Transcutaneous device fasteners

Abstract

The guide assembly (100) is transluminally advanceable to the subject's heart. The guide assembly includes (i) a guide frame (110) deployable within the heart, (ii) one or more fasteners (40) secured to the guide frame, each fastener defining a closed loop (28), and (iii) a guide rail (102) threaded through the fasteners such that deployment of the guide frame to a site positions the guide rail along tissue (10). The tools (50, 56) are configured to fasten an implant (160) along tissue while guided by the guide rails, and secure the implant to the tissue such that the implant is coupled to the guide frame by being disposed through the loops of the fasteners. The fasteners are unlockable within the heart, allowing the guide frame to be decoupled from the implant. Other implementations are also described.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 140,226, filed on January 21, 2021, entitled "Fasteners for Percutaneous Devices" by Herman et al., the content of which is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0002] Some percutaneous techniques, including transcatheter techniques such as transcatheter cardiac interventions, require components to be separated from each other while they are within the body of the treated subject. For example, a tool for delivering and / or manipulating an implant may advantageously be securely coupled to the implant until a certain time and then securely separated from the implant until the tool is removed from the subject. In some instances, the components exert significant forces on their couplings before and during separation. In some instances, it is advantageous for the separation mechanism itself not to cause movement of the components that are being separated from each other.

Summary of the Invention

[0003] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, no feature included in an example of this summary is required by the claims unless the claims expressly list those features. Also, the features, components, steps, concepts, etc. described in the examples in this summary and elsewhere in this disclosure can be combined in various ways. The various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

Means for Solving the Problems

[0004] Several application examples describe clamps used in percutaneous devices, including implants and delivery devices, or systems for such implants. The clamps may comprise longitudinal members, the curved portion of which can be formed into a loop that resists expansion and / or release until intentionally released, after which it becomes easily expandable and / or releaseable.

[0005] The longitudinal member may include braided and / or torsion material such as a cord. A channel may extend laterally through the longitudinal member at a channel portion located between the two ends of the longitudinal member. In some applications where the longitudinal member comprises braided material, the longitudinal member may be passed between strands of the braid, i.e., the channel is defined between strands of the braid. A loop is formed by passing the first end of the longitudinal member through the channel, thereby causing the curved portion to extend in a loop away from the first end and channel toward the second end and channel portion of the longitudinal member.

[0006] To prevent the loop from expanding and / or opening (i.e., to lock the fastener), the rod may extend laterally through the first end of the longitudinal member.

[0007] In some applications, the first end extends out of the channel (i.e., through and beyond the channel) away from the channel portion and the curved portion of the loop. In some of these applications, the rod extends laterally through the portion of the first end that extends out of the channel, thereby preventing the loop from expanding by lying across the opening of the channel. In some applications, the first end also returns through the channel, and the rod extends through two portions of the first end.

[0008] In some applications, the first end loops around the second end rather than passing through a channel in the second end. In some of these applications, the rod extends, for example, through two portions of the first end on either side of the loop.

[0009] In some applications, the rod can extend laterally through a portion of the first end that is positioned within the channel, thereby preventing loop expansion by securing the portion of the first end to the channel wall. The fastener can be released by removing the rod from the first end of the longitudinal member.

[0010] In some applications, a clamp is used to restrain the implant in a crimped state by positioning the clamp's loop around the implant. The implant can be biased to an expanded state, thereby allowing the implant to self-expand without the clamp restraining it. In some applications, the implant is delivered to the patient's heart in its crimped state (e.g., within a catheter) while restrained by the clamp, and once the implant is positioned within the heart, it can self-expand by withdrawing the rod from the longitudinal member, thereby expanding or completely releasing the loop.

[0011] In some applications, the guide assembly can be advanced transcatheterally into the patient's heart. The guide assembly includes (i) a guide frame deployable within the heart, (ii) one or more clamps fixed to the guide frame, each defining a closed loop, and (iii) a guide rail. The guide rail may be fixed by the clamps (e.g., through) so that the deployment of the guide frame at the site positions the guide rail along the tissue. The tool is configured to position and fix the implant along the tissue while being guided by the guide rail. This fixation may be coupled to the guide frame by the implant being routed through the loops of the clamps. The clamps are unlockable within the heart, thereby allowing the guide frame to be detached from the implant.

[0012] Therefore, according to some applications, a system and / or apparatus is provided which includes a fastener for use in the heart of a patient, the fastener comprising a rod and a longitudinal member.

[0013] The longitudinal member may have (i) a first end including the first end of the longitudinal member, (ii) a second end, (iii) a curved portion, and (iv) a channel portion disposed between the second end and the curved portion, defining a channel that penetrates the longitudinal member and extends laterally.

[0014] The longitudinal member can be arranged such that the curved portion extends in a loop toward the first end, away from the second end and the channel portion, and the first end extends from the curved portion and through the channel, thereby closing the loop.

[0015] The rod can extend laterally through the first end, thereby preventing the first end from sliding through the channel.

[0016] In some applications, the longitudinal member is the first longitudinal member of a set of longitudinal members of the fastener.

[0017] In some applications, the set further includes a second longitudinal member defining a first end including a first end of the second longitudinal member, a second end, a curved portion, and a channel portion disposed between the second end of the second longitudinal member and the curved portion of the second longitudinal member.

[0018] In some applications, the channel portion defines a channel that extends laterally through a second longitudinal member.

[0019] In some applications, the second longitudinal member is positioned such that the curved portion of the second longitudinal member extends in a loop toward the first end of the second longitudinal member, away from the second end and the channel portion of the second longitudinal member, and the first end of the second longitudinal member extends from the curved portion of the second longitudinal member and through the channel of the second longitudinal member, thereby closing the loop of the second longitudinal member.

[0020] In some applications, the rod extends further laterally through the first end of the second longitudinal member of the assembly, thereby preventing the first end of the second longitudinal member from sliding through the channel of the second longitudinal member.

[0021] In some applications, the system and / or apparatus further includes an implant in a crimped state and is also biased into an expanded state, and the longitudinal member is positioned around the implant such that the loop is tightly fitted around the implant, thereby constraining the implant to the longitudinal member in a crimped state by preventing the first end of the rod from sliding through the channel.

[0022] In some applications, the first end extends from the channel in a direction away from the curved portion, the longitudinal member defines a first opening of the channel, a first opening facing the curved portion, and a second opening of the channel, the second opening faces the first end, and the rod extends laterally through the first end between the second opening and the first end, whereby the expansion of the loop is restricted by the rod abutting the second opening at the channel portion.

[0023] In some applications, the rod extends laterally through the channel portion and the first end of the channel.

[0024] In some applications, the fastener is configured such that the loop can be released by removing the rod from the first end and sliding the first end within the channel.

[0025] In some applications, the rod is rigid.

[0026] In some applications, the rod is flexible.

[0027] In some applications, the longitudinal member is longitudinally elastic.

[0028] In some applications, the longitudinal member includes a cord.

[0029] In some applications, the longitudinal member includes a polymer.

[0030] In some applications, the longitudinal member includes a suture.

[0031] In some applications, the loop defines a loop plane, and the rod extends laterally through the first end in an orientation substantially orthogonal to the loop plane.

[0032] In some applications, the loop defines a loop plane, and the rod extends laterally through the first end in an orientation substantially parallel to the loop plane.

[0033] In some application examples, the rod length is longer than 1 meter.

[0034] In some application examples, the rod length is less than 2 cm.

[0035] In some application examples, the rod length is less than 1 cm.

[0036] In some application examples, the rod length is less than 0.5 cm.

[0037] In some applications, the system and / or apparatus further includes a catheter that defines a lumen that can be advanced transcatheterally toward the patient's heart, and a longitudinal member is deliverable from the distal end of the catheter.

[0038] In some applications, the rod is coupled to a tether, which is more flexible than the rod, and the clamp is deliverable from the catheter, while at least a portion of the tether extends proximal from the rod through the catheter.

[0039] In some applications, the clamp can be advanced transcatheterally toward the patient's heart so that the catheter bends, causing at least a portion of the tether to bend.

[0040] In some applications, the clamp can be advanced transtubally toward the patient's heart while at least a portion of the rod is positioned within the lumen of the catheter.

[0041] In some applications, the rod is flexible, and the clamp can be advanced transtubally toward the patient's heart so that the catheter bends, causing at least a portion of the rod to bend.

[0042] In some applications, the system and / or apparatus further includes deployable members, which are connected to loops.

[0043] In some applications, at least a portion of the deployable member extends through the loop and is dimensioned relative to the loop to prevent the deployable member from sliding against the loop.

[0044] In some applications, the loop is tightly attached around at least a portion of the deployable member.

[0045] In some applications, the deployable member defines multiple supports, and at least one of the supports extends through a loop.

