatively, the at least one collapsible portion of the tissue grabber surrounds at least one opening of the tissue grabber, for example a front opening of the tissue grabber. In some embodiments, the at least one collapsible portion is configured to reduce a width of the at least one opening in at least 30%, for example in at least 50%, in at least 60%, in at least 70%, in at least 90%, in at least 95%, or any intermediate, smaller or larger percentage value, when collapsed.

[0100] According to some embodiments, the tissue grabber comprises a flexible skirt, optionally surrounding the at least one opening. In some embodiments, the at least one collapsible portion is located between the flexible skirt and a proximal end of the tissue grabber. Alternatively, the at least one collapsible portion comprises the flexible skirt.According to some embodiments, the tissue grabber comprises at least one fastener surrounding the tissue grabber body at the at least one collapsible portion. In some embodiments, the at least one fastener is coupled, to an inner surface of the tissue grabber body and / or to an outer surface of the tissue grabber body. In some embodiments, the at least one fastener is configured to controllably contract and inwardly collapse the at least one collapsible portion. In some embodiments, the at least one fastener is configured to reversibly contract the collapsible portion.

[0101] An aspect of some embodiments relates to a tissue grabber, for example an expandable tissue grabber, having at least one distal opening, and a flexible skirt portion surrounding the at least one distal opening which is shaped and sized to contact a tissue wall. In some embodiments, the tissue grabber is configured to apply suction, for example vacuum, on the tissue wall while the flexible skirt portion seals a fluid flow path between the tissue grabber and the tissue wall. In some embodiments, the flexible skirt portion extends outwardly, and is optionally shaped as a funnel or a cone having a distal end that is wider than a proximal portion or proximal end of the flexible skirt portion .

[0102] According to some embodiments, the tissue grabber comprises a body formed from an expandable skeleton, configured to expand in a relaxed state. In some embodiments, the flexible skirt portion extends distally to the expendable skeleton. In some embodiments, the expandable skeleton is coated with a flexible coating also forming the flexible skirt portion. Alternatively, the flexible skirt portion is formed from at least one layer of a sheet material coupled to the expandable skeleton coating.

[0103] According to some exemplary embodiments, the tissue grabber body comprises at least one collapsible portion configured to be controllably inwardly collapsed, for example to have a reduced width of more than 30%, for example more than 50%, more than 70%, more than 90%, or any intermediate, smaller or larger value, relative to a width of the at least one collapsible portion prior to collapsing. In some embodiments, the at least one collapsible portion is located at the flexible skirt portion. Optionally, the lip portion is collapsible. Optionally, the flexible skirt portion is collapsible. Alternatively, the at least one collapsible portion of the tissue grabber body is located proximally to the lip portion, for example proximally to the flexible skirt portion, between the tissue grabber distal opening at a proximal end of the tissue grabber.

[0104] According to some embodiments, collapsing of a tissue grabber tissue capturing portion, optionally the collapsible portion of the capturing portion, or a body of the capturing portion, reduces an inner volume defined by the tissue grabber capturing portion or the body thereof in up to 80%, in up to 70%, in up to 60%, in up to 50%, in up to 40%, in up to 30%, in up to 20%, or any intermediate, smaller or larger value. In some embodiments, during collapsing of the tissue grabbercapturing portion, up to 80% of a tissue grabber capturing portion is collapsed, while at least 20%, at least 40%, at least 50%, or any intermediate, smaller or larger percentage value, of the tissue grabber capturing portion remains uncollapsed, for example has a reduction in width of less than 30%, less than 15%, less than 10%, less than 5%, less than 1% or any intermediate, smaller or larger value, relative to a width of the tissue capturing portion prior to collapsing.

[0105] An aspect of some embodiments relates to controlling a force applied by a tissue grabber on tissue positioned within an inner volume of the tissue grabber. In some embodiments, the force is controlled by receiving an indication about the force applied on the tissue, and controlling the applied force manually. In some embodiments, the force is controlled by at least one force limiter, optionally a spring or an elastic extender, coupled to the tissue grabber and configured to control a force applied on the tissue grabber, for example on at least one collapsible portion of the tissue grabber. In some embodiments, the force is controlled by preforming a collapsible tissue grabber to be inwardly collapsed in a relaxed state, and to a apply a predetermined force level on tissue within the tissue grabber.

[0106] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0107] Exemplary general process for grabbing tissue

[0108] According to some exemplary embodiments, a device for grabbing, for example holding body tissue is used, for example, in order to allow tissue manipulation. In some embodiments, manipulation tissue comprises pushing pulling, twisting, and / or turning the grabbed tissue. Alternatively or additionally, the grabbed tissue is used as an anchoring point, optionally to stabilize an implant permanently within the body, or when transiently stabilizing a device, for example an isolating device or an ablating device within a subject body.

[0109] According to some exemplary embodiments, tissue grabbing is controlled, for example to prevent grabbing and optionally manipulating the grabbed tissue with excess force, for example to prevent tissue damage.

[0110] Reference is now made to fig. 1, depicting a general process for grabbing tissue, according to some exemplary embodiments of the invention.

[0111] According to some exemplary embodiments, a tissue grabber device is introduced into a body lumen, at block 102. In some embodiments, the body lumen comprises a LAA, a right atrialappendage (RAA), a colon, large intestine, small intestine, stomach, pharynx, or throat. In some embodiments, the tissue grabber enters into the body lumen in a collapsed state, and is configured to expand within the body lumen. Alternatively, the tissue grabber enters into the boy lumen in an expanded state.

[0112] According to some exemplary embodiments, the tissue grabber is positioned adjacent to a body lumen wall, for example at a distance shorter than 20 millimeters (mm), shorter than 10mm, shorter than 5mm, shorter than 1mm, or any intermediate, smaller or larger distance value, from the body lumen wall. Alternatively, the tissue grabber, optionally a distal end of the tissue grabber, is positioned in contact with the body lumen wall.

[0113] According to some exemplary embodiments, a body lumen wall is convexed into the tissue grabber, at block 104. In some embodiments, a portion of the body lumen wall is convexed into the tissue grabber through at least one opening of the tissue grabber. In some embodiments, the body lumen wall portion is convexed into the tissue grabber, when suction, for example vacuum is applied from the tissue grabber via the at least one opening onto the body lumen wall.

[0114] According to some exemplary embodiments, a small portion of the convexed wall is contacted by the tissue grabber, at block 106. In some embodiments, a small portion of the convexed wall is contacted by an inner surface of the tissue grabber. Alternatively or additionally, the small portion of convexed wall is contacted by one or more retainers located within the tissue grabber. In some embodiments, the small portion of convexed wall is contacted by an inner surface of a collapsed part of the tissue grabber.

[0115] According to some exemplary embodiments, the small portion of the convexed wall contacted by the tissue grabber has a size of less than 50%, less than 40%, less than 20%, less than 10%, or any intermediate, smaller or larger percentage value of the overall size of the convexed body lumen wall.

[0116] According to some exemplary embodiments, contacting the small portion of the convexed wall comprises holding the small portion with a force smaller than the force needed to penetrate through the convexed wall, In some embodiments, the force applied on the convexed tissue, optionally the maximal force, is up to about 24 Newtons (N), for example between 0 and about 24N, between 5N and 20N, between 10N and 20N, between 15N and 24N, or any intermediate, smaller or larger value.

[0117] According to some exemplary embodiments, the contacting comprises controllably contacting and holding the small portion of the convexed wall. In some embodiments, the contacting comprises reversibly contacting the small portion of convexed wall, such that the tissue grabber can be released from the convexed wall, for example when body lumen manipulation iscompleted. Alternatively, for example when using the convexed wall portion as an anchoring point for an implant, the tissue grabber is irreversibly coupled to the convexed wall portion.

[0118] According to some exemplary embodiments, the body lumen is invaginated, at least partly using the contacted body lumen wall, at block 108. In some embodiments, the body lumen is partially invaginated into the body lumen. For example, in some embodiments when the body lumen comprises a LAA, the LAA is partly invaginated such that the invaginated portion of the LAA remains within the invaginated portion of the LAA. Alternatively, the LAA is completely invaginated through the LAA opening, into the LA. In some embodiments, the invagination is performed by retraction of the tissue grabber in a direction opposite to the penetration direction at block 102 while holding, grabbing the convexed portion of the body lumen wall, optionally in case the body lumen is the LAA, the tissue grabber is retracted into the LA, while the tissue grabber in contact and holds the convexed portion of the LAA wall.

[0119] According to some exemplary embodiments, following invagination, the body lumen is optionally closed, at block 110. In some embodiments, closure of the body lumen opening at block 110 is performed by at least one of, placing an isolator implant inside the body lumen and / or the body lumen opening, to isolate the body lumen from other body lumens of the body, or by placing a fastener over the inverted body lumen, for example over a base or close to a base of the invaginated body lumen, optionally adjacent to the body lumen opening, when the body lumen is fully invaginated.

[0120] Exemplary tissue grabber

[0121] According to some exemplary embodiments, a tissue grabber device is configured to draw tissue, for example to convex a wall of a body lumen, into an inner volume of the tissue grabber, and to mechanically capture the tissue inside the inner volume.

[0122] Reference is now made to fig. 2A, depicting a block diagram of a tissue grabber, according to some exemplary embodiments of the invention.

[0123] According to some exemplary embodiments, a tissue grabber device, for example tissue grabber 202 comprises an elongated body 204, having a long axis 203, a proximal end 206 configured to be positioned outside a subject body, and a tissue capturing portion 208, optionally shaped as a capturing cup, at a distal end 210, configured to be introduced into a body lumen, for example into a LAA of a heart. In some embodiments, the device 202 is shaped and sized to be introduced in a subject body, for example into a subject heart via a catheter.

[0124] According to some exemplary embodiments, the tissue capturing portion 208 is an expandable portion, configured to move between a collapsed state within the catheter, and toexpand when exiting the catheter distal opening, to acquire an expanded state. In some embodiments, the tissue capturing portion 208 expands when relaxed. Alternatively, the capturing portion 208 is configured to be collapsed in a relaxed state, and to acquire an expanded state upon application of force on the capturing portion body.

[0125] According to some exemplary embodiments, the body 212 of the tissue capturing portion 208, comprises at least one inner volume 214, and at least one distal opening 216 to the inner volume 214. In some embodiments, the distal opening 216 is a front opening, positioned to face tissue located distally in front of the device 202. In some embodiments, the body 212 is shaped as a cup or a cone, having the distal opening 216.

