Systems and methods for restracting an implant

Abstract

The implant (100) comprises: (i) a first anchor and a second anchor (120); (ii) a tether (130) extending between the first anchor and the second anchor; and (iii) a shape memory band (140) extending alongside the tether between the first anchor and the second anchor. A delivery assembly (110) is adapted (a) to contract the implant at the heart by applying energy to the shape memory band such that the shape memory band pulls the first and second anchors together closer, and (b) to secure the implant in its contracted state by locking a stop (154) to the tether. Other embodiments are also described.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to each of the following:

[0003] Provisional U.S. Patent Application 63 / 420,507, filed on October 28, 2022, and entitled "Systems and methods for contracting implant", issued to Syed et al.; and

[0004] Provisional U.S. Patent Application 63 / 513,547, filed on July 13, 2023, and entitled "Systems and methods for contracting implants", issued to Syed et al.

[0005] Each of the above - mentioned applications is hereby incorporated by reference in its entirety for all purposes. Background Art

[0006] Some percutaneous techniques, including trans - luminal techniques such as transcatheter heart interventions, require the components of an implant to contract once the implant is anchored to the tissue of the heart. In some cases, contracting components within the heart may exert significant forces on the tissue anchors of the implant that are anchored to the tissue, for example, undesirably pulling the anchors out of the tissue. Summary of the Invention

[0007] This Summary of the Invention is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in the examples of this Summary of the Invention are not claimed unless the claims expressly state those features. Additionally, the features, components, steps, concepts, etc. described in the examples of this Summary of the Invention and elsewhere in this disclosure can be combined in a variety of ways. The various features and steps described elsewhere in this disclosure can be included in the examples outlined herein.

[0008] Methods, systems, devices, apparatuses, etc. for contracting an implant implanted at a real or simulated heart are disclosed. In some embodiments, the implant is implanted at the heart, and then a contracting force is applied to the implant to cause the tissue of the heart to contract, for example, to improve heart function.

[0009] In some embodiments, it may be desirable to provide at least a portion of this contractile force from within the heart rather than providing the entire contractile force from outside the subject. For example, in some embodiments in which the implant includes anchor members that are anchored to the heart and connected by tethers extending between the anchor members, it may be advantageous to provide at least a portion of the contractile force from within the heart when the implant is contracted by pulling the anchor members toward each other rather than by pulling the tethers from outside the subject, such as by having another component of the implant pull the anchor members toward each other. For example, this can advantageously allow for a smaller force to be applied to the tethers during contraction, and / or can allow for a more controlled and / or reliable contraction of the implant.

[0010] In some embodiments, the implant is an annuloplasty implant. In some embodiments, the implant (e.g., an annuloplasty implant) includes a plurality of anchor members that can be anchored around the annulus of the heart. In some embodiments, a tether (e.g., a wire, a contractile member, a cord, and / or a thread) extends between at least a first anchor member and a second anchor member of the plurality of anchor members.

[0011] In some embodiments, a shape memory band extends between the first anchor member and the second anchor member, e.g., alongside the tether.

[0012] In some embodiments, the anchor members are first anchored at the annulus and then electrical energy is applied to the shape memory band (e.g., via a delivery tool that can be electrically connected to the band) to temporarily contract the implant. In response to the electrical energy, the shape memory band contracts, thereby reducing the distance between the first anchor member and the second anchor member, e.g., by pulling the anchor members toward each other.

[0013] In some embodiments, the band remains contracted while the electrical energy is continued to be applied. In some embodiments, a lock is locked to the tether while the electrical energy is continued to be applied to the shape memory band, thus maintaining the implant in a contracted state by maintaining the reduced distance between the anchor members. The lock may have been present prior to the application of the electrical energy, or may be advanced to the implant while the electrical energy is continued to be applied.

[0014] As described herein, the electrical augmentation of the contraction of the implant can reduce the pulling force (e.g., by a user manipulating its handle or controls) applied to the tether from outside the heart to contract the implant.

[0015] According to some embodiments, a system (e.g., for use at or on a real or simulated heart) includes an implant. In some embodiments, the implant includes a first anchor and a second anchor, and a tether extending between the first anchor and the second anchor. In some embodiments, a shape memory band extends between the first anchor and the second anchor beside the tether.

[0016] In some embodiments, the system further includes a delivery assembly adapted to contract the implant at the heart. In some embodiments, the delivery assembly is adapted to contract the implant at the heart by applying energy to the shape memory band such that the shape memory band pulls the first anchor and the second anchor closer together.

[0017] In some embodiments, the delivery assembly is further adapted to fix the tension in the implant by locking a stop to the tether.

[0018] In some embodiments, the implant is an annuloplasty implant.

[0019] In some embodiments, each of the first anchor and the second anchor includes a helical tissue engaging element.

[0020] In some embodiments, the delivery assembly includes an anchor driver adapted to drive the first anchor into the tissue of the heart.

[0021] In some embodiments, the shape memory band is a nitinol band.

[0022] In some embodiments, the shape memory band is fixed to both the first anchor and the second anchor.

[0023] In some embodiments, the first anchor is drivable into the tissue of the heart while the second anchor is positioned within the delivery assembly at the heart.

[0024] In some embodiments, the implant is a first implant, the system further includes a second implant, and the delivery tool is configured to arrange the first implant and the second implant around the annulus of the heart.

[0025] In some embodiments, the first anchor and the second anchor are anchors among a plurality of anchors of the implant. In some embodiments, both the tether and the shape memory band extend between the plurality of anchors.

[0026] In some embodiments, the stop is a bead that is slidable above and along the tether.

[0027] In some embodiments, the delivery assembly includes a locking tool configured to advance the stop above and along the tether.

[0028] In some embodiments, the shape memory band is heat-set to assume a contracted shape upon application of the energy.

[0029] In some embodiments, the contracted shape is a zigzag shape.

[0030] In some embodiments, the contracted shape is a serpentine shape.

[0031] In some embodiments, the contracted shape is a helical shape.

[0032] In some embodiments, the shape memory band is adapted to return towards a relaxed state in response to cessation of application of the energy to the shape memory band.

[0033] In some embodiments, the first anchor and the second anchor are a first pair of anchors, and the implant includes multiple pairs of anchors. In some embodiments, the shape memory band is a first shape memory band, and the implant includes multiple shape memory bands, each of which connects the anchors in a corresponding pair. In some embodiments, the tether extends between all of the anchors in the multiple pairs. In some embodiments, the tether extends between only some (but not all) of the anchors in the multiple pairs.

[0034] In some embodiments, the implant defines a band-free gap in which no shape memory band connects the first pair of anchors to a second pair of anchors that is adjacent the first pair within the implant.

[0035] In some embodiments, the stop is a first stop among a plurality of stops. In some embodiments, for each pair of anchors, the delivery assembly is adapted to iteratively fix the tension in the implant by: (i) applying the energy to the shape memory band connecting the anchors in the pair, and (ii) fixing the tension in the section of the tether between the anchors in the pair by locking the corresponding stop among the plurality of stops to the tether.

[0036] In some embodiments, the delivery assembly is configured to apply the energy wirelessly to each of the shape memory bands.

[0037] In some embodiments, the shape memory band is heat-set to transition towards the contracted shape at a temperature greater than 37.5 degrees Celsius.

[0038] In some embodiments, the shape memory band is heat-set to transition towards the contracted shape at a temperature greater than 45 degrees Celsius.

[0039] In some embodiments, the shape memory band is heat-set to transition towards the contracted shape at a temperature greater than 50 degrees Celsius.

[0040] In some embodiments, the shape memory band is heat-set to transition towards the contracted shape at a temperature less than 60 degrees Celsius.

[0041] In some embodiments, for each of the first anchor and the second anchor, the anchor includes an anchor head and a collar, the collar surrounding the anchor head and being rotatable about the anchor head. In some embodiments, the shape memory band is attached to the collar of the first anchor and the collar of the second anchor.

[0042] In some embodiments, each collar defines an eyelet, and the tether extends through the eyelet of the first anchor and the eyelet of the second anchor.

[0043] In some embodiments, the tether is slidable through the eyelet of the second anchor.

[0044] In some embodiments, the first anchor includes a terminal on the collar, the terminal being electrically connectable to the delivery assembly and configured to conduct the energy from the delivery assembly to the shape memory band.

[0045] In some embodiments, the delivery assembly includes a catheter configured to deliver the implant transvascularly to the heart.

[0046] In some embodiments, the catheter is configured to deliver the implant transfemorally to the heart.

[0047] In some embodiments, the first anchor includes a terminal electrically connected to the shape memory band, and the delivery system is configured to apply the energy to the shape memory band via the terminal.

[0048] In some embodiments, the first anchor includes a tissue engaging element configured to anchor the first anchor to the tissue by being driven into the tissue, and the terminal is electrically isolated from the tissue engaging element.