[0046] In some applications, the deployable component is an implant.

[0047] In some applications, the deployable component is a fluorescent marker.

[0048] In some applications, the deployable component is a stent.

[0049] In some applications, the deployable component is an artificial heart valve.

[0050] In some applications, expandable members are self-extending.

[0051] In some applications, the deployable components are balloon-expandable.

[0052] In some applications, the fastener is configured such that the deployable member can be detached from the loop by removing the rod from the first end and sliding the first end within the channel.

[0053] In some applications, the system and / or apparatus further include elongated members, and fasteners connect the elongated members to deployable members.

[0054] In some applications, the elongated members are fixed to the curved portion of the longitudinal members.

[0055] In some applications, the elongated member is configured to extend transcatheterally from outside the patient to the patient's heart, so that the deployable member can be positioned inside the patient's heart by manipulating the proximal end of the elongated member.

[0056] In some applications, the system and / or apparatus further includes a stopper coupled to a long member, the stopper being wider than the long member to prevent the long member from sliding against the loop.

[0057] According to some applications, a method for use with an implant is further provided, which includes crimping the implant and positioning the longitudinal member to form a loop around the implant such that, while the implant is crimped, the first end of the longitudinal member extends through a channel that penetrates the longitudinal member and extends laterally in the channel portion of the longitudinal member.

[0058] In some applications, the method involves constraining the implant in a crimped state by preventing loop expansion by puncturing the rod through the first end, thereby preventing the rod from sliding through the channel at the first end.

[0059] In some applications, puncturing the rod through the first end involves puncturing the rod laterally through the first end, thereby preventing the loop from expanding as the rod laterally abuts the channel portion against the longitudinal member.

[0060] In some applications, the longitudinal member is the first longitudinal member of a set of longitudinal members, and this method is

[0061] The second longitudinal member of that assembly is arranged in a loop around the implant,

[0062] This includes piercing the rod through the first end of the second longitudinal member, thereby preventing the rod from expanding the loop of the second longitudinal member.

[0063] In some applications, arranging a longitudinal member to form a loop around an implant involves arranging the longitudinal member to form a loop and then passing the loop over the implant.

[0064] In some applications, positioning a longitudinal member to form a loop around the implant includes forming a loop around the implant by inserting the first end into the channel site and pulling the first end away from the channel site before puncturing the rod through the first end.

[0065] In some applications, the longitudinal member is elastic in the longitudinal direction, and arranging the longitudinal member to form a loop involves elastically stretching the longitudinal member by pulling the first end away from the channel portion, and puncturing the rod through the first end involves puncturing the rod through the first end while the longitudinal member is in an elastically stretched state.

[0066] In some applications, the method further includes releasing the first end so that the elastic contraction of the longitudinal member pulls the rod toward the channel portion.

[0067] In some applications, a portion of the first end of a longitudinal member extends out of the channel away from the channel portion, and a rod extends laterally through a portion of the first end, thereby preventing loop expansion by a rod in contact with the channel portion.

[0068] In some applications, the rod extends laterally through the channel portion and the first end of the channel.

[0069] In some applications, the method further includes advancing the catheter transcatheterally toward the patient's heart and delivering the implant from the distal end of the catheter while the implant is restrained in a crimped state by a longitudinal member.

[0070] In some applications, the method further includes facilitating the expansion of the implant by making it easier to enlarge the loop by removing the rod from the longitudinal member.

[0071] In some applications, the implant is biased into an expanded state, and facilitating the expansion of the implant includes facilitating the expansion of the loop so that the implant self-expands.

[0072] In some applications, making a loop easier to expand includes making it easier to release the loop.

[0073] In some applications, the rod is flexible, and delivering the implant from the distal end of the catheter includes delivering the implant from the distal end of the catheter such that the rod extends from the longitudinal member through the catheter proximal away from the patient, and withdrawing the rod from the longitudinal member includes withdrawing the rod from the longitudinal member by pulling the rod proximal away from outside the patient.

[0074] In some applications, the rod is coupled to a tether that is more flexible than the rod, and delivering the implant from the distal end of the catheter includes delivering the implant from the distal end of the catheter such that the tether extends proximal through the catheter and away from the patient, and withdrawing the rod from the longitudinal member includes withdrawing the rod from the longitudinal member by pulling the tether proximal from outside the patient.

[0075] In some applications, delivering the implant from the distal end of the catheter further includes delivering the entire rod from the catheter, thereby allowing the tether to extend within the distal end of the catheter and extending away from the patient.

[0076] The above methods and steps can be carried out in living animals or in simulations, for example, in cadavers, cadaveric hearts, simulators (e.g., a simulated body part, heart tissue), etc.

[0077] According to some applications, a system and / or apparatus for use in the cardiac tissue of a patient is further provided, comprising a guide assembly, implants, and tools.

[0078] The guide assembly may include a guide frame that is transcatheterally advancing toward the heart and deployable at a site within the heart; one or more clamps fixed to the guide frame, each clamp defining a closed loop and being locked to maintain the loop; and a guide rail, which is threaded through the clamps to position the guide rail along the tissue by deploying the guide frame at the site.

[0079] The tool can be configured to position the implant along the tissue while being guided by a guide rail, and to secure the implant to the tissue so that it is coupled to the guide frame by being positioned through the loops of a clamp.

[0080] One or more fasteners can be released within the heart, allowing the guide frame to be detached from the implant.

[0081] In some applications, the guide frame is configured to unfold within the atrioventricular valves of the heart.

[0082] In some applications, the guide rail is held in an arc around at least a portion of the guide frame by fasteners.

[0083] In some applications, the guide rails are radiopaque.

[0084] In some applications, the system and / or apparatus further includes rods, and one or more of the fasteners include a longitudinal member that defines a loop by an end of the longitudinal member extending through a channel extending laterally through the longitudinal member, and is locked by a rod extending laterally through the end, preventing the end from sliding through the channel.

[0085] In some applications, each of one or more fasteners can be released by sliding the rod from its end.

[0086] In some applications, the implant includes a helical member, which can be implanted along the tissue by rotation of the helical member.

[0087] In some application examples, the axial length of the helical member is 5 to 12 cm.

[0088] In some applications, the helical member has a sharp tip.

[0089] In some applications, the helical member defines a central channel, and the implant can be implanted along the tissue while the guide rail extends along the central channel.

[0090] In some applications, the guide rail is configured to slide axially through the central channel proximal to it while the implant is maintained in a state where it is implanted along the tissue with the guide rail extending along the central channel.

[0091] In some applications, the system and / or apparatus further includes a retractable member extending coaxially through a channel defined by a guide rail, the guide rail being axially slidable in the proximal direction along the retractable member, (i) passing proximal through the central channel and (ii) leaving the retractable member within the central channel.

[0092] In some applications, the system and / or apparatus further includes a stopper coupled to the distal end of the shrinking member, thereby causing the tension acting on the shrinking member to shrink the helical member longitudinally by the stopper preventing the shrinking member from sliding through the central channel.

[0093] In some applications, the stopper is a first stopper, and the system and / or apparatus further includes a second stopper configured to lock the tension of the contraction member by being coupled proximal to the contraction member from the helical member.

[0094] In some applications, the helical member defines a series of bends, and the implant can be transplanted along the tissue by screwing the helical member along the surface of the tissue such that a portion of each bend is embedded in the tissue and another portion of each bend is positioned outside the tissue.

[0095] In some applications, the guide rail is configured to limit the depth to which the helical member penetrates the tissue.

[0096] In some applications, the central channel has a diameter, and the guide rail has a thickness of at least 25 percent of the diameter of the central channel.

[0097] In some applications, the thickness of the guide rail is at least 40 percent of the diameter of the central channel.

[0098] In some applications, the thickness of the guide rail is at least 50 percent of the diameter of the central channel.

[0099] In some applications, the thickness of the guide rail is at least 70 percent of the diameter of the central channel.

[0100] In some applications, the system and / or apparatus further includes a stopper coupled to the distal end of the guide rail, thereby causing the longitudinal tension on the guide rail to contract the helical member by the stopper, which prevents the guide rail from sliding proximal to the central channel.

[0101] In some applications, the stopper is a first stopper, and the system and / or apparatus further includes a second stopper configured to lock tension within the guide rail by being coupled proximal to the guide rail from the helical member.

[0102] In some applications, the tissue is the tissue of the cardiac valve ring, and the implant is configured such that, after the implant is placed along the tissue, the contraction of the helical member causes the valve ring tissue to contract.

[0103] In some applications, the helical member has sufficient flexibility to follow the guide rail along the tissue.

[0104] In some application examples, the helical members have a constant pitch.