[0126] According to some exemplary embodiments, a width, for example maximal width of the tissue capturing portion 208, optionally of the body 212, in an expanded state, is up to 50 mm, for example up to 40mm, up to 30 mm, or any intermediate, smaller or larger value. In some embodiments, a width, for example maximal width of the tissue capturing portion 208, optionally of the body 212, in a collapsed state, is smaller than 25 mm, for example smaller than 20 mm, smaller than 15 mm, smaller than 10 mm, or any intermediate, smaller or larger value.

[0127] According to some exemplary embodiments, the elongated body 204 comprises a channel, for example a suction channel, traveling along the and within the elongated body. In some embodiments, the suction channel is fluidically connected to the capturing portion 208. In some embodiments, the suction channel fluidically interconnects the capturing portion 208 with at least vacuum source, for example at least one syringe, or a vacuum pump. In some embodiments, the capturing portion 208 comprises at least one proximal opening 218, functionally coupled to the suction channel, for example to allow application of suction from the suction channel via the at least one distal opening 216 onto tissue.

[0128] According to some exemplary embodiments, at least part or all of the body 212 is formed from a skeleton, optionally flexible, optionally elastic, skeleton, configured to expand, optionally self-expand, and to contract when force is applied on the body. In some embodiments, the skeleton is formed as a web-like structure, for example a net structure, optionally made from wires. In some embodiments, the skeleton, formed as a web-like, net structure, is made from a superelastic material, optionally from shape memory alloy, for example Nickel-Titanium Alloys (Nitinol), Copper-Based Alloys, Iron-Based Alloys, Cobalt-Based Alloys, Magnesium Alloys, Zirconium-Based Alloys, and / or from High-Performance Polymers.

[0129] According to some exemplary embodiments, the skeleton is coated with a coating formed as at least one layer of sheet material. In some embodiments, the coating comprises at least one of, Polyurethane, Silicone, Polyethylene Terephthalate (PET), Fluorinated Ethylene Propylene (FEP),Thermoplastic polyurethane (TPU), Poly(ether-block-amide) (PEBA), and Nylon. In some embodiments, the at least one coating layer is attached to an outer surface of the skeleton. Alternatively, the at least one coating layer is attached to an inner surface of the skeleton. Alternatively, the skeleton is disposed between at least one later of coating, and at least one inner layer of coating.

[0130] According to some exemplary embodiments, the body, for example body 212, comprises a skirt, for example a flexible optionally elastic, lip 220, optionally shaped as a flexible skirt, surrounding the distal opening 216. In some embodiments, the elastic lip extends radially outwardly relative to axis 203, optionally forming a cone shape, or a funnel shape, having a distal end or a distal openings that is wider than a proximal portion of the skirt.

[0131] In some embodiments, the flexible skirt comprises a circumferential flaring portion extending radially outwardly and distally to the distal opening 216 of the body 212. Optionally, the circumferential flaring portion in bendable in a proximal direction, for example when the flexible skirt is pushed against a wall of a body lumen, for example against the LAA wall. In some embodiments, the circumferential flaring portion comprises a coated skeleton or scaffold, optionally also forming at least partly the body 212. Alternatively, the circumferential flaring portion comprises unsupported coating which optionally extends distally to a skeleton or a scaffold forming the body 212. In some embodiments, the circumferential flaring portion is shaped as a cone or a funnel, having a distal end that is wider than a proximal end of the flaring portion. In some embodiments, a coating of the circumferential flaring portion is similar to the coating of the body 212, or is a different coating. Optionally, the coating of the body 212 and the coating of the circumferential flaring portion have a similar number of layers or a different number of layers, for example the coating of the circumferential flaring portion is thicker or thinner compared to the thickness of the coating of the body 212. Alternatively, the coating of the circumferential flaring portion has the same thickness as the thickness of the coating of the body 212.

[0132] According to some exemplary embodiments, the skirt 220 also termed here as a lip 220, extends distally to a skeleton, for example a shape memory alloy skeleton of the body 212. In some embodiments, the skirt 220 comprises at least one layer of sheet material optionally flexible or elastic sheet material. In some embodiments, a thickness of the skirt 220 and / or of the at least one layer of the sheet material forming the skirt 220 is larger than a thickness of a coating of the skeleton of the body 212. In some embodiments, a thickness of the skirt 220 or of the skirt coating is between 50 micrometer (pm) and 500 pm, for example between 70 pm and 200 pm, between 100 pm and 300 pm, between 100 pm and 200 pm, or any intermediate, smaller or larger value. In some embodiments, a thickness of the skeleton coating of the body 212 is smaller than 100 pm, forexample smaller than 80 pm, smaller than 50 pm, or any intermediate, smaller or larger value. In some embodiments, the thickness of the skirt 220 is larger than 100 pm, for example larger than 120 pm, larger than 150 pm, or any intermediate, smaller or larger value.

[0133] A potential advantage of having a thick flexible skirt 220 may be to allow bending of the entire circumferential skirt 220, as a single unit in a proximal direction, when the skirt is pushed against a tissue wall, for example against the wall of the LAA. In some embodiments, the bending of the skirt 220 is along an interface region between the skeleton forming the body and the skirt 220, for example interface 219

[0134] In some embodiments, a maximal width, optionally outer width, 222 of a distal end of the flexible skirt 220 is larger than an average width of the capturing portion 208. In some embodiments, an average width 224 or a maximal width of the capturing portion, is between about 1 mm and about 20 mm, for example between 1 mm and 10 mm, between 5 mm and 10 mm, between 7 mm and 10 mm, or any intermediate, smaller or larger value. In some embodiments, a width 222 is between about 1mm and about 30 mm, for example between 5 mm and 25 mm, between 20 mm and 30 mm, between 25 mm and 30 mm, or any intermediate, smaller or larger value.

[0135] According to some exemplary embodiments, the flexible skirt 220 comprises the skeleton and the skeleton coating. Alternatively, the flexible skirt is located distally to the skeleton and is formed from the skeleton coating which extends distally to the skeleton structure. Alternatively, the flexible skirt 220 is formed at least one layer of sheet material functionally coupled to the skeleton and / or to the skeleton coating, optionally by welding. Optionally, the flexible skirt 220 is preformed to have a funnel like shape, or a cone-like shape. In some embodiments, a thickness of the flexible skirt 220 is larger than a thickness of the skeleton coating, for example to increase rigidity of the flexible skirt, optionally to prevent formation of local folds and / or to allow bending of the flexible skirt as a single unit, relative to a proximally positioned skeleton.

[0136] According to some exemplary embodiments, the flexible skirt 220 is configured to be placed in contact with a tissue surface, optionally to be pushed against the tissue surface. In some embodiments, the flexible skirt 220 is configured to flex or bend according to contour or anatomy of the tissue surface. In some embodiments, the flexible skirt is configured to form a sealing interface between the capturing portion 208 and a tissue surface contacted by the capturing portion 208.

[0137] According to some exemplary embodiments, the seal between the capturing portion 208 and a tissue surface can be achieved using the flexible skirt 220, forming a sealing interface that extends radially outwardly, optionally from the rim of the capturing portion 208, to contact thetissue. In some embodiments, the flexible skirt 220 conforms to the irregularities of the tissue surface, optionally creating a continuous and airtight interface. In some embodiments, when suction is applied within the capturing portion 208, the lip 220 is drawn against the tissue, and optionally proximally, enhancing the seal and preventing air leaks. Optionally, forming a sealed interface by the lip 220 allows efficient suction application while maintaining a stable and reliable connection between the capturing portion 208 and the tissue.

[0138] According to some exemplary embodiments, the device 202 comprises at least one fastener 226, functionally coupled to the body 212 of the capturing portion 208. In some embodiments, the at least one fastener 226 surrounds the body 208 and / or surrounds the inner volume 214. In some embodiments, the fastener 226 is coupled to the skeleton of the body 212 and / or to the coating of the skeleton. In some embodiments, the fastener 226 is coupled to an inner surface of the body 212 facing the inner volume 214. Alternatively, the fastener 226 is coupled to an outer surface of the body 212.

[0139] According to some exemplary embodiments, the fastener 226 surrounds a portion of the body 212 and is configured to contract the body portion, inwardly into the inner volume 214. In some embodiments, the contracted portion size is smaller than 100% of the body 212 size, for example smaller than 80%, smaller than 60%, smaller than 50%, smaller than 30%, smaller than 20%, smaller than 10%, smaller than 5%, or any intermediate, smaller or larger percentage value.

[0140] According to some exemplary embodiments, the fastener 226 is coupled to the body 212 between proximally to the flexible skirt 220 and is configured to contract a portion of the body 212 proximally to the flexible skirt 220. Alternatively or additionally, the fastener 226 is coupled to flexible skirt 220, and is configured to contract the flexible skirt 220. In some embodiments, contraction of the flexible skirt 220, closes the distal opening 216. In some embodiments, the at least one fastener comprises at least two optionally spaced-apart fasteners. In some embodiments, at least one first fastener of the at least two fasteners is coupled to the flexible skirt, and at least one second fastener of the at least two fasteners is coupled to the body 212 proximally to the flexible skirt. In some embodiments, the at least two fasteners are configured to be contracted simultaneously, or independently.

[0141] According to some exemplary embodiments, the fastener 226, is functionally coupled to a fastener actuator 228, configured to controllably fasten the fastener 226 and optionally loosen the fastener. In some embodiments, the fastener actuator 228 controls the fastener 226 state, by delivering a force from outside the subject body to the fastener 226. In some embodiments, the fastener actuator 228 comprises at least one wire, rod, or cable. In some embodiments, the fastener actuator extends along the long axis 203 of the device 202, between the fastener 226 and a proximalend 206 of the device 202, configured to remain outside the subject body. In some embodiments, axially movement and / or rotation of the fastener actuator 228, for example a proximal end of the actuator located outside the subject body, controls fastening of the fastener 226, for example fastening level and / or whether the fastener 226 is fastened or loosen.

[0142] According to some exemplary embodiments, the device 202 comprises at least one force limiter 230 coupled to the fastener actuator 230, is part of the fastener actuator, integrated with the fastener actuator, and / or interconnects the fastener actuator 228 and the fastener 226. In some embodiments, the at least one first limiter is configured to limit a force applied on the fastener to control the fastening degree of the fastener. In some embodiments, controlling the fastening degree allows, for example, to control a contraction or collapse degree of the capturing portion 208. In some embodiments, the at least one force limiter comprises a spring-based limiter, optionally used to absorb excess force and limit force transmission to the fastener 226.

