Patent ID: 12245758

DETAILED DESCRIPTION OF APPLICATIONS

FIG.1Ais a schematic illustration of a tissue anchor20that is configured to be anchored to a cardiac tissue wall, in accordance with an application of the present invention. Tissue anchor20comprises a metal wire22that has exactly two wire ends: a first wire end24A and a second wire end24B. Wire22is shaped so as to define:a straight anchor-shaft portion26, which has (i) a proximal end28and (ii) a distal end30, anda tissue-coupling portion31, which extends from distal end30of straight anchor-shaft portion26, such that straight anchor-shaft portion26is disposed along wire22between tissue-coupling portion31and first wire end24A.

Typically, tissue anchor20further comprises an anchor head33that is coupled to and supports straight anchor-shaft portion26. Optionally, anchor head33comprises one or more collars34, such as distal and proximal collars34A and34B, as shown. Alternatively, anchor head33comprises only a single collar34or does not comprise any collars34. Optionally, anchor head33further comprises a sealing element36, which is sized and shaped to be inserted with anchor head33into an incision through the cardiac tissue wall. Sealing element36, along with at least a portion of anchor head33, remains in the incision upon completion of the implantation of expandable tissue anchor20. Sealing element36is configured to promote hemostasis to provide sealing of the incision. For some applications, sealing element36comprises a metal or a polymer, such as a bioabsorbable polymer, which breaks down after healing and hemostasis occur. For some applications, sealing element36implements techniques described in PCT Publication WO 2019/089262 and/or U.S. Provisional Application 62/628,457, filed Feb. 9, 2018, both of which are assigned to the assignee of the present application and are incorporated herein by reference.

For some applications, such as shown inFIG.1A(and in some of the other figures), proximal end28of straight anchor-shaft portion26is at first wire end24A. Alternatively, proximal end28of straight anchor-shaft portion26does not coincide with first wire end24A, such as described hereinbelow with reference toFIG.3Cregarding tissue anchor270, mutatis mutandis.

Reference is still made toFIG.1Aand is additionally made toFIGS.1B-C, which are schematic illustrations of two views of wire22, in accordance with an application of the present invention. Although wire22is typically coupled to anchor head25, as described above, for clarity of illustration anchor head25is not shown inFIGS.1B-C.FIGS.1A-C(andFIG.1D, described hereinbelow) show tissue-coupling portion31in an unconstrained state in which tissue-coupling portion31is not constrained by any external forces. (It is noted that straight anchor-shaft portion26may be configured to be straight only because it is constrained by anchor head33, or, alternatively, even if it were not constrained by anchor head33.)

Tissue anchor20is configured such that when tissue-coupling portion31is in the unconstrained state, such as shown inFIGS.1A-C:tissue-coupling portion31of wire22is shaped so as to define a tail end portion32that includes second wire end24B,tissue-coupling portion31of wire22crosses itself at first and second loop-end longitudinal portions40A and40B along wire22, so as to define a looped portion44, which generally defines a looped-portion plane46that forms an angle α (alpha) of between 75 and 90 degrees (e.g., 90 degrees) with an anchor-shaft axis48of straight anchor-shaft portion26,first loop-end longitudinal portion40A is closer to first wire end24A (and thus typically to proximal end28of straight anchor-shaft portion26) along wire22than second loop-end longitudinal portion40B is to first wire end24A along wire22(and thus typically to proximal end28of straight anchor-shaft portion26), anda greatest absolute distance D1between first loop-end longitudinal portion40A and first wire end24A is greater than a greatest absolute distance D2between second loop-end longitudinal portion40B and first wire end24A (thus, in addition, typically a greatest absolute distance between first loop-end longitudinal portion40A and proximal end28of straight anchor-shaft portion26is greater than a greatest absolute distance between second loop-end longitudinal portion40B and proximal end28of straight anchor-shaft portion26).

As described hereinbelow with reference toFIG.8, tissue anchor20is delivered to a cardiac chamber within a deployment tool. Tissue-coupling portion31is delivered in an unexpanded generally elongate configuration within the deployment tool, through the cardiac tissue wall from a first side of the wall to a second side of the wall, such as described hereinbelow with reference toFIG.8. Tissue-coupling portion31is further configured, upon deployment, to expand on the second side of the cardiac tissue wall, such as described hereinbelow with reference toFIG.8.

