Heart valve annuloplasty

Abstract

An annuloplasty device is configured to mechanically deform annuloplasty tissue while providing structural disruption energy to induce plastic deformation. In some embodiments, the mechanical deformation includes vacuum-induced tissue attachment, optionally with or without additional operations to pull or extend the tissue. In some embodiments, the mechanical deformation includes torsional deformation of the tissue. Optionally, torsional deformation is limited by the device to a predetermined twist angle, such as in the range of 60 DEG to 120 DEG. In some embodiments, the torsional deformation includes rotating a shaft extending between tissue embedding needles of the device from a first angle oblique to the local circumference to a second angle and past an intermediate angle perpendicular to the local circumference. In some embodiments, a non-piercing transducer delivers structure disruption energy by contacting a surface of annulus tissue.

Description

[0001] Related applications

[0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 63 / 433,510, filed on December 19, 2022, and U.S. Provisional Patent Application No. 63 / 523,680, filed on June 28, 2023; the contents of each application are incorporated by reference as if fully set forth herein.

[0003] Field of the Invention and Background Art

[0004] The present invention, in some embodiments thereof, relates to the field of structural heart disease and, more particularly but not exclusively, to annuloplasty.

[0005] Patients with insufficiency of heart valves (such as the mitral valve) may undergo the implantation of an annuloplasty ring, which is sutured to the annular tissue of the heart valve. The goal is to reduce and / or stabilize the circumference of the valve. This procedure can be performed as an open-chest surgery or, with some devices, through an intravascular (transcatheter) approach.

[0006] As the valve circumference decreases, the valve leaflets move closer together, achieving a better seal (coaptation) and reducing or eliminating valve regurgitation.

[0007] International Patent Publication No. WO2002 / 097130 (filed on May 4, 2021, whose inventors are the inventors of the present disclosure) is incorporated herein by reference in its entirety. International Patent Publication No. WO2002 / 097130 describes annuloplasty devices that utilize structurally disruptive energy in combination with mechanical manipulation and methods of use thereof. Summary of the Invention

[0008] According to one aspect of some embodiments of the present disclosure, a valve ring forming device is provided, which is configured to deliver structural destructive energy to a tip terminating a distal end of a catheter body of the device, the valve ring forming device comprising: a shell of the tip extending between a proximal side connected to the catheter body and a distal side; and a plurality of needles, each of which: extends distally from a position of the tip within the anchoring shell and is sized and sharp to puncture the collagen tissue of a human heart valve annulus; wherein the needles are configured to move by rotating relative to the valve annulus with a force sufficient to twist a portion of the collagen tissue by at least 45° while the needles are inserted into the collagen tissue; and wherein the movement of the inserted needle to twist the collagen tissue also causes the needles and the collagen tissue to rotate relative to the shell.

[0009] According to some embodiments of the present disclosure, movement of the inserted needles rotates collagen tissue extending along an axis connecting two of the plurality of needles.

[0010] According to some embodiments of the present disclosure, the annuloplasty device is configured to limit rotation of tissue extending along the axis to a predetermined maximum rotation relative to the housing of less than 180°.

[0011] According to some embodiments of the present disclosure, the predetermined maximum rotation is less than about 110°.

[0012] According to some embodiments of the present disclosure, the predetermined maximum rotation is greater than about 70°.

[0013] According to some embodiments of the invention, the plurality of needles consists of exactly two needles.

[0014] According to some embodiments of the present invention, the distance between the axis centers of two needles among the plurality of needles is positioned at 1-2 mm.

[0015] According to some embodiments of the present disclosure, an annuloplasty device includes a controller actuatable from a proximal side of the catheter body to cause twisting of a portion of the collagen tissue and movement of the needle relative to a proximal-distal axis of the housing.

[0016] According to some embodiments of the present disclosure, the controller includes an element that is adjusted by manual operation, and the annuloplasty device restricts rotation of the needle and the collagen tissue relative to the housing by restricting movement of the manually operated element.

[0017] According to some embodiments of the present disclosure, the controller operates by releasing stored energy to perform the rotation, and the annuloplasty device limits rotation of the needle and collagen tissue relative to the housing by limiting the stored energy.

[0018] According to some embodiments of the present disclosure, the distal face of the housing comprises at least one orifice through which the at least one needle extends; and the annuloplasty device limits rotation of the needle and the collagen tissue relative to the housing by interference between the at least one needle and a periphery of the orifice.

[0019] According to some embodiments of the present disclosure, the distal face of the housing comprises a plurality of apertures through each of which a corresponding needle extends; and the annuloplasty device limits rotation of the needle and collagen tissue relative to the housing by interference between at least one needle and the periphery of its corresponding aperture.

[0020] According to some embodiments of the present disclosure, rotation of the needle relative to the housing is limited by interference contact with a stop element within the housing.

[0021] According to some embodiments of the present disclosure, the interference contact with the stop element includes interference between an assembly of the rotating needle and a portion of the assembly housing that functions as the stop element.

[0022] According to some embodiments of the present disclosure, rotation of the plurality of needles relative to the housing applies a torque of at least 0.01 N·m to the collagen tissue.

[0023] According to some embodiments of the present disclosure, the plurality of needles apply sufficient torque to the collagen tissue to drag a portion thereof through a rotation approximately as great as a rotation of an axis extending between the needles, relative to the proximal-distal axis of the housing.

[0024] According to some embodiments of the present disclosure, the force driving the rotation is transmitted along the catheter body by rotation of the control member.

[0025] According to some embodiments of the present invention, the annuloplasty device limits rotation by limiting rotation of the control member.

[0026] According to some embodiments of the present disclosure, the force driving the rotation is transmitted along the catheter body by longitudinal translation of the control member through the catheter body.

[0027] According to some embodiments of the present invention, the annuloplasty device limits rotation by limiting translation of the control member.

[0028] According to some embodiments of the present disclosure, the needles maintain a fixed distance from each other during rotation.

[0029] According to some embodiments of the present disclosure, the needles change distances between each other during rotation.

[0030] According to some embodiments of the present disclosure, the structurally damaging energy comprises radiofrequency energy transmitted along the wire to the tip.

[0031] According to some embodiments of the present invention, the needle-shaped object is an electrode, and the electrode is connected to a power supply connector on the proximal side of the annuloplasty device via a wire.

[0032] According to some embodiments of the present disclosure, when the needle is inserted into collagenous tissue, the lead is operable to transmit radiofrequency energy to an electrode positioned in contact with the tissue alongside the needle.

[0033] According to some embodiments of the present disclosure, the needle is retractable and extendable relative to the housing.

[0034] According to some embodiments of the present disclosure, an annuloplasty device includes a steering sheath, and a catheter is configured to be advanced through the steering sheath to reach the target collagen tissue.

[0035] According to some embodiments of the present disclosure, the steering sleeves are configured to move in unison to assume a curl and bend out of a curled plane when the steering sleeves are actuated.

[0036] According to some embodiments of the present disclosure, the steering sheath is configured to bend from a straightened configuration to form a section of the steering sheath into a helical shape.

[0037] According to some embodiments of the present disclosure, the helical shape comprises a distal segment of the steering sheath attached to a more proximal segment of the steering sheath, and the more proximal segment of the steering sheath bends from a straightened configuration to form the curvature while remaining substantially within the plane of the curvature.

[0038] According to some embodiments of the present disclosure, the plurality of needles comprise a radiopaque material, and the housing comprises at least one radiopaque marker positioned alongside the needles to indicate a distal advancement status of the needles relative to the radiopaque marker.

[0039] According to some embodiments of the present disclosure, the at least one radiopaque marker of the housing includes two radiopaque markers on opposite sides of the housing to indicate an orientation of the housing based on a visual distance of the two radiopaque markers when viewed in a fluoroscopic image.

[0040] According to some embodiments of the present disclosure, an annuloplasty device includes an electrical contact mechanism in electrical communication with an indicator configured to indicate a position of the plurality of needles relative to the housing based on a relative position of the electrical contacts.

[0041] According to some embodiments of the present disclosure, the electrical contact mechanism includes at least one first electrical contact fixed to the housing, and at least one second electrical contact moving with the needle; wherein the luminescence of the indicator indicates the contact status between the at least one first electrical contact and the at least one second electrical contact.