[0143] According to some exemplary embodiments, the device comprises one or more force indicators, configured to indicate a level of force applied on the capturing portion 208, for example when retracting the capturing portion 208, while capturing tissue inside the inner volume 214. In some embodiments, the one or more force indicators, are coupled or part of the elongated body 204, and located between a proximal end 206 and a distal end 208 of the elongated body 204, or between the elongated body 204 and the capturing portion 208. In some embodiments, the one or more force indicators comprises a telescopic body, optionally elastic body, having markings on an external surface of the body. In some embodiments, the markers are radiopaque markers, visible from outside the subject body under fluoroscopy imaging. In some embodiments, pulling or retracting the elongated body exposes the radiopaque markers according to the applied force, optionally when the telescopic body extends.

[0144] Alternatively, the one or more force indicators comprises at least one sensor, configured to sense a force applied on the elongated body and / or capturing portion 208.

[0145] A potential advantage of having at least one force limiter and / or at least one force indicator may be, to better control the force applied on the capturing portion 208, and on tissue captured within the capturing portion 208, during tissue manipulation or invagination, performed using the device 202, in order avoid unwanted damage or rupture of the tissue due to application of excess force.

[0146] Reference is now made to fig. 2B and 2C, depicting contraction, optionally selective contraction, of a capturing portion of a tissue grabber device, according to some exemplary embodiments of the invention.According to some exemplary embodiments, for example as shown in fig. 2B, once tissue, for example body lumen wall, is introduced into the inner volume 214 via the distal opening 216, a fastener 226 coupled is fastened around the body 212. In some embodiments, fastening of the fastener 226, selectively collapses a portion of the capturing portion body 212 located proximally to the flexible skirt 220, into the inner volume 214. Optionally, the body 212 collapses and contacts the tissue 250.

[0147] According to some exemplary embodiments, for example a shown in fig. 2C, in case the fastener 226 is coupled to the flexible skirt 220, fastening of the fastener collapses the flexible skirt 220, and optionally closes the distal opening 216. In some embodiments, closure of the distal opening 216 captures the tissue 250 inside the inner volume 214.

[0148] Exemplary general process for controllably applying force on tissue

[0149] Reference is now made to fig. 3, depicting a general process for controllably capturing and / or manipulating tissue, according to some exemplary embodiments of the invention.

[0150] According to some exemplary embodiments, a capturing portion of a tissue grabber penetrates into a body lumen, via a body lumen opening, at block 312. In some embodiments, the capturing portion, for example capturing portion 208 of tissue grabber 202 describes in fig. 2A, penetrates into the body lumen, as described at block 102 of fig. 1.

[0151] According to some exemplary embodiments, following penetration into body lumen, a distal end of the capturing portion contacts a body lumen wall via a flexible skirt, at block 314. In some embodiments, the flexible skirt 220 surrounds at least one distal opening 216, optionally a front opening, used to form an air tight sealing between the capturing portion distal opening and the body lumen wall.

[0152] According to some exemplary embodiments, vacuum is applied through the capturing portion distal opening onto the body lumen wall facing the opening, at block 316. In some embodiments, the vacuum is applied while the flexible skirt contacts the wall to maintain the sealed fluid flow between the tissue grabber and the wall.

[0153] According to some exemplary embodiments, the vacuum is applied with a force sufficient to convex a portion of the body lumen into the tissue grabber, at block 318. In some embodiments, the vacuum is applied with a force of up to 1 Atmospheres (ATM), for example with a force of 0.8 ATM, with a force of up to 0.5 ATM, or any intermediate, smaller or larger value.

[0154] According to some exemplary embodiments, following convexing, a portion of the capturing portion is inwardly contracted, at block 320. In some embodiments, the portion of the tissue grabber is inwardly collapsed, for example to reduce an inner volume of the tissue grabberand / or to close an opening, for example a distal opening of the tissue grabber. In some embodiments, the capturing portion inwardly collapses, for example to trap and / or hold the convexed tissue within the capturing portion.

[0155] According to some exemplary embodiments, a force is controllably applied by the capturing portion on tissue inside the tissue grabber, for example on the convexed tissue, at block 322. In some embodiments, the force is controllably applied during the contraction or collapse of the capturing portion at block 320. In some embodiments, the force is controllably applied on tissue inside the tissue grabber by a flexible and / or soft material attached to an inner surface of the tissue grabber, between the tissue grabber wall and the tissue within the tissue grabber. Alternatively, or additionally, the applied force is controlled by a force limiter, for example the force limiter 230 shown in fig. 2A, configured to limit the contraction of the tissue grabber capturing portion.

[0156] According to some exemplary embodiments, the force is controllably applied up to a maximal force of 24 newtons (N), for example up to maximal force of 20N, up to maximal force of 18N, up to a maximal force of 15N, or any intermediate, smaller or larger value. In some embodiments, the application of force on the captured tissue is also controlled during invagination, for example at block 324.

[0157] According to some exemplary embodiments, the body lumen is invaginated using the convexed wall, at block 324. In some embodiments, the body lumen is invaginated, for example, by retracting or pulling the tissue grabber capturing portion out from the body lumen while holding the convexed body lumen wall within the capturing portion inner volume, for example inner volume 214 shown in fig. 2A. In some embodiments, the body lumen is partially invaginated such that the convexed body lumen wall remains within the body lumen. Alternatively, the body lumen is completely invaginated.

[0158] According to some exemplary embodiments, an indication about the force applied on the tissue is optionally generated, at block 326. In some embodiments, the indication is generated during body lumen invagination. In some embodiments, the indication is a human detectable indication, visible from outside the subject body. In some embodiments, the indication is visible under x-ray imaging, for example Fluoroscopy.

[0159] According to some exemplary embodiments, following invagination, the body lumen is optionally closed.

[0160] Exemplary system for body lumen closure

[0161] Reference is now made to fig. 4A, depicting a system for closing a body lumen, for example the LAA, according to some exemplary embodiments of the invention.According to some exemplary embodiments, a system 400 for closing a body lumen, for example the LAA, comprises an elongated and hollow delivery device, for example a guide device 402, optionally shaped and sized to be introduced into the LA. In some embodiments, the device 402 is flexible and comprises at least one inner channel, optionally a working channel, shaped and sized to allow passage of one or more tools. In some embodiments, the device 402 is a tube, a catheter or a sleeve. In some embodiments, the device 402 is optionally shaped and sized to be transeptally introducible into the LA. Optionally, the device 402 is shaped and sized and / or flexible to be transvasculary introducible into the heart, for example into the right atrium (RA). In some embodiments, the maximal outer diameter of the device 402 is between 5 French (Fr) and 35 Fr, for example between 5 Fr and 20 Fr, between 10 Fr and 35 Fr, between 5 Fr and 15 Fr, or any intermediate, smaller or larger value. In some embodiments, the maximal outer diameter of the device 402 is between 1.5 mm and 12 mm, for example between 1.5 mm and 6 mm, between 3 mm and 10 mm, between 6 mm and 12 mm, or any intermediate, smaller or larger value. In some embodiments, the maximal outer diameter of system 400 is the maximal outer diameter of the device 402.

[0162] According to some exemplary embodiments, the device 402 defines an inner lumen, for example a working channel 404 having a distal opening 406.

[0163] According to some exemplary embodiments, the system 400 comprises a tissue grabber device 403 shaped and sized to pass within the working channel 404. In some embodiments, the tissue grabber device 403 comprises an elongated body 405, terminating with a distal tissue capturing portion, for example a capturing cup 407. In some embodiments, the capturing cup 407 is configured to penetrate into the LAA, and be placed in contact with a wall of the LAA. In some embodiments, a distal edge 409 of the capturing cap 407, optionally surrounding at least one distal opening 411 of the capturing cup, is configured to be placed in contact with the LAA wall. In some embodiments, the distal edge 409 is soft and / or flexible, and optionally extends radially outwardly forming a funnel or a cone, optionally into an inner volume of the capturing cup 407. In some embodiments, the tissue grabber device 403 is similar to device 202, and the capturing cup 407 is similar to capturing portion 208, both shown in fig. 2A.

[0164] According to some exemplary embodiments, the elongated body 405 comprises at least one channel, for example a suction channel, fluidically connecting at least one vacuum source and the capturing cup 407. In some embodiments, the tissue grabber device 403 further comprises at least one capturing cup manipulator, for example fastener 418 coupled to the capturing cup 407, optionally to a portion of the capturing cup 407. In some embodiments, the fastener 418 is configured to controllably contract and inwardly collapse a portion of the capturing cup 407 intoan inner volume of the capturing cup, for example as described with respect to fastener 226 shown in fig. 2A.

[0165] Alternatively, in some embodiments, for example when the capturing portion is configured to collapsed in a relaxed state, the capturing cup manipulator comprises at least one expander, configured to controllably expand the capturing portion 407. In some embodiments, controllable expansion of the capturing portion allows, for example to open the distal opening 411, to allow penetration of tissue into the capturing portion inner volume.

[0166] According to some exemplary embodiments, the device 403 comprises a capturing cup manipulator actuator, for example actuator 419 functionally coupled to the capturing cup manipulator, for example to fastener 418. In some embodiments, the actuator is configured to control fastening and / or expanding of the fastener 418, optionally by applying force from outside the subject body on the fastener 418. In some embodiments, the fastener 418 and the actuator 419 are similar to the fastener 226 and the actuator 228 shown in fig. 2A.

[0167] According to some exemplary embodiments, application of vacuum within the suction channel in body 405 and through the distal opening 411, when the distal edge 409 contacts the LAA wall, inverts, for example convexes, a portion of the LAA wall into the capturing cup 407.

[0168] According to some exemplary embodiments, the body 405 is bendable, for example controllably bendable. In some embodiments, at least a portion of the body 405 is controllably steerable, optionally controllably bendable, for example to allow steering and / or bending of a distal end of the body 405 and the capturing cup 407 within the LAA. In some embodiments, a maximal width of the distal opening 411 of the tissue capturing cup 407 is between about 5mm and about 50 mm, for example between 5 mm and 25 mm, between 20 mm and 50 mm, or any intermediate, smaller or larger value. In some embodiments, a width of the body 405 is between about 0.5 mm and about 12 mm, for example between about 0.5mm and about 3mm, between about 1mm and about 4 mm, between about 2 mm and about 5mm, between about 4 mm and about 8 mm, between about 5mm and about 10 mm, between about 6 mm and about 12 mm or any intermediate, smaller or larger range of values.