[0049] In some embodiments, the system further includes an extracorporeal generator and a conductor adapted to electrically connect the terminal to the generator. In some embodiments, the generator is adapted to apply the energy to the shape memory band via an electrical connection between the conductor and the terminal.

[0050] In some embodiments, the conductor is adapted to extend from the terminal through the delivery assembly and out of the subject, where the conductor is connected to the generator.

[0051] In some embodiments, the delivery assembly further includes a wireless transmitter adapted to wirelessly transmit the energy. In some embodiments, the implant includes a receiver adapted to receive the wireless energy and transfer at least a portion of the energy to the shape memory band.

[0052] In some embodiments, the wireless transmitter is adapted to electromagnetically transmit the energy.

[0053] In some embodiments, the first anchor and the second anchor are a first pair of anchors, and the implant includes multiple pairs of anchors. In some embodiments, the shape memory band may be a first shape memory band, and the implant may include multiple shape memory bands, each of the shape memory bands connecting the anchors in the corresponding pair.

[0054] In some embodiments, the implant further includes a hub to which the delivery assembly may engage.

[0055] In some embodiments, the hub may include a switch that can be operated by the delivery assembly to select a subset of the shape memory bands to which the energy is to be applied.

[0056] In some embodiments, the subset of the shape memory bands includes only a single shape memory band.

[0057] In some embodiments, the subset of the shape memory bands includes multiple shape memory bands.

[0058] In some embodiments, the hub includes hub terminals, and the delivery assembly is adapted to engage the hub terminals in a manner that places the delivery assembly in electrical connection with the hub.

[0059] In some embodiments, the delivery assembly is adapted to operate the switch by rotating the switch.

[0060] In some embodiments, the switch is a rotary switch.

[0061] In some embodiments, the rotary switch has at least four switching positions.

[0062] In some embodiments, for each subset of shape memory bands, the implant includes corresponding terminals electrically connected to the respective subset. In some embodiments, each terminal is electrically connected to the switch via a corresponding wire. In some embodiments, operating the switch to select the subset electrically connects the delivery assembly to the corresponding terminals of the subset.

[0063] In some embodiments, the system further includes an external generator adapted to apply the energy to the subset of shape memory bands via an electrical connection between the generator and the corresponding terminals of the subset.

[0064] In some embodiments, each wire is electrically isolated from the other wires.

[0065] In some embodiments, the delivery assembly is adapted to iteratively contract each subset by sequentially delivering energy pulses to each subset.

[0066] According to some embodiments, a method (e.g., usable at or on a real or simulated heart) includes anchoring an implant to tissue of a heart by anchoring a first anchor of the implant to the tissue and anchoring a second anchor of the implant to the tissue, with a tether of the implant extending between the first anchor and the second anchor.

[0067] In some embodiments, the method includes subsequently reducing the distance between the first anchor and the second anchor by applying energy to a shape memory band extending alongside the tether between the first anchor and the second anchor.

[0068] In some embodiments, the method includes subsequently fixing the reduced distance by locking a stop to the tether.

[0069] In some embodiments, the method further includes stopping the application of energy after fixing the reduced distance.

[0070] In some embodiments, reducing the distance includes reducing the distance without applying tension to the tether.

[0071] In some embodiments, the implant is an annuloplasty implant, and anchoring the first anchor and the second anchor to the tissue of the heart includes anchoring the first anchor and the second anchor to tissue of the annulus.

[0072] In some embodiments, applying the energy to the shape memory band includes wirelessly transmitting the energy to the implant.

[0073] In some embodiments, applying the energy to the shape memory band includes applying the energy to the shape memory band such that the shape memory band is heated to a temperature greater than 37.5 °C.

[0074] In some embodiments, anchoring the first anchor and the second anchor to the tissue of the heart includes driving the tissue engaging elements of the first anchor and the tissue engaging elements of the second anchor into the tissue.

[0075] In some embodiments, the method further includes sliding the stopper over and along the tether such that the stopper abuts the second anchor.

[0076] In some embodiments, anchoring the first anchor to the tissue includes anchoring the first anchor to the tissue while the second anchor is disposed within the distal portion of a delivery assembly disposed within the heart.

[0077] In some embodiments, the method further includes trimming excess tether after locking the stopper to the tether.

[0078] In some embodiments, the implant is a first implant, and the method includes implanting a plurality of implants in an arrangement along the tissue.

[0079] In some embodiments, the first anchor and the second anchor are anchors among a plurality of anchors of the implant. In some embodiments, anchoring the implant to the tissue includes anchoring the implant along the tissue while both the tether and the shape memory band extend between the plurality of anchors.

[0080] In some embodiments, the method further includes applying tension to the tether before locking the stopper to the tether.

[0081] In some embodiments, applying tension to the tether includes applying tension to the tether after beginning to apply energy to the shape memory band.

[0082] In some embodiments, the first anchor and the second anchor are a first pair of anchors, and the implant includes multiple pairs of anchors. In some embodiments, the shape memory band is a first shape memory band, and the implant includes a plurality of shape memory bands, each of the shape memory bands connecting the anchors in a corresponding pair.

[0083] In some embodiments, the method includes implanting the implant along the tissue while the tether extends between all of the anchors in the plurality of pairs.

[0084] In some embodiments, anchoring the implant to the tissue includes anchoring the implant to the tissue in a manner that defines a band - free gap in which no shape - memory band connects the first pair of anchors to a second pair of anchors of the implant, the second pair being adjacent the first pair within the implant.

[0085] In some embodiments, the stop is a first stop of a plurality of stops. In some embodiments, for each pair of anchors, the method includes iteratively fixing the tension in the implant by: (i) applying the energy to the shape - memory band connecting the anchors in the pair, and (ii) fixing the tension in the section of the tether between the anchors in the pair by locking the corresponding stop of the plurality of stops to the tether.

[0086] In some embodiments, the method includes delivering the implant trans - luminally to the heart.

[0087] In some embodiments, delivering the implant trans - luminally to the heart includes delivering the implant trans - femoral - arterially to the heart.

[0088] In some embodiments, applying the energy to the shape - memory band includes applying the energy to the shape - memory band such that the shape - memory band transitions toward a contracted shape.

[0089] In some embodiments, the method further includes, after locking the stop to the tether, ceasing to apply the energy to the shape - memory band such that the shape - memory band returns toward a relaxed state.

[0090] In some embodiments, the implant includes multiple pairs of anchors, the first anchor and the second anchor being a pair of the pairs of anchors. In some embodiments, the shape - memory band can be a first shape - memory band, the implant includes a plurality of shape - memory bands, and each of the shape - memory bands connects the anchors in a corresponding pair.

[0091] In some embodiments, the implant can further include a hub. In some embodiments, the hub can include a switch.

[0092] In some embodiments, the method can further include, before applying the energy to the first shape - memory band, selecting a subset of the plurality of shape - memory bands, the subset including the first shape - memory band, by operating the switch.

[0093] In some embodiments, reducing the distance between the first anchor and the second anchor by applying energy to the first shape memory band includes reducing the distance between the first anchor and the second anchor by applying the energy to a selected subset of the shape memory bands.

[0094] In some embodiments, the switch is a rotary switch, and operating the switch includes rotating the rotary switch.

[0095] One or more of the above methods can be performed on a living animal or a non-living simulator, such as on a cadaver, a cadaver heart, a phantom (e.g., having simulated body parts, tissues, etc.).

[0096] According to some embodiments, a method (e.g., usable at and / or for a real or simulated heart) includes implanting an implant at a heart by fixing a plurality of anchors of the implant to tissue of the heart, the anchors being connected together via (i) a shape memory band and / or (ii) a tether.

[0097] In some embodiments, the method includes transitioning the implant toward a contracted state by applying electrical energy to the shape memory band such that the anchors move closer together.

[0098] In some embodiments, the method includes locking the implant in the contracted state by applying a stop to the tether.

[0099] One or more of the above methods can be performed on a living animal or a non-living simulator, such as on a cadaver, a cadaver heart, a phantom (e.g., having simulated body parts, tissues, etc.).

[0100] According to some embodiments, a method (e.g., usable at and / or for a real or simulated heart) includes anchoring a first anchor and a second anchor and a portion of a tether extending between the first anchor and the second anchor to tissue of the heart, the portion having a length. In some embodiments, the method includes subsequently facilitating reduction of the length of the portion of the tether by applying electrical energy to a shape memory band extending alongside the tether between the first anchor and the second anchor.

[0101] In some embodiments, the method includes subsequently fixing the reduced length by locking a stop to the tether.

[0102] According to some embodiments, a system and / or device that includes an implant (e.g., that can be used at or in a real or simulated heart) includes a plurality of shape memory bands configured such that applying energy to a shape memory band causes a corresponding portion of the implant to contract.