[0042] According to one aspect of some embodiments of the present disclosure, there is provided a valve ring forming device configured to deliver structurally destructive energy to a tip at a distal end of a terminating catheter body, the valve ring forming device comprising: a first needle and a second needle, each needle: extending distally from a position of an anchoring tip and being sized and sharp to pierce collagen tissue of a human heart valve annulus; wherein the first needle and the second needle are respectively fixed to a first stent and a second stent; and wherein the first stent occupies a lumen of the second stent, and the first stent and the second stent rotate relative to each other.

[0043] According to some embodiments of the present disclosure, while the needle is inserted into the collagen tissue, the first scaffold and the second scaffold move the needle relative to each other with a force sufficient to twist a portion of the collagen tissue by at least 45°.

[0044] According to some embodiments of the present disclosure, rotation of the first bracket and the second bracket relative to each other is limited to a maximum value of less than 180°.

[0045] According to some embodiments of the present disclosure, the structurally damaging energy comprises radiofrequency energy transmitted along the wire to the tip.

[0046] According to some embodiments of the present invention, the needle-shaped object is an electrode, and the electrode is connected to a power supply connector on the proximal side of the annuloplasty device via a wire.

[0047] According to some embodiments of the present disclosure, the needle is retractable and extendable relative to a sheath through which the first stent and the second stent are configured to be advanced to reach the target collagen tissue.

[0048] According to some embodiments of the present disclosure, the sheath includes a steering mechanism.

[0049] According to one aspect of some embodiments of the present disclosure, there is provided a valve ring forming device configured to deliver structure-destroying energy to a tip terminating at a distal end of a catheter body, the valve ring forming device comprising: an orifice at the tip configured to be pressure-connected to a controllable vacuum source through the catheter body and shaped, sized, and positioned to rest against collagen tissue of a human heart valve annulus and, when vacuum is activated from the vacuum source, to attach to and deform a portion of the collagen tissue; and a transducer attached to a wire configured to transmit structure-destroying energy from an electrical energy source to the transducer and positioned within a range of the orifice sufficient to conduct the structure-destroying energy to the deformed portion of the collagen tissue.

[0050] According to some embodiments of the present disclosure, the orifice is elongated.

[0051] According to some embodiments of the present disclosure, the transducer is an electrode.

[0052] According to some embodiments of the present disclosure, the transducer includes an acoustic energy transducer or a thermal energy transducer.

[0053] According to some embodiments of the present disclosure, the minimum radius of curvature of the orifice is equal to or greater than about 0.25 mm.

[0054] According to some embodiments of the present disclosure, the transducer at least partially defines a periphery of the aperture.

[0055] According to some embodiments of the present disclosure, the transducer is positioned so that it contacts the surface of the collagen tissue portion in the suction orifice.

[0056] According to some embodiments of the present disclosure, the transducer is positioned so that it contacts a surface of a portion of collagenous tissue adjacent at least a peripheral portion of the orifice.

[0057] According to some embodiments of the present disclosure, the transducer includes portions located on at least two opposing sides of the aperture.

[0058] According to some embodiments of the present disclosure, the transducer and the aperture are configured to move relative to each other along a proximal to distal axis.

[0059] According to an aspect of some embodiments of the present disclosure, there is provided a method of performing annuloplasty on a human heart valve annulus, the method comprising: attaching a tip of an annuloplasty device to a portion of collagen tissue of the annulus; pulling the attachment portion of the tip of the annuloplasty device while simultaneously pushing the tissue with a transducer, the combined action of the pulling and pushing deforming the tissue between the transducer and the attachment portion; and delivering structurally damaging energy through the transducer such that the attachment portion plastically deforms toward its deformed shape.

[0060] According to some embodiments of the present disclosure, attaching comprises vacuum attaching to the collagen tissue portion.

[0061] According to some embodiments of the present disclosure, the pulling comprises pulling a portion of the collagen tissue into the groove.

[0062] According to one aspect of some embodiments of the present disclosure, a method of performing annuloplasty on a human heart valve annulus is provided, the method comprising: placing a distal surface of a tip of an annuloplasty device against a portion of collagen tissue of the annulus, the distal surface comprising a surface of a transducer configured to deliver structurally damaging energy; attaching to the collagen tissue to form an attachment thereto; deforming the collagen tissue by manipulating the attachment; and delivering structurally damaging energy through the surface of the transducer to plastically deform the attached portion.

[0063] According to some embodiments of the present disclosure, twisting pulls the first portion of the collagen tissue to the first position more laterally than the second position while also maintaining the second portion of the collagen tissue in the second position.

[0064] According to some embodiments of the present disclosure, the second position includes two regions, each region being located on an opposite side of the first portion.

[0065] According to one aspect of some embodiments of the present disclosure, a method of performing annuloplasty on a human heart valve annulus is provided, the method comprising: positioning a transducer of an annuloplasty device to contact an outer surface of a portion of collagen tissue of the annulus; and while the transducer remains in contact with the outer surface: inserting a plurality of needles to puncture the outer surface; moving the needles to deform the collagen tissue; and delivering structural damaging energy through the transducer.

[0066] According to some embodiments of the present disclosure, the positioning transducer further positions at least one aperture proximate to the transducer in contact with the outer surface, and when the plurality of needles are inserted, the plurality of needles extend from the at least one aperture.

[0067] According to one aspect of some embodiments of the present invention, a method for performing an annular remodeling surgery on a human heart valve is provided, the method comprising: inserting a first needle and a second needle of a annular remodeling device into a portion of collagen tissue of the annulus so that an axis passing between the first needle and the second needle and extending along the surface of the collagen tissue has a first direction; moving at least one of the first needle and the second needle so that the axis extending between the first needle and the second needle rotates to a second direction; and providing structural destruction energy to plastically deform the tissue deformed by the movement; wherein the first needle and the second needle are inserted into the collagen tissue of the annulus at an angle within 55° to an average plane of the entire circumference of the annulus.

[0068] According to one aspect of some embodiments of the present disclosure, a method for performing annuloplasty on a human heart valve ring is provided, the method comprising: inserting a first needle and a second needle of an annuloplasty device into a portion of collagen tissue of the annulus so that an axis passing between the first and second needles and extending along the surface of the collagen tissue has a first direction; moving at least one of the first needle and the second needle so that the axis extending between them rotates to a second direction; and providing structural destruction energy to plastically deform the tissue distorted by the movement; wherein a plane parallel to the height axis of the annulus is within approximately 15° of a bisector of an angle defined by the first direction and the second direction.

[0069] According to some embodiments of the present disclosure, the height axis extends from a first side of the annulus to a second side of the annulus and is perpendicular to a plane having a maximum uniform distance from a periphery of the annulus.

[0070] According to some embodiments of the present disclosure, attaching the annuloplasty device cusps to the collagen tissue of the annulus includes attaching to the periphery of the annulus at an angle within 55° from a mean plane of the periphery.

[0071] According to some embodiments of the present disclosure, attaching the apex of the annuloplasty device to a portion of the collagen tissue of the annulus includes attaching to the periphery of the annulus at an angle within 55° from a mean plane of the periphery.

[0072] According to some embodiments of the present disclosure, positioning the transducer to contact an outer surface of the collagen tissue portion of the annulus includes approaching and contacting the periphery of the annulus at an angle within 55° from a mean plane of the periphery.

[0073] According to some embodiments of the present invention, the first needle and the second needle inserted into the annuloplasty device are also inserted at an angle within 55° to the average plane of the valve annulus circumference.

[0074] According to some embodiments of the present disclosure, the interference contact with the stop element includes interference between an assembly of the rotating needle and a portion of an assembly housing that serves as the stop element.

[0075] According to some embodiments of the present disclosure, the method includes measuring impedance during providing, and stopping providing when an impedance above a threshold is sensed, the threshold being selected from the range of 1800-2500Ω.

[0076] According to some embodiments of the present disclosure, the threshold value is 2250Ω.

[0077] According to some embodiments of the present disclosure, the method includes approximating a portion of collagen tissue while measuring impedance, and performing the inserting while measuring impedance within a range between 220Ω and 500Ω.

[0078] According to some embodiments of the present disclosure, the method includes measuring impedance during insertion, and initiating movement after insertion when an impedance within a range between 240Ω and 360Ω is measured.