[0169] According to some exemplary embodiments, the system 400 comprises at least one ligator assembly, for example ligator assembly 420 shaped and sized to move within the working channel 404, and over the at least one tissue grabber device 403. In some embodiments, the at least one ligator assembly 420 comprises at least one ligator 422, for example shaped as a loop, and a ligator actuator 424. In some embodiments, the at least one ligator loop comprises a suture loop, a band, a wire, a lasso, and / or a wire mesh. In some embodiments, the ligator loop 422 is configured tomove between a loose or open state to a tightened state, for example an irreversibly tightened state, when actuated by the actuator 424.

[0170] According to some exemplary embodiments, the system 400 comprises at least isolator, for example hollow LAA isolator 426, comprising an elongated body 432 terminating with a distal cover 428, for example an expandable distal cover. In some embodiments, the distal cover 428 is shaped as a concave distal cover. In some embodiments, the distal cover 328 is configured to expand when exiting the working channel 404 in the LA, and to be positioned in contact with tissue of the LA wall surrounding a LAA opening, within the LA. In some embodiments, the expandable distal cover 428 comprises a distal opening 430.

[0171] According to some exemplary embodiments, the isolator body 432 comprises a channel, for example a suction channel, terminating with the distal cover 428. In some embodiments, a proximal opening of the channel suction channel is connectable to a vacuum source.

[0172] According to some exemplary embodiments, the expandable distal cover 428 is configured to contact the LA wall around the LAA opening, and to form a sealed flow path between the LAA lumen and the suction channel in body 432. In some embodiments, forming the sealed flow path allows to prevent entry of particles, for example blood clots, tissue particles and / or debris from the LAA lumen into the LA, optionally when the LAA is manipulated. In some embodiments, application of vacuum through the LAA isolator suction channel 332 and the distal opening 430 of the cover 428, allows for example to actively remove the particles from the LAA optionally before, during and / or after manipulation of the LAA.

[0173] According to some exemplary embodiments, the expandable distal cover 428 comprises a wire mesh, covered with a sheet of material. In some embodiments, the wire mesh is optionally formed from a shape-memory alloy, for example Nitinol. In some embodiments, the expandable distal cover 428 expands in a relaxed state, and / or is collapsed when retracted or positioned within the working channel 404. In some embodiments, when expanded, a width of the distal cover 428 is larger than a maximal width of the opening 406 of the device 402. In some embodiments, when expanded the distal cover 428 has a maximal width in a range of about 1mm to about 50 mm, for example about 1.5mm to about 5mm, about 2mm to about 6mm, about 5mm to about 10mm, about 2mm to about 10mm, about 6mm to about 15mm or any intermediate, smaller or larger range of values.

[0174] According to some exemplary embodiments, the at least one ligator assembly 420 is coupled at least partly to the LAA isolator 426, optionally releasably coupled to the LAA isolator 426. Optionally, in some embodiments, when the at least one ligator assembly 420 is coupled to the isolator 426, the isolator 426 is used for positioning a loop of the ligator assembly around theLA opening, and not for isolating the LAA from the LA. In some embodiments, the loop 422 of the at least one ligator 420 is coupled to the expandable distal cover 428, for example close to the distal opening 420. In some embodiments, the loop 422 is coupled to the inner surface of the distal cover 428. Alternatively, the loop 422 is coupled to the outer surface of the distal cover 428. In some embodiments, the actuator 424 functionally coupled to the loop 422 passes within the body 432, optionally within the suction channel or outside the suction channel. In some embodiments, actuator 424 is optionally coupled to the outer surface of the body 432. In some embodiments, the at least one ligator assembly 420 and the at least one isolator 426 are at least partly coupled to each other when moving within the working channel 404, for example into the LA.

[0175] According to some exemplary embodiments, the loop 422 is coupled, for example reversibly attached to an inner surface of the distal cover 428, at a distance of up to 5 cm, for example up to 3 cm, up to 1 cm, up to 0.5 or any intermediate, smaller or larger value from the opening 430. In some embodiments, movement of the actuator 424, for example pushing, pulling, retracting and / or turning detaches the loop 422 from the cover 428. Additionally, or optionally, movement of the shaft 424 tightens the loop 422, optionally around tissue located within the distal cover 428. Additionally, or optionally, movement of the actuator 424 disconnects the actuator 424 from the loop 422, for example when the loop is tightened around a tissue.

[0176] According to some exemplary embodiments, the isolator 426 is a reshaper, for example LAA reshaper, configured to reshape a portion of the LAA invaginated into the distal cover 428, for example before tightening of the at least one ligator 422 to the invaginated LAA. In some embodiments, reshaping of the invaginated LAA allows, for example to reduce the volume and / or the size of the invaginated LAA tissue left inside the LA after LAA closure by the at least one ligator.

[0177] According to some exemplary embodiments, the system comprises the guiding device 402, optionally a catheter, sheath or sleeve, having the working channel 404, the tissue grabber device 403, the at least one ligator assembly 420, and optionally the isolator 426.

[0178] Reference is now made to fig. 4B, depicting a distal and proximal portions of a system for closure of a body lumen, according to some exemplary embodiments of the system.

[0179] According to some exemplary embodiments, system 450 is configured to allow controlled invagination of a body lumen, for example partial or complete invagination. In some embodiments, the system is used for invaginating the LAA, optionally at least partly into the LA. In some embodiments, the system has a distal portion 452 configured to be positioned inside the subject body, and a proximal portion 454 configured to be positioned outside the subject body. In some embodiments, the proximal portion comprises a plurality of control units, optionally includinghandles, for example control unit 451 of a steerable sheath for example device 402, a control unit 453 of an over tube for optionally controlling positioning of an isolator in the LA and the introducing of the tissue grabber into the LA A, , a control unit 455 of a ligator device, for example of an isolator 426 and / or of a ligator assembly 420, and a control unit 457 of a tissue grabber, for example tissue grabber 403, as shown in fig. 4A. Optionally, the proximal portion 454 also includes a control unit of an isolator, for example isolator 426 shown in fig. 2A. In some embodiments, the control units are configured to control movements and / or actuation of distal ends of each of the devices located inside the subject body, at the distal portion 452.

[0180] For example, as shown in fig. 4C, showing an enlarged distal portion 452, the proximal control units control a delivery device, for example delivery sheath 456, an isolator distal cover 458 and a ligator assembly coupled to the cover 458, shaped and sized to travel within the delivery sheath 456, and a tissue grabber device having a capturing portion 460 shaped and sized to travel within the isolator 458.

[0181] According to some exemplary embodiments, the control units are arranged on at least one rail 462, allowing axial movement of the tissue grabber device, the isolator device, and / or the ligator, optionally relative to each other, and optionally relative to the delivery sheath 456. In some embodiments, the at least one rail 462 is coupled, optionally adjustably coupled to a base 464, via at least one adjustable connectors, configured to adjust an angle of the rail 462 relative to the base 464, optionally according to location of an entry site into the subject body.

[0182] According to some exemplary embodiments, the system is operated in the following order in a procedure for closure of a LAA:

[0183] Step 1 - Septal Puncture & Guidewire Access, image LAA with pigtail, place stiff wire in Pulmonary vein;

[0184] Step 2 - Access sheath and dilator introduction;

[0185] Step 3 - Delivery system (over tube + ligation assembly + tissue grabber assembly) introduction; Step 4 - Positioning towards the LAA ostium;

[0186] Step 5 - Deployment of tissue grabber cup (small cup);

[0187] Step 6 - Positioning of the tissue grabber cup in the LAA;

[0188] Step 7 - LAA tissue grabbing by vacuum;

[0189] Step 8 - Ligation cup (Big cup, isolator cup) deployment;

[0190] Step 9 - LAA tissue inversion;

[0191] Step 10- Tissue ligation;

[0192] Step 11- Delivery system retrieval;

[0193] Step 12- Suture cutter introduction and suture cut;Step 13- System retrieval.

[0194] Exemplary body lumen closure process

[0195] Reference is now made to fig. 5, describing a detailed process for closure of a body lumen, for example a LAA, according to some exemplary embodiments of the invention.

[0196] According to some exemplary embodiments, the LAA of a subject is optionally visualized, at block 502. Optionally, the LAA opening in the LA is visualized at block 502. In some embodiments, the LAA is visualized from within the body, for example using a catheter, an endoscope or an imaging device. Alternatively, the LAA is visualized from outside the body, for example using at least one imaging device, for example x-ray, ultrasound, computed tomography (CT), or Magnetic resonance imaging (MRI).

[0197] According to some exemplary embodiments, a LAA shape and / or size is optionally assessed at block 504. In some embodiments, the LAA shape and / or size is assessed, based on the visualization results. In some embodiments, a width and / or shape of the LAA opening in the LA is assessed at block 504, for example based on the visualization results. In some embodiments, a depth, and / or a distance of a LAA wall region from the LAA opening is assessed.

[0198] According to some exemplary embodiments, a LAA closure system or a component thereof, for example the system 400 or 450 shown in figs. 4A and 4B respectively, is optionally selected, at block 506. In some embodiments, an isolator cover, for example cover 428 or cover 458 shown in figs. 4A and 4B respectively, is selected, for example according to the width of the LAA opening assessed at block 504. In some embodiments, a selected cover, for example an expandable cover, has a maximal width which is larger than the LAA opening.

[0199] According to some exemplary embodiments, a guide device having a working channel is transseptally introduced into the LA, at block 508. In some embodiments, a distal end of the guide device, for example guide device 402 shown in fig. 4A, is introduced, for example transeptally, into the LA.

[0200] According to some exemplary embodiments, the LAA is optionally isolated from the LA, at block 510. In some embodiments, the LAA is optionally isolated using an LAA isolator for example isolator 426 shown in fig. 4A. In some embodiments, the LAA is optionally isolated from the LA by placing an isolating cover, for example distal cover 428, surrounding a distal opening of a suction channel of the LAA isolator, over the LAA opening in the LA, and in contact with the LA wall. In some embodiments, isolating the LAA, for example prior to and / or during LAA manipulation, allows for example to prevent entry of particles from the LAA, for example blood clots and / or debris into the LA and into the blood stream.According to some exemplary embodiments, vacuum is optionally applied on LAA lumen, at block 512. In some embodiments, the vacuum is optionally applied via the suction tube of the LAA isolator, for example when the isolating cover is at least partly in contact with the LA wall around the LAA opening.

[0201] According to some exemplary embodiments, a distal end of a tissue grabber comprising a capturing cup, is introduced into the LAA, at block 514. In some embodiments, the distal end of tissue grabber comprising the grabber cup, for example capturing cup 208 shown in fig. 2A, or capturing cup 407 or 460, extends out from the working channel of the guiding device, and optionally from the isolator body, and enters through the LAA opening into the LAA. In some embodiments, the capturing cap expands within the LA or within the LAA. In some embodiments, tissue grabber body comprising the capturing portion extends out from the working channel of the guide device and is navigated within the LAA using a control unit located outside the body, for example at proximal section 454 shown in fig. 4B.