Tissue anchor20is configured such that when proximal end28of straight anchor-shaft portion26is pulled along anchor-shaft axis48away from looped-portion plane46, mechanical contact between first and second loop-end longitudinal portions40A and40B locks looped portion44and prevents looped portion44from straightening as a result of the applied tension. Typically, the above-mentioned pulling is performed using tether52coupled to tissue anchor20, such as to anchor head33, as described hereinbelow. (The mechanical contact between first and second loop-end longitudinal portions40A and40B may either be direct, or via a coating or fabric560described hereinbelow with reference toFIGS.6A-B.)

Typically, tissue anchor20is configured such that when tissue-coupling portion31of wire22is in the unconstrained state, anchor-shaft axis48does not pass through a space54surrounded by and defined by looped portion44, such as shown inFIGS.1A-C.

Typically, tissue anchor20is configured such that when tissue-coupling portion31of wire22is in the unconstrained state, looped portion44includes exactly one turn, such as shown inFIGS.1A-C. Alternatively, looped portion44includes more than one turn (configuration not shown).

For some applications, tissue anchor20is configured such that when tissue-coupling portion31of wire22is in the unconstrained state, wire22crosses itself exactly once, at first and second loop-end longitudinal portions40A and40B along wire22.

For some applications, tissue anchor20is configured such that when tissue-coupling portion31of wire22is in the unconstrained state, wire22defines only a single looped portion44.

For some applications, when tissue-coupling portion31of wire22is in the unconstrained state, tail end portion32generally falls in looped-portion plane46, such as shown inFIGS.1A-C, and thus may aid with anchoring.

For some applications, when tissue-coupling portion31of wire22is in the unconstrained state, no portion of tail end portion32is parallel to straight anchor-shaft portion26.

For some applications, such as shown inFIGS.1A-C, tissue anchor20is configured such that when tissue-coupling portion31of wire22is in the unconstrained state, wire22is shaped so as to define a first-loop-end curved portion50along which first loop-end longitudinal portion40A is located. Alternatively, tissue anchor20is configured such that when tissue-coupling portion31of wire22is in the unconstrained state, wire22is shaped so as to define a first-loop-end straight portion along which first loop-end longitudinal portion40A is located (such as metal wire622, described hereinbelow with reference toFIG.7); in this case wire22may optionally be shaped so as to define a second-loop-end curved portion along which second loop-end longitudinal portion40B is located (configuration not shown), or wire22may not be shaped so as to define a second-loop-end curved portion (such as metal wire622, described hereinbelow with reference toFIG.7).

For some applications, wire22is not shaped so as to define any looped portions proximal to proximal end28of straight anchor-shaft portion26.

For some applications, a system10is provided that comprises tissue anchor20and a tether52affixed to tissue anchor20, such as to anchor head33, e.g., to distal collar34A of anchor head33. Thus, tether52is typically indirectly coupled to straight anchor-shaft portion26via anchor head33. For some applications, system10further comprises a second tissue anchor38separate and distinct from tissue anchor20. Typically, second tissue anchor38is couplable to, or coupled to, tissue anchor20by tether52. For some applications, second tissue anchor38comprises a stent39, as shown. Alternatively, second tissue anchor38comprises another type of tissue anchor, such as a helical tissue anchor, as known in the art; another tissue anchor identical or similar to tissue anchor20; a tissue anchor known in the art; or any of the tissue anchors described in the patent application publications and/or patents incorporated hereinbelow by reference.

For some applications, when tissue-coupling portion31of wire22is in the unconstrained state, looped portion44is shaped as an open looped portion in which first and second loop-end longitudinal portions40A and40B are not in mechanical contact with each other (either directly, or via a coating or fabric560described hereinbelow with reference toFIGS.6A-B). (In these applications, looped portion44is considered “an open looped portion” in the sense that wire22curves back toward itself and crosses itself to define space54, even though first and second loop-end longitudinal portions40A and40B are not in mechanical contact with each other.) For these applications, tissue anchor20is configured such that when proximal end28of straight anchor-shaft portion26is pulled along anchor-shaft axis48away from looped-portion plane46, first and second loop-end longitudinal portions40A and40B come in mechanical contact with each other (either directly, or via a coating or fabric560described hereinbelow with reference toFIGS.6A-B).