[0103] In some embodiments, the hub may include hub terminals and / or a switch, the energy is applied via the hub terminals, and the switch is operable to select the shape memory band to which the energy is directed.

[0104] In some embodiments, the system / device further includes a delivery assembly configured to deliver the implant into a subject, the delivery assembly including a shaft adapted to engage the hub terminals in a manner that places the delivery assembly in electrical connection with the hub. In some embodiments, the hub may be adapted to operate the switch to select the shape memory band.

[0105] In some embodiments, the shaft is flexible and adapted to be advanced trans-luminally into the tissue of the subject.

[0106] In some embodiments, the shaft is adapted to operate the switch by rotating the switch.

[0107] In some embodiments, the plurality of shape memory bands are grouped into subsets of the plurality of shape memory bands. In some embodiments, for each subset of shape memory bands, the implant may include corresponding terminals electrically connected to the respective subset.

[0108] In some embodiments, each terminal may be electrically connected to the switch via a corresponding wire. In some embodiments, operating the switch to select a subset may electrically connect the shaft to the corresponding terminals of the subset.

[0109] In some embodiments, the system / device further includes an extracorporeal generator electrically connected to the shaft and adapted to apply the energy to the subset of shape memory bands via an electrical connection between the shaft and the corresponding terminals of the subset.

[0110] In some embodiments, each wire is electrically isolated from the other wires.

[0111] In some embodiments, the switch is a rotary switch.

[0112] In some embodiments, the rotary switch has at least four switching positions.

[0113] Any of the above-described methods and any method of using the systems, components, devices, apparatuses, etc. herein can be performed on a living subject (e.g., a human or other animal) or on a simulacrum (e.g., a cadaver, cadaver heart, virtual human, phantom, etc.). By simulation, a body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can optionally include a computerized and / or physical representation.

[0114] Any of the above systems, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safe use on a patient, and the above methods can include (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) sterilizing one or more of the systems, devices, apparatuses, components, etc. herein (or alternatively the method consists of such sterilization).

[0115] The concepts herein will be more fully understood from the following detailed description of example embodiments herein in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0116] Figure 1A - E is a schematic diagram of a system including an implant and techniques for causing the implant to contract, according to some embodiments;

[0117] Figure 2 、 3 and 4 are schematic diagrams of different uses and / or variations of an implant implanted around the annulus of a real or simulated heart, according to some embodiments; and

[0118] Figure 5 and 6A - C is a schematic diagram of a hub on an implant that is operable to select a subset of the implants to which energy is applied. DETAILED DESCRIPTION

[0119] This application relates to methods and systems for causing an implant implanted at the heart to contract. In some embodiments, an implant is implanted at the heart (e.g., the heart of a living subject and / or the heart of a simulacrum), and then a contracting force is applied to the implant to cause the tissue of the heart to contract, e.g., to improve heart function. In some embodiments, it may be desirable to provide at least a portion of this contracting force from within the subject's heart rather than providing the entire contracting force from outside the subject.

[0120] For example, in some embodiments in which the implant includes anchors anchored to the heart and connected by tethers extending between the anchors, it may be advantageous to provide at least a portion of the contractile force from within the heart, such as by having another component of the implant pull the anchors toward each other, when the implant is contracted by pulling the anchors toward each other rather than by pulling the tethers from outside the subject to provide the overall contractile force. For example, this can advantageously allow for a lesser force to be applied to the tethers during contraction, and / or can allow for a more controlled and / or reliable contraction of the implant.

[0121] Now referring to Figure 1A -E, the figure is a schematic illustration of a system 1000 according to some embodiments. The system 1000 includes an implant 100 and may further include a delivery assembly 110 adapted to deliver and implant the implant 100 trans-luminally (e.g., transfemorally) at the heart. The delivery assembly 110 generally includes a catheter 112, an anchor driver 116, and a locking tool 114.

[0122] The implant 100 includes a plurality of anchors 120, e.g., a first anchor 120a and a second anchor 120b. Each anchor 120 has a head 124 and a tissue engaging element 128 that extends distally away from the head. The tissue engaging element 128 is shown as a helical and / or screw-in tissue engaging element, however any other type of tissue engaging element may be used, e.g., darts, staples, or clips. The implant 100 further includes a tether 130 that extends between the anchors 120a and 120b. The tether 130 may be a cord, rope, wire, suture, cable, and / or wire.

[0123] In some embodiments, the implant 100 is an annuloplasty implant adapted to be implanted at the annulus 10 of the heart. In some embodiments, the annulus 10 is the mitral annulus. In some embodiments, the annulus 10 is the tricuspid annulus.

[0124] System 1000 further includes a shape memory band 140 that extends between the anchors 120a and 120b, for example, alongside the tether 130. The shape memory band 140 can be made of nitinol or any other shape memory alloy. The shape memory band 140 can include a piezoelectric material. The shape memory band 140 is adapted (e.g., thermally set) to assume a contracted state when heated, such as by applying electrical energy (e.g., radio frequency (RF) current) to the band. In some embodiments, the shape memory band 140 is adapted to return towards a relaxed state when cooled, such as when electrical energy is no longer applied to the band. The shape memory band 140 can be configured (e.g., thermally set) such that its transition temperature (i.e., the temperature at which it transitions towards its contracted state) is greater than 37.5 °C (e.g., greater than 40 °C, such as greater than 42 degrees Celsius) and / or less than 60 °C (e.g., less than 50 °C).

[0125] In some embodiments, each anchor head 124 includes a collar 126 (e.g., a ring) that, for example, surrounds the anchor head and is rotatable about the anchor head by being rotatably coupled to the anchor, such as by being rotatably coupled to another component of the head 124 that is fixedly coupled to the tissue engaging element 128 of the anchor. In some embodiments, the anchor 120 and / or the anchor head 124 and / or its collar 126 are similar to those described in Kasher's WO 2021 / 084407, with necessary modifications, which patent is incorporated herein by reference in its entirety. In some embodiments, the eyelets 122 are mounted on each collar 126 of each anchor head, and the tether 130 extends through these eyelets. In some embodiments, the tether 130 can slide through the eyelets, or at least through the eyelets of the anchor 120b.

[0126] In some embodiments, the shape memory band 140 is fixed to the head of each of the anchors 120a and 120b (e.g., fixed to its collar 126) such that transitioning the band towards its contracted state pulls the anchors towards each other.

[0127] In some embodiments, connecting the eyelets 122 and the band 140 to the rotatable collar 126 advantageously allows the tissue engaging element 128 to be screwed into the tissue without undesirably winding or tangling the tether 130 or the band 140 around the anchor 120 (e.g., around the head 124). For example, the collar 126 can remain stationary relative to the tissue while the tissue engaging element 128 rotates relative to the tissue.

[0128] In some embodiments, terminal 148 is mounted on at least one of the anchors 120a and 120b, and electrical energy is transmitted through the terminal to the shape memory band 140. For example, terminal 148 can be electrically and / or mechanically connected to the shape memory band 140, for example, via a conductive element of the anchor head 124, such as through both the terminal and the band connected to the collar 126. In some embodiments, terminal 148 is electrically isolated from the tissue engagement element 128, for example, to prevent electrical energy from being transmitted to the tissue of the heart.

[0129] Figure 1A An anchor driver 116 is shown driving a second anchor 120b into the tissue of the annulus 10, where a first anchor 120a has been anchored to the tissue. The first anchor 120a can be delivered to the heart with a first stop 152 on a tether 130 positioned distally of the anchor. This can prevent the anchor 120a from slipping off the tether 130. During driving of the anchor into the tissue, the anchor driver 116 can be received within a catheter 112, for example, as Figure 1A shown. In some embodiments, the driving of the anchor 120 is as described in WO 2021 / 084407 to Kasher, with necessary modifications. In some embodiments, the anchor driver 116 is as described in U.S. Patent Application Publication US2014 / 0309661 to Sheps et al., which is incorporated herein by reference in its entirety.

[0130] In some embodiments, the anchors 120a and 120b are driven into the heart tissue while the tether 130 and / or the shape memory band 140 has extended therebetween. In some embodiments, during implantation of the implant 100, the tether 130 (e.g., via the catheter 112) extends from the anchor through the vasculature of the subject, for example, to the exterior of the subject. Once both the anchors 120a and 120b have been driven into the tissue, the anchor driver 116 can be withdrawn from the heart and from the subject ( Figure 1B ). Figure 1B The band 140 is shown in its relaxed state.