[0079] According to an aspect of some embodiments of the present disclosure, a steering sheath for an annuloplasty device is provided, configured to transition between a straightened configuration and a bent configuration upon receiving steering control, wherein the bent configuration comprises a helical shape at a distal end of the steering sheath.

[0080] According to some embodiments of the present disclosure, the steering sheath includes a section leading to a helically shaped distal end that, in the curved configuration, exhibits a curvature that remains substantially within a plane of curvature.

[0081] According to one aspect of some embodiments of the present disclosure, there is provided an annuloplasty device configured to deliver structurally damaging energy to a device tip terminating at a distal end of a catheter body, the annuloplasty device comprising: a transducer configured to deliver structurally damaging energy to a plurality of sites at peripheral locations around a heart valve annulus; an elongated steerable body tilted by the transducer and comprising an elongated control member; wherein the control member is actuatable to coordinately curl the steerable body and bend the steerable body out of a curling plane.

[0082] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this disclosure pertains. Although methods and materials similar or equivalent to the methods and materials described herein can be used in practicing or testing the embodiments of this disclosure, exemplary methods and / or materials are described below. In the event of a conflict, the patent specification (including definitions) shall prevail. In addition, materials, methods, and examples are illustrative only and are not intended to limit the present invention.

[0083] It will be understood by those skilled in the art that various aspects of the present disclosure may be embodied as a system, method or computer program product. Therefore, various aspects of the present disclosure may take the form of a pure hardware embodiment, a pure software embodiment (including firmware, resident software, microcode, etc.) or an embodiment of a combination of software and hardware, which are collectively referred to herein as "circuit", "module" or "system" (for example, the method may be implemented using a "computer circuit"). In addition, certain embodiments of the present disclosure may take the form of a computer program product embodied in one or more computer-readable media containing computer-readable program code. The implementation of the method and / or system of certain embodiments of the present disclosure may include performing and / or completing selected tasks manually, automatically or a combination of the two. In addition, according to the actual instruments and equipment of certain embodiments of the method and / or system of the present disclosure, multiple selected tasks may be implemented by hardware, software or firmware and / or a combination thereof (for example, using an operating system).

[0084] For example, the hardware for performing the selected tasks according to certain embodiments of the present disclosure can be implemented as a chip or circuit. As software, the selected tasks according to certain embodiments of the present disclosure can be implemented as multiple software instructions executed by a computer using any suitable operating system. In certain embodiments of the present disclosure, one or more tasks performed in the method and / or system are performed by a data processor (also referred to herein as a "digital processor," referring to a data processor that operates using digital bit groups), such as a computing platform for executing multiple instructions. The instruction execution element of the processor may include (for example) one or more microprocessor chips, ASICs and / or FPGAs. Optionally, the data processor includes a volatile memory for storing instructions and / or data and / or a non-volatile memory for storing instructions and / or data, such as a magnetic hard disk and / or removable media. Optionally, a network connection is also provided. Optionally, a display and / or a user input device, such as a keyboard or mouse, is also provided. Any of these implementations are more generally referred to as instances of computer circuits herein.

[0085] Some embodiments of the present disclosure may employ any combination of one or more computer-readable media. A computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (non-exhaustive list) of computer-readable storage media include: an electrical connection having one or more lines, a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer-readable storage medium may be any tangible medium that can contain or store a program that can be used by or in conjunction with an instruction execution system, apparatus, or device. A computer-readable storage medium may also contain or store information for use by such a program, for example, data structured in a manner recorded on a computer-readable storage medium so that a computer program can access it as, for example, one or more tables, lists, arrays, data trees, and / or other data structures. As used herein, a computer-readable storage medium that records data in a retrievable form as a digital bit group is also referred to as a digital memory. It should be understood that in some embodiments, a computer-readable storage medium may also be used as a computer-writable storage medium if the computer-readable storage medium is not read-only in nature and / or is in a read-only state.

[0086] As used herein, a data processor is "configured" to perform data processing operations if it is coupled to a computer-readable medium to receive instructions and / or data from the medium, process them, and / or store the results of the processing in the same or another computer-readable medium. The processing performed (optionally the data) is specified by the instructions, with the result that the processor runs according to the instructions. The processing behavior may be referred to in addition or alternatively by one or more other terms; for example: comparing, estimating, determining, calculating, identifying, associating, storing, analyzing, selecting, and / or converting. For example, in some embodiments, a digital processor receives instructions and data from a digital memory, processes the data according to the instructions, and / or stores the results of the processing in a digital memory. In some embodiments, "providing" the processing results includes one or more of transmitting, storing, and / or presenting the processing results. Presentation optionally includes displaying on a display, providing the results in a form accessible to human senses by sound indication, printout, or otherwise.

[0087] A computer-readable signal medium may include a propagated data signal with computer-readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take a variety of forms, including but not limited to electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium may be any non-computer-readable storage medium capable of communicating, propagating, or transporting a program for use by or in connection with an instruction execution system, apparatus, or device.

[0088] Program code embodied on a computer readable medium and / or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0089] The computer program code for performing the operation of some embodiments of the present disclosure can be written in any combination of one or more programming languages, including object-oriented programming languages ​​(such as Java, Smalltalk, C++, etc.) and traditional procedural programming languages ​​(such as "C" programming languages ​​or similar programming languages). In addition or alternatively, a sequence of logical operations (optionally, the logical operations corresponding to computer instructions) can be embedded in the design of ASIC and / or the configuration of FPGA devices. The program code can be executed entirely on the user's computer, partially on the user's computer (as an independent software package), partially on the user's computer, partially on the user's computer, partially on the remote computer, or completely on the remote computer or server. In the latter case, the remote computer can be connected to the user's computer through any type of network (including local area network (LAN) or wide area network (WAN)), or can be connected to an external computer (for example, by using the Internet of an Internet service provider).

[0090] Some embodiments of the present disclosure will be described below with reference to flowcharts and / or block diagrams of methods, devices (systems), and computer program products according to embodiments of the present invention. It should be understood that each box in the flowchart and / or block diagram, as well as the combination of boxes in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device to generate a machine so that the instructions executed by the processor of the computer or other programmable data processing device create a device for implementing the functions / actions specified in the flowchart and / or block diagram blocks.

[0091] These computer program instructions may also be stored in a computer-readable medium, which may instruct a computer, other programmable data processing device, or other apparatus to operate in a specific manner so that the instructions stored in the computer-readable medium produce an article of manufacture including instructions for implementing the functions / actions specified in the flowchart and / or block diagram blocks.

[0092] The computer program instructions may also be loaded onto a computer, other programmable data processing device or other apparatus to cause a series of operational steps to be performed on the computer, other programmable device or other apparatus to produce a computer-implemented process, such that the instructions executed on the computer or other programmable apparatus provide a process for implementing the functions / actions specified in the flowchart and / or block diagram blocks.

[0093] Some of the methods described herein are generally designed for computer use only and may not be feasible or practical for a human expert to perform purely manually. If a human expert were to perform a similar task manually (e.g., inspecting an object), they might need to use a completely different approach, such as leveraging expert knowledge and / or the pattern recognition capabilities of the human brain, which would be much more efficient than manually performing the method steps described herein.

[0094] Brief Description of Several Figures

[0095] Some embodiments of the present disclosure have been described herein by way of example only, with reference to the accompanying drawings. These embodiments will now be described in detail with reference to the accompanying drawings. It should be emphasized that the details shown are merely examples, intended to provide an illustrative discussion of the embodiments of the present disclosure. In this regard, the description with reference to the accompanying drawings will provide those skilled in the art with a clear understanding of how to practice the embodiments of the present disclosure.