For other applications, when tissue-coupling portion31of wire22is in the unconstrained state (i.e., even before proximal end28of straight anchor-shaft portion26is pulled along anchor-shaft axis48away from looped-portion plane46), looped portion44is shaped as a closed looped portion in which first and second loop-end longitudinal portions40A and40B are in mechanical contact with each other (either directly, or via a coating or fabric560described hereinbelow with reference toFIGS.6A-B).

As used in the present application, including in the claims, the term “looped portion” includes within its scope both an open looped portion and a closed loop portion.

Reference is now made toFIG.1D, which is a schematic illustration of a system60comprising a tissue anchor70and tether52, in accordance with an application of the present invention. Except as described below, system60is identical to system10and tissue anchor70is identical to tissue anchor20described hereinabove with reference toFIGS.1A-C, and like reference numerals refer to like parts.

Unlike in tissue anchor20, described hereinabove with reference toFIG.1A, tether52is coupled to tissue anchor70by being coupled directly to straight anchor-shaft portion26. Tissue anchor70does not comprise anchor head33. Thus, tether52is typically directly coupled to straight anchor-shaft portion26. For some applications, like system60, system10further comprises second tissue anchor38separate and distinct from tissue anchor70. Typically, second tissue anchor38is couplable to, or coupled to, tissue anchor70by tether52.

Reference is now made toFIG.2A, which is a schematic illustration of a tissue anchor120that is configured to be anchored to a cardiac tissue wall, in accordance with an application of the present invention. Reference is also made toFIG.2B, which is a schematic illustration of a metal wire122of tissue anchor120, in accordance with an application of the present invention. Except as described below, tissue anchor120is identical to tissue anchor20described hereinabove with reference toFIGS.1A-C, and like reference numerals refer to like parts. Tissue anchor120may also implement the features of tissue anchor70, described hereinabove with reference toFIG.1D.

When a tissue-coupling portion131of wire122is in the unconstrained state, a tail end portion132of tissue-coupling portion131of wire122is shaped so as to define at least one first-loop-end curved portion154. For some applications, a distance between anchor-shaft axis48and a point on first-loop-end curved portion154farthest from anchor-shaft axis48equals between 40% and 150%, such as between 60% and 100%, of a distance between anchor-shaft axis48and a point on looped portion44farthest from anchor-shaft axis48. This arrangement may add balance to the anchoring provided by tissue anchor120.

Reference is now made toFIG.3A, which is a schematic illustration of a tissue anchor220that is configured to be anchored to a cardiac tissue wall, in accordance with an application of the present invention. Reference is also made toFIG.3B, which is a schematic illustration of a metal wire222of tissue anchor220, in accordance with an application of the present invention. Except as described below, tissue anchor220is identical to tissue anchor20described hereinabove with reference toFIGS.1A-C, and like reference numerals refer to like parts. Tissue anchor220may also implement the features of tissue anchor70, described hereinabove with reference toFIG.1D.

When tissue-coupling portion231of wire222is in the unconstrained state, a tail end portion232of tissue-coupling portion231of wire222is shaped so as to define at least one straight portion256. Straight portion256typically extends to second wire end24B. For some applications, a distance between anchor-shaft axis48and a point on straight portion256(e.g., second wire end24B) farthest from anchor-shaft axis48equals between 40% and 150%, such as between 60% and 100%, of a distance between anchor-shaft axis48and a point on looped portion44farthest from anchor-shaft axis48. This arrangement may add balance to the anchoring provided by tissue anchor220.

Reference is now made toFIG.3C, which is a schematic illustration of a tissue anchor270that is configured to be anchored to a cardiac tissue wall, in accordance with an application of the present invention. Except as described below, tissue anchor270is identical to tissue anchor220, described hereinabove with reference toFIGS.3A-B, and like reference numerals refer to like parts. Any of the tissue anchors described herein may implement the features of tissue anchor270, mutatis mutandis.

In this configuration, proximal end28of a straight anchor-shaft portion276of wire222of tissue anchor270does not coincide with first wire end24A; instead, first wire end24A is proximal to proximal end28of straight anchor-shaft portion276along wire222. For example, wire222may be at least partially curved between first wire end24A and proximal end28of straight anchor-shaft portion276(e.g., bent away from anchor-shaft axis48), as shown inFIG.3C, and/or may define one or more sharp angles between first wire end24A and proximal end28of straight anchor-shaft portion276(configuration not shown).