[0105] According to several application examples, a method is provided for use in the heart of a patient, comprising deploying a guide assembly to a location within the heart. The guide assembly includes a guide frame and fasteners. Each fastener is secured to the guide frame and defines a closed loop.

[0106] In some applications, the guide rail is threaded through a loop to position the guide rail along the cardiac tissue in order to deploy the guide assembly to the site.

[0107] In some applications, the method involves implanting an implant along tissue while being guided by a guide rail, thereby securing the implant to the tissue and aligning it through a loop of a clamp.

[0108] In some applications, the method subsequently includes releasing the loop within the heart and removing the guide frame and clamp from the heart while the implant remains implanted along the tissue.

[0109] In some applications, the site is the atrioventricular valve of the heart, the cardiac tissue is the tissue of the valve ring of the atrioventricular valve, and deploying the guide assembly at the site involves deploying the guide frame within the atrioventricular valve, thereby aligning the guide rail along the valve ring of the heart.

[0110] In some applications, the method further includes removing the guide rail from the patient by sliding it away from the implant after the implant has been placed along the tissue.

[0111] In some applications, at least a portion of the guide assembly is radiopaque, and tissue contraction involves contracting the tissue while being guided by at least one fluoroscopic image including a portion of the guide assembly.

[0112] In some applications, each of the fasteners includes a longitudinal member, and the guide assembly further includes at least one rod, and deploying the guide assembly includes deploying the guide assembly while each of the longitudinal members is positioned such that a loop is defined by the end of the longitudinal member extending through a channel extending laterally through the longitudinal member, and the end is locked by the rod extending laterally through the end, and preventing the end from sliding through the channel.

[0113] In some applications, the method further includes releasing the fastener by removing the rod from the end after (i) the implant has been secured to the tissue and positioned through the fastener's loop, and (ii) before the loop is released.

[0114] In some applications, releasing the loop includes releasing the loop while the fastener remains fixed to the guide frame, and removing the guide frame and fastener from the heart includes removing the fastener from the heart by removing the guide frame while the fastener remains fixed to the guide frame.

[0115] In some applications, the implant includes a helical member, and implanting the implant along the tissue involves screwing the helical member into the tissue via the rotation of the helical member.

[0116] In some applications, removing the guide frame and fasteners from the heart involves removing the guide frame and fasteners from the heart while at least a portion of the guide rail remains connected to the helical member inside the heart.

[0117] In some applications, screwing a helical member into a tissue by rotating the helical member involves applying torque to the proximal end of the helical member.

[0118] In some applications, screwing a helical member into tissue involves screwing the helical member into the tissue such that the thread axis of the helical member is aligned with the surface of the tissue.

[0119] In some applications, screwing a helical member into tissue includes screwing the helical member into tissue such that the helical member is at least partially embedded within the tissue.

[0120] In some applications, the helical member defines multiple bends, and screwing the helical member into the tissue involves screwing the helical member into the tissue such that a portion of each bend is embedded in the tissue and another portion of each bend is positioned above the tissue.

[0121] In some applications, the helical member defines a central channel, and implanting the implant along the tissue involves implanting the helical member along the tissue with the helical member passed on a guide rail and the guide rail extending through at least a portion of the central channel.

[0122] In some applications, transplanting a helical member along tissue involves using guide rails to transplant the helical member along tissue while limiting the depth to which the helical member penetrates the tissue.

[0123] In some applications, the method includes removing the guide frame and fasteners from the heart, advancing a tension tool toward the heart, using the tension tool to contract the tissue by applying tension to at least a portion of the guide rail, and removing the tension tool from the heart, thereby maintaining at least a portion of the guide rail and helical member implanted along the tissue.

[0124] In some applications, the method further includes locking the tension of at least a portion of the guide rail by locking the stopper to the guide rail.

[0125] The above methods and steps can be carried out in living animals or in simulations, for example, in cadavers, cadaveric hearts, simulators (e.g., a simulated body part, heart tissue), etc.

[0126] According to some applications, a method for use in the heart of a patient is provided, comprising advancing a catheter transcatheterally toward the heart, wherein the catheter is coupled to a clamp and carries a guide rail, and the method includes delivering the guide rail from the catheter into the heart, thereby causing the guide rail to pass through a loop of the clamp and extend along the tissue of the heart. The method also includes deploying an implant along the tissue from the catheter, guided by sliding the loop along the guide rail.

[0127] In some applications, this method subsequently involves detaching the catheter from the guide rail by releasing the loop within the heart.

[0128] In some application examples, cardiac tissue is the tissue of the valve ring of the cardiac atrioventricular valve, and the delivery of the guide rail involves delivering the guide rail into the heart from a catheter, thereby passing the guide rail through the loop of the clamp and extending along the valve ring tissue.

[0129] In some applications, the method further includes detaching the catheter from the guide rail, then intratubally advancing the tension tool toward the implant, then applying tension to at least a portion of the implant using the tension tool, and then removing the tension tool from the patient.

[0130] In some applications, the guide rails include radiopaque material, and the tensioning is applied using a tensioning tool, with assistance from at least one fluoroscopic image including the guide rails.

[0131] In some applications, the guide rail comprises a radiopaque material, and the deployment of the implant along the tissue includes deploying the implant along the tissue while being further guided by at least one fluoroscopic image including the guide rail.

[0132] In some applications, this method further includes removing the catheter from the patient before advancing the tension tool.

[0133] In some applications, advancing the catheter toward the heart includes advancing the catheter toward the heart within its sheath, withdrawing the catheter from the heart includes withdrawing the catheter from the patient through its sheath, and advancing the tension tool includes advancing the tension tool toward the heart through its sheath.

[0134] In some applications, the implant includes a shrinkable member, and applying tension to at least a portion of the implant includes applying tension to the shrinkable member.

[0135] In some applications, the implant further includes a first tissue anchor and a second tissue anchor, and applying tension to the shrinkage member includes applying tension to the shrinkage member such that the distance between the first tissue anchor and the second tissue anchor decreases.

[0136] In some applications, at least a second tissue anchor is slidably coupled to a shrinkage member, and applying tension to the shrinkage member includes sliding the shrinkage member relative to at least the second tissue anchor.

[0137] In some applications, deploying the implant involves deploying the implant so that the first and second tissue anchors pass through the shrinkage member.

[0138] In some applications, the guide rail is defined by a guide frame, and the delivery of the guide rail involves deploying the guide frame within the heart so that the guide rail complements the shape of the tissue.

[0139] In some applications, the guide frame includes one or more struts projecting away from the plane defined by the guide frame, and deploying the guide frame into the heart includes delivering the guide frame into the heart such that each of the one or more struts projects away from the guide frame and extends through the respective commissures of the atrioventricular valves of the heart.

[0140] The above methods and steps can be carried out in living animals or in simulations, for example, in cadavers, cadaveric hearts, simulators (e.g., a simulated body part, heart tissue), etc.

[0141] According to some applications, a system and / or apparatus for use in the tissue of a patient is further provided, comprising a guide rail, an implant, and a transplant assembly. The transplant assembly may include a clamp defining a loop at its distal end, and the transplant assembly is configured to transtube the guide rail along the tissue of the patient with the loop passing through the guide rail.

[0142] In some applications, the implantation assembly is also configured to be guided along the guide rail by passing a loop through the guide rail, allowing the implant to be implanted transcatheterally along the tissue, and then detached from the guide rail within the body by releasing the loop, thereby enabling the implantation assembly to be removed from the patient independently of the guide rail.

[0143] In some applications, the implant assembly can be advanced transcatheterally toward the patient's tissue with the clamp loops passed through guide rails.

[0144] In some applications, the guide rails include radiopaque materials.

[0145] In some applications, the fastener includes a longitudinal member positioned to define a loop by a first end of the longitudinal member extending through a channel that penetrates the longitudinal member and extends laterally in a channel portion of the longitudinal member, and a rod that extends laterally through the first end and prevents the loop from opening by preventing the first end from sliding through the channel.

[0146] In some applications, the rod can be removed from the longitudinal member, and once the rod is removed from the longitudinal member, the loop can be released by sliding the first end within the channel.

[0147] In some applications, the guide rail is compressible for transcatheter delivery to tissue and expandable within the body for positioning along the tissue.

[0148] In some applications, the guide rail has a predetermined expanded shape that complements the shape of the tissue, is compressible from the predetermined expanded shape to a compressed shape for transcatheter delivery to the tissue, and is expandable within the body from the compressed shape to the predetermined expanded shape.

[0149] In some application examples, the tissue includes the tissue of the congenital heart valve ring.

[0150] In some applications, the guide rail is formed in such a shape that it defines one or more struts, which project away from the plane defined by the base frame, and (1) a base frame having a shape that tracks around the innate heart valve annulus, and (2) one or more struts that provide an indicator of one or more commissures of the innate heart valve.