[0096] In the attached figure:

[0097] Figure 1A is a schematic diagram of a heart annuloplasty device operable to shape valve annulus tissue using vacuum according to some embodiments of the present disclosure;

[0098] Figure 1B In order to utilize according to some embodiments of the present disclosure Figure 1A A schematic flow chart of a method for performing annuloplasty using a device;

[0099] Figures 1C-1E Schematically shows some embodiments of the present disclosure Figure 1A the operation of the device;

[0100] Figure 1F According to some embodiments of the present disclosure, Figure 1A Schematic diagram of the damage caused by the device;

[0101] Figure 2A is a photograph of a lesion created in vitro in the tricuspid valve of a porcine heart using a device according to some embodiments of the present disclosure;

[0102] Figures 2B-2E is a pre-lesion area of ​​a lesion created in vitro in a porcine tricuspid valve using a device according to some embodiments of the present disclosure ( Figure 2B 、2D ) and after injury ( Figure 2C 、 2E )photo;

[0103] Figure 2F is a photograph of an incisional lesion created in vitro in the tricuspid valve of a porcine heart using a device according to some embodiments of the present disclosure;

[0104] Figure 2G Schematic overview of some embodiments of the present disclosure Figure 2F The area corresponding to the features of the photo;

[0105] Figures 2H-2I is a photograph of a row of lesions created in vitro in a mitral valve of a porcine heart using a device according to some embodiments of the present disclosure;

[0106] Figure 2J is a photograph of a row of incisional lesions created in vitro in a mitral valve of a porcine heart using a device according to some embodiments of the present disclosure;

[0107] Figure 3A is a schematic diagram of the distal end of a heart valve annuloplasty device according to some embodiments of the present disclosure;

[0108] Figure 3B is a schematic diagram of a distal end view of a tip of a heart valve annuloplasty device according to some embodiments of the present disclosure;

[0109] Figure 3C is a schematic diagram of a handle and a connection area of ​​a heart valve annuloplasty device according to some embodiments of the present disclosure;

[0110] Figures 4A-4B Schematic diagram of the distal end of a cardiac annuloplasty device according to some embodiments of the present disclosure, with its vacuum connection element in an advanced position ( Figure 4A ) and retracted position ( Figure 4B );

[0111] Figure 4C Schematically illustrating some embodiments of the present disclosure Figures 4A-4B damage caused by the device;

[0112] Figure 5A is a schematic diagram of a heart annuloplasty device operable to shape valve annulus tissue using needle puncture and twisting according to some embodiments of the present disclosure;

[0113] Figure 5B Some embodiments of the present disclosure utilize Figure 5A A schematic flow chart of a method for performing annuloplasty using a device;

[0114] Figure 5C-5FSchematically shows some embodiments of the present disclosure Figure 5A the operation of the device;

[0115] Figure 5G According to some embodiments of the present disclosure, Figure 5A Schematic diagram of the damage caused by the device;

[0116] Figures 6A-6B According to some embodiments of the present disclosure, using Figure 5A The device was used to generate injury areas in vitro in pig hearts before injury ( Figure 6A ) and after injury ( Figure 6B )

[0117] Figures 6C-6D According to some embodiments of the present disclosure Figure 6B Before the incision of the injury ( Figure 6C ) and after ( Figure 6D ) appearance photos;

[0118] Figures 6E-6F According to some embodiments of the present disclosure, using Figure 5A The device was used to generate injury areas in vitro in pig hearts before injury ( Figure 6E ) and after injury ( Figure 6F )

[0119] Figure 6G According to some embodiments of the present disclosure, Figure 6F Photos of the injury after incision;

[0120] Figure 6H According to some embodiments of the present disclosure, Figure 6B Estimation of tissue motion and needle electrode position on lesion images;

[0121] Figure 6I According to some embodiments of the present disclosure Figure 6B estimated motion of

[0122] Figures 7A-7B schematically illustrates a distal end of a heart valve annuloplasty device in different operating states according to some embodiments of the present disclosure;

[0123] Figure 7C Schematically illustrating some embodiments of the present disclosure Figure 7B An end view of the operating status of

[0124] Figure 7D schematically illustrates the distal end of a heart valve annuloplasty device in different operating states according to some embodiments of the present disclosure;

[0125] Figure 7ESchematically illustrating some embodiments of the present disclosure Figure 7D An end view of the operating status of

[0126] Figures 8A-8B schematically illustrates the distal end of a heart valve annuloplasty device in different operating states according to some embodiments of the present disclosure;

[0127] Figure 9 is used in an in vitro injury procedure of a porcine heart valve according to some embodiments of the present disclosure Figures 8A-8B Photographs of heart valve annuloplasty devices;

[0128] Figures 10A-10C Schematically illustrating the distal end of a heart valve annuloplasty device in different operating states according to some embodiments of the present disclosure;

[0129] Figure 11 schematically illustrates a distal end of a heart valve annuloplasty device according to some embodiments of the present disclosure;

[0130] Figures 12A-12B Schematic representation of a cuff of a tip portion of an annuloplasty device according to some embodiments of the present disclosure;

[0131] Figure 12C schematically illustrates a housing of a cusp of an annuloplasty device according to some embodiments of the present disclosure;

[0132] Figure 13A schematically illustrates a partially assembled apex of an annuloplasty device according to some embodiments of the present disclosure;

[0133] Figure 13B-13C schematically illustrates a partially assembled tip of an annuloplasty device to which a housing has been added, according to some embodiments of the present disclosure;

[0134] Figure 13D schematically illustrates the tip of an annuloplasty device now with a catheter sheath added, according to some embodiments of the present disclosure;

[0135] Figure 14 a fluoroscopic (X-ray) image showing the distal tip of an annuloplasty device in situ (ie, within a chamber of the heart) according to some embodiments of the present disclosure;

[0136] Figure 15A schematically illustrates a horizontal (transverse) cross-section through the left side of the heart (including the left atrium and left ventricle) according to some embodiments of the present disclosure;

[0137] Figure 15Bshows a 3D reconstructed ultrasound image looking down on the valve from a vantage point above the valve and a horizontal (transverse) cross-section, according to some embodiments of the present disclosure;

[0138] Figure 15C schematically illustrates a horizontal (transverse) cross-section through the left side of the heart (including the left atrium and left ventricle) according to some embodiments of the present disclosure;

[0139] Figure 15D schematically illustrates a coronal (coronal plane) cross section through the left side of the heart (including the left atrium and left ventricle) according to some embodiments of the present disclosure;

[0140] Figure 15E shows that according to some embodiments of the present disclosure, a planar ultrasound image of a coronal cross-section (corresponding to a coronal section) of a valve (e.g., showing leaflets) is provided;

[0141] Figure 15F schematically illustrates a coronal (coronal plane) cross section through the left side of the heart (including the left atrium and left ventricle) according to some embodiments of the present disclosure;

[0142] Figures 16A-16H shows a series of 3-D reconstructed ultrasound images obtained at different positions and / or articulations of the cusp as the cusp moves a needle element around the circumference of the mitral valve annulus according to some embodiments of the present disclosure;

[0143] Figure 16I Will Figure 16A The various positions of –16H are superimposed in one image.

[0144] Figures 17A-17B shows an in situ (i.e., within a chamber of the heart) fluoroscopic (X-ray) image and schematic diagram of a needle assembly (which may comprise a radiopaque material such as tantalum) relative to a radiopaque marker, according to some embodiments of the present disclosure;

[0145] Figure 18A schematically illustrates views of a needle assembly and radiopaque markers in different rotational positions according to some embodiments of the present disclosure;

[0146] Figures 18B to 18D shows an X-ray image of the distal tip according to some embodiments of the present disclosure, including views of the needle from different rotation angles;

[0147] Figures 19A to 19B Schematic representation of an outer sleeve pre-configured to exhibit a compound bend with increased curvature and out-of-plane displacement according to some embodiments of the present disclosure;

[0148] Figures 19C-19DSchematic representation of an outer cannula (or the catheter itself, similarly configured for steering) relative to a generally saddle-shaped valve annulus according to some embodiments of the present disclosure;

[0149] Figure 20 is a schematic flow chart illustrating target and / or desired thresholds and / or ranges of bioimpedance (in ohms (Ω)) at various stages and / or conditions during an annuloplasty procedure according to some embodiments of the present disclosure; and

[0150] Figure 21 is a schematic flow chart illustrating a method of operating an annuloplasty device according to some embodiments of the present disclosure.

[0151] Description of specific embodiments of the invention

[0152] The present invention, in some embodiments thereof, relates to the field of structural heart disease and, more particularly but not exclusively, to annuloplasty.

[0153] Overview

[0154] One broad aspect of some embodiments of the present disclosure relates to annuloplasty using energy applied to the annular region to induce tissue contraction and / or remodeling. Examples of valves treated in some embodiments of the present disclosure include, but are not limited to, the tricuspid valve and the mitral valve.