[0202] According to some exemplary embodiments, a distal end of capturing portion is placed in contact with the LAA wall, at block 516. In some embodiments, the distal end of the capturing portion, for example a flexible skirt or edge 220 shown in fig. 2A, is placed at least partly in contact with the LAA wall.

[0203] According to some exemplary embodiments, vacuum is optionally applied through the capturing cup distal opening on the LAA wall, at block 518.

[0204] According to some exemplary embodiments, a portion of the LAA wall is inverted, optionally convexed, into the capturing portion, at block 520. In some embodiments, the applied vacuum convexes the LAA wall portion into the capturing cup. In some embodiments, the LAA wall penetrates up to a distance of 5 cm, for example up to a distance of 4 cm, 3 cm, 1 cm, 0.8 cm, 0.5 cm or any intermediate, smaller or larger value, into the capturing cup. In some embodiments, the LAA wall is convexed into the capturing cup while the capturing cup distal flexible skirt is placed at least partly in contact with the LAA wall.

[0205] According to some exemplary embodiments, the capturing cup is collapsed, at block 522. In some embodiments, the tissue grabber capturing cup is selectively inwardly collapses, for example to capture the convexed LAA wall within the capturing cup inner volume. In some embodiments, the inwardly collapsing of the capturing cap traps the convexed LAA wall within the capturing cup by closing a distal opening of the capturing cup and / or by contacting the convexed LAA wall.

[0206] According to some exemplary embodiments, the LAA is invaginated using the grabber, at block 524. In some embodiments, the LAA is invaginated at least partly into the LA through theLAA opening, by retraction of the tissue grabber into the LA, while holding the convexed LAA wall in the capturing portion. In some embodiments, the LAA is invaginated by moving the tissue grabber into the working channel of the delivery device while the grabber capturing portion holds the convexed wall. In some embodiments, vacuum is applied on the captured convexed LAA, via a suction channel of the tissue grabber, for example to retain the LAA wall inside the capturing portion. Optionally, vaccum is applied via the isolator on the LAA during invagination, for example to evacuate clots and / or debris released during the invagination into the isolation suction channel.

[0207] According to some exemplary embodiments, the LAA is optionally at least partly invaginated into a LAA isolator cover positioned over the LAA opening in the LA, at block 526. In some embodiments, the LAA isolator, for example the isolator cover is used as a LAA reshaper, configured to reshape a portion of the LAA invaginated into the LAA reshaper. Alternatively, the LAA is optionally at least partly invaginated into a LAA reshaper at block 422. In some embodiments, the LAA reshaper is configured to reshape a portion of the LAA invaginated into the LAA reshaper, for example without isolating the LAA from the LA.

[0208] According to some exemplary embodiments, the invaginated LAA is closed at block 528. In some embodiments, at least one ligator, for example a fastener is attached, for example irreversibly attached, to the invaginated LAA, for example to prevent re-formation of a LAA lumen. In some embodiments, the at least one ligator is attached to the invaginated LAA while the invaginated LAA is held by the tissue grabber capturing portion.

[0209] According to some exemplary embodiments, the at least one ligator, for example a loop, is positioned around the invaginated LAA, at block 528. In some embodiments, the loop, for example a closure loop is placed around a base of the invaginated LAA within the LA. In some embodiments, the loop is optionally placed around the invaginated LAA, while the invaginated LAA is held within the LAA isolator and / or within the LAA reshaper. Alternatively, when the invagination is a partial invagination, a ligator, for example a loop, is positioned around an invaginated portion of the LAA, within the LAA, optionally to be used as an anchoring point pf an implant configured to be positioned inside the LAA and / or in the LA.

[0210] According to some exemplary embodiments, in case the ligator, for example the loop is coupled to the isolator cover, fastening of the loop around the invaginated LAA, decouples the ligator loop from the isolator cover.

[0211] In some embodiments, the at least one ligator, for example the loop is tightened around the invaginated LAA, optionally irreversibly tightened around the invaginated LAA.

[0212] According to some exemplary embodiments, the at least one tissue grabber is optionally released from the invaginated LAA, at block 532. In some embodiments, the at least one grabberis released from the invaginated LAA, optionally after tightening of the loop. In some embodiments, after the release of the grabber from the invaginated LAA, the grabber is removed from the body.

[0213] According to some exemplary embodiments, the LAA closure system is disconnected from the closure loop, at block 534. In some embodiments, the LAA closure system is disconnected from the closure loop after the closure loop is tightened to the invaginated LAA. In some embodiments, the LAA closure system is disconnected from the closure loop by cutting a string or a wire between the LAA closure system and the loop. In some embodiments, when the closure loop comprises a suture, a suture cutter is used to disconnect the closure loop from the system.

[0214] According to some exemplary embodiments, the LAA closure system is retracted from the subject body, at block 536. In some embodiments, the LAA closure system is retracted from the subject body while leaving the invaginated LAA closed by the closure loop.

[0215] Exemplary tissue grabber with a collapsible portion

[0216] Reference is now made to figs. 6A-6D depicting a tissue grabber having a capturing cup with a distal flexible edge, according to some exemplary embodiments of the invention.

[0217] According to some exemplary embodiments, a tissue grabber, for example tissue grabber 602 comprises an elongated body 604 having a proximal end 606 and a distal end 608. In some embodiments, the tissue grabber comprises a capturing portion 610, for example a capturing head, optionally shaped as a cup, having at least one distal, optionally front, opening. In some embodiments, the capturing portion 610 is an expandable capturing portion, configured to expand, in a relaxed state.

[0218] According to some exemplary embodiments, the capturing portion 610 comprises an expandable skeleton, optionally a wire, web skeleton, optionally formed from a shape memory alloy, for example Nitinol. In some embodiments, the expandable skeleton 612 is configured to be in a collapsed state within a delivery device, for example a sheath, or catheter, when introduced into a body, and to move to an expanded state, when exiting the delivery device. In some embodiments, the expandable skeleton 612 is self-expandable.

[0219] According to some exemplary embodiments, the skeleton 612, is coated with at least one layer of coating 614, optionally flexible coating formed from at least one of, Polyurethane, Silicone, PET, FEP, TPU, PEBA, and Nylon. In some embodiments, at least one layer of coating covers the skeleton, and defines a partially enclosed inner volume of the capturing cup 610. In some embodiments, the capturing cup 610 comprises a distal, optionally front, opening 618 to the inner volume 616.According to some exemplary embodiments, the capturing portion 610 comprises a distal flexible skirt, for example a flexible edge 620 surrounding the distal opening 618. In some embodiments, the flexible edge 620 is positioned distally to the skeleton 612. In some embodiments, the flexible edge 620 extends to an axial distance 622 of up to 30 mm, for example up to 20 mm, up to 10 mm, or any intermediate, smaller or larger axial distance relative to a distal end 624 of the skeleton 612, or relative to distal rim of the skeleton.

[0220] According to some exemplary embodiments, the flexible edge 620 extends radially outwardly, relative to a long axis 626, and is shaped as a funnel or a cone. In some embodiments, the flexible edge 620 is configured to be pressed against tissue surface, and is flexible and optionally soft, for example to conform to anatomy and curvature of the tissue surface.

[0221] According to some exemplary embodiments, the body 604 comprises at least one suction channel terminating with the capturing portion 610. In some embodiments, the tissue grabber 602 is configured to apply vacuum from the suction channel and the capturing portion distal opening onto the tissue wall, with forces sufficient to attract the capturing portion 610 towards the tissue wall, while the flexible edge 620 contacts the tissue wall, optionally to form an air tight seal between the tissue wall and the capturing portion inner volume 616.

[0222] According to some exemplary embodiments, the tissue grabber further comprises at least one fastener 628 coupled to the capturing portion proximally to the flexible edge 620. In some embodiments, the at least one fastener is configured to controllably contract, optionally inwardly collapse, a portion of the capturing portion 610 into the inner volume 616. In some embodiments, the at least one fastener 628 is shaped as a ring, and surrounds the capturing portion 610. In some embodiments, the at least one fastener 628 is coupled to an inner surface of the capturing portion 610 facing the inner volume 616, or to an outer surface of the capturing portion 610. Alternatively or additionally, the at least one fastener 628 is coupled to the skeleton 612.

[0223] According to some exemplary embodiments, the at least one fastener 628 is under a control of a fastener actuator 630, for example at least one wire, cable or rod, configured to apply force on the fastener 628 from outside the subject body, for example to contract and / or expand the fastener 628. In some embodiments, the actuator 630 controls a state of the fastener 628 by retracting, pulling, turning, pushing or any type of movement of the actuator 630.

[0224] Reference is now made to fig. 6E, depicting a tissue capturing portion in an expanded state, having a distal flexible skirt, according to some exemplary embodiments of the invention.

[0225] According to some exemplary embodiments, a tissue capturing portion of a tissue grabber device, for example capturing portion 650, is an expandable capturing portion, optionally radially expandable capturing portion. In some embodiments, the tissue capturing portion 650 is configuredto self-expand when relaxed, for example outside a delivery device. In some embodiments, the tissue capturing portion defines an internal volume, and has a long axis 651 a proximal opening 652 to the internal volume configured to be fluidically coupled to at least one channel, for example a suction channel positioned in an elongated body of the tissue grabber, and a distal front opening 654 to the internal volume.

[0226] According to some exemplary embodiments, the tissue capturing portion 650, for example a body of the tissue capturing portion 650 comprises an axially rigid portion comprising a skeleton 656, and a distal flexible skirt 658 located distally to the skeleton 656 and configured to bend in response to a force applied axially on the flexible skirt, optionally in a direction of axis 651, for example as shown in figs. 6C and 6d with respect to edge 620. In some embodiments, the flexible skirt is configured to bend backwards, in a proximal direction when pushed in a distal direction against a tissue surface, for example a wall of the LAA.

[0227] According to some exemplary embodiments, the skeleton 656 is coated with at least one layer of coating material. Optionally, the skeleton 656 is sandwiched between at least two layers of coating. In some embodiments, the skeleton 656 is formed as a frame of spaced apart wires, optionally in a shape of a web or a mesh. In some embodiments, the skeleton 656 is formed from a superelastic material or from a shape memory alloy, for example Nitinol.