[0151] In some application examples, the implant includes at least one tissue anchor.

[0152] In some application examples, the implant includes at least two tissue anchors.

[0153] In some applications, the implant further includes a shrinkage member slidably coupled to at least two tissue anchors.

[0154] In some applications, at least two tissue anchors are passed through the shrinkage member.

[0155] In some applications, the system and / or apparatus further include a tension tool adapted to apply tension to a contraction member.

[0156] Furthermore, according to some applications, a method is provided for use in the heart of a patient, comprising advancing a clamp-connected implant transcatheterally toward the heart, wherein the clamp comprises a longitudinal member arranged in a loop such that a first end of the longitudinal member extends through a channel that penetrates the longitudinal member and extends laterally at a channel portion of the longitudinal member, and a rod that extends laterally through the first end and prevents the first end from sliding through the channel.

[0157] In some applications, the method includes delivering the implant into the heart from a catheter while the implant is coupled to a clamp, and then withdrawing the rod from the first end.

[0158] In some applications, advancing an implant coupled to a clamp transcatheter toward the heart involves advancing at least a portion of the implant extending through the loop of the clamp transcatheter toward the heart.

[0159] In some applications, advancing a clamped implant transcatheter toward the heart includes advancing a clamped implant transcatheter toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the horse toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the heart toward the first end first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the heart toward the heart toward the heart toward the heart toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end toward the first end

[0160] In some applications, removing the rod from the first end involves removing the rod from the first end such that the implant is released from the loop and the fastener remains attached to the elongated member.

[0161] The above methods and steps can be carried out in living animals or in simulations, for example, in cadavers, cadaveric hearts, simulators (e.g., a simulated body part, heart tissue), etc.

[0162] A further understanding of the nature and advantages of the present invention is described below in the description and claims, and in particular in conjunction with the accompanying drawings, which show similar parts having the same reference number. [Brief explanation of the drawing]

[0163] [Figure 1] Figure 1 is a schematic diagram of a fastener and its modifications, illustrating several application examples. [Figure 2] Figure 2 is a schematic diagram of a fastener and its modifications, illustrating several application examples. [Figure 3] Figure 3 is a schematic diagram of a fastener and its modifications, illustrating several application examples. [Figure 4] Figure 4 is a schematic diagram of a fastener and its modifications, illustrating several application examples. [Figure 5] Figure 5 is a schematic diagram of the systems and techniques used in each application example, where fasteners are used as components of a system for positioning implants. [Figure 6]Figure 6 is a schematic diagram of the systems and techniques used in each application example, where fasteners are used as components of a system for positioning implants. [Figure 7] Figure 7 is a schematic diagram of the systems and techniques used in each application example, where fasteners are used as components of a system for positioning implants. [Figure 8] Figures 8A to 8C are schematic diagrams of systems and techniques for arranging fasteners, based on several application examples. [Figure 9] Figures 9A to 9I are schematic diagrams of systems and techniques that use multiple fasteners within a system to guide implant placement, according to their respective application examples. [Figure 10] Figure 10 is a schematic diagram of systems and techniques that use multiple fasteners within a system to guide implant placement, according to various application examples. [Figure 11] Figure 11 is a schematic diagram of the systems and techniques used in each application example, where fasteners are used as components of a system for guiding implant placement. [Figure 12] Figures 12A to 12G are schematic diagrams of the systems and techniques used in each application example, where fasteners are used as components of a system for guiding implant placement. [Figure 13] Figures 13A and 13B are schematic diagrams of fasteners and their modified forms, illustrating several application examples. [Figure 14] Figure 14 is a schematic diagram of a fastener and its modified forms, based on several application examples. [Figure 15] Figure 15 is a schematic diagram of a fastener and its modified forms, illustrating several application examples. [Modes for carrying out the invention]

[0164] Refer to Figures 1-5, 13A-13B, and 14, which are schematic diagrams of embodiments of the fastener 40 (e.g., its modifications 40a, 40b, 40c, and 40d) according to several application examples, as well as the technique for use with them. The fastener 40 includes a longitudinal member 20 positioned in the loop 28. Figure 1 shows the longitudinal member 20 and includes an inset showing that the longitudinal member may include braided material such as cord. However, it should be noted that in some application examples, the longitudinal member may include different materials and / or have different structures. For example, the longitudinal member 20 may include one or more of string, ribbon, polymer, protein, and metal. The longitudinal member 20 may also include sutures.

[0165] The longitudinal member 20 has a first end 20a including a first end 21 of the longitudinal member, a second end 20c including a second end 22 of the longitudinal member, and a curved portion 20b between the first end and the second end. Between the first end 21 and the second end 22, the longitudinal member 20 has a channel portion 26 that defines a channel 24 that extends laterally through the longitudinal member. That is, the channel 24 extends laterally through the body of the longitudinal member 20 at the channel portion 26. In some applications where the longitudinal member 20 includes braided material, the longitudinal member may be passed between strands of the braid, i.e., the channel 24 is defined between strands of the braid.

[0166] The longitudinal member 20 has a thickness of at least 0.1 mm (e.g., at least 0.2 mm, e.g., at least 0.3 mm) and / or 1 mm or less (e.g., 0.5 mm or less, e.g., 0.4 mm or less, e.g., 0.3 mm or less). For example, the longitudinal member 20 may have a thickness of 0.2 to 0.4 mm. In some applications, the longitudinal member 20 may be sutures of USP specification 2-0, 3-0, or 4-0.

[0167] Loop 28 is formed by the first end 20a which is passed through channel 24. In the resulting arrangement of the longitudinal member 20, the curved portion 20b extends away from the first end 20a and channel 24 and returns towards channel portion 26. Figure 4 shows an embodiment in which this can be achieved by looping the curved portion of the yarn 80 around the first end 20a with the two free ends of the yarn positioned on the other side of channel 24 (i.e., so that the two lengths of the yarn extend through the channel), and then pulling the ends of the yarn to pull the first end 20a through the channel.

[0168] To prevent the loop 28 from expanding and / or opening (for example, to keep the longitudinal member within the loop), the rod 30 extends laterally through the first end 20a, thereby preventing the first end from sliding within the channel 24 (i.e., from sliding within the channel in a direction that would expand and / or open the loop). In other words, the presence of the rod 30 through the first end 20a locks the fastener 40. The rod 30 may be long and flexible enough for tube-like use (for example, as described below), but may also be rigid enough not to bend and to not slide within the channel 24. For example, the rod 30 may include a wire (for example, containing a metal such as nitinol or stainless steel, and / or a polymer). However, it should be noted that in some applications, the rod may contain different materials and / or have different structures. In some applications, the end of the rod defines a sharp puncture tip for puncturing the first end 20a. In some of these applications, the puncture tip contains a rigid, non-flexible material.

[0169] The rod 30 may have a thickness greater than 0.01 mm and / or less than 1 mm (e.g., 0.05 to 0.5 mm, e.g., 0.05 to 0.2 mm, e.g., 0.1 mm).

[0170] The rod 30 may have a length greater than 0.1 cm (e.g., 0.1 to 2 cm, e.g., 0.1 to 1 cm, e.g., 0.2 to 0.5 cm, e.g., 0.5 cm) and / or less than 2 m (e.g., 1 to 2 m, e.g., 1.5 m).

[0171] Therefore, it is assumed that the small size of the fastener 40 is advantageous for its use in percutaneous (e.g., transluminal) techniques, such as those described below (but not limited to). Furthermore, the simplification of the fastener 40, including the absence of catches, claws, retainers, or other protruding components and the absence of complex mechanical mechanisms, is advantageous in that it increases the reliability of the fastener, especially when it is subjected to strong forces (e.g., under stress) when it is necessary to release the fastener. For example, it is assumed that the fastener 40 remains reliably disengaged, since the rod 30 is kept in a position where it can reliably slide out of the channel 24, even when the longitudinal member 20 is under considerable tension.

[0172] Figures 1 and 2 illustrate a modified fastener 40a of the fastener 40, in which the rod 30 extends laterally through a portion of the first end 20a extending from the channel portion 24 of the channel, thereby pulling the first end toward the channel portion 26 and the curved portion 20b, the rod is pulled toward the opening of the channel, thereby causing the rod to lie relative to the opening and effectively obstructing the rod, thus preventing the first end from sliding within the channel and expanding the loop 28. In some applications, to minimize the sliding of the first end 20a through the channel 24, the rod 30 extends through the first end close to the channel portion 26.

[0173] Figure 3 shows a modified fastener 40b of the fastener 40, in which the rod 30 extends laterally through a portion of the first end 20a disposed within the channel 24, thereby preventing the loop 28 from expanding by fixing a portion of the first end to the wall of the channel.