[0155] Currently, the gold standard for treating atrial fibrillation is to use radiofrequency energy to ablate the area along the left atrial wall surrounding the pulmonary veins. A reported side effect of this procedure is pulmonary vein stenosis (PVS). PVS can also occur with ablation procedures performed using other methods, such as cryoablation (e.g., J. Matilda et al., J Cardiovasc Electrophysiol. 2017 Mar;28(3):298–303. Pulmonary Vein Stenosis After Second-Generation Cryoballoon Ablation).

[0156] PVS is caused by constriction of the pulmonary veins due to shrinkage of the ablated tissue area. The physiological mechanism of pulmonary vein stenosis due to ablation is scarring of the connective tissue surrounding the pulmonary veins, as described, for example, in Vincent JAM Pulmonary Vein Stenosis After Catheter Ablation, Electroporation Versus Radiofrequency by Vincent JAM et al., Circ Arrhythm Electrophysiol. 2014 Aug;7(4):734–8.

[0157] The inventors describe an endovascular treatment method for treating leaky heart valves by utilizing tissue contraction induced by the application of structure-destructive energy. Leakage is characterized by the failure of the heart valve leaflets to coapt—they fail to fully close in response to back pressure. This results in blood regurgitation and impairs the heart's pumping efficiency.

[0158] In some embodiments of the present disclosure, tissue on the periphery of the valve annulus is reshaped by applying structurally disruptive energy in combination with applying mechanical forces that deform the tissue.

[0159] In some embodiments, this includes energy sufficient to induce tissue fibrosis. In some embodiments, the energy is delivered in the form of radiofrequency (RF) electromagnetic energy, thereby producing localized heating of the tissue, for example, to the extent of inducing fibrosis. In some embodiments, another form of energy delivery that produces heating is used. Providing energy in a form that is converted to produce significant heating only when delivered to the target site, and / or providing energy in a form that can be focused to the target and does not produce a significant heating effect outside the focal area has potential advantages. For example, using acoustic energy (e.g., focused ultrasound) or laser energy. The effect of applying structurally destructive energy to tissue is also referred to herein as "damage." Such treatment may also be referred to as "ablation," for example, as long as it causes cell death in a portion of the treated tissue. The delivery of energy may directly damage the valve annulus tissue (i.e., damage the collagen tissue of the valve annulus) and / or nearby tissue; for example, the atrial wall above the mitral or tricuspid valve.

[0160] Some embodiments of the present disclosure are configured and operable to apply mechanical forces to the treatment site where structurally disruptive energy is applied. In short, the tissue undergoes mechanical deformation (e.g., compression, but not necessarily compression) in the area of ​​energy delivery, thereby deforming its shape. After the structurally disruptive energy is applied and released, at least a portion of the mechanical deformation remains in the tissue, i.e., plastic deformation.

[0161] Properly placed and optionally repeated at multiple sites, this procedure is expected to restore coaptation of the leaflets of a regurgitant heart valve or, if coaptation is not achieved, to reduce the severity of regurgitation by reducing the gaps that remain in the leaflets in their most closed state. In some cases, the initial loss of normal coaptation of the valve leaflets is itself caused by remodeling (lengthening) of the valve annulus. Therefore, treatment that shrinks the valve annulus can restore the heart valve leaflets to their original relationship.

[0162] The plastic deformation effect does not necessarily require the application of structurally destructive energy to induce cell death (or at least not complete cell death). For example, at a sub-ablation threshold, the fibrotic structure of the tissue can be made more ductile by heating and / or by changes in pH due to the passage of an electrolytic current. The structural destruction that produces this ductility can optionally be induced simultaneously with or separately (in time) from the mechanical operation. However, the duration of plastic ductility may be so short that it is actually necessary to first induce mechanical deformation and then maintain the mechanical deformation while applying structurally destructive energy.

[0163] The effects of plastic remodeling under mechanical force in the embodiments described herein are generally very pronounced; that is, they occur within a short period of time during or after application of structurally damaging energy while a procedure is being performed using a tool to apply the mechanical force.

[0164] Without being bound by any particular theory, these very pronounced effects can be understood as being influenced by the disruptive effects of coagulation, which relieves stresses and / or strains in tissues deformed by external mechanical forces. This effectively causes the tissue to assume a new "preferred shape" in the coagulated state even after the external mechanical force is removed (i.e., plastic deformation occurs). When structurally disruptive energy is applied to tissues deformed by external forces, the existence of non-coagulation mechanisms that influence plastic deformation cannot be ruled out. For example, a mechanism has been proposed whereby the electrolysis of water in a tissue region generates free protons that temporarily affect the self-association of the collagen matrix, making it more ductile.

[0165] In addition to the above, the damage caused by the structurally damaging energy itself may also cause the annulus to shrink and correspondingly shorten the overall circumference of the annulus. Without being limited to a particular theory, shrinkage may be caused by factors such as loss of cellular structure, relaxation of stress within connective fibers, persistent tissue denaturation (coagulation) effects after energy delivery, and / or the effects of the healing process after treatment.

[0166] Contraction can include immediate or nearly immediate effects (eg, due to fluid loss or shrinkage of cellular components), as well as slower effects due to, for example, induced atrophy and / or healing processes.

[0167] The two main types of cardiac tissue ablation for the treatment of atrial fibrillation are thermal ablation, for example using radiofrequency (RF) energy or ultrasonic energy, and cryoablation. Both ablative techniques are associated with pulmonary vein stenosis. However, due to the differences in the two mechanisms, there may be differences in the tissue remodeling effects. For example, the thermal ablation effect includes coagulation that acts directly on structural cellular components, while the main effect of cryoablation is the destruction of cellular tissue and processes, resulting in subsequent degradation of structural cellular components, which may be under biological control. Electroporation is another cell ablation mechanism whose initial effect is mainly destructive rather than denaturing (coagulation). As mentioned above, electrolysis of tissue water has also been proposed as a mechanism for destroying the collagen matrix by partial acidification. In some embodiments, another mechanism for applying structural destruction energy is provided; for example, acoustic energy (e.g., focused ultrasound) or laser energy. Direct application of thermal energy is not excluded, for example, by electrical heating of a heating element in contact with the tissue to be reshaped. However, energy application that penetrates tissue prior to conversion to thermal energy has potential advantages in terms of even energy distribution, avoidance of hot spots (eg, scorching or other "overheating"), and / or safety.

[0168] In some embodiments of the present disclosure, annuloplasty by structural destruction of tissue can reduce the total circumference of the valve by up to about 5-10%, or possibly by a greater amount. Remodeling of the valve annulus can be directed to any selected location along the circumference of the valve annulus; for example, destruction of tissue at approximately evenly distributed locations, or destruction of tissue at grouped locations around one or more specific areas of the periphery. The size of tissue involved in a single injury may be reduced by more than 5-10%. For example, in vitro experiments described herein found that a localized treatment area of ​​approximately 5 mm in diameter could shrink by more than a factor of 20%, and up to a factor of 40%. These values ​​may not represent upper limits.

[0169] One aspect of some embodiments of the present disclosure relates to annuloplasty devices that combine the use of structurally disruptive energy with mechanical manipulation through torsion.

[0170] For example, it can be understood from the teachings of International Patent Publication No. WO 2002 / 097130 that torsion applied to tissue can provide a means of imparting mechanical deformation to the tissue that can be plastically set by imparting structural failure energy.

[0171] In further studies, the inventors found that, given the same overall device diameter, using torsion-induced mechanical contraction could produce greater contraction than clamping compression (where the needles move toward each other). For example, using a clamping compression device, the average contraction per injury was 1.9 mm, while using a torsion-induced device, the contraction per injury increased to approximately 2.5 mm.

[0172] In some embodiments of the present disclosure, the torsional force is applied by rotating two independently piercing manipulator elements about a common center. Such manipulator elements are also referred to herein as needles (more specifically, when the same element has both electrode and mechanical manipulation functions, it may also be referred to as a "needle electrode").

[0173] For example, compared to direct needle-to-needle compressive motion (squeezing), twisting offers the potential advantage of applying mechanical compression to tissue outside the needles (potentially including outside the needles, generally along the axis extending between the two needles, and alongside the axis). In contrast, direct compression between the two needles may be somewhat reduced (e.g., as long as they are not close to each other). Different tissue contraction patterns can provide a more uniform distribution of internal forces, which helps reduce the likelihood of tearing when structural damage energy is applied, and / or may help reduce unnecessary deformation in the treated valve annulus. A greater contraction distribution can also reduce the amount of peak deformation introduced, so that for similar, the same, or greater amounts of contraction introduced, the end result is a relatively smoother surface. For example, a single larger central compression area can be replaced by a lower central protrusion, and peripheral folds can be added as needed to further accommodate the introduced deformation.