Reference is now made toFIG.4A, which is a schematic illustration of a tissue anchor320that is configured to be anchored to a cardiac tissue wall, in accordance with an application of the present invention. Reference is also made toFIG.4B, which is a schematic illustration of a metal wire322of tissue anchor320, in accordance with an application of the present invention. Except as described below, tissue anchor320is identical to tissue anchor20described hereinabove with reference toFIGS.1A-C, and like reference numerals refer to like parts. Tissue anchor320may also implement the features of tissue anchor70, described hereinabove with reference toFIG.1D.

When tissue-coupling portion331of wire322is in the unconstrained state, such as shown inFIGS.4A-B:tissue-coupling portion331of wire322is shaped so as to define a tail end portion332that includes second wire end24B,tissue-coupling portion331of wire322crosses itself at first and second loop-end longitudinal portions340A and340B along wire322, so as to define a looped portion344, which generally defines a looped-portion plane346that forms an angle of between 75 and 90 degrees (e.g., 90 degrees) with anchor-shaft axis48of straight anchor-shaft portion26,first loop-end longitudinal portion340A is closer to first wire end24A along wire322than second loop-end longitudinal portion340B is to first wire end24A along wire322, anda greatest absolute distance D1between first loop-end longitudinal portion340A and first wire end24A is greater than a greatest absolute distance D2between second loop-end longitudinal portion340B and first wire end24A.

When tissue-coupling portion331of wire322is in the unconstrained state, wire322is shaped so as to define a first-loop-end curved portion350along which first loop-end longitudinal portion340A is located. Tissue anchor320is configured such that when proximal end28of straight anchor-shaft portion26is pulled along anchor-shaft axis48away from looped-portion plane46, wire322, at second loop-end longitudinal portion340B, snaps into first loop-end longitudinal portion340A at first-loop-end curved portion350of wire22. This snapping locks looped portion344and prevents straightening of looped portion344.

For some applications, tissue anchor320is configured such that when tissue-coupling portion331of wire322is in the unconstrained state, an inner curved surface358of first-loop-end curved portion350has a radius of curvature rCequal to between 80% and 120% (e.g., between 90% and 110%, such as 100%) of a radius of wire322along second loop-end longitudinal portion340B. For some applications, first-loop-end curved portion350extends directly from distal end30of straight anchor-shaft portion26.

Typically, when wire322is snapped into first loop-end longitudinal portion340A at first-loop-end curved portion350of wire322, inner curved surface358of first-loop-end curved portion350surrounds at least 180 degrees of wire322at first loop-end longitudinal portion340A. For example, inner curved surface358may surround 180 degrees, or slightly more, such as shown inFIGS.4A-B, or at least 200 degrees, such as shown inFIGS.5A-B, described hereinbelow. The configurations illustrated inFIGS.4A-B,5A-B, and6A-B may implement the lesser degree of surrounding shown inFIGS.4A-Band6A-B or the greater degree of surrounding shown inFIGS.5A-B.

For some applications, when tissue-coupling portion331of wire322is in the unconstrained state, tail end portion332is shaped so as to define at least one straight portion356. Straight portion356typically extends to second wire end24B.

Reference is now made toFIG.5A, which is a schematic illustration of a tissue anchor420that is configured to be anchored to a cardiac tissue wall, in accordance with an application of the present invention. Reference is also made toFIG.5B, which is a schematic illustration of a metal wire422of tissue anchor420, in accordance with an application of the present invention. Except as described below, tissue anchor420is identical to tissue anchor320described hereinabove with reference toFIGS.4A-B, and like reference numerals refer to like parts. Tissue anchor420may also implement the features of tissue anchor70, described hereinabove with reference toFIG.1D.

When a tissue-coupling portion431of wire422is in the unconstrained state, a tail end portion432of tissue-coupling portion431of wire422is shaped so as to define at least one tail-end-portion curved portion454.

Reference is now made toFIGS.6A and6B, which are schematic illustrations of metal wires322of tissue anchors520A and520B, respectively, that are configured to be anchored to a cardiac tissue wall, in accordance with respective applications of the present invention. Except as described below, tissue anchors520A and520B are identical to tissue anchor320described hereinabove with reference toFIGS.4A-B, and like reference numerals refer to like parts. The features of tissue anchors520A and520B may also be implemented in combination with the other tissue anchors described herein, mutatis mutandis.