[0228] According to some exemplary embodiments, the flexible skirt 658 surrounds the distal opening 654, and is shaped as a funnel having a wide distal end and a narrower proximal end functionally coupled to the axially rigid portion, for example to the skeleton or to the skeleton coating. In some embodiments, the flexible skirt 658 extends distally to the skeleton 656 to a distance 660 of between about 1 mm and about 5 mm, or any intermediate, smaller or larger value from the skeleton 656. In some embodiments, a maximal width 662 of the flexible skirt in an expanded state is between 15 mm and 50 mm, for example between 15 mm and 40 mm, between 20 mm and 35 mm, between 25 mm and 40 mm, or any intermediate, smaller or larger value.

[0229] According to some exemplary embodiments, a maximal length 664 of the tissue grabber capturing portion 650 is between about 10 mm and about 22 mm, for example between about 12 mm and about 20 mm, between about 15 mm and about 20 mm, between about 15 mm and about 22 mm, or any intermediate, smaller or larger value.

[0230] According to some exemplary embodiments, an inner width 666 of the capturing portion 650 in an expanded state, optionally of the rigid region of the capturing portion comprises the skeleton 656, is between about 5 mm and about 15 mm, for example between about 5 mm and about 10 mm, between about 7 mm and about 15 mm, or any intermediate, smaller or larger value. In some embodiments, an outer width of the capturing portion 650 in an expanded state, optionallyof the rigid region of the capturing portion comprises the skeleton 656, is between about 6 mm and about 16 mm, for example between about 6 mm and about 12 mm, between about 8 mm and about 12 mm, or any intermediate, smaller or larger value.

[0231] According to some exemplary embodiments, at least one fastener, for example fastener 668 is coupled to the capturing portion 650, for example to the axially rigid portion, proximally to the flexible skirt 658, and is configured to contract a body of the tissue capturing portion 650, for example controllably contract, the tissue capturing portion body. In some embodiments, the at least one fastener is configured to apply a force inwardly towards the internal volume that is sufficient to collapse the axially rigid portion into the internal volume. In some embodiments, controlling the activation of the at least one fastener 668 allows, for example, to apply force of up to about 24 Newtons (N), for example a force between 0 and about 24N, between about 5N and about 20N, between about 10N and about 20N, between about 15N and about 24N, or any intermediate, smaller or larger value, on the capturing portion 650.

[0232] According to some exemplary embodiments, the at least one fastener comprises at least one wire or a cable surrounding the internal volume or the capturing portion outer surface. In some embodiments, the at least one fastener passes within loops, for example loops 670 and 672 coupled to a circumference of the tissue capturing portion 650.

[0233] According to some exemplary embodiments, the flexible skirt 658 is formed from at least one layer of flexible material, optionally elastic material, and is configured to increase a contact area between the capturing portion 650 and a tissue surface, for example to allow efficient application of vacuum on the tissue surface via a distal opening of the tissue capturing portion, for example distal opening 654 of the axially rigid portion comprising the skeleton. In some embodiments, the flexible skirt 658 is configured to bend and flex and conform to anatomy and / or curvatures of the tissue surface, when placed in contact with the tissue surface, for example when an inner surface of the flexible skirt 658 is placed in contact with the tissue surface.

[0234] In some embodiments, the flexible skirt 658 comprises or is shaped as a circumferential flaring portion extending radially outwardly and distally to the skeleton 656. Optionally, the circumferential flaring portion in bendable in a proximal direction, for example when the flexible skirt 658 is pushed against a wall of a body lumen, for example against the LAA wall. In some embodiments, the circumferential flaring portion comprises a coated skeleton or scaffold, optionally also forming at least partly the capturing portion 650. Alternatively, the circumferential flaring portion comprises unsupported coating which optionally extends distally to the skeleton 656 or scaffold of the portion 650. In some embodiments, the circumferential flaring portion is shaped as a cone or a funnel, having a distal end that is wider than a proximal end of the flaringportion. In some embodiments, a coating of the circumferential flaring portion is similar to the coating of the portion 650 covering the skeleton 656, or is a different coating. Optionally, the coating of the portion 650 and the coating of the circumferential flaring portion, for example skirt 658 have a similar number of layers or a different number of layers, for example the coating of the circumferential flaring portion is thicker or thinner compared to the thickness of the coating of the portion 650. Alternatively, the coating of the circumferential flaring portion has the same thickness as the thickness of the coating of the portion 650.

[0235] In some embodiments, a thickness of the skirt 658 or of the skirt coating is between 50 micrometer (pm) and 500 pm, for example between 70 pm and 200 pm, between 100 pm and 300 pm, between 100 pm and 200 pm, or any intermediate, smaller or larger value. In some embodiments, a thickness of the skeleton 656 coating of the portion 650 is smaller than 100 pm, for example smaller than 80 pm, smaller than 50 pm, or any intermediate, smaller or larger value. In some embodiments, the thickness of the skirt 220 is larger than 100 pm, for example larger than 120 pm, larger than 150 pm, or any intermediate, smaller or larger value.

[0236] A potential advantage of having a thick flexible skirt 658 may be to allow bending of the entire circumferential skirt 650, as a single unit in a proximal direction, when the skirt is pushed against a tissue wall, for example against the wall of the LAA. In some embodiments, the bending of the skirt 658 is along an interface region between the skeleton 656 and the skirt 658, for example interface region 619 shown in fig. 6E, along an interface 611 between the skirt or flexible edge 620 and skeleton 612, shown in figs. 6A and 6D.

[0237] According to some exemplary embodiments, a maximal outer width of the tissue capturing portion 650 in a collapsed state, is between about 1 mm and about 5 mm, or any intermediate, smaller or larger value.

[0238] Exemplary LAA closure using a tissue grabber having a collapsible portion

[0239] Reference is now made to figs. 7A-7I, depicting closure of a body lumen, for example a LAA, using a tissue grabber having a capturing cup with a collapsible portion, according to some exemplary embodiments of the invention.

[0240] According to some exemplary embodiments, for example as shown in fig. 7A, a delivery device, for example sheath 702 is navigated into the LA 704. In some embodiments, a distal opening 706 of the sheath 702 is positioned in the LA 704 and optionally close to the LAA opening 708, for example at a distance of at least 5 mm from the opening 708, for example at a distance of at least 10 mm, a5 mm, 20 mm, 25 mm or any intermediate, smaller or larger value. In some embodiments, a capturing cup 610 of a tissue grabber exits through the opening 706 into the LA704. Alternatively, the sheath is inserted into the LAA 710 and the capturing cup 610 exits the opening 706 into the LAA 710. In some embodiments, the capturing cup 610 expands when exiting the sheath 702.

[0241] According to some exemplary embodiments, for example as shown in fig. 7B, the capturing cup 610 is advanced towards the LA wall 712, such that the flexible edge 620 is placed in contact with the wall 712. In some embodiments, the capturing cup 610 is pushed against the wall, to ensure firm contact between the flexible edge 620 and the wall 712.

[0242] According to some exemplary embodiments, for example as shown in fig. 7C, vacuum is applied via a suction channel in the tissue grabber body 604, and the capturing cup distal opening onto the LAA wall. In some embodiments, the flexible edge 620 is bendable. In some embodiments, the application of vacuum pushes the capturing cup 610 against the wall 712 in a first direction, while optionally bending backwards in an opposite direction the flexible edge 620.

[0243] According to some exemplary embodiments, for example as shown in fig. 7D, the vacuum is applied with sufficient force to convex a portion of the LAA wall, for example convex portion 714 into an inner volume of the capturing cup 610.

[0244] According to some exemplary embodiments, for example as shown in fig. 7E, a fastener 628 of the capturing cup 610 is fastened, inwardly collapsing a portion of the capturing cup, while the capturing cup 610 is in the LAA 710. In some embodiments, collapsing of a portion of the capturing cup 610, traps or captures the convexed portion of the LAA within the capturing cup 610 inner volume, optionally limiting or preventing its exit through the distal opening of the capturing cup 610 .

[0245] According to some exemplary embodiments, for example as shown in figs. 7F and 7G, the tissue grabber with capturing portion 610 is retracted into the sheath 702 while grabbing the convexed LAA wall within the capturing portion, leading to invagination of the LAA into the LA. In some embodiments, the tissue grabber is retracted into the LA 704, and optionally into an isolator cover, cover 720 positioned over the LAA opening, for example to prevent escape of blood clots and / or debris from the LAA into the blood stream during invagination.

[0246] According to some exemplary embodiments, for example as shown in fig. 7H, once the LAA is invaginated in a desired extent, a ligator loop 722 coupled to the isolator cover 720, optionally surrounding the distal opening of the cover 720, is fastened around the invaginated LAA. In some embodiments, fastening of the ligator loop 722, decouples the ligator loop 722 from the cover.According to some exemplary embodiments, for example as shown in fig. 71, once the invaginated LAA is fastened by the ligator loop 722, the closure system is removed from the body, leaving in the body only the ligator loop 722 tightened around the closed LAA.

[0247] Exemplary tissue grabber having a collapsible flexible edge

[0248] According to some exemplary embodiments, a capturing portion, for example a capturing cup, comprises a fastener associated with a flexible skirt, that is configured to selective collapse the flexible skirt, and thereby close the distal opening of the capturing cup. In some embodiments, closing the distal opening captures tissue inside the capturing cup inner volume.

[0249] Reference is now made to figs. 8A-8E depicting a tissue grabber having a capturing cup with a collapsible flexible skirt, according to some exemplary embodiments of the invention.

[0250] According to some exemplary embodiments, a tissue grabber 802 comprises an elongated body 804, optionally comprising a suction channel, terminating with a capturing cup, for example capturing cup 806, for example as described in fig. 6A. In some embodiments, skeleton 812 and coating 814 are similar to skeleton 612 and coating 614 described in fig. 6A. In some embodiments, for example as shown in figs. 8A and 8B, at least one fastener 807 is associated with a flexible skirt portion 808 of the capturing cup 806, extending radially outwardly relative to long axis 826 of the tissue grabber 802. In some embodiments, the fastener 807, is configured to contract the flexible skirt portion 808, and close a distal opening 810 of the capturing portion 806.

[0251] According to some exemplary embodiments, the fastener 807 is coupled to a rigid rim 816 of the capturing portion 806, configured to restrict and prevent collapse of the capturing portion proximally to the fastener 807, for example as shown in fig. 8B, showing the capturing portion 806 in a collapsed closed state, where the distal opening 810 is narrowed in at least 20%, in at least 50%, in at least 70%, in at least 80%, in at least 90%, relative to a maximal opening of the distal opening 810.

[0252] Reference is now made to figs. 9A and 9B, showing capturing of LAA within the capturing cup by closing the distal opening, according to some exemplary embodiments of the invention.