[0174] Loop 28 can be considered to lie on the loop plane (e.g., defining the loop plane). In some applications, the rod 30 extends laterally through the first end 20a in an orientation substantially parallel to or coinciding with the loop plane (e.g., as shown in Figures 1 and 2). In some applications, the rod 30 extends laterally through the first end 20a in an orientation substantially perpendicular to the loop plane (e.g., as shown in Figure 3).

[0175] The loop 28 can be released by withdrawing the rod 30 from the first end 20a, thereby allowing the first end to slide within the channel 24, expanding and / or opening the loop. In some applications, the rod 30 is long and flexible, so that it can be delivered transcatheterally (e.g., internally) through the patient's vascular system toward the heart. Thus, the clamp 40 can be released by withdrawing the rod from the longitudinal member by pulling the rod proximally from the outside of the patient.

[0176] Figures 13A-13B and 14 show fasteners 40c and 40d, respectively, which are variations of fastener 40. In contrast to the above example in which the rod 30 extends through the first end 20a in only one portion, Figures 13A-14 show an example in which the rod extends through the first end in both the first portion 33' and the second portion 33'', thereby securing the first end within the secondary loop 29. The secondary loop 29 can be positioned between the first portion and the second portion.

[0177] The first portion 33' is positioned on the first portion 20a' of the first end, and the second portion 33'' is positioned on the second portion 20a'' of the first end 20a. The first portion 20a' extends from the primary loop 28 and channel toward the secondary loop 29. The second portion 20a'' extends backward from the secondary loop 29 toward the channel 24 and the first end 21. In some applications, fasteners 40c and / or 40d can be formed by first forming the secondary loop 29 and then pushing the secondary loop through the channel 24.

[0178] The fasteners 40c and 40d are configured such that when the rod 30 is retracted proximal by a first distance, the rod exits the first portion 33' but not the second portion 33'', thereby allowing the first portion, and not the second portion, to slide through the channel 24. This is assumed to favorably allow for preliminary expansion of the loop 28 without completely releasing the loop (i.e., without completely releasing the fastener). This is shown in the transition between Figure 13A and Figure 13B, showing the loop 28 slightly expanding as the rod is retracted from the first portion, with the first portion 33' sliding through the channel 24. In applications where the fastener 40c is used with implants (e.g., as described below), this is assumed to give the operator an opportunity to withdraw the rod from the first portion 33' and slightly expand (e.g., relax) the loop 28, and then decide whether to complete the implantation. If transplantation is deemed unsuitable, the loop remains closed as the rod 30 continues to extend through the second site 33", allowing the clamp 40c to enable repositioning and / or retrieval of the implant.

[0179] In some applications, the force applied to the first portion 20a by the rod 30 can be mitigated by the secondary loop 29 and / or by the rod extending through the first portion in both portions. For example, a force that can pull the first end toward the channel 24 may be more widely distributed across the first end. Similarly, the presence of the rod 30 in the second portion 33'' can reduce the likelihood of the first end fraying in response to the rod's pressure on the first portion 33', because the rod resists such force pulling the first portion through the channel 24. This, more advantageously, allows for less extra length of the first end 20a needed to prevent this undesirable fraying.

[0180] In the fastener 40c, the second portion 20a'' extends rearward through the channel 24 toward the first end 21.

[0181] In fastener 40d, the second portion 20a'' does not extend rearward through the channel, so that the longitudinal member extends only through the channel by the first portion 20a'. In such embodiments, it is assumed that removing the rod 30 from only the first portion 33' results in an intermediate configuration similar to that shown in fastener 40a, where the rod 30 extends only through the first portion 20a in a single portion.

[0182] Here, we refer to Figure 15, which shows fasteners 40e in several application examples. Fasteners 40e can be considered as modified versions of fasteners 40.

[0183] The fastener 40e includes a longitudinal member 20', which may be identical to the longitudinal member 20 described above, except that it does not have a channel through it and does not have a thread passing through it. Rather, the first portion 20a is formed into a secondary loop 29 by the first portion looping around the second portion 20c. Similar to fasteners 40c and 40d, the secondary loop 29 is fastened by a rod 30 extending through the first portion 20a at the first portion 33' and the second portion 33'', and the secondary loop is between the first portion and the second portion.

[0184] Furthermore, similar to fasteners 40c and 40d, the first portion 33' is positioned on the first portion 20a' of the first end, and the second portion 33'' is positioned on the second portion 20a'' of the first end 20a. The first portion 20a' extends from the primary loop 28 toward the secondary loop 29. The second portion 20a' extends backward from the secondary loop 29 toward the first end 21. Note that the first portion 20a', the second portion 20a'', and the rod 30 collectively define a closed loop around the second portion 20c. That is, the secondary loop 29 and the rod 30 collectively define a closed loop around the second portion 20c.

[0185] In some applications, it is assumed that the arrangement shown as fastener 40e can advantageously eliminate the requirement of a channel defined through the longitudinal member. In some applications, it is further assumed that this arrangement can offer advantages similar to those described for fasteners 40c and 40d, for example, the advantage that the primary loop can be slightly expanded without releasing the fastener by removing the rod from the first portion.

[0186] In some applications, a single rod 30 can be used to engage multiple clamps (for example, to prevent expansion and / or opening of multiple loops 28) by extending through the first end 20a of the loop. Figure 5 illustrates such an application, showing multiple clamps 40 used to restrain an implant 60, such as an artificial heart valve or stent, in a crimped state. In some applications, the implant 60 may be biased to be in an expanded state (i.e., self-expanding), thereby the loops 28 restraining the self-expanding of the implant. The implant is optionally deliverable via catheter 52 while being restrained in its crimped state by the clamps. In some applications, the implant 60 is tightly crimped before being restrained with the clamps 40, and then the loops 28 are positioned around the crimped implant. In some applications, the clamps 40 may be pre-assembled and the loops 28 passed over the crimped implant.

[0187] It should be noted that while the implant 60 can initially expand slightly until it is pressed against the loop 28, the state constrained by the clamp 40 can still be considered its compressed state. Once the implant 60 is positioned within the heart (e.g., delivered from the distal end of the catheter 52), the rod 30 can be withdrawn from the loop 28. Once released from the constraint of the loop, the implant 60 can be biased into an expanded state, thereby allowing the implant to self-expand within the heart. That is, withdrawing the rod 30 from the first end 20a facilitates the expansion and / or release of the loop (e.g., triggers it), thereby allowing the implant to self-expand and thus deploy within the heart. Despite the expansion force applied by the implant 60 on the loop 28, it is assumed that the rod 30 remains slidable out of the channel 24 without excessive pulling of the rod that might, in some cases, inadvertently move the implant 60.

[0188] In some application examples, implant 60 may be expandable with a balloon.

[0189] As described above, the rod 30 may be sufficiently long and flexible for transcatheter use. For example, while the clamp 40 is being used transcatheterally (for example, when a catheter such as catheter 52 is used to deliver an implant such as implant 60), the clamp can be advanced transcatheter toward the heart while at least a portion of the rod is positioned within the lumen of the catheter. For example, the rod 30 can be easily bent in response to the bending of the catheter in which it extends.

[0190] It should be noted that in some applications, the arrangement of multiple longitudinal members 20 restrained (e.g., locked) by a single rod 30 as a loop 28, such as the arrangement shown in Figure 5, may optionally be considered as a single fastener including multiple longitudinal members and a single rod.

[0191] The longitudinal member 20 can be connected using the connector 42, so that once the implant 60 is deployed into the heart by removing the rod 30, the longitudinal member can be retracted from the heart by removing the connector from the patient through the catheter.

[0192] Here, refer to the schematic diagrams in Figures 6 and 7, which illustrate an application in which the implant 60 can be positioned within the heart using a positioning tool 90 (including, for example, a long member such as a shaft) that is coupled to the implant using at least one fastener 40. Note that other deployable members can be used in place of the implant 60, with appropriate modifications.

[0193] The positioning tool 90 may be long and at least partially flexible, so that once the implant is positioned in the heart, the positioning tool can extend from the portion of the heart to which the implant is connected, through the vascular system, proximal to the patient, thereby allowing the positioning tool, and consequently the implant, to be manipulated by adjusting the positioning tool outside the body.

[0194] The connection between the positioning tool 90 and the implant 60 by the fastener 40 can be achieved by the fastener fixed to the positioning tool and the loop 28 passed over / around at least a portion of the implant 60. In some applications, as also illustrated, the implant 60 includes multiple supports positioned, for example, within a cellular structure. In some such applications, as also illustrated, the loop 28 is passed around the supports of the implant 60 (for example, through one or more cells in the cellular structure of the implant), thereby ensuring that the positioning tool 90 is securely connected to the implant.