Tissue anchors520A and520B further comprise a fabric560that covers a portion of metal wire322including first loop-end longitudinal portion340A (tissue anchor520A, shown inFIG.6A) or second loop-end longitudinal portion340B (tissue anchor520B, shown inFIG.6B). Fabric560may help prevent erosion of the metal of wire322in the event that second loop-end longitudinal portion340B moves back and forth with respect to first-loop-end curved portion350(e.g., in a crook defined by first-loop-end curved portion350).

Reference is now made toFIG.7, which is a schematic illustration of a metal wire622of a tissue anchor620that is configured to be anchored to a cardiac tissue wall, in accordance with an application of the present invention. Except as described below, tissue anchor620is identical to tissue anchor20described hereinabove with reference toFIGS.1A-C, and like reference numerals refer to like parts. Tissue anchor620may also implement the features of tissue anchor70, described hereinabove with reference toFIG.1D, or any of the other tissue anchors described herein, mutatis mutandis; for example, tissue anchor620may comprise anchor head33. Although a tail end portion432of a tissue-coupling portion631of wire622is shown as being shaped so as define at least one tail-end-portion curved portion454, alternatively tail end portion432does not define any tail-end-portion curved portions, such as shown inFIGS.1A-D,3A-C,4A-B, and6A-B.

Tissue anchor620is configured such that a tissue-coupling portion631of wire622is in the unconstrained state, (a) a tissue-coupling portion631of wire622crosses itself at first and second loop-end longitudinal portions640A and640B along wire622, so as to define a looped portion644, and (b) tissue-coupling portion631is shaped so as to define:a first-loop-end straight portion623A along which a first loop-end longitudinal portion640A is located, and/ora second-loop-end straight portion623B along which a second loop-end longitudinal portion640B is located.

It is noted that wire622of looped portion644is shown inFIG.7as looping from first-loop-end straight portion623A to second-loop-end straight portion623B in a clockwise direction, as viewed from above the looped-portion plane (i.e., from the side of the looped-portion plane opposite first wire end24A). Wire622may also loop in a counterclockwise direction. Similarly, the wires of the looped portions of the tissue anchors shown inFIGS.1A-D,2A-B,3A-C,4A-B,5A-B, and6A-B are shown as looping from the first-loop-end straight portion to the second-loop-end straight portion in a counterclockwise direction, as viewed from above the looped-portion planes; these wires may also loop in a clockwise direction.

Reference is now made toFIG.8, which is a schematic illustration of a method of deploying tissue anchor120through a myocardial tissue wall160, in accordance with an application of the present invention. Although inFIG.8tissue anchor120is shown deployed through a myocardial tissue wall, tissue anchor120may also be deployed through other cardiac tissue walls, such as the interatrial septum, either at or not at the fossa ovalis, or through other non-cardiac tissue walls. Indeed, the tissue anchors described herein may be deployed in any number of bodily locations where it is desired to anchor into or behind tissue for purposes of moving such tissue relative to adjacent tissue. AlthoughFIG.8shows the deployment of tissue anchor120, the other tissue anchors described herein may be similarly deployed.

Tissue anchor120is delivered to a target site, such as a cardiac chamber, within a deployment tool, with tissue-coupling portion131in an unexpanded generally elongate configuration within the deployment tool. The deployment tool may comprise a hollow needle. The cardiac chamber may be a right atrium164(as shown), a right ventricle166(configuration not shown), a left atrium (configuration not shown), or a left ventricle (configuration not shown). Tissue-coupling portion131of wire122is delivered in the unexpanded generally elongate configuration through a cardiac tissue wall from a first side of the cardiac tissue wall to a second farther side of the cardiac tissue wall. In one application, the hollow needle is used to puncture through a first side of a myocardial tissue wall160and visceral pericardium182(which is part of the epicardium), avoiding vasculature such as the right coronary artery (RCA)178. For some applications, the deployment tool is then further directed, beyond the second farther side of the cardiac tissue wall, into the pericardial cavity180between visceral pericardium182and parietal pericardium184, carefully avoiding puncturing parietal pericardium184and fibrous pericardium186. Although the performance of these steps of the method is not shown inFIG.8, these steps may be performed using techniques described in PCT Publication WO 2018/035378 to Tobis et al., which is incorporated herein by reference, with reference toFIGS.6A-Cthereof.