[0174] Furthermore, there may be a limit to how much any given tissue surface can contract, so there is a potential advantage to mechanical deformation methods that distribute the contraction over a larger area. Annular contraction is preferably concentrated in the vicinity of where the leaflets should coapt. Therefore, being able to achieve a relatively large amount of contraction within a single lesion may be critical. Since the available circumferential space at the preferred placement location is limited, each treatment site at that location preferably achieves as much contraction as reliably as possible. In any event, this can reduce the number of accessible treatment sites overall, thereby potentially simplifying and / or shortening the annuloplasty procedure. By concentrating the contraction in areas away from fragile and / or functionally critical areas, it can also make it easier to design the procedure to avoid being too close to fragile and / or functionally critical tissue areas (such as the atrioventricular node, such as in the case of tricuspid annuloplasty).

[0175] Torsional deformation of tissue can allow the use of a smaller device footprint to achieve the same effective constriction distance per treatment site. For example, rather than reducing the footprint of an initial contact width of approximately 4 mm by approximately 2 mm (e.g., through clamping), a rotational motion (torsion) can be used to achieve a fixed initial width footprint of 1.5 mm to achieve the same effective constriction. This has the potential to allow more treatment sites to be placed in a single procedure, thereby achieving greater overall constriction. It has the potential to allow for more concentrated (higher linear density) placement of treatment sites, thereby concentrating annular remodeling in locations believed to be most likely to promote valve coaptation and / or avoid risk areas (e.g., areas near the atrioventricular node or other sensitive areas). In addition, it may leave more unaltered tissue for modification in future procedures, for example, if the valve continues to remodel over time and / or it is found that the initial procedure did not achieve the full or expected effect. This may also allow the physician to be less aggressive in the first annuloplasty procedure, leaving the option of a second annuloplasty more open if necessary.

[0176] In the case of a pinching / squeezing method, the degree of contraction is determined by the compression and / or displacement of the tissue within the initial "bite" distance of the operating element. This "bite" distance sets a maximum level of contraction at each site; however, in practice, the degree of tissue contraction or displacement is not expected to be sufficient to fully converge the biting "mouth" (e.g., needle, pin, or other clamping and / or piercing element). Therefore, the maximum contraction may be much less than the initial bite distance.

[0177] However, with torsional deformation, tissue regions moving in opposite directions are also offset from each other so that they do not move directly toward each other (in the direction of collision). Thus, for example, a 90° rotation may cause certain distances along at least certain axes (e.g., the distance between two tissue regions in the peripheral direction around the valve annulus) to shorten by approximately the total distance between the needles. Not all areas will be affected in this way; for example, torsion will also produce complementary transformations in other tissues (e.g., shifting a previously "vertical" tissue arrangement to make it more "horizontal"; i.e., farther along the periphery of the valve annulus). However, by appropriately initially placing the manipulator and selecting its rotation angle, the overall pattern of tissue deformation caused by torsion may deviate from complete radial symmetry (e.g., contraction primarily along the periphery of the valve annulus and less along the height of the valve annulus).

[0178] Furthermore, because torsion tends to pull the tissue radially inward overall, it also induces a component of tissue compression. This compression (e.g., peak percentage) may be lower than the compressive force applied to the "clamped" tissue, but may also be distributed over a larger area (e.g., including compression in an area consistent with but exceeding the "bite" diameter formed by the manipulator), thereby potentially producing a net effect on the peripheral dimensions that is similar to or greater than the compression achieved with the same "bite" diameter.

[0179] Given the different alternative priorities, distributing the annular constriction as evenly as possible may have potential advantages—for example, to reduce the degree of intervention at any single site and / or to avoid inducing abnormalities in annular form or function. In this case, the emphasis may shift to the uniformity of the treatment effect and, accordingly, how the magnitude of the constriction occurring at each site can be controlled in a planned manner.

[0180] In some embodiments of the present disclosure, a valve ring forming device is provided that is configured to apply torsional deformation by providing a limited range of motion to a needle, the motion being limited by the device to a predetermined maximum angle or otherwise specified maximum distance. The limit can be absolute or can be dependent on operating the device in a self-limiting intended mode. In some embodiments, the full range of motion available is also the amount of tissue that is generally preferred or selected by the user for collection. In some embodiments, the range of motion is selectable, for example by selecting which particular valve ring forming device to use, and / or by adjusting settings (e.g., slot size, protrusions or other interfering elements, or controlling the range of motion) to impose the desired limit on the range of motion. In some embodiments, partial rotation within the limited available range is also an option, where the limit on rotation (e.g., acts as a safety limit).

[0181] The rotation limit may be provided by, for example, a stop device comprising structures that physically interfere with each other to prevent further movement after contact. Such a stop device may be provided at the tip of the device (e.g., to directly prevent rotation beyond a certain angle), and / or may be provided to limit movement of the control element. Additionally or alternatively, sensing may be provided to indicate the rotational position, for example using electrical contacts or other forms of electronically and / or mechanically implemented position-encoded indications. The sensing status may be indicated to the user by an LED, a tactile vibrator, a buzzer and / or a speaker, an on-screen indication, or other means.

[0182] Providing a predetermined range of rotational motion has the potential advantage of applying torsional force in a manner sufficient to achieve contraction, but not excessively so as to cause tearing or other unintended damage when applying force and / or delivering structurally destructive energy. For example, heating by radiofrequency energy may soften tissue to an extent that may cause the tissue to tear under excessive stress. Thus, there may be a preferred (e.g., validated) maximum amount of rotation that can be safely tolerated.

[0183] Furthermore—also related to the types of issues discussed above—predetermined rotational ranges of motion facilitate application of torsion in a predictable and / or repeatable manner. For example, surgical planning can needle specific amounts of valve circumference reduction and / or other remodeling using a specific number of treatment sites. Being able to set (or select) a contraction target using an annuloplasty device and having it inherently ensure that the contraction target is achieved is a potential advantage.

[0184] In some embodiments of the present disclosure, an annuloplasty device is provided that is configured to apply a torsional deformation by rotating two independently puncturing manipulators about a common center located between them. Additionally or alternatively, in some embodiments of the present disclosure, an annuloplasty device is provided that is configured to apply a torsional deformation by rotating two independently puncturing manipulators about a common center located closer to one of the members. Optionally, the common center is also along the axis of one of the puncturing manipulators. In some embodiments, the torsion is generated in conjunction with direct compression applied by the needles being brought closer together. Optionally, the direct compression is transient (e.g., the two needles slide past each other but eventually return to their original distance).

[0185] Although differences in rotational axis offset may somewhat alter how the needle applies force through tissue as it rotates, the redistribution of force is likely to ultimately shift the effective axis (if not fixed in place) to the same final position, thus producing little, if any, difference.

[0186] When two needles initially penetrate the tissue, changes in the direction of another axis centered on and passing through them can result in significant differences in the resulting tissue deformation pattern. Roughly described, tissue in surface areas angularly closer to the initial puncture axis defined above may tend to be pulled more around its center (i.e., tangentially), while tissue in surface areas farther from that axis may tend to be pulled more toward the center (i.e., radially). Thus, depending on the direction of the initial puncture axis, all four quadrants along one axis (e.g., along the annular circumference) have a significant contraction component, while only two quadrants along the orthogonal axis (e.g., along the annular height axis) have a significant contraction component. In other words, there is a "contraction ratio" between the two axes, which is not necessarily equal to 1 and is also referred to herein as contraction anisotropy. The actual contraction anisotropy may depend on the amount of angular twist imparted to the needle and may be particularly relevant for rotations much less than a full rotation (e.g., less than 180° or less than 90°). In some embodiments, the needle can be rotated at least 45° upon insertion into the tissue. The needles are anchored at the proximal ends to provide sufficient rigidity to overcome forces in the tissue resisting deformation. For example, the needles are anchored to a common base that is rotatable within the housing, or to respective bases that are movable relative to the housing by rotation or other means. In some embodiments, one of the needles is anchored to the housing, while the base anchoring the other needle is movable relative to the housing.