[0131] In some embodiments, a conductor 144 (e.g., a wire) extends from an extracorporeal generator 160 to the terminal 148, for example, via the catheter 112. The generator 160 is adapted to apply electrical energy to the shape memory band 140 via the conductor 144 and the terminal 148, so as to apply heat to the band such that the band transitions towards its contracted state. Figure 1CIllustrates the electrical energy applied to the tape 140, and the tape has responsive-ly transitioned towards its contracted state. As shown, this pulls the anchors 120a and 120b towards each other (shown by arrows), causing the implant to contract. In some embodiments, during the application of electrical energy to the shape memory tape 140, there is a closed circuit (e.g., a closed loop) between the generator 160 and the terminal 148, e.g., via a conductor 144 that extends from the generator to the terminal (e.g., via the conduit 112) and from the terminal back through the conduit to the generator.

[0132] In the illustrated example, the tape 140 has a zigzag shape in its contracted state. However, it should be understood that the scope of the present disclosure includes tapes 140 configured to have other contracted shapes that pull the anchors 120 towards each other. Non-limiting examples of such other contracted shapes include serpentine shapes and coil (e.g., helical) shapes.

[0133] When the shape memory tape 140 is held in its contracted state (e.g., while continuing to apply electrical energy to the shape memory tape), the slack that may be present in the tether 130 can be taken up (e.g., by pulling the tether proximally), and then the tether can be locked relative to the anchor 120b, e.g., using a second stop 154 ( Figure 1D ). The stop 154 can be positioned such that it abuts the anchor 120b, e.g., such that it abuts the eyelet 122 of the anchor 120b. In some embodiments, although the slack is taken up, no additional substantial tension is applied to the tether 130 before locking.

[0134] In some embodiments, not only is the slack taken up, but additional tension is applied to the tether 130 before locking. Additionally, in some embodiments, the application of electrical energy is substantially simultaneous with the application of tension to the tether 130, e.g., the contraction of the tape 140 simply adds to the contraction provided by tensioning the tether.

[0135] As described above, compared to such electrically enhanced similar systems that do not provide contraction, the contraction of the tape 140 can advantageously allow less (or even substantially no) pulling force to be applied to the tether 130.

[0136] Additionally or alternatively, such electrical enhancement can enhance the control and / or reliability of the contraction of the implant 100. In some embodiments, during the taking up of the slack in the tether 130 (and / or the tensioning of the tether), the locking tool 114 is adapted to apply a reference force to the anchor 120b, e.g., by pushing the anchor as the tether is pulled proximally (e.g., via the stop 154).

[0137] Figure 1CIt is shown that electrical energy can be applied before the advancement tool 114 and / or the stopper 154, but it is mainly intended to illustrate that the application of electrical energy can be independent of any tension in the tool and / or the tether 130. However, it should be noted that in some embodiments, Figure 1C the state shown in may not exist during the procedure. For example, the tool 114 and / or the stopper 154 may be present at the anchor 120b before the application of electrical energy.

[0138] In some embodiments, a locking tool 114 is used to advance the stopper. In some embodiments, the stopper 152 and / or the stopper 154 are variants or substantially the same as one or more of the stoppers described in WO 2021 / 084407 of Kasher et al.

[0139] In some embodiments, the tether 130 is then cut (e.g., trimmed) proximal to, for example, the stopper 154, and the delivery assembly 110 is withdrawn, thereby implanting the implant 100 within the heart ( Figure 1E ). Electrical energy application to the band 140 can be stopped before or after cutting the tether 130. Figure 1E It is shown that the band 140 has responsively returned towards its relaxed state, although the band has more slack portions than in Figure 1B because the anchors 120 have moved closer to each other.

[0140] Now referring to Figure 2 、 3 and 4, the figures illustrate different uses and / or variants of the implant 100 implanted around the annulus 10 of the heart according to some embodiments. Figures 2 - 4 Each of the implants shown in can be adapted to be used with the system 1000 (or a variant thereof), e.g., can be deliverable via the delivery assembly 110 (or a variant thereof). In some embodiments, Figures 2 - 4 the implants shown in use the same general techniques described with reference to Figure 1A -E for contraction, e.g., applying electrical energy to one or more shape memory bands of the implant to cause the implant to contract or facilitate the contraction of the implant, and then locking the implant in the contracted state by locking one or more tensions within the tethers of the implant.

[0141] Figure 2 An example implant arrangement 200 including multiple implants 100 is shown. As described above, in some embodiments, each implant 100 includes a pair of anchors 120 and a tether 130 extending therebetween. Additionally, in some embodiments, each implant 100 includes a shape memory band 140 that extends between the anchors alongside the tether 130.

[0142] In some embodiments, each implant 100 of the implant arrangement 200 may be anchored and / or constricted with reference to Figure 1A -E as described above, with necessary modifications.

[0143] In some embodiments, each implant 100 of the implant arrangement 200 may be anchored independently of one another. For example, the implants of the implant arrangement may be anchored sequentially.

[0144] In some embodiments, each implant 100 of the implant arrangement 200 may be constricted independently of one another. For example, the implants of the implant arrangement may be constricted sequentially.

[0145] In some embodiments, each implant 100 constricts immediately after its implantation and immediately before the implantation of the next implant in the implant arrangement. In some embodiments, multiple (e.g., all) implants of the implant arrangement are anchored and then constricted in unison. For example, the constriction of each implant may be adjusted in coordination with the constriction of the other implants of the implant arrangement.

[0146] In some embodiments, each implant 100 of the implant arrangement 200 has a pair of stoppers 152 and 154 positioned at opposite ends of its respective tether 130 to maintain tension in each tether. In some embodiments, a pair of anchors 120 of each implant 100 are delivered together. For example, the first anchor of the pair is delivered while the second anchor is positioned within the delivery assembly 110 at the heart.

[0147] Figure 3 An exemplary implant 300 is shown that includes multiple anchors 320 and a single tether 330 extending between the anchors. In some embodiments, the implant 300 includes multiple shape memory bands 340, each shape memory band extending between a respective pair 302 of anchors 320, e.g., between anchors in each pair that are adjacent to one another within the implant.

[0148] In some embodiments, each band 340 extends alongside the tether 330. In some embodiments, the respective band 340 extends between each anchor and its adjacent anchor. For example, each pair 302 is connected to another pair via a shape memory band (e.g., the bands 340 are present throughout the length of the implant).

[0149] However, in some embodiments, and as shown, each pair 302 is not connected to another pair (e.g., an adjacent pair) via a shape memory band. That is, there is a "bandless gap" between the bands 340. However, as shown, each pair 302 is generally connected to its adjacent pair via the tether 330 (e.g., the tether extends throughout the length of the implant).

[0150] Similar to that described for implant 100, at least one anchor 320 in each pair 302 can include a terminal 148 through which electrical energy can be applied to the strap 340 of the pair.

[0151] Implant 300 can include multiple pairs of stoppers 352 and 354 positioned on tether 330, such as on either side of each pair 302 of anchors (e.g., as shown). After anchoring each pair 302 of anchors 320, that portion of implant 300 is contracted (e.g., as described with reference Figure 1A -E, with necessary modifications). That is, electrical energy can be applied to the strap 340 between newly deployed pairs, and the contraction is locked using stopper 354.

[0152] In some embodiments, the portion of the implant at each pair 302 is contracted before the next pair is anchored. That is, the contraction of the implant can be performed iteratively, for example, during the implantation of the implant. It should be noted that in such cases, the tether 330 is typically not cut until the contraction of the entire implant 300 is complete.

[0153] In some embodiments, multiple pairs (e.g., all pairs) of pairs 302 of implant 300 are anchored and then contracted uniformly.

[0154] In some embodiments, the stoppers are not locked on both sides of all pairs of anchors, but rather the user can select how many anchors or pairs of anchors to deploy before applying stopper 354 to lock the tension in that section of the implant. Thus, in some embodiments, the tether can effectively be divided into sections, where each section has a degree of tension independent of the other sections.

[0155] In some embodiments, electrical energy can be applied to at least one strap associated with a section of the implant before locking the tension in that section of the implant, in order to enhance the contraction of that section of the tether.

[0156] In some embodiments, implant 300 includes a single pair of stoppers 352 and 354, with one of the stoppers positioned distal to the most distal anchor and the other stopper positioned proximal to the most proximal anchor.

[0157] Figure 4 An example implant is shown that includes multiple anchors 420, a single tether 430 extending between the anchors, and a single shape memory strap 440 extending alongside the tether and also between the anchors.

[0158] In some embodiments, only a single anchor 420 of the implant includes the terminal 148 such that electrical energy is applied via the terminal to the shape memory band 440 to cause the entire band to contract. For example, this can be the last anchor to be anchored or the first anchor to be anchored.

[0159] In some embodiments, a single pair of stoppers 452 and 454 can be used to lock the tension in the implant, for example, via a tether 430 positioned on either side of the first deployed anchor and the last deployed anchor.