[0195] In some applications, the positioning tool 90 is fixed to the longitudinal member 20 so that, once the fastener is released (i.e., by removing the rod 30), the longitudinal member remains fixed to the positioning tool. For example, a fixing element 95 fixed to the positioning tool 90 may extend through a loop 28 (e.g., as shown in Figure 6) or through a lateral hole in the curved portion 20b or second end 20c of the longitudinal member 20 (e.g., as shown in Figure 7). An example of how the fixing element 95 can be fixed to the positioning tool 90 is a closed loop defined by the fixing element, extending around the positioning tool (e.g., as shown in Figure 7) and / or extending through a passage defined through the positioning tool (e.g., as shown in Figure 6). The fixing element can be constructed in various ways, such as sutures, wires, clips, fasteners, etc.

[0196] In some applications, the stopper 98 is coupled to the distal end of the tool 90 and is at least wider than the distal end of the tool. The stopper 98 prevents the loop 28 from sliding relative to the tool 90 (for example, away from it distally).

[0197] The implant 60 can be positioned and repositioned using the tool 90, for example, before and / or after the implant is deployed at the graft site. Once the desired position is achieved, the implant positioning tool 90 can be detached from the tool by retracting the rod 30, thereby allowing the loop 28 to be released. It is assumed that, as described elsewhere in this specification, the rod 30 will be made easier to slide out of the channel 24, thereby facilitating the release of the clamp 40 without inadvertently moving the implant 60.

[0198] As described above, the rod 30 may be long enough to extend transcatheterally into the patient's heart and may also be flexible. However, in some applications, the rod 30 may be short (e.g., 1-10 mm in length, e.g., 2-8 mm in length, e.g., 2-5 mm) and attached to a tether 32 that can extend transcatheterally from the patient (e.g., as shown in Figure 7) from the rod in the heart. For example, while the clamp 40 is being used transcatheterally, the clamp is deliverable from the catheter while at least a portion of the tether extends proximal from the rod through the catheter, so that the rod 30 can be removed from the longitudinal member 20 by pulling the tether proximal from outside the patient. The tether 32 may be more flexible than the rod 30 (e.g., the rod may be rigid), and this flexibility may make the transcatheter technique even smoother. For example, the tether can bend easily in response to the bending of the catheter extending through it. Although the use of tether 32 is shown only in Figure 7, it should be understood that this can be adapted and applied to other applications described herein as appropriate.

[0199] Refer to Figures 8A to 8C, schematic diagrams illustrating applications in which the longitudinal member 20 is elastic in the longitudinal direction. In some applications, it is desirable that the fastener 40 be positioned such that the loop 28 is tightly fitted to a component (e.g., an implant 60) and firmly grips the component, for example, so that the component does not slide against the loop. It is assumed that such tightness can be achieved by configuring the longitudinal member 20 to be elastic. In some of these applications, the first end 20a is pulled through the channel 24 and away from the channel 24 to a degree sufficient to stretch the longitudinal member 20 (Figure 8A). The rod 30 is then inserted through the first end 20a, often near the channel 24 (Figure 8B). The first end 20a is then released, and the elastic contraction of the longitudinal member pulls the rod 30 toward the channel portion 26, and the loop 28 tightens the implant (Figure 8C).

[0200] Herein, refer to Figures 9A to 9I, schematic diagrams illustrating the use of the fastener 40 as a component of system 155 in several application examples. System 155 may comprise a guide assembly 100 and an implant 160 and be used for the atrioventricular valve of the patient's heart.

[0201] The guide assembly 100 includes, according to some applications, a guide rail 102 for guiding the implantation of an implant 160 along the tissue of a heart valve, for example, the annulus 10 of a heart valve (for example, as part of an annulus repair procedure).

[0202] The guide assembly 100 also often comprises a guide frame 110 that is expandable within the patient's heart (e.g., self-expanding or balloon-expanding). In some applications, the guide frame 110 is also expanded within an atrioventricular valve, e.g., the atrioventricular valve being treated, as illustrated. The expansion of the guide frame pushes at least a portion of the valve leaflets AL and PL radially outward, often pressing the guide frame against the annular tissue (e.g., pushing the valve leaflets AL and PL downward away from the annular). Nevertheless, the valve often remains at least partially functional, often for example, to allow the guide frame 110 to open and blood to flow through it, and / or to keep the valve leaflets AL and PL partially functional (e.g., downstream of the guide frame) to provide a final unidirectional flow of blood through the valve.

[0203] Multiple fasteners 40 restrain the longitudinal members of the fasteners in the loop 28 (for example, by a rod 30 extending through the first end 20a), and the guide rail 102 is fixed along a portion of the perimeter of the guide frame 110, through which it passes, for example, the guide rail extends circumferentially around at least a portion of the guide frame. Thus, by positioning the guide frame 110 within the valve, the guide rail 102 is positioned along the tissue of the valve annulus (for example, in contact with the atrial surface of the valve annulus or slightly upstream of the atrial surface). As described below, the guide rail 102 functions as a guide for the implantation of the implant 160, for example, defining at least partially the shape that the implant 160 will take upon its implantation.

[0204] The guide assembly 100 can be advanced transcatheterally (e.g., transfemoral) through the catheter 50 while the guide frame 110 is in a contracted state, and once deployed from the distal end of the catheter, the guide frame 110 expands within the heart (Figure 9A), positioning the guide rail 102 along the tissue of the valve annulus 10 (Figure 9B). In some applications, the guide rail 102 also extends further from the guide frame 110 in a direction away from the heart proximal to the heart, as shown. In some applications, the rod 30 also extends from the guide frame 110 and in a direction away from the heart proximal to the heart (e.g., the rod extends through the catheter 50 and proximal to the patient, so that the rod can be withdrawn from the clamp 40 while the clamp is positioned within the heart).

[0205] In some applications, the implant 160 comprises a helical member 165 defining a helix, the helix extending around a central channel 166 defined by the helix. In some applications, the helical member is adapted to be fixed into tissue (e.g., valve ring 10) via rotation (i.e., screwing into the tissue). In some applications, the helical member 165 has a sharp tip 167 adapted to facilitate fixing the helical member to the tissue. The helical member 165 may be flexible enough to advance transcatheterally to the heart and follow the guide rail 102. However, the helical member 165 may often be stiff enough to be screwed into the tissue by applying torque to the proximal end of the helical member. For example, the helical member 165 may generally exhibit deflection flexibility (i.e., its central longitudinal axis can be easily deflected), but may generally not exhibit torsional flexibility (i.e., the helix may not be easily untwisted (i.e., unwound), or may not be able to twist further). In some applications, in its stationary state, the helical member 165 has an axial length of 2 to 20 cm (e.g., 2 to 12 cm, e.g., 3 to 12 cm, e.g., 5 to 12 cm) (i.e., the length along its central axis, not the helical length along its helical shape).

[0206] In some applications, the helical member 165 is configured to have a constant pitch along its length and / or to have a generally constant pitch during fixation to the tissue. Nevertheless, in some applications, and as will be described below, the helical member 165 can contract axially (i.e., its pitch can be reduced) after being fixed to the tissue.

[0207] In some applications, once the guide assembly 100 is in place, the helical member 165 advances from the catheter 50 and along the guide rail 102, for example, with the guide rail passing through the central channel 166 (Figures 9C-9E). The implant 160 is guided by the guide rail 102 and implanted along the tissue, thereby directing the implantation along the tissue. That is, the guide rail 102 extends along the tissue to provide a trajectory for the implant to advance. Thus, the guide rail 102 can define the shape that the implant 160 will take upon implantation. As shown, the guide rail 102 may arc around at least a portion of the guide frame 110, thereby fixing the helical member 165 in an arc around at least a portion of the valve ring.

[0208] In some applications, the guide rail 102 can extend along tissue (e.g., valve ring 10) in a manner that complements (e.g., generally matches) the shape of the tissue. In some such applications, this can be easily achieved by having sufficient flexibility in the guide frame 110, so that its extended shape is influenced by the existing shape of the tissue.

[0209] The helical member 165 can be implanted along the tissue so as to be at least partially screwed into the tissue. For example, an anchor driver 56 may be coupled to the proximal portion of the helical member 165, and the rotation of the helical member can screw it into the tissue. The guide rail 102 often directs the helical member 165 so that a portion of each bend is embedded in the tissue of the annulus 10, and another portion of each bend is located outside the tissue (e.g., in the atrium 12). In some applications, the thread axis of the helical member 165 is located along the surface of the tissue. In some applications, the thread axis may be parallel to the surface of the tissue but within the tissue (e.g., the helical member is in a deeper part of the tissue), or parallel to the surface of the tissue but within the atrium (e.g., the helical member is in a shallower part of the tissue). Figures 9C to 9E schematically illustrate an application example in which the implant is partially embedded in the tissue during transplantation, causing a portion of each curve of the helical member to sink into the tissue, while a portion of each curve remains above the tissue.