As shown inFIG.8, tissue anchor120is released from the deployment tool such that straight anchor-shaft portion26of wire122is disposed at least partially within the cardiac tissue wall, and tissue-coupling portion131of wire122expands outside the second farther side of the cardiac tissue wall (optionally within pericardial cavity180, as shown inFIG.8), and assumes the shape described hereinabove, thereby anchoring tissue anchor120to myocardial tissue wall160.

Once tissue anchor120has been anchored to myocardial tissue wall160at the target site, expanded tissue-coupling portion131, including looped portion44thereof, is tightly drawn against the second farther side of myocardial tissue wall160(typically via visceral pericardium182) at the target site by applying tension to tissue anchor120by pulling proximal end28of straight anchor-shaft portion26along anchor-shaft axis48away from looped-portion plane46. The tension is thus applied to tissue-coupling portion131and thus to myocardial tissue wall160, thereby moving myocardial tissue wall160at the target site relative to adjacent cardiac tissue. For some applications, such motion can have the benefit of altering the geometry of a nearby cardiac valve, such as the tricuspid valve or the mitral valve. Typically, the tension is applied using tether52.

Reference is now made toFIGS.9A and9B, which are schematic illustrations of tissue anchors720A and720B, respectively, that are configured to be anchored to a cardiac tissue wall, in accordance with respective applications of the present invention.

Reference is also made toFIG.10, which is a schematic illustration of a tissue anchor820that is configured to be anchored to a cardiac tissue wall, in accordance with an application of the present invention.

Tissue anchors720A,720B, and820comprise:straight anchor-shaft portions726A,726B, and826, respectively; andtissue-coupling portions731A,731B, and831, respectively.

Tissue anchors720A,720B, and820are configured such that when tissue-coupling portions731A,731B, and831, respectively, are in respective unconstrained states in which the tissue-coupling portions are not constrained by any external forces, as shown inFIGS.9A-Band10:tissue-coupling portions731A,731B, and831are shaped so as to define (i) elongate intermediate portions735A,735B, and835, respectively, that extend from distal ends730A,730B, and830, respectively, of straight anchor-shaft portions726A,726B, and826, respectively, and (ii) forked distal portions737A,737B, and837, respectively, that extend from distal ends741A,741B, and841, respectively, of intermediate portions735A,735B, and835, respectively, and define two tines743A,743B, and843, respectively, andtine-passing portions745A,745B, and845, respectively, of tissue anchors720A,720B, and820, respectively, pass between the two tines743A,743B, and843, respectively.

For some applications, such as shown inFIGS.9A and10for tissue anchors720A and820, respectively, tine-passing portions745A and845are defined by straight anchor-shaft portions726A and826, respectively. For other applications, such as shown inFIG.9Bfor tissue anchor720B, tine-passing portion745B is defined by intermediate portion735B. Alternatively, the tine-passing portion is defined partially by the straight anchor-shaft portion and partially by the intermediate portion (configuration not shown). Tissue anchor820may alternatively be shaped such that tine-passing portion845is defined by intermediate portion835, similar to the configuration shown inFIG.9B(configuration not shown).

For some applications, each of the tissue anchors is configured such that when the tissue-coupling portion is in the unconstrained state, exactly one tine-passing portion of the tissue anchor passes between the two tines, as shown inFIGS.9A-Band10.

For some applications, each of the tissue anchors is configured such that when the tissue-coupling portion is in the unconstrained state, the two tines generally define a tine plane747that forms an angle of between 60 and 90 degrees (e.g., between 75 and 90 degrees) with an anchor-shaft axis749of the straight anchor-shaft portion (labeled inFIG.9Afor tissue anchor720A, but equally applicable to tissue anchors720B and820).

For some applications, tissue anchors720A,720B, and820are configured such that when tissue-coupling portions731A,731B, and831are in the unconstrained states, intermediate portions735A,735B, and835are at least partially curved.

For some applications, tissue anchors720A,720B, and820further comprising a fabric that at least partially covers the tissue-coupling element, such as described, for example, regarding fabric560with reference toFIGS.6A-B.