[0160] Now referring Figure 5 and 6A -C, the figure shows a system 5000 that includes an implant 500 that includes a hub 580 that can be operated by a delivery assembly 510 to select a subset of the shape memory bands of the implant to which energy is applied.

[0161] In some embodiments, implant 500 is similar to either implant 200 or 300. For example, implant 500 can include a plurality of anchors 520 and a plurality of shape memory bands 540, each shape memory band extending between a corresponding subset of the anchors, such as between adjacent anchors within the implant.

[0162] In some embodiments, implant 500 includes a single tether 530 that extends between all of the anchors.

[0163] In some embodiments, implant 500 includes a plurality of tethers, each of which extends between a corresponding subset of the anchors. As described above, in some embodiments, each shape memory band 540 can (e.g., temporarily) contract to pull the anchors to which the shape memory band is connected closer together to facilitate contraction of the implant via tether 530.

[0164] Rather than having the delivery assembly individually engage each terminal to apply energy to each corresponding subset of the shape memory bands, delivery assembly 510 can simply engage hub 580 to be electrically connected to each of the shape memory bands. For example, hub 580 can include hub terminals 582, and components of the delivery assembly (e.g., shaft 544, such as a wire or rod) are adapted to intracardially engage the hub terminals (e.g., when the hub is positioned within the heart) to electrically connect the delivery assembly to the hub (e.g., as Figure 5 shown).

[0165] In some embodiments, hub 580 includes switch 584, which can be operated by delivery assembly 510 (e.g., its shaft 544) to select a subset of the shape memory bands to be electrically connected to. In the illustrated example, switch 584 is a rotary switch that is operated by rotation. However, it should be understood that other electromechanical and / or electronic switches can be used. In some embodiments, an operator (e.g., a doctor) can simply rotate shaft 544 within the switch to rotate the dial, thereby selecting an appropriate subset of shape memory bands to contract.

[0166] In some embodiments, system 5000 can include generator 560, which can be a variant of or substantially the same as generator 160, and electrical energy is applied to the shape memory bands via the generator.

[0167] In some embodiments, each shape memory band 540 or a subset of each shape memory band can include terminals 548, and delivery assembly 510 is adapted to apply energy via the terminals. In some embodiments, each terminal 548 can be electrically connected to hub 580 via a corresponding wire 550. In some embodiments, each wire 550 can be electrically isolated from other wires. In some embodiments, shape memory band 540 or a subset of the shape memory bands can be contracted by selecting a corresponding position on switch 584 (e.g., using shaft 544) to electrically connect generator 560 to one or more corresponding terminals of one or more shape memory bands.

[0168] Figure 6A -C shows an example sequence of applying energy to various shape memory bands 540 of implant 500. As Figure 6A shown, in some embodiments, generator 560 can be electrically connected to the hub by engaging delivery assembly 510 (e.g., its shaft 544) within hub terminal 582 (e.g., delivery assembly 510 can include wires that provide electrical conduction).

[0169] In some embodiments, implant 500 can be delivered to the heart, where shaft 544 has been engaged with hub 580. In some embodiments, shaft 544 can engage hub terminal 582 intracardially, for example, after the implant has been delivered to the heart.

[0170] Figure 6B shows an example subset of shape memory bands (e.g., single band 540) that contract by applying energy to the band. As Figures 6B to 6CAs shown by the transition between, the switch 584 is then rotated, and then electrical energy is applied to different subsets of the shape memory bands. This can advantageously allow the implant to be effectively divided into sections, where each section has a degree of tension independent of the other sections. For example, in an embodiment where the implant 500 includes a tether 530, the tether can be contracted during (and / or after) application of energy to a section of the implant (e.g., a subset of the shape memory bands within the section), which can advantageously allow the section of the tether to contract to a different degree of tension than other sections of the tether.

[0171] Although the switch 584 is shown as having six discrete positions, it should be understood that any other number of positions is possible. For example, the switch 584 can have 2 positions, 3 positions, or at least 4 positions and / or fewer than 20 positions, such as 4 - 20 positions. Each position can electrically connect the delivery assembly 510 (e.g., the generator 560) to a single shape memory band and / or a subset of shape memory bands. For example, some positions on the switch 584 can connect the delivery assembly to a single shape memory band, and other positions can connect the delivery assembly to multiple shape memory bands (e.g., a combination of shape memory bands). Thus, the operator can programmatically determine which subsets of the shape memory bands contract. For example, the operator may wish to contract the shape memory bands that are more closely aligned with the forward axis of the valve being treated (e.g., Figure 5 bands 1 and 6 in the example shown) to, for example, pull the anterior and posterior leaflets of the valve towards each other.

[0172] In some embodiments, the delivery assembly 510 is adapted to iteratively contract the shape memory bands 540, for example, by rotating the switch 584 and applying a small current pulse to each shape memory band.

[0173] Figure 5 An embodiment is shown where the implant 500 is an annuloplasty implant that includes a sleeve 590, which can be implanted circumferentially along the valve annulus. In some embodiments, the implant 500 includes a spool 592 that can be actuated (e.g., rotated) to adjust the tension in the tether 530, for example, to contract the sleeve 590 to contract the tissue. In some embodiments, and as Figure 5 shown, the spool 592 can be housed within (or co - housed with) the hub 580. In some embodiments, in addition to electrically connecting the delivery assembly to the hub 580, the shaft 544 can additionally be used to contract the tether 530. For example, in the embodiment shown, the shaft 544 can also be used to actuate (e.g., rotate) the spool.

[0174] In some embodiments, the sleeve 590 and / or the implant 500 are variants of the sleeve and / or implant as described in U.S. Patent Application Publication 2015 / 0272734 to Sheps et al. and / or U.S. Patent Application Publication 2018 / 0049875 to Iflah et al., each of which is incorporated by reference. Although the implant 500 is shown as an annuloplasty implant that includes a sleeve, it should be understood that an annuloplasty implant that does not include a sleeve can be similarly used, e.g., any of the annuloplasty implants described in U.S. Patent Application Publication 2021 / 0145584 to Kasher et al., International Patent Application Publication WO 2022 / 064401 to Halabi et al., and / or International Patent Application Publication WO 2022 / 172149 to Shafigh et al., each of which is incorporated by reference herein. Additionally, the implant 500 can be an implant other than an annuloplasty implant.

[0175] Referring again to Figures 1A - 6C . In some embodiments, instead of applying electrical energy to one or more shape memory bands via a wired connection (e.g., via a conductor such as conductor 144), wireless energy is applied to the subject (e.g., from outside the subject or from within the heart), which in turn causes one or more shape memory bands to assume their contracted state. In some embodiments, one or more terminals 148 may not be required.

[0176] In some embodiments in which multiple shape memory bands are used, applying wireless energy can cause all the bands to contract simultaneously. Alternatively, in some embodiments, the bands can be caused to contract sequentially (e.g., one at a time). This can be achieved by sequentially positioning a transmitter of wireless energy (e.g., an induction coil) near each band within the heart, for example, and / or by configuring each band to respond to a different frequency of wireless energy.

[0177] In some embodiments, the wireless energy can be in the form of the wireless RF (radio frequency) domain.

[0178] In some embodiments, receiver coils (not shown) can be included in the heads of at least one of the anchors (e.g., at least one anchor of each pair). Such coils receive the wireless energy and transfer it to the shape memory bands, thereby heating the shape memory bands.

[0179] The concepts described above can be applied to other types of implants and / or devices, with the necessary modifications. For example, the concepts described above can be applied to any implant and / or device that includes one or more tethers located between two or more components, such as similar shape memory and / or electro-responsive materials, or the bands can be integrated and / or aligned with one or more tethers to allow tightening as described above.

[0180] In some embodiments, the concepts herein can be applied to edge-to-edge repair implants where tethers connect leaflet anchors, and the concepts herein can be used to clamp and / or move the leaflet anchors closer together (e.g., with a shape member and / or electro-responsive material or band along the tether), e.g., as described in U.S. Patent Application No. 63 / 420,440 to Bloodworth et al. filed Oct. 28, 2022 and entitled “Heart valve repair devices and methods,” which is incorporated herein by reference for all purposes.

[0181] In some embodiments, the concepts herein can be applied to implants that can be used for leaflet repair (e.g., for plication, treatment of prolapse, or another treatment), where tethers connect leaflet anchors, and the concepts herein can be used to clamp and / or move the leaflet anchors closer together (e.g., with a shape member and / or electro-responsive material or band along the tether) to address the leaflets and / or valve, as in International Patent Publication WO 2022 / 250983, which is incorporated herein by reference for all purposes.