[0187] It should also be noted that for a larger (and possibly maximum) contraction in a selected direction (e.g., between points A and B), the initial puncture axis may be angled relative to a mid-plane perpendicular to and bisecting AB such that the mid-plane bisects the scan angle of the needle from its initial position to its final position that establishes the puncture angle. For example, if the scan angle is approximately 90°, the initial puncture axis is at an angle of approximately 45° relative to the bisecting mid-plane. In order to maximize contraction of the circumference of the annulus, the mid-plane may be selected to extend parallel to the valve height axis (e.g., the axis extending from a first side of the annulus to a second side of the annulus and perpendicular to a plane having a maximum uniform distance from the periphery of the annulus). Noting anticipated variations in anatomy and / or implementation of these instructions, the mid-plane is preferably within 15° of the actual bisecting angle, or another angle, for example, selected to be 10°, 20°, or 25°.

[0188] Thus, in some embodiments, torsional deformation comprises rotating an axis extending between the tissue-embedding needles of the device from a first angle oblique to the local circumferential direction to a second angle perpendicular to the local circumferential direction, and through intermediate angles perpendicular to the local circumferential direction. In some embodiments, the first and second angles are substantially equally offset from the intermediate angle, e.g., within 15° of each other. In some embodiments, the first and second angles differ from each other by approximately 60° to 120°.

[0189] In order to resolve disagreements arising from the foregoing description in competing applications, it is preferred that the result (if comparable) or definition (otherwise) be closer to the circumference definition of the main valve circumference. The main valve circumference extends as a closed curve along the outer surface of the collagen tissue of the valve annulus. It is located at equidistant positions between the edges of the collagen tissue. For practical calculation purposes, the edge distances are measured only at a few clearly identifiable landmark positions around the circumference, preferably 8 positions, preferably evenly distributed, preferably one of which is fixed at the widest part of the valve annulus. The intermediate positions are smoothly interpolated by spline fitting. If it is necessary to select a specific heartbeat phase to resolve the definition of the circumference accurately enough, it is preferred that the phase of the heart valve annulus be closer to the planar shape. These considerations are generally optionally applicable to resolve disagreements about the geometric details of the valve circumference.

[0190] Annuloplasty offers potential advantages in controlling contraction anisotropy. The effect of torsion-induced deformation may differ from "clamping" methods of introducing mechanical deformation in that the effect is omnidirectional; the tissue tends to be at least partially pulled inward from all sides. This may result in torsion-induced contraction along the annulus height axis, which is not necessarily therapeutic in itself, although it may also provide potential benefits (e.g., relative to clamping-type deformation), such as contraction uniformity, contraction distribution, and / or stress relief. Therefore, in some embodiments of the present disclosure, control and manipulation methods are provided to help control how contraction anisotropy is introduced into the target tissue.

[0191] In some embodiments of the present disclosure, the rotating needle is constructed to rotate in response to actuation of a controller on the distal side of an elongated element to which it is attached (e.g., an elongated tubular element, also referred to herein as a catheter). The controller optionally includes (for example) a button, a knob, a slider, a lever, or other mechanism. The controller optionally operates, for example, as a release device (e.g., a spring-loaded tension). Optionally, the controller rotates the needle through an angle corresponding to the degree of motion imparted to the controller. The rotating needle is configured to rotate while embedded in the annular tissue so that the annular tissue around it moves therewith. Thus, the controller applied thereto is configured to transmit a torque much greater than that required to rotate the needle in a free fluid, for example, at least 0.002 N·m, 0.005 N·m, 0.01 N·m, 0.02 N·m, or other torque amounts. In some embodiments, the torsion is sufficient to deform the tissue according to one or more different criteria. For example, needle rotation causes some tissue to move relative to one needle (the reference needle) by at least 90% of the distance (e.g., between two points on the periphery around the reference needle) that another needle (the moving needle in a given reference frame) moves relative to the reference needle. The tissue can be tissue in direct contact with the moving needle or other tissue, such as tissue at least 25%, 50%, 75%, or 100% of the distance from the moving needle. This standard uses the reference needle to define the rotational reference frame used for measurement; the actual rotation applied (i.e., relative to a reference frame consisting of a distant fixed object) is not necessarily a rotation of one needle about the other; it can even be a rotation of the reference needle about the nominally "moving" needle. This standard can be modified to include a minimum threshold for relative angular motion of the needles, such as at least 30°, at least 45°, at least 60°, or at least 90°. The same standard can be applied when the needles also change their relative distance, modified as needed to account for relative linear motion.

[0192] To maintain stability during rotation, the needles are preferably short, but long enough to accommodate their role in manipulating tissue. For example, the needles are approximately 2-6 mm, 2-8 mm, or other lengths. In addition, the needles are stably fixed (e.g., mounted on a mounting block) so that they can transmit the manipulating torque to the tissue rather than deforming themselves, for example, not bending more than about 10°, preferably less than 10°. The needles can be mounted so that (for example) their axes are approximately 1-2 mm apart, for example, approximately 1.3 mm apart. This distance range is suitable for (for example) needles with a maximum diameter of approximately 0.6 mm (e.g., a 0.4 mm x 0.4 mm square cross-section needle) and an entire catheter with a maximum outer diameter of approximately 5 mm. In some embodiments, the axial centers of the needles are mounted at a larger distance, for example, approximately 3 mm, approximately 4 mm, or other distances. This distance is preferably no greater than the axial height of the valve annulus (e.g., a circumferentially continuous ring of collagen tissue). In some embodiments, the distance is less than 80%, less than 66%, less than 50%, or other maximum relative distance of the height. Larger distances may cause the annulus to deform to an unacceptable degree along the axial height axis, but they may allow less damage to achieve the target degree of constriction. However, in some cases, such deformation is acceptable and easy to control, for example, by alternating clockwise and counterclockwise deformation. In some cases, it may even be necessary to perform a larger deformation in the same direction, for example, to restore the valve shape from a particularly deformed annulus.

[0193] In some embodiments, the needle can be alternately extended and retracted along the proximal-distal axis of its housing (i.e., the housing can be pulled out / advanced, and / or the needle can be advanced / retracted). In the retracted state, the needle can move within the body without hooking onto unintended structures. For example, during positioning, the needle can contact the valve annulus in the retracted state, thereby avoiding the risk of scratching and / or entanglement with the valve leaflets. In the extended state (e.g., after the proximal end of the housing housing the needle is placed against the valve annulus tissue to be treated), the needle can be operated to engage the valve annulus tissue.

[0194] In some embodiments, the housing comprises the distal portion of an elongated tubular element (also referred to herein as a catheter), and / or a separate element attached to the distal end of the catheter. In some embodiments, the housing comprises a portion of an outer sleeve for introducing a needle into a specific area. Optionally, the housing is specialized for the function of the tip of the annuloplasty device. For example, the shape and / or size of the distal portion may optionally differ from the cross-section of the catheter from which it extends distally, thereby accommodating one or more elements of a mechanism that drives needle movement, and / or the needle itself. In some embodiments, the housing is provided with echogenic structures, such as grooves, cross-hatching, or other surface textures, which may enhance visualization of its position under echocardiography. In some embodiments, the housing is provided with radiopaque structures (e.g., made of tantalum, gold, and / or tungsten) to enhance visualization. In some embodiments, at least one needle can be moved relative to the housing in a manner that applies a torsional force to the tissue when the needle is inserted into the tissue.

[0195] In some embodiments, the drive to rotate the needle is controlled so that a predetermined amount of rotation occurs for each corresponding control movement and / or force applied. This advantageously provides feedback ("feel") to the device operator, enabling them to determine the status of the tip, such as whether it is applying sufficient resistance to indicate proper insertion into tissue, whether it is not experiencing a loss of resistance that could indicate tearing and / or loss of engagement, and / or whether it is applying excessive resistance that could indicate a jam or unexpected resistance to insertion (e.g., in previously treated, previously fibrotic, and / or calcified tissue).

[0196] Actuation can include, for example, converting linear motion of an elongated control member (e.g., a wire or string) into rotational motion at the tip; for example, by winding or unwinding it from a needle-like mount to rotate it, optionally overcoming a restoring force such as a tension spring. In some embodiments, the control member can also be a component along which structurally destructive energy is transmitted to the tip, such as a conductive wire.