Reference is made toFIGS.9A-B. For some applications, each of tissue anchors720A and720B comprises a single metal wire722that is shaped so as to define straight anchor-shaft portion726A,726B and tissue-coupling portion731A,731B. For some of these applications, a proximal end728of straight anchor-shaft portion726A,726B coincides with a proximal end724of wire722. Alternatively, proximal end728of straight anchor-shaft portion726A,726B does not coincide with proximal end724of wire722, such as described hereinabove with reference toFIG.3Cregarding tissue anchor270, mutatis mutandis.

Reference is made toFIG.10. For some applications, tissue anchor820comprises two metal wires822A and822B that are shaped so as to together define straight anchor-shaft portion826and tissue-coupling portion831. Tissue anchor820is configured such that when tissue-coupling portion831is in the unconstrained state, as shown inFIG.10, the two metal wires822A and822B:run alongside (i.e., directly adjacent) each other along at least a portion of straight anchor-shaft portion826and along at least a portion of intermediate portion835, andare separate from each other along forked distal portion837, such that the two wires822A and822B respectively define the two tines843.

Typically, but not necessarily, the two metal wires822A and822B are fixed to each other at least partially along straight anchor-shaft portion826and at least partially along intermediate portion835.

For some applications, a proximal end828of straight anchor-shaft portion826coincides with a proximal end824A and/or824B of at least one of the two wires822A and822B, such as with both proximal ends724A and724B, as shown inFIG.10. Alternatively, proximal end828of straight anchor-shaft portion826does not coincide with proximal end824A and/or824B of at least one of the two wires822A and822B, such as described hereinabove with reference toFIG.3Cregarding tissue anchor270, mutatis mutandis.

Reference is again made toFIGS.9A-Band10. For some applications, tissue anchors720A,720B, and820are configured such that:when tissue-coupling portions731A,731B, and831are in the unconstrained states, intermediate portions735A,735B, and835, respectively, are not in mechanical contact with themselves or with either of the two tines743A,743B, and843, respectively (either directly, or via a coating or the above-mentioned optional fabric), andwhen proximal end728,828of straight anchor-shaft portion726A,726B, and826, respectively, is pulled, along anchor-shaft axis749away from tine plane747, intermediate portions735A,735B, and835, respectively, come in mechanical contact with at least one element selected from the group consisting of: intermediate portions735A,735B, and835, respectively (i.e., a different longitudinal portion of the intermediate portion) and at least one of the two tines743A,743B, and843, respectively (either directly, or via a coating or the above-mentioned optional fabric).

For some of these applications, tissue anchors720A,720B, and820are configured such that when proximal end728,828of straight anchor-shaft portion726A,726B, and826, respectively, is pulled along anchor-shaft axis749away from tine plane747, intermediate portions735A,735B, and835, respectively, come in mechanical contact with tissue-coupling portions731A,731B, and831, respectively, at junctions751A,751B, and851, respectively, at which the tissue-coupling portion forks into the two tines.

Reference is still made toFIGS.9A-Band10. Typically, each of tissue anchors720A,720B, and820further comprises an anchor head that is coupled to and supports the straight anchor-shaft portion. The anchor head may implement any of the features of anchor head33described hereinabove with reference toFIG.1A. Alternatively, the tissue anchors do not comprise an anchor head, such as described hereinabove regarding tissue anchor70, with reference toFIG.1D. A tissue anchor system may be provided that comprises one of tissue anchors720A,720B, and820and a tether, and, optionally, a second tissue anchor, such as described hereinabove with reference toFIGS.1A and1D.

For some applications, tissue anchors720A,720B, and820are deployed generally as described hereinabove with reference toFIG.8for tissue anchor20, mutatis mutandis. The tissue anchor is delivered, to a cardiac chamber, within a deployment tool with the tissue-coupling portion is in an unexpanded generally elongate configuration. The tissue-coupling portion is delivered in the unexpanded generally elongate configuration through a cardiac tissue wall from a first side of the cardiac tissue wall to a second farther side of the cardiac tissue wall. The tissue anchor is released from the deployment tool such that the straight anchor-shaft portion of the wire is disposed at least partially within the cardiac tissue wall, the tissue-coupling portion is disposed outside the second farther side of the cardiac tissue wall (optionally within pericardial cavity180, as shown inFIG.8), and the tine-passing portion of the tissue anchor passes between the two tines.