[0182] Example Application (Some non-limiting examples of the concepts herein are cited below):

[0183] Example 1. A system that can be used at or in a real or simulated heart, the system comprising: (A) an implant comprising: (i) a first anchor and a second anchor, (ii) a tether extending between the first anchor and the second anchor, and / or (iii) a shape memory band extending alongside the tether between the first anchor and the second anchor, and / or (B) a delivery assembly adapted to cause the implant to contract at the heart by: (i) applying energy to the shape memory band such that the shape memory band pulls the first anchor and the second anchor closer together, and / or (ii) fixing the tension in the implant by locking a stopper to the tether.

[0184] Example 2. The system of Example 1, wherein the implant is an annuloplasty implant.

[0185] Example 3. The system of any one of Examples 1-2, wherein each of the first anchor and the second anchor comprises a helical tissue engaging element.

[0186] Example 4. The system according to any one of Examples 1 to 3, wherein the delivery assembly includes an anchor driver adapted to drive the first anchor into the tissue of the heart.

[0187] Example 5. The system according to any one of Examples 1 to 4, wherein the shape memory band is a nitinol band.

[0188] Example 6. The system according to any one of Examples 1 to 5, wherein the shape memory band is fixed to both the first anchor and the second anchor.

[0189] Example 7. The system according to any one of Examples 1 to 6, wherein the first anchor is drivable into the tissue of the heart, and the second anchor is disposed within the delivery assembly at the heart.

[0190] Example 8. The system according to any one of Examples 1 to 7, wherein the implant is a first implant, the system further includes a second implant, and the delivery assembly is configured to arrange the first implant and the second implant around the annulus of the heart.

[0191] Example 9. The system according to any one of Examples 1 to 8, wherein: (A) the first anchor and the second anchor are anchors among a plurality of anchors of the implant, and / or (B) both the tether and the shape memory band extend between the plurality of anchors.

[0192] Example 10. The system according to any one of Examples 1 to 9, wherein the stop is a bead that is slidable above and along the tether.

[0193] Example 11. The system according to Example 10, wherein the delivery assembly includes a locking tool configured to advance the stop above and along the tether.

[0194] Example 12. The system according to any one of Examples 1 to 11, wherein the shape memory band is heat-set to assume a contracted shape when the energy is applied.

[0195] Example 13. The system according to Example 12, wherein the contracted shape is a zigzag shape.

[0196] Example 14. The system according to Example 12, wherein the contracted shape is a serpentine shape.

[0197] Example 15. The system according to Example 12, wherein the contracted shape is a helical shape.

[0198] Example 16. The system according to Example 12, wherein the shape memory band is adapted to return towards a relaxed state in response to cessation of application of the energy to the shape memory band.

[0199] Example 17. The system according to any one of Examples 1 to 16, wherein: (A) the first anchor and the second anchor are a first pair of anchors, the implant comprising multiple pairs of anchors, and / or (B) the shape memory band is a first shape memory band, the implant comprising multiple shape memory bands, each of the shape memory bands connecting the anchors in a corresponding pair, and / or (C) the tether extends between all of the anchors in the multiple pairs.

[0200] Example 18. The system according to Example 17, wherein the implant defines a band-free gap in which no shape memory band connects the first pair of anchors to a second pair of anchors, the second pair being adjacent the first pair within the implant.

[0201] Example 19. The system according to Example 17, wherein: (A) the stop is a first stop of a plurality of stops, and / or (B) for each pair of anchors, the delivery assembly is adapted to iteratively fix the tension in the implant by: (i) applying the energy to the shape memory band connecting the anchors in the pair, and / or (ii) fixing the tension in the section of the tether between the anchors in the pair by locking a corresponding one of the plurality of stops to the tether.

[0202] Example 20. The system according to Example 17, wherein the delivery assembly is configured to apply the energy wirelessly to each of the shape memory bands.

[0203] Example 21. The system according to any one of Examples 1 to 20, wherein the shape memory band is thermally set to transition towards a contracted shape at a temperature greater than 37.5 degrees Celsius.

[0204] Example 22. The system according to Example 21, wherein the shape memory band is thermally set to transition towards the contracted shape at a temperature greater than 45 degrees Celsius.

[0205] Example 23. The system according to Example 22, wherein the shape memory band is thermally set to transition towards the contracted shape at a temperature greater than 50 degrees Celsius.

[0206] Example 24. The system according to Example 22, wherein the shape memory band is thermally set to transition towards the contracted shape at a temperature less than 60 degrees Celsius.

[0207] Example 25. The system according to any one of Examples 1 to 24, wherein: (A) for each of the first anchor and the second anchor, the anchor comprises an anchor head and a collar, the collar surrounding the anchor head and being rotatable about the anchor head, and / or (B) the shape memory band is attached to the collar of the first anchor and the collar of the second anchor.

[0208] Example 26. The system according to Example 25, wherein each collar defines an eyelet, and wherein the tether extends through the eyelet of the first anchor and the eyelet of the second anchor.

[0209] Example 27. The system according to Example 26, wherein the tether is slidable through the eyelet of the second anchor.

[0210] Example 28. The system according to Example 25, wherein the first anchor comprises a terminal on the collar of the first anchor, the terminal being electrically connectable to the delivery assembly and configured to conduct the energy from the delivery assembly to the shape memory band.

[0211] Example 29. The system according to any one of Examples 1 to 28, wherein the delivery assembly comprises a catheter configured to deliver the implant transvascularly to the heart.

[0212] Example 30. The system according to Example 29, wherein the catheter is configured to deliver the implant transfemorally to the heart.

[0213] Example 31. The system according to any one of Examples 1 to 30, wherein the first anchor comprises a terminal electrically connected to the shape memory band, and the delivery assembly is configured to apply the energy to the shape memory band via the terminal.

[0214] Example 32. The system according to Example 31, wherein: (A) the first anchor comprises a tissue engaging element configured to anchor the first anchor to the tissue by being driven into the tissue of the heart, and / or (B) the terminal is electrically isolated from the tissue engaging element.

[0215] Example 33. The system according to Example 31, wherein: (A) the system further comprises an extracorporeal generator and a conductor adapted to electrically connect the terminal to the generator, and / or (B) the generator is adapted to apply the energy to the shape memory band via an electrical connection between the conductor and the terminal.

[0216] Example 34. The system according to Example 33, wherein the conductor is adapted to extend from the terminal through the delivery assembly and out of the subject, and wherein the conductor is connected to the generator.

[0217] Example 35. The system according to any one of Examples 1 to 34, wherein: (A) the delivery assembly further comprises a wireless transmitter adapted to wirelessly transmit the energy, and / or (B) the implant comprises a receiver adapted to receive wireless energy and transfer at least a portion of the energy to the shape memory band.

[0218] Example 36. The system according to Example 35, wherein the wireless transmitter is adapted to electromagnetically transmit the energy.

[0219] Example 37. The system according to any one of Examples 1 to 36, wherein: (A) the first anchor and the second anchor are a first pair of anchors, and the implant comprises multiple pairs of anchors, (B) the shape memory band is a first shape memory band, and the implant comprises multiple shape memory bands, each of the shape memory bands connecting the anchors in a corresponding pair, and / or (C) the implant further comprises a hub, the delivery assembly is engageable with the hub, and the hub comprises a switch operable by the delivery assembly to select a subset of the shape memory bands to which the energy is to be applied.

[0220] Example 38. The system according to Example 37, wherein the subset of the shape memory bands comprises only a single shape memory band.

[0221] Example 39. The system according to Example 37, wherein the subset of the shape memory bands comprises multiple shape memory bands.

[0222] Example 40. The system according to Example 37, wherein the hub comprises hub terminals, and the delivery assembly is adapted to engage the hub terminals in a manner that places the delivery assembly in electrical connection with the hub.

[0223] Example 41. The system according to Example 37, wherein the delivery assembly is adapted to operate the switch by rotating the switch.

[0224] Example 42. The system according to Example 37, wherein the switch is a rotary switch.

[0225] Example 43. The system according to Example 42, wherein the rotary switch has at least four switching positions.

[0226] Example 44. The system according to Example 37, wherein: (A) for each subset of shape memory bands, the implant includes corresponding terminals electrically connected to the respective subset, (B) each terminal is electrically connected to the switch via a corresponding wire, and / or (C) operating the switch to select the subset electrically connects the delivery assembly to the respective terminals of the subset.

[0227] Example 45. The system according to Example 44, further comprising an external generator adapted to apply the energy to the subset of shape memory bands via an electrical connection between the generator and the respective terminals of the subset.

[0228] Example 46. The system according to Example 44, wherein each wire is electrically isolated from the other wires.

[0229] Example 47. The system according to Example 44, wherein the delivery assembly is adapted to iteratively contract each subset by sequentially delivering energy pulses to each subset.