[0253] According to some exemplary embodiments, for example as shown in fig. 9A and as described in fig. 7D, application of vacuum through the capturing cup 806 on a LAA wall 902 contacting the flexible edge 808, convexes a portion 904 of the LAA wall 902 into the capturing cup inner volume, while the flexible edge 808 remains in contact with the LAA wall 902.

[0254] According to some exemplary embodiments, for example as shown in fig. 9B, fastening the fastener 807, collapses the flexible funnel shaped edge, and narrows the distal opening 810. In some embodiments, narrowing of the distal opening 810, traps the convexed portion 904 of theLAA wall, within the capturing cup inner volume, and prevents its exit from the capturing cup 806 during LAA invagination, for example as described in figs. 7E-7I.

[0255] Exemplary tissue grabber capturing cup with expandable opening

[0256] According to some exemplary embodiments, a tissue capturing portion of a tissue grabber, for example a capturing cup, is preformed to be collapsed in a relaxed state, for example to have a narrowed or closed opening, in a relaxed state. In some embodiments, upon application of force on the capturing cup, the capturing cup expands and the opening is widened, for example to allow penetration of tissue into the capturing cup.

[0257] Reference is now made to figs. 10A and 10B, depicting a tissue capturing cup with an expandable opening, in a collapsed closed state (10A), and in an open expanded state (10B), according to some exemplary embodiments of the invention.

[0258] According to some exemplary embodiments, a capturing cup 1002 comprises an expandable body 1004 defining an inner volume and at least one opening 1006, for example a distal, optionally front, opening. In some embodiments, the body 1004 comprises an expandable skeleton 1008, coated with at least one layer of sheet material. In some embodiments, the capturing cup 1002 comprises at least one fastener 1010, associated and optionally surrounding the opening 1006. Optionally, the fastener 1010 is functionally coupled to the skeleton 1008.

[0259] According to some exemplary embodiments, the capturing cup 1002 is preformed to have a narrowed, optionally closed opening 1006, in a relaxed state. In some embodiments, the fastener 1010 in a relaxed state is contracted, for example as shown in fig. 10A. In some embodiments, applying force on the fastener 1010, for example by at least one fastener actuator optionally comprising tension wires 1012 and 1014, stretches skeleton 1008 and / or the body 1004 at opposite directions, to open the opening 1006.

[0260] A potential advantage of having an expandable capturing cup, collapsed in a relaxed state, may be to better control the force applied on tissue within the capturing cup by performing the capturing cup to apply a known predetermined inward force when relaxed.

[0261] Exemplary force limiter

[0262] According to some exemplary embodiments, at least one fastener of a tissue capturing cup, or a fastener actuator coupled to the fastener, comprises one or more force limiters. In some embodiments, the force limiters are configured to limit the force applied on the fastener, and the force applied by the capturing cup when collapsed on tissue inside the capturing cup.Reference is now made to fig. 11, comprising a tissue grabber having one or more force limiters, according to some exemplary embodiments of the invention.

[0263] According to some exemplary embodiments, a tissue grabber 1002 comprises a distal capturing cup 1104, having a fastener 1106 surrounding the capturing cup body 1008. In some embodiments, the fastener 1106 is configured to inwardly collapse the body 1108, when fastened, for example by pulling fastener actuator, comprising at least one wire 1110. In some embodiments, the fastener 1106 and / or the at least one wire 1110 comprise at least one force limiter, configured to limit or control the delivery of force to the fastener 1106.

[0264] According to some exemplary embodiments, the at least one force limiter comprises a superelastic material, configured to be in a compressed state when relaxed. Alternatively, the at least one force limiter comprises at least one spring. In some embodiments, pulling of the at least force limiter expands the force limiter in a predetermined gradual expansion rate, and optionally up to a maximal expansion degree. In some embodiments, the at least one force limiter is positioned in the fastener 1106, or is part of the fastener. Alternatively or additionally, the at least one force limiter is positioned or is part of the fastener actuator 1110, for example part of at least one wire or cable.

[0265] Exemplary force indicator

[0266] According to some exemplary embodiments, a tissue grabber comprises at least one force indicator, configured to generate an indication, optionally a human detectable indication, regarding the force applied on tissue captured by the tissue grabber. In some embodiments, the at least one force indicator comprises a radiopaque marker, visible from outside the body under fluoroscopy.

[0267] Reference is now made to fig. 12A, depicting a tissue grabber having an elastic body portion with at least two force indicators, according to some exemplary embodiments of the invention.

[0268] According to some exemplary embodiments, tissue grabber 1202 comprises an elongated body 1204, terminating with a distal tissue capturing portion 1206. In some embodiments, the elongated body 1204 comprises an elastic portion 1208, configured to axially extend along a long axis of the body 1204, for example during invagination, when the tissue grabber is retracted in a proximal direction 1210. In some embodiments, the elastic portion 1208 or the body 1214 comprises two spaced-apart markers, for example radiopaque markers 1212 and 1214. In some embodiments, a distance between the markers, for example when the elastic portion is relaxed is known. In some embodiments, pulling the body 1204 in direction 1210 extends the elastic portion 1208 causing the distance between the two markers 1212 and 1214. In some embodiments, the increase in distance is correlated with the amount of force applied on a tissue captured in thecapturing portion 1216. Optionally, when reaching a predetermined distance between the markers 1212 and 1214, the force applied on the tissue is a maximal allowed force, and the pulling of the body 1204 and / or the invagination, is optionally stopped.

[0269] According to some exemplary embodiments, for example as shown in figs. 12B and 12C, the elastic portion comprises at least one spring, having at least two marked coils, optionally with radiopaque marking, for example marking 1222 and 1224. In some embodiments, a distance between the markings is known when the spring is in a relaxed state, and / or when a known force is applied on the spring. In some embodiments, the distance between the marked coils is correlated with the force applied on the body 1204 and with the spring expansion. In some embodiments, when the distance between the marked coils exceeds a predetermined distance, indicating the maximal allowed force to be applied on the tissue, application of force on the body 1204 is stopped.

[0270] Figs. 12D and 12E, show force indication during invagination, according to some exemplary embodiments of the invention.

[0271] According to some exemplary embodiments, for example as shown in fig. 12D, the capturing portion 1230 of the tissue grabber 1232 holds a portion of the LAA wall 1234, optionally a convexed portion of the LAA wall. In some embodiments, the spring 1236 is compressed, optionally in a relaxed state, prior to retraction of the tissue grabber and LAA invagination, for example as shown in fig. 12D.

[0272] According to some exemplary embodiments, for example as shown in fig. 12E, during invagination, optionally, when the LAA is completely invaginated, the force applied on the convexed LAA wall 1234 is high, and the distance between marked coils of the spring deliver a human detectable indication regarding the applied force.

[0273] According to some exemplary embodiments, for example as shown in fig. 12F, the force indication is provided by at least one detector, for example a sensor. In some embodiments, the tissue grabber body 1240 comprises an extendable portion, optionally a telescopic portion, and two or more sensors 1242, optionally each on a different part of the telescopic portion. In some embodiments, the sensors are configured to sense a change in a distance between them and to deliver at least one signal to a control unit outside the subject body via wiring 1246, indicating a force applied on the extendable portion.

[0274] Alternatively, the tissue grabber body comprises at least one sensor, for example an optical sensor for delivering an indication about a distance between two markings on an extendable portion of the body, which indicates a force applied on the body.Exemplary capturing cup with a soft inner layer

[0275] Reference is now made to figs. 13A and 13B, depicting a tissue grabber having a tissue capturing cup with an inner soft layer, according to some exemplary embodiments of the invention.

[0276] According to some exemplary embodiments, an inner layer of a tissue capturing cup 1302 comprises one or more soft regions 1304 of soft material, optionally cushioned regions, surround at least partly an inner volume of the capturing cup, or attached to an inner surface of the capturing cup 1302. In some embodiments, the one or more soft regions are located at an inner surface of regions configured to be inwardly collapsed onto tissue inside the capturing cup 1302, or be placed in contact with tissue during invagination.

[0277] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

[0278] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0279] The term “consisting of’ means “including and limited to”.

[0280] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0281] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0282] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0283] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicatenumber and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0284] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0285] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0286] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0287] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0288] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0289] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that sectionheadings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A tissue grabber device, comprising:an elongated body having a long axis, a proximal section and a distal section shaped and sized to be inserted into a body lumen via a working channel of a delivery device;an expandable tissue capturing portion at said distal section, shaped and sized to be introduced into said body lumen from outside a subject body via said working channel in a collapsed state, and to expand outside said working channel, said expandable capturing portion comprises:an expandable body having a proximal end coupled to said elongated body and a distal end shaped and sized to contact a tissue surface in said body lumen, said body defines at least one internal volume, and comprises at least one distal opening at said expandable body distal end to said internal volume;at least one fastener functionally coupled to said expandable body, wherein said at least one fastener is configured to controllably inwardly collapse into said internal volume a portion of said expandable body.

2. A device according to claim 1, wherein said at least one fastener is configured to controllably inwardly collapse into said internal volume up to 90% of the expandable body.

3. A device according to any one of claims 1 or 2, wherein said at least one fastener is configured to controllably inwardly collapse into said internal volume up to 50% of the expandable body.

4. A device according to any one of the previous claims, wherein said at least one fastener is configured to controllably inwardly collapse a portion of said expandable body, while at least 10% of said expandable body remains uncollapsed.

5. A device according to any one of the previous claims, wherein said elongated body comprises at least one suction channel fluidically interconnecting a vacuum source with said expandable body, and configured to allow application of vacuum through said expandable body distal opening on said tissue surface, with a force sufficient to convex a portion of said tissue surface into said inner volume via said at least one distal opening.

6. A device according to any one of the previous claims, wherein said at least one fastener is shaped as a loop or a ring, and surrounds said internal volume.

7. A device according to any one of the previous claims, wherein said expandable body comprises a flexible distal skirt at said expandable body distal end, wherein said flexible distal skirt surrounds said at least one distal opening and extends distally and radially outwardly, to form a cone or a funnel shape, wherein at least an inner surface of said flexible distal skirt is shaped and sized to contact said tissue surface.

8. A device according to any one of the previous claims, wherein aid at least one fastener is coupled to a portion of said expandable body surrounding said at least one distal opening, and is configured to controllably collapse said portion to narrow or close said at least one distal opening.

9. A device according to claim 7, wherein said at least one fastener is coupled to said expandable body proximally to said flexible distal skirt, and is configured to controllably inwardly collapse a portion of said expandable body located proximally to said flexible distal skirt.