Typically, after the tissue anchor is released from the deployment tool, tension is applied to the tissue anchor by pulling the proximal end of the straight anchor-shaft portion, along the anchor-shaft axis of the straight anchor-shaft portion, away from the tine plane generally defined by the two tines.

For some applications, the tissue anchor is released from the deployment tool such that the intermediate portion is not in mechanical contact with itself or with either of the two tines (either directly, or via a coating or the above-mentioned optional fabric). Pulling the proximal end of the straight anchor-shaft portion away from the tine plane brings the intermediate portion in mechanical contact with at least one element selected from the group consisting of: the intermediate portion and at least one of the two tines. For example, pulling the proximal end of the straight anchor-shaft portion away from the tine plane may bring the intermediate portion in mechanical contact with the tissue-coupling portion at a junction at which the tissue-coupling portion forks into the two tines.

Typically, pulling the proximal end of the straight anchor-shaft portion along the anchor-shaft axis away from the tine plane tightly draws the tines against the second far side of the cardiac tissue wall (typically via visceral pericardium182).

For some applications, the cardiac tissue wall is a myocardial tissue wall, and the tissue-coupling portion is delivered in the unexpanded generally elongate configuration through the myocardial tissue wall into the pericardial cavity between visceral pericardium and parietal pericardium, generally alongside and against the parietal pericardium, without penetrating the parietal pericardium.

The scope of the present invention includes embodiments described in the following applications, which are assigned to the assignee of the present application and are incorporated herein by reference. For some applications, techniques and apparatus described in one or more of the following applications are combined with techniques and apparatus described herein: U.S. Pat. No. 8,475,525 to Maisano et al.; U.S. Pat. No. 8,961,596 to Maisano et al.; U.S. Pat. No. 8,961,594 to Maisano et al.; PCT Publication WO 2011/089601; U.S. Pat. No. 9,241,702 to Maisano et al.; U.S. Provisional Application 61/750,427, filed Jan. 9, 2013; U.S. Provisional Application 61/783,224, filed Mar. 14, 2013; U.S. Provisional Application 61/897,491, filed Oct. 30, 2013; U.S. Provisional Application 61/897,509, filed Oct. 30, 2013; U.S. Pat. No. 9,307,980 to Gilmore et al.; PCT Publication WO 2014/108903; PCT Publication WO 2014/141239; U.S. Provisional Application 62/014,397, filed Jun. 19, 2014; PCT Publication WO 2015/063580; US Patent Application Publication 2015/0119936; U.S. Provisional Application 62/086,269, filed Dec. 2, 2014; U.S. Provisional Application 62/131,636, filed Mar. 11, 2015; U.S. Provisional Application 62/167,660, filed May 28, 2015; PCT Publication WO 2015/193728; PCT Publication WO 2016/087934; US Patent Application Publication 2016/0235533; US Patent Application Publication 2016/0242762; PCT Publication WO 2016/189391; US Patent Application Publication 2016/0262741; U.S. Provisional Application 62/376,685, filed Aug. 18, 2016; U.S. Provisional Application 62/456,206, filed Feb. 8, 2017; U.S. Provisional Application 62/456,202, filed Feb. 8, 2017; U.S. Provisional Application 62/465,410, filed Mar. 1, 2017; U.S. Provisional Application 62/465,400, filed Mar. 1, 2017; U.S. Provisional Application 62/516,894, filed Jun. 8, 2017; U.S. Provisional Application 62/530,372, filed Jul. 10, 2017; PCT Publication WO 2018/035378; U.S. Provisional Application 62/570,226, filed Oct. 10, 2017; U.S. Provisional Application 62/579,281, filed Oct. 31, 2017; U.S. Provisional Application 62/596,658, filed Dec. 8, 2017; PCT Publication PCT Publication WO 2018/148364; US Patent Application Publication 2018/0221148; U.S. Provisional Application 62/628,457, filed Feb. 9, 2018; PCT Publication WO 2018/160456; US Patent Application Publication 2018/0249993; International Application PCT/US18/036609, filed Jun. 8, 2018; US Patent Application Publication 2018/0353297; PCT Publication WO 2019/013994; International Application PCT/US2018/045523, filed Aug. 7, 2018; PCT Publication WO 2019/074815; PCT Publication WO 2019/089262; and PCT Publication WO 2019/157116.

Patents and patent application publications incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated patents and patent application publications in a manner that conflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.

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