[0230] Example 48. A method that can be used at and / or in a real or simulated heart, the method comprising: (A) anchoring an implant to real or simulated tissue of the heart by anchoring a first anchor of the implant to the tissue and anchoring a second anchor of the implant to the tissue, with a tether of the implant extending between the first anchor and the second anchor, (B) subsequently reducing the distance between the first anchor and the second anchor by applying energy to a shape memory band extending beside the tether between the first anchor and the second anchor, and / or (C) subsequently fixing the reduced distance by locking a stop to the tether.

[0231] Example 49. The method according to Example 48, further comprising stopping the application of energy after fixing the reduced distance.

[0232] Example 50. The method according to any one of Examples 48 to 49, wherein reducing the distance comprises reducing the distance without applying tension to the tether.

[0233] Example 51. The method according to any one of Examples 48 to 50, wherein the implant is an annuloplasty implant, and wherein anchoring the first anchor and the second anchor to the tissue of the heart comprises anchoring the first anchor and the second anchor to the tissue of the annulus of the heart.

[0234] Example 52. The method according to any one of Examples 48 to 51, wherein applying the energy to the shape memory band comprises wirelessly transmitting the energy to the implant.

[0235] Example 53. The method according to any one of Examples 48 to 52, wherein applying the energy to the shape memory band comprises applying the energy to the shape memory band such that the shape memory band is heated to a temperature greater than 37.5 °C.

[0236] Example 54. The method according to any one of Examples 48 to 53, wherein anchoring the first anchor and the second anchor to the tissue of the heart comprises driving the tissue engaging elements of the first anchor and the tissue engaging elements of the second anchor into the tissue.

[0237] Example 55. The method according to any one of Examples 48 to 54, further comprising sliding the stopper above and along the tether such that the stopper abuts the second anchor.

[0238] Example 56. The method according to any one of Examples 48 to 55, wherein anchoring the first anchor to the tissue comprises anchoring the first anchor to the tissue while the second anchor is disposed within a distal portion of a delivery assembly disposed within the heart.

[0239] Example 57. The method according to any one of Examples 48 to 56, wherein the method further comprises trimming excess tether after locking the stopper to the tether.

[0240] Example 58. The method according to any one of Examples 48 to 57, wherein the implant is a first implant, and wherein the method comprises implanting a plurality of implants in an arrangement along the tissue.

[0241] Example 59. The method according to any one of Examples 48 to 58, wherein: (A) the first anchor and the second anchor are anchors among a plurality of anchors of the implant, and / or (B) anchoring the implant to the tissue comprises anchoring the implant along the tissue while both the tether and the shape memory band extend between the plurality of anchors.

[0242] Example 60. The method according to any one of Examples 48 to 59, wherein: (A) the implant comprises a plurality of pairs of anchor members, the first anchor member and the second anchor member being a pair of the pairs of anchor members; (B) the shape memory band is a first shape memory band, the implant comprising a plurality of shape memory bands, each of the shape memory bands connecting the anchor members in a corresponding pair; (C) the implant further comprises a hub, the hub comprising a switch; (D) the method further comprises selecting a subset of the plurality of shape memory bands, the subset including the first shape memory band, by operating the switch before applying the energy to the first shape memory band; and / or (E) reducing the distance between the first anchor member and the second anchor member by applying energy to the first shape memory band comprises reducing the distance between the first anchor member and the second anchor member by applying the energy to the selected subset of shape memory bands.

[0243] Example 61. The method according to Example 60, wherein the switch is a rotary switch, and wherein operating the switch comprises rotating the rotary switch.

[0244] Example 62. The method according to any one of Examples 48 to 61, further comprising applying tension to the tether before locking the stopper to the tether.

[0245] Example 63. The method according to Example 62, wherein applying tension to the tether comprises applying tension to the tether after starting to apply energy to the shape memory band.

[0246] Example 64. The method according to any one of Examples 48 to 63, wherein: (A) the first anchor member and the second anchor member are a first pair of anchor members, the implant comprising a plurality of pairs of anchor members; (B) the shape memory band is a first shape memory band, the implant comprising a plurality of shape memory bands, each of the shape memory bands connecting the anchor members in a corresponding pair; and / or (C) the method comprises implanting the implant along the tissue, with the tether extending between all of the anchor members in the plurality of pairs.

[0247] Example 65. The method according to Example 64, wherein anchoring the implant to the tissue comprises anchoring the implant to the tissue in a manner that defines a band-free gap in which no shape memory band connects the first pair of anchor members to a second pair of anchor members of the implant, the second pair being adjacent the first pair within the implant.

[0248] Example 66. The method according to Example 64, wherein: (A) the stop is a first stop among a plurality of stops, and / or (B) for each pair of anchors, the method includes iteratively fixing the tension in the implant by: (i) applying the energy to the shape memory tape connecting the anchors in the pair, and / or (ii) fixing the tension in the section of the tether between the anchors in the pair by locking a corresponding stop among the plurality of stops to the tether.

[0249] Example 67. The method according to any one of Examples 48 to 66, wherein the method includes delivering the implant transvascularly to the heart.

[0250] Example 68. The method according to Example 67, wherein delivering the implant transvascularly to the heart includes delivering the implant transfemorally to the heart.

[0251] Example 69. The method according to any one of Examples 48 to 68, wherein applying the energy to the shape memory tape includes applying the energy to the shape memory tape such that the shape memory tape transitions towards a contracted shape.

[0252] Example 70. The method according to Example 69, wherein the method further includes, after locking the stop to the tether, ceasing to apply the energy to the shape memory tape such that the shape memory tape returns towards a relaxed state.

[0253] Example 71. The method according to any one of Examples 48 to 70, wherein the method is performed on a simulator.

[0254] Example 72. The method according to any one of Examples 48 to 70, wherein the method further includes sterilizing the implant before anchoring the implant to the tissue of the heart.

[0255] Example 73. A method that can be used at and / or for use at a real or simulated heart, the method including: (A) implanting an implant at the heart by fixing a plurality of anchors of the implant to real or simulated tissue of the heart, the anchors being connected together via (i) a shape memory tape and (ii) a tether, (B) causing the implant to transition towards a contracted state by applying electrical energy to the shape memory tape such that the anchors move closer together, and / or (C) locking the implant in the contracted state by applying a stop to the tether.

[0256] Example 74. The method according to Example 73, wherein the method is performed on a simulator.

[0257] Example 75. The method according to Example 73, wherein the method further comprises sterilizing the implant before anchoring the implant to the tissue of the heart.

[0258] Example 76. A method that can be used at and / or for use at a real or simulated heart, the method comprising: (A) anchoring a first anchor and a second anchor, and a portion of a tether extending between the first anchor and the second anchor, the portion having a certain length, to the tissue of the heart, (B) subsequently promoting a reduction in the length of the portion of the tether by applying electrical energy to a shape memory band extending beside the tether between the first anchor and the second anchor, and / or (C) subsequently fixing the reduced length by locking a stopper to the tether.

[0259] Example 77. The method according to Example 76, wherein the method is performed on a simulator.

[0260] Example 78. The method according to Example 76, wherein the method further comprises sterilizing the first anchor and the second anchor before anchoring.

[0261] Example 79. A device comprising an implant, the device comprising: (A) a plurality of shape memory bands configured such that applying energy to a shape memory band causes a corresponding portion of the implant to contract, and / or (B) a hub comprising: (i) hub terminals through which the energy is applied, and / or (ii) a switch operable to select the shape memory band to which the energy is directed.

[0262] Example 80. The device according to Example 79, wherein the device further comprises a delivery assembly configured to deliver the implant into a subject, and the delivery assembly comprises a shaft adapted to: (A) engage the hub terminals in a manner that places the delivery assembly in electrical connection with the hub, and / or (B) operate the switch to select the shape memory band.

[0263] Example 81. The device according to Example 80, wherein the shaft is flexible and adapted to be advanced trans-luminally into the tissue of the subject.

[0264] Example 82. The device according to Example 80, wherein: (A) the plurality of shape memory bands are grouped into subsets of shape memory bands, (B) for each subset of shape memory bands, the implant comprises corresponding terminals electrically connected to the respective subset, (C) each terminal is electrically connected to the switch via a corresponding wire, and / or (D) operating the switch to select a subset will electrically connect the shaft to the corresponding terminals of the subset.

[0265] Example 83. The apparatus according to Example 82, further comprising an external generator electrically connected to the shaft and adapted to apply the energy to a subset of the shape memory bands via an electrical connection between the shaft and corresponding terminals of the subset.

[0266] Example 84. The apparatus according to Example 82, wherein each wire is electrically isolated from the other wires.

[0267] Example 85. The apparatus according to any one of Examples 79 to 84, wherein the switch is a rotary switch.

[0268] Example 86. The apparatus according to Example 85, wherein the rotary switch has at least four switching positions.