10. A device according to claim 7, wherein said at least one fastener is coupled to said flexible distal skirt, and is configured to controllably inwardly collapse said flexible distal skirt.

11. A device according to any one of claims 7 to 10, wherein said flexible distal skirt is flexible enough to bend backwards when pushed against said tissue surface.

12. A device according to any one of claims 7 to 11, wherein said flexible distal skirt is configured to contact said tissue surface at angle smaller than 45 degrees.

13. A device according to any one of claims 7 to 12, wherein said flexible skirt is formed from at least one layer of flexible material configured to bend and conform the flexible skirt to anatomy of said tissue surface being contacted by said flexible skirt.

14. A device according to claim 13, wherein said expandable body comprises an expandable skeleton shaped as a web of wires, coated with at least one layer of coating, wherein said flexible skirt is located distally to said expandable skeleton.

15. A device according to claim 14, wherein said flexible skirt is coupled to said expandable skeleton and / or to said expandable skeleton coating.

16. A device according to any one of claims 14 or 15, wherein said at least one layer of coating of said expandable skeleton extends distally to said expandable skeleton, forming said flexible skirt.

17. A device according to claim 13, wherein said expandable body comprises an expandable skeleton shaped as a web of wires, coated with at least one layer of coating, and wherein said flexible skirt comprises said expandable skeleton and / or said expandable skeleton coating.

18. A device according to any one of claims 14 to 17, wherein said expandable skeleton is formed from a shape memory alloy.

19. A device according to any one of claims 14 to 18, wherein said at least one layer of flexible material and / or said expandable skeleton coating comprises at least one of, Polyurethane, Silicone, Polyethylene Terephthalate (PET), Fluorinated Ethylene Propylene (FEP), Thermoplastic polyurethane (TPU), Poly(ether-block-amide) (PEBA), and Nylon.

20. A device according to any one of claims 14 to 19, wherein an inner surface of a portion of said expandable body configured to be inwardly collapsed by said at least one fastener, comprises at least one soft section.

21. A device according to any one of the previous claims, comprising at least one fastener actuator coupled to said at least one fastener and extending between said at least one fastener and said proximal section of said elongated body, wherein application of force on said at least one fastener actuator fastens said at least one fastener and controllably inwardly collapsed said expandable body portion.

22. A device according to claim 21, comprising:at least one control unit coupled to said proximal section of said elongated body, wherein said at least one control unit comprises at least one control interface for controlling manually movement of said elongated body distal section and said expandable body, and for controllablyapply force on said at least one fastener actuator for controlling fastening of said at least one fastener.

23. A device according to any one of claims 21 or 22, comprising at least one extendable force limiter in said at last one fastener actuator and / or in said at least one fastener, configured to limit the force applied by the at least one fastener on said expandable body during fastening of said at least one fastener.

24. A device according to any one of the previous claims, wherein said elongated body comprises an extendable portion positioned between said proximal section and said distal section, and at least two axially spaced apart radiopaque markers in said extendable portion or at opposite ends of said extendable portion, wherein said at least two axially spaced apart radiopaque markers are configured to deliver a visual indication about a force applied on said elongated body according to extension of said extendable portion and a change in distance between said at least two axially spaced apart radiopaque markers.

25. A device according to any one of claims 1 to 23, wherein said elongated body comprises an extendable portion positioned between said proximal section and said distal section, wherein said device comprising at least one detector functionally coupled to said extendable portion and configured to detect a force applied on said elongated body according to extension of said extendable portion.

26. A device according to any one of the previous claims, wherein a maximal width of said expandable tissue capturing portion in an expanded state is up to 40 mm.

27. A device according to any one of the previous claims, wherein a maximal width of the expandable body in a collapsed state is smaller than 10 mm.

28. A device according to any one of the previous claims, wherein said expandable capturing portion is shaped as a cup, and wherein said at least one distal opening is a front opening.

29. A device according to any one of the previous claims, wherein said body lumen is a left atrial appendage (LAA) of a heart, and wherein said tissue surface comprises a wall of said LAA.

30. A device according to any one of claims 1 to 28, wherein said body lumen comprises a right atrial appendage (RAA), a colon, a large intestine, a small intestine, a stomach, a pharynx, or a throat, and wherein said tissue surface comprises a wall of said body lumen.

31. A left atrial appendage (LAA) invaginating system, comprising:a delivery device having a proximal opening and a distal opening, wherein said delivery device is shaped and sized to be introduced into a left atrium (LA) of a heart in a subject body;a tissue grabber device, comprising:an elongated body comprising a suction channel, having a long axis, a proximal section and a distal section shaped and sized to be inserted into said LA via a working channel of said delivery device;an expandable tissue capturing portion at said distal section, shaped and sized to be introduced into said LAA and to be placed in contact with a LAA wall, wherein said expandable tissue capturing portion defines an internal volume and comprises at least one distal opening to said internal volume;wherein said tissue grabber device is configured to apply vacuum on said LAA wall via said at least one distal opening with a force sufficient to convex a portion of said LAA wall into said internal volume of said expandable tissue capturing portion;wherein said expandable tissue capturing portion is configured to be partially collapsed to capture said convexed portion of said LAA within said internal volume, while said tissue grabber is retracted and invaginates said LAA into said LA.

32. A system according to claim 31, wherein said expandable tissue capturing portion comprises a flexible distal skirt surrounding said at least one distal opening and extends distally and radially outwardly to form a cone or a funnel shape, wherein said flexible distal skirt is shaped and sized to contact said LAA prior to and / or during application of vacuum onto said LAA wall.

33. A system according to claim 32, wherein said tissue grabber device comprises at least one fastener functionally coupled to said expandable capturing portion, wherein fastening of said at least one fastener collapses a portion of said tissue capturing portion into said internal volume while at least 10% of said tissue capturing portion remains uncollapsed.

34. A system according to claim 33, wherein said at least one fastener is functionally coupled to said expandable capturing portion proximally to said flexible distal skirt, and configured to be fastened proximally to said flexible distal skirt.

35. A system according to claim 33, wherein said at least one fastener is functionally coupled to said flexible distal skirt and is configured to collapse said flexible distal skirt.

36. A system according to any one of claims 31 to 35, comprising a LAA isolator configured to cover a LAA opening within the LA, to prevent flow of particles, debris and / or blood clots from said LAA into said LA.

37. A system according to claim 36, wherein said LAA isolator comprises a channel terminating with an expandable cover, wherein said expandable cover is configured to be in a collapsed state within said delivery device and to expand within said LA, and wherein retraction of said tissue grabber into said LA while holding said convexed portion of said LAA within said internal volume, invaginates said LAA into said expandable cover.

38. A system according to claim 37, comprising at least one ligator releasably coupled to an inner surface of said expandable cover and is configured to detach from said expandable and to be fastened around said invaginated LAA.

39. A system according to claim 38, wherein said at least one ligator comprises a suture loop or a lasso, coupled to an inner surface of said LAA isolator around a distal opening of said LAA isolator through which the expandable tissue capturing portion holding the convexed LAA portion is retracted into the LAA isolator.

40. A system according to any one of claims 31 to 39, comprising:at least two control units configured to be positioned outside said subject body, wherein said at least two control units comprise a first control unit coupled to said delivery device and configured to control axial movement and / or steering of said delivering device within said subject body, and a second control unit functionally coupled to said tissue grabber device and configured to control axial movement of said tissue grabber device within the subject body and partial collapsing of said expandable capturing portion;at least one guiding rail defining a movement range, wherein said at least two control units are axially arranged along said at least one guiding rail and are axially movable within said at leastone guiding rail relative to each other, wherein said guiding rail comprises at least one movement limiter configured to limit movement of one or more of said at least two control units relative to each other and / or relative to said defined movement range.

41. A tissue grabber device, comprising:an elongated body having a long axis, a proximal section and a distal section shaped and sized to be inserted into a body lumen via a working channel of a delivery device;a tissue capturing portion at said distal section, shaped and sized to be introduced into said body lumen from outside a subject body via said working channel in a collapsed state, and to controllably expand outside said working channel in response to a force applied on said tissue capturing portion, said expandable capturing portion comprises:a body having a proximal end coupled to said elongated body and a distal end shaped and sized to contact a tissue surface in said body lumen, said body defines at least one internal volume, and comprises at least one distal opening at said body distal end to said inner volume, wherein said body is configured to acquire a collapsed state, in rest, and to expand to an expanded state in response to a force applied on said body;at least one body expander functionally coupled to said body, wherein said at least one body expander is configured to controllably expand said body in response to a force applied on the at least one body expander from outside said subject body.

42. A method for invagination of a body lumen, comprising:introducing a tissue capturing device from a first body lumen into a second body lumen, said tissue capturing device comprises an internal volume, at least one distal opening to said internal volume, and a flexible distal end surrounding said at least one distal opening;contacting a wall of said second body lumen with said flexible distal end;convexing a portion of said wall into said internal volume;collapsing a portion of said tissue capturing device into said internal volume while said convexed portion is inside said internal volume, to capture said convexed wall portion within said tissue capturing device;invaginating at least partly said second body lumen by retracting said tissue capturing device into said first body lumen while said convexed wall portion remains captured within said tissue capturing device.

43. A method according to claim 42, wherein said collapsing comprises collapsing up to 80% of said tissue capturing device while at least 20% of said tissue capturing device remains uncollapsed.

44. A method according to any one of claims 42 or 43, wherein said collapsing comprises reducing a volume of said internal volume in up to 80% relative to the internal volume of an uncollapsed tissue capturing device.

45. A method according to any one of claims 42 to 44, wherein said collapsing comprises narrowing said at least one distal opening.

46. A method according to any one of claims 42 to 45, wherein said convexing comprises applying suction via said at least one distal opening onto said wall during said contacting with a force sufficient convex said portion of said wall into said internal volume.

47. A method according to any one of claims 42 to 46, wherein a volume of said convexed wall fills at least 30% of said internal volume.

48. A method according to any one of claims 42 to 47, comprising closing said invaginated second body lumen by positioning and tightening a ligator around said invaginated body lumen following said invaginating.

49. A method according to any one of claims 42 to 48, comprising isolating before, during and / or after said invaginating said second body lumen from said first body lumen by positioning a cover over an opening of said second body to prevent release of blood clots and / or debris out from said second body lumen through said first body lumen.

50. A method according to any one of claims 42 to 49, wherein said method is a method for invaginating a left atrial appendage (LAA), wherein said first body lumen comprises a left atrium (LA), and wherein said second body lumen comprises said LAA.

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