[0210] In some applications, after the helical member 165 is fixed along the tissue, at least a portion of the guide assembly 100 is withdrawn from the heart, often via a catheter 50. For example, the guide frame 110 can also be withdrawn with the clamp 40 still attached, as shown in the figure.

[0211] In some applications, during implantation, the guide frame 110 is bonded to the tissue of the valve ring 10 via the implant 160, and in order to remove the guide frame from the patient, it is necessary to detach the guide frame from the implant. For example, and as will be described below with reference to Figures 9H to 9I, in some applications, the distal portion of the guide rail 102 additionally functions as a retractable member 122 of the implant 160 (for example, becoming a retractable member 122 of the implant 160), and for example, at least the distal portion of the guide rail can reside permanently in the heart as a component of the implant. In some such applications, the helical member 165 fixes the guide rail 102 to the tissue in order to facilitate the removal of the guide frame 110 from the heart independently of the guide rail, so that the clamp 40 is released, thereby freeing the guide frame from the guide rail. This can be achieved by removing the rod 30 from the longitudinal member 20 (Figure 9F), which allows the fastener 40 to be released in response to being pulled away from the guide rail by, for example, the guide frame 110 (as schematically shown, for example, by the transition between the insets in Figure 9F and Figure 9G). In Figure 9F, the longitudinal member 20 is no longer constrained by the rod 30 and therefore no longer functions as a fastener, hence the reference numeral 40 is shown in parentheses.

[0212] The release of the fastener 40 described above is also assumed to favorably release the fastener (and thus the guide frame 110 to which it is coupled) when the helical member 165 is passed through the loop 28 of one or more fasteners while the helical member is screwed along the tissue.

[0213] In some applications, once the helical member 165 is fixed along the tissue, tension is applied to the guide rail 102 to adjust (e.g., contract) the valve ring, thereby causing the distal portion of the guide rail to function as a contraction member 122 of the implant 160 (e.g., becoming a contraction member 122 of the implant 160) (Figure 9H). For example, at least in part, a first stopper 104a fixed to the distal end of the guide rail 102 prevents the distal end of the guide rail from sliding proximal through the helical member 165, and the tension on the guide rail 102 (i.e., the contraction member 122) causes the helical member to contract longitudinally. A tension tool 120 delivered from the catheter 50 can be used to facilitate the application of tension.

[0214] Once tension is applied, it is locked by attaching the second stopper 104b to the guide rail 102, often proximal to the helical member 165, thereby defining, for example, the contraction member 122 as part of the guide rail 102 positioned between the first stopper 104a and the second stopper 104b. The stopper 104b can be applied by tool 120. In some applications, tension is applied by pulling on the guide rail 102 while simultaneously applying a force in the opposite direction by pushing, for example, the second stopper 104b distally via the tensioning tool 120. Figure 9I shows the implant 160 implanted along the valve ring 10 after tension has been applied to the guide rail 102 (i.e., the contraction member 122).

[0215] Figures 9A to 9I show a guide assembly 100 used in a patient's heart to guide, for example, the annular ossoplasty procedure. Note that the guide assembly can be used with any tissue and for other medical procedures.

[0216] In some applications, the guide rail is removed from the patient after the helical member has been at least partially implanted along the tissue. For example, the guide rail may not have a stopper fixed at its distal end and may be pulled proximally through the central channel of the helical member. Therefore, in such applications, the guide rail is not a component of the implant (e.g., it is not a component of the implant).

[0217] Refer here to Figure 10, a schematic diagram of system 180 for use on the heart valves of a patient, according to several application examples. System 180 may be identical to system 155 unless otherwise noted. According to several application examples, system 180 includes a guide assembly 182 with guide rails 184 for guiding the implantation of a helical member 165 along the tissue of the valve ring 10 of the congenital heart valve (for example, as part of annular repair). The guide assembly 182 also often includes a guide frame, such as a guide frame 110.

[0218] Similar to the guide rail 102 described herein, the guide rail 184 serves to guide the fixation of the helical member 165, although the guide rail 184 may be thicker and more rigid than the guide rail 102. Furthermore, the guide rail 184 often does not have a stopper fixed to its distal end and can be configured to be pulled out proximally through the central channel 166 of the helical member 165 after the helical member has been at least partially implanted along the tissue.

[0219] The additional thickness of the guide rail 184 can, for example, limit the depth to which the helical member 165 can penetrate the tissue by the guide rail in contact with the surface of the tissue. For example, the guide rail 184 may have a thickness (i.e., the inner diameter of the helical member) of at least 25% (e.g., at least 40%, e.g., at least 50%, e.g., at least 70%) of the diameter of the central channel 166 of the helical member 165. To facilitate the penetration of the helical member 165 into the tissue and / or the withdrawal of the guide rail 184 from the helical member, the thickness of the guide rail can be 95% or less (e.g., 90% or less, e.g., 80% or less, e.g., 70% or less) of the diameter of the central channel 166.

[0220] As described above, the guide rail 184 can be configured to be removed after the helical member 165 has been fixed in place. Therefore, the guide rail 184 does not function (or cannot function) as a shrinkage member. In some applications, a separate shrinkage member (e.g., shrinkage wire) 186 is provided that extends through the central channel 166 of the helical member 165, for example coaxially with the guide rail 184 (for example, through a lumen defined by the guide rail, as shown in the figure), or along the guide rail, and remains in place even after the guide rail has been removed. In some applications, the shrinkage member can be introduced after the helical member 165 has been implanted. In some applications, no separate shrinkage member is used, and for example, the helical member 165 itself modulates the tissue.

[0221] Refer here to Figures 11 and 12A-12G, which are schematic diagrams illustrating the use of the fastener 40 as a component of system 200 in several application examples. System 200 comprises an implant 264, a guide rail 242, and an implantation assembly 250 configured to implant the implant guided by the guide rail.

[0222] The system 200 often comprises a base frame 240 adapted to fit into a valve ring such that a portion of the base frame defines a guide rail 242 and extends along the upstream side of the valve ring 10 into which the implant 264 is implanted. For example, as also shown, the base frame 240 may define a ring (which may be circular or non-circular) in which a portion defines a guide rail 242. As schematically shown in Figure 11, the base frame 240 may define one or more (e.g., two or three) struts 246 (e.g., struts 246a and struts 246b) that project away from the plane defined by the base frame and are configured to extend downstream through each commissar of the valve. The struts 246 support and / or stabilize the base frame 240 at the valve. Therefore, by positioning the base frame 240 on the valve, the guide rail 242 is positioned along the tissue of the valve annulus (for example, in contact with the atrial surface of the valve annulus, or slightly upstream of the atrial surface). As described below herein, the guide rail 242 acts as a guide for the implantation of the implant 264, for example, defining at least partially the shape that the implant 264 will take upon implantation.

[0223] The base frame 240 (for example, its guide rail 242) further provides a fluorescence fluoroscopy indicator of the biostructure and can further facilitate the guidance and implantation of the implant 264.

[0224] The implantation assembly 250 includes a tool 280 (e.g., including a catheter, shaft, and / or driver) adapted to advance transcatheterally (e.g., transfemoral) into the patient's heart, often within a sheath 270. The tool 280 can define an internal lumen, and the implant 264 can be delivered through the internal lumen and from the distal end of the tool. A base frame 240 may be coupled to the distal end portion of the tool 280 via a clamp 40, and remains in place once the base frame 240 is deployed on the valve. The tool 280 may be long and at least partially flexible, so that while the base frame 240 is deployed on the valve, the tool can extend proximal from the patient through the vascular system from the base frame.

[0225] Figure 12A shows the delivery state of the implantation assembly 250, where the implantation assembly is deliverable transcatheter toward the heart within the sheath 270 while the base frame 240 is coupled to the tool 280. In the delivery state, the base frame 240 can be compressed within the sheath 270. In some applications, as also shown, the fastener 40 is disposed laterally from the outer surface of the distal end portion of the tool 280 (e.g., coupled). In some applications, the rod 30 is disposed laterally from the distal end portion of the tool 280 by extending, for example, from the lateral opening 282 of the tool. For example, the rod 30 extends along the tool 280 within the secondary lumen of the tool and can exit the secondary lumen at the opening 282.

[0226] The base frame 240 can be configured to automatically expand towards a predetermined extended shape that complements the shape of the tissue when deployed.