[0269] Any of the systems, components, devices, parts, apparatuses, etc. in the present disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure its safe use for patients, and the methods herein can include (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) sterilizing the relevant systems, devices, parts, apparatuses, etc. (or alternatively the method includes or consists of the sterilization).

[0270] Additionally, the techniques, methods, operations, steps, etc. described or suggested herein or in the references incorporated herein and any methods of using the systems, components, devices, apparatuses, etc. herein can be performed on a living subject (e.g., a human, other animal, etc.) or on an analog (e.g., a cadaver, cadaver heart, phantom, virtual human, etc.). When performed on an analog, body parts (e.g., heart, tissue, valve, etc.) can be assumed to be simulated or can optionally be referred to as "simulated" (e.g., simulated heart, simulated tissue, simulated valve, etc.), and can optionally include computerized and / or physical representations of body parts, tissues, etc. The term "simulated" encompasses use on a cadaver, computer phantom, virtual human (e.g., if just an in-air demonstration is performed on a virtual heart), etc.

[0271] The invention is not limited to the examples specifically shown and described above. Instead, the scope of the invention includes both combinations and sub - combinations of the various features described above, as well as its variations and modifications not in the prior art, which will occur to those skilled in the art after reading the foregoing description.

Claims

1. A system for use at the heart, the system comprising: an implant, the implant comprising: a first anchor and a second anchor; a tether extending between the first anchor and the second anchor; and a shape memory band extending between the first anchor and the second anchor alongside the tether; and a delivery assembly adapted to cause the implant to contract at the heart by: applying energy to the shape memory band such that the shape memory band pulls the first anchor and the second anchor closer together, and fixing the tension in the implant by locking a stop to the tether.

2. The system according to claim 1, wherein the implant is an annuloplasty implant.

3. The system according to any one of claims 1 to 2, wherein each of the first anchor and the second anchor comprises a helical tissue engaging element.

4. The system according to any one of claims 1 to 3, wherein the delivery assembly comprises an anchor driver adapted to drive the first anchor into the tissue of the heart.

5. The system according to any one of claims 1 to 4, wherein the shape memory band is a nitinol band.

6. The system according to any one of claims 1 to 5, wherein the shape memory band is fixed to both the first anchor and the second anchor.

7. The system according to any one of claims 1 to 6, wherein the first anchor can be driven into the tissue of the heart while the second anchor is positioned within the delivery assembly at the heart.

8. The system according to any one of claims 1 to 7, wherein the implant is a first implant, the system further comprises a second implant, and the delivery assembly is configured to arrange the first implant and the second implant around the annulus of the heart.

9. The system according to any one of claims 1 to 8, wherein: the first anchor and the second anchor are anchors among a plurality of anchors of the implant, and both the tether and the shape memory band extend between the plurality of anchors.

10. The system according to any one of claims 1 to 9, wherein the stop is a bead that can slide over and along the tether.

11. The system according to claim 10, wherein the delivery assembly comprises a locking tool configured to advance the stop over and along the tether.

12. The system according to any one of claims 1 to 11, wherein the shape memory band is thermally formed to assume a contracted shape when the energy is applied.

13. The system according to claim 12, wherein the contracted shape is a zigzag shape.

14. The system according to claim 12, wherein the contracted shape is a serpentine shape.

15. The system according to claim 12, wherein the contracted shape is a helical shape.

16. The system according to claim 12, wherein the shape memory band is adapted to return towards a relaxed state in response to cessation of application of the energy to the shape memory band.

17. The system according to any one of claims 1 to 16, wherein: the first anchor and the second anchor are a first pair of anchors, and the implant comprises multiple pairs of anchors, the shape memory band is a first shape memory band, the implant comprises multiple shape memory bands, each of the shape memory bands connecting the anchors in a corresponding pair, and the tether extends between all of the anchors in the multiple pairs.

18. The system according to claim 17, wherein the implant defines a bandless gap in which no shape memory band connects the first pair of anchors to a second pair of anchors, the second pair being adjacent the first pair within the implant.

19. The system according to claim 17, wherein: the stop is a first stop of a plurality of stops, and for each pair of anchors, the delivery assembly is adapted to iteratively fix the tension in the implant by: applying the energy to the shape memory band connecting the anchors in the pair, and fixing the tension in the section of the tether between the anchors in the pair by locking a corresponding one of the plurality of stops to the tether.

20. The system according to claim 17, wherein the delivery assembly is configured to apply the energy wirelessly to each of the shape memory bands.

21. The system according to any one of claims 1 to 20, wherein the shape memory band is thermally set to transition towards a contracted shape at a temperature greater than 37.5 degrees Celsius.

22. The system according to claim 21, wherein the shape memory band is thermally set to transition towards the contracted shape at a temperature greater than 45 degrees Celsius.

23. The system according to claim 22, wherein the shape memory band is thermally set to transition towards the contracted shape at a temperature greater than 50 degrees Celsius.

24. The system according to claim 22, wherein the shape memory band is thermally set to transition towards the contracted shape at a temperature less than 60 degrees Celsius.

25. The system according to any one of claims 1 to 24, wherein: for each of the first anchor and the second anchor, the anchor comprises an anchor head and a collar, the collar surrounding the anchor head and being rotatable about the anchor head, and the shape memory band is attached to the collar of the first anchor and the collar of the second anchor.

26. The system according to claim 25, wherein each collar defines an eyelet, and wherein the tether extends through the eyelet of the first anchor and the eyelet of the second anchor.

27. The system according to claim 26, wherein the tether is slidable through the eyelet of the second anchor.

28. The system according to claim 25, wherein the first anchor comprises a terminal on the collar of the first anchor, the terminal being electrically connectable to the delivery assembly and configured to conduct the energy from the delivery assembly to the shape memory band.

29. The system according to any one of claims 1 to 28, wherein the delivery assembly comprises a catheter configured to deliver the implant transvascularly to the heart.

30. The system according to claim 29, wherein the catheter is configured to deliver the implant transfemorally to the heart.

31. The system according to any one of claims 1 to 30, wherein the first anchor comprises a terminal electrically connected to the shape memory band, and the delivery assembly is configured to apply the energy to the shape memory band via the terminal.

32. The system according to claim 31, wherein: the first anchor comprises a tissue engaging element configured to anchor the first anchor to the tissue by being driven into the tissue of the heart, and the terminal is electrically isolated from the tissue engaging element.

33. The system according to claim 31, wherein: the system further comprises an extracorporeal generator and a conductor adapted to electrically connect the terminal to the generator, and the generator is adapted to apply the energy to the shape memory band via an electrical connection between the conductor and the terminal.

34. The system according to claim 33, wherein the conductor is adapted to extend from the terminal through the delivery assembly and out of the subject, where the conductor is connected to the generator.

35. The system according to any one of claims 1 to 34, wherein: the delivery assembly further comprises a wireless transmitter adapted to wirelessly transmit the energy, and the implant comprises a receiver adapted to receive the wireless energy and transfer at least a portion of the energy to the shape memory band.

36. The system according to claim 35, wherein the wireless transmitter is adapted to transmit the energy electromagnetically.

37. The system according to any one of claims 1 to 36, wherein: the first anchor and the second anchor are a first pair of anchors, the implant comprises multiple pairs of anchors, the shape memory band is a first shape memory band, the implant comprises multiple shape memory bands, each of the shape memory bands connecting the anchors in a corresponding pair, and the implant further comprises a hub, the delivery assembly being engageable with the hub, and the hub comprising a switch operable by the delivery assembly to select a subset of the shape memory bands to which the energy is to be applied.

38. The system according to claim 37, wherein the subset of shape memory bands comprises only a single shape memory band.

39. The system according to claim 37, wherein the subset of shape memory bands comprises multiple shape memory bands.

40. The system according to claim 37, wherein the hub comprises hub terminals, and the delivery assembly is adapted to engage the hub terminals in a manner that places the delivery assembly in electrical connection with the hub.

41. The system according to claim 37, wherein the delivery assembly is adapted to operate the switch by rotating the switch.

42. The system according to claim 37, wherein the switch is a rotary switch.

43. The system according to claim 42, wherein the rotary switch has at least four switching positions.

44. The system according to claim 37, wherein: for each subset of shape memory bands, the implant comprises corresponding terminals electrically connected to the respective subset, each terminal is electrically connected to the switch via a corresponding wire, and operating the switch to select the subset electrically connects the delivery assembly to the corresponding terminals of the subset.

45. The system according to claim 44, further comprising an external generator adapted to apply the energy to the subset of shape memory bands via an electrical connection between the generator and the corresponding terminals of the subset.

46. The system according to claim 44, wherein each wire is electrically isolated from the other wires.

47. The system according to claim 44, wherein the delivery assembly is adapted to iteratively contract each subset by sequentially delivering energy pulses to each subset.

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