[0227] In some applications, the implant 264 comprises several tissue anchors 260a–260g adapted to be fixed to the tissue of the valve ring 10 (so that, for example, the anchor / screw axis of the tissue anchors is substantially perpendicular to the surface of the tissue). The tissue anchors 260a–260g can be connected to one another via shrinkage members (e.g., tethers) 262 which can be slidably coupled to the tissue anchors (e.g., by passing through holes defined by the heads of each tissue anchor), so that once the tissue anchors are implanted along the tissue, tension is applied to the shrinkage members 262, pulling the anchors together and thereby reducing the circumference of the valve ring.

[0228] In some applications, once the transplant assembly 250 is in position, for example, with the guide rail 242 passed through the loop 28 of the tool 280 (Figure 12B), the tool is positioned along the guide rail at the first site for transplanting the first tissue anchor 260a. The first tissue anchor 260a is then made easier to fix to the tissue at the first site by the tool 280 (for example, by unfolding from the distal end of the tool). As described above, the tool 280 may include a driver that can screw the tissue anchor into the tissue.

[0229] Next, a second site is selected along the tissue for implantation of the second tissue anchor 260b, and the tool 280 is advanced along the guide rail 242, causing the loop 28 of the fastener 40 to slide along the guide rail, thereby positioning it at the second site (Figure 12C). The second anchor 260b is then fixed to the tissue at the second site. This process is repeated as the tool 280 slides along the guide rail 242 (Figures 12D-12E), so that the guide rail provides a trajectory along which the implant will be implanted. The guide rail 242 thus defines the shape that the implant 264 will take upon implantation. As shown, the tissue anchor 260 can be implanted along the tissue such that the shrinkage member 262 forms an arc around at least a portion of the valve ring.

[0230] Note that the number of tissue anchors 260 shown is illustrative, and the implant 264 may have more or fewer tissue anchors.

[0231] In some applications, once the implant 264 is deployed along the tissue (e.g., implanted) (e.g., once the tissue anchors 260a-260g are fixed along the tissue), the tool 280 is detached from the guide rail 242 by releasing the clamp 40, for example by removing the rod 30 from the longitudinal member 20, for example by removing the rod into the tool 280 (Figure 12F). The tool 280 is then withdrawn from the heart, leaving the implant 264, and in many cases the base frame 240, also in the heart (Figure 12G).

[0232] In some applications, tension is then applied to the contraction member 262 to adjust (e.g., contract) the valve ring, thereby reducing the distance between tissue anchors 260, for example, by causing the contraction member to slide against the tissue anchors. For example, the tension tool may be similar to or identical to the tension tool 120 delivered via the sheath 270, but can be modified as appropriate to facilitate tension application and maintenance, as described with reference to Figures 9H to 9I. In some applications, it is assumed that such a tension tool (e.g., tool 120) cannot advance through the sheath 270 in the presence of tool 280, and therefore it is advantageous for the fastener 40 to facilitate the internal separation of tool 280 from the guide rail 242 and the entire base frame 240.

[0233] In some applications, at least a portion of the base frame 240 (e.g., at least a portion of the guide rail 242) includes a radiopaque material that can further facilitate the implantation and / or adjustment of the implant 264. For example, the mechanical guidance of the tool 280 by the guide rail 242 can be enhanced by fluoroscopic guidance, for example, guided by at least one fluoroscopic image including the guide rail. For example, fluoroscopy can make it easier to determine the position of the distal end of the tool relative to the guide rail, for example, the position of the distal end along the guide rail. Similarly, fluoroscopy may be used so that the distal end of the tool is positioned radially outward from the guide rail (i.e., further from the valve leaflet than the guide rail). Furthermore, the base frame 240 may be configured to contract during the contraction of the valve ring 10, thereby facilitating fluoroscopic monitoring of the valve ring 10 while tension is applied to the contraction member 262. Therefore, it is assumed that in at least some applications, it is advantageous to hold the base frame 240 in place during the adjustment of the implant 264, and thus it is advantageous that the fastener 40 facilitates the detachment of the tool 280 from the base frame within the body.

[0234] The systems, apparatus, devices, implants, methods, and techniques described above may be used in combination with the systems, apparatus, devices, implants, methods, and / or techniques disclosed by Sheps et al. in U.S. Provisional Patent Application No. 62 / 877,785, filed July 23, 2019, entitled “Visualization of the Anatomical Structure of Heart Valves by Fluorescence,” and / or PCT Application No. PCT / IL2020 / 050807, filed July 22, 2020, entitled “Visualization of the Anatomical Structure of Heart Valves by Fluorescence,” each of which is incorporated herein by reference for all purposes. Furthermore, the techniques, methods, steps, etc. described or suggested herein or in these incorporated references may be carried out in living animals or in non-living simulations, such as cadavers, cadaveric hearts, simulators (e.g., simulated body parts, tissues, etc.).

[0235] Naturally, throughout this application, references to the fastener 40 may refer to any of its variations, such as fasteners 40a, 40b, 40c, 40d, and 40e, or any combination thereof.

[0236] Naturally, throughout this application, the term “lateral” is not intended to be understood as precisely perpendicular, but rather generally means crossing or passing through. For example, the first end 20a may extend laterally through the longitudinal member of the channel portion by extending through the longitudinal member at an angle other than 90 degrees with respect to the longitudinal member of the channel portion. Similarly, the rod 30 may extend “laterally” through the longitudinal member at an angle other than 90 degrees with respect to the longitudinal member.

[0237] The present invention is not limited to the examples specifically illustrated and described above. Rather, the scope of the present invention includes both combinations and partial combinations of the various features described above, as well as changes and modifications thereto that are not in the prior art and which can be conceived by reading the above description. Furthermore, the techniques, methods, operations, steps, etc. described or suggested herein can be carried out in living animals or in non-living simulations, for example, in cadavers, cadaveric hearts, simulators (e.g., parts of the body being simulated, tissues, etc.).

Claims

1. A system used in heart tissue, A helical member including multiple bends, A guide assembly having a distal portion that can advance transtubally to the heart while in a delivery state, the guide assembly A guide frame that can expand within the heart towards an expanded state. Guide rails, and A plurality of fasteners configured to hold the guide rail in a guide arrangement around at least a portion of the guide frame, A guide assembly comprising, A driver configured to fix the helical member along the inner surface of the heart by screwing the helical member along the guide rail, within and along the tissue, so that a portion of each bend of the helical member is embedded within the tissue, while the guide rail is in the guide position, A system that includes these features.

2. The system according to claim 1, wherein the guide frame is self-extending.

3. The system according to claim 1, wherein the system is configured to facilitate the withdrawal of the guide rail and the guide frame from the heart while the helical member remains inside the heart.

4. The system according to claim 1, wherein the plurality of fasteners are configured to hold the guide rail along the inner surface of the tissue adjacent to the guide frame.

5. The system according to claim 1, wherein in the guide arrangement, the guide rail is held in an arc shape around at least a portion of the guide frame by the fastener.

6. The system according to claim 1, wherein each of the fasteners can be opened within the heart to detach the guide frame from the guide rail.

7. The system according to claim 1, wherein the driver is configured to fix the helical member along the inner surface of the heart tissue by the rotation of the helical member.

8. The system according to claim 1, further comprising a sheath, wherein the distal portion of the guide assembly is transtubeably advanced to the heart while in a delivery state within the sheath.

9. The system according to claim 1, wherein the system comprises an annular-forming implant, and the helical member is a component of the annular-forming implant.

10. The aforementioned tissue is the tissue of the heart valve ring, which surrounds the valve orifice. The guide assembly is configured such that the guide frame is adjacent to the valve ring, and the guide frame is positioned through the orifice. The cardiac surface of the tissue adjacent to the guide frame is the surface of the valve ring tissue facing the atrium. The system according to claim 9, wherein the driver is configured to fix the helical member along the surface of the valve ring tissue facing the atrium.

11. The system according to claim 1, wherein the helical member defines a plurality of bends surrounding a central channel of the helical member, and the helical member can be fixed along the inner surface of the tissue of the heart while the guide rail extends into the central channel.

12. The system according to claim 11, wherein the guide rail is configured to limit the penetration depth of the helical member into the tissue.

13. The system according to claim 11, further comprising: a contraction member extending coaxially through the central channel; and a tension tool configured to apply tension to the contraction member to contract the helical member in the axial direction, thereby contracting the tissue to which the helical member is fixed.

14. The system according to claim 13, wherein the guide rail can be pulled out from the helical member by sliding the guide rail proximal to the central channel while the helical member remains fixed along the tissue, and the shrinkage member remains exposed within the central channel.

15. The system according to claim 14, further comprising a stopper coupled to the distal end of the contraction member, wherein tension applied to the contraction member causes the helical member to contract longitudinally by the stopper which prevents the contraction member from sliding through the central channel.

16. The system according to claim 15, wherein the stopper is a first stopper, and the system further comprises a second stopper configured to lock the tension of the contraction member by being connectable proximal to the contraction member from the helical member.

Images