[0197] In some embodiments, the control member drives a gear or pulley arranged to provide a mechanical advantage to rotate the needle mount. In some embodiments, the control member drives the rotation by rotating itself (about its longitudinal axis), and its torsional stiffness is sufficiently large and / or the effect is repeatable (e.g., by being preloaded until it overcomes the resistance to rotation in at least one direction of rotation) such that the rotation angle of the needle is predictable at the resistance that the needle would be expected to absorb from the annular tissue during insertion.

[0198] In some embodiments, the connecting rod driving the rotation is elastic and / or flexible (rotational and / or longitudinal) such that the actual rotation of the tissue-embedding needle achieved per unit of controlled driving force delivered is variable and / or nonlinear. Thus, the driving force can be accumulated by the flexible connecting rod partially absorbing (by deformation) the force and partially transmitting the force until sufficient force is transmitted to the needle through the stable mounting of the needle to cause it to rotate. In this case, the rotation of the needle can be achieved gradually as the controller is moved, and / or can be achieved all at once, such as by triggering the release of energy accumulated in the device; for example, energy stored in a spring.

[0199] Whether under predictable control or nonlinear / less reproducible control, the final amount of twist can be determined by limiting the available range of rotational motion, as described above. Hard limits on rotation have the potential advantage that, once the full range of motion is achieved, nonlinear and / or reproducible errors in the actual motion compared to the commanded motion may not be significant during the procedure. Partial rotation within the available range of motion may result in a smaller amount of contraction per induced injury, which may be appropriate for the design of a specific treatment procedure.

[0200] At least two further types of control can be distinguished that are operable to control the directionality of torsion-induced tissue manipulation. First, in some embodiments of the present disclosure, the device can be steered in a manner that maintains directional control. For example, the device can be advanced along the valve's elevation axis (e.g., near the valve's center, but not necessarily near the center) and bent away from that axis toward the valve's periphery. When the curved device (including the steering sheath or other steering mechanism) is rotated about the elevation axis, the alignment of the distal face of the device tip will maintain its initial orientation relative to the valve's elevation axis regardless of where the tip is steered. Furthermore, if the tip is rotated about its longitudinal (proximal-to-distal) axis, the distal face of the device tip will change its rotation relative to the valve's elevation axis. The direction of the tip can be understood and controlled by providing appropriate indications of the current relative rotational state of the steering sheath and its steered annuloplasty device. Indications can include, for example, markings on a handle controller, radiopaque markings, echogenic features, mitigation devices, and / or optical or electronic encoders.

[0201] Secondly, in some embodiments of the present disclosure, the degree of twist applied (before and / or after the needle is inserted) may affect the direction and / or magnitude of the anisotropy, as well as the total amount of tissue deformation applied. For example, the rotation of the needle can be partially driven before the needle is inserted into the tissue to change the direction of the contraction anisotropy. This can include operating a controller different from the controller used to drive the needle rotation during tissue manipulation, or it can be the same controller. For example, the rotation of the entire catheter body can be used to change the direction of the needle before insertion, and another controller can be used to change the rotation of the needle relative to the catheter body after insertion. In addition, applying a relatively large or small twist from the starting direction may affect the level of contraction anisotropy (although in this case, the total amount of mechanical contraction may also be affected). Features and methods related to the torsion angle of the control device are described above.

[0202] To explain the background of anisotropy control in more detail: The target outcome of annuloplasty is to shrink the circumference of the treated annulus (or valve ring), perhaps by only a few percent (e.g., 5-10%). For example, in the case of the human mitral valve, the normal circumference may be about 8-9 cm; in the case of the human tricuspid valve, the normal circumference is about 12-14 cm. However, the axial height of the collagenous (fibrous) tissue of the valve annulus is also only a few mm (e.g., less than 10 mm). Therefore, any shrinkage caused is a much larger proportion of the axial height than it is of the circumference of the actual needle pair (the average or a large fraction thereof). Therefore, a potential advantage is to concentrate the axis of maximum shrinkage at the circumference, while applying relatively low shrinkage along the axial height of the valve annulus.

[0203] However, in some cases, rotating the contraction anisotropy to a different direction may be helpful, for example, to equalize contraction and help avoid introducing shape irregularities to the annulus. For example, directionally controlling the axis of contraction anisotropy may help avoid or reduce the creation and / or exacerbation of annular shape irregularities. These examples may include abrupt changes in annular height, irregularities in annular axial position (e.g., resulting in annular bowing), a decrease in flexibility, and / or changes in flexibility that functionally interfere with annular shape dynamics.

[0204] During a heartbeat, the annulus may, for example, bend between a relatively flat shape and a relatively saddle-shaped shape. During annuloplasty, it may be preferable to induce contraction in the saddle-shaped articulation region (the region where the annulus reverses its bend) differently than elsewhere in the annuloplasty procedure to promote (or at least avoid interfering with) bending in the correct direction. For example, a contraction region induced preferentially along the valve height axis (rather than the local circumferential axis) may resist bending less than in normal annular dynamics.

[0205] It is noteworthy that the normal annulus is capable of significant dynamic remodeling (although this remodeling may have been impaired by the time annuloplasty is required). Where feasible, it is advantageous to retain as much residual tissue flexibility as possible intact in order to facilitate valve coaptation. In contrast, in certain uses and / or embodiments of the present disclosure, the purpose may be to introduce a curvature or kink in the annulus. For example, this may be intended to introduce an opposite curvature or kink that cannot be solved (or cannot be completely solved) by simply reducing the circumference size. In this case, controlling the contraction anisotropy can provide the surgeon with a tool to assist in reshaping the annulus. It is noteworthy that contraction anisotropy can measure not only relative contraction along orthogonal transverse axes; it can also apply to the directionality of deformation along a single axis (e.g., upward or downward); for example, the directionality of deformation caused by an offset in the location of the lesion. For example, it may be preferable to pull tissue above the axial direction towards a position below the axial direction, or vice versa.

[0206] For ease of illustration, and without limiting the scope to a specific model of tissue deformation under torsional forces, the following description of the effects of torsion on tissue is helpful in understanding the consequences of torsional contraction of valve annular tissue. The torsional contraction pattern often involves some degree of pulling on the tissue in all or nearly all radial directions, as some components of the generated force are converted into tangential stresses, which tend to pull the region, at least partially, inwards to a distance greater than the tangential circle. However, when the amplitude of rotation is significantly less than a full rotation, such as less than a half-turn (closer to a quarter-turn is more common in some embodiments of the present disclosure), the contraction pattern often predominates in the direction of the initial motion, particularly in regions that can be directly pulled in that direction by one of the moving needles. Comparing this stretching motion to the motion of the tissue on the side of the needle most directly pushing against it, the tissue may be more likely to contract its planar equivalent area under compression than to expand under tension. Even when the actual surface and / or volume remain largely unchanged, this contraction in planar equivalent area can be accommodated by expansion and / or wrinkling. However, expansion under tension is limited by the elasticity of the fibrous tissue. Even if such elasticity exists, it may be relatively low compared to the tissue's ability to undergo lateral compression through expansion / wrinkling.

[0207] In some embodiments, more than two needles are used, for example, three, four, five or more needles. Whether two or more needles are provided, any number of needles can additionally serve as electrodes through which ablation energy is delivered, and / or as sensing electrodes (e.g., sensing impedance to help detect insertion and / or tissue state). When the number of needles is greater than two, the deformation pattern introduced may tend to reduce anisotropy. For example, a quadruple deformation pattern (for four needles) repeats every 90° rather than every 180° (for a two-fold deformation pattern). The peak force concentrated on a single needle can be reduced. If more than two needles are also used as electrodes, the peak heating concentrated on a single needle can be reduced (for the same total energy and / or power). Using two needles has the potential advantages of, for example, concentrating the insertion force on a smaller surface area, and / or packaging the device in a smaller delivery size.

[0208] All needles have the same geometric shape, with no particular limitation. For example, one needle may have a smaller radius / maximum dimension, while a second needle may have a larger radius / maximum dimension. The needles may optionally have a square cross-section (e.g., a cross-section of 0.4 mm x 0.4 mm), or have other cross-sectional shapes; for example, they may be circular, triangular, or other shapes. A flat cross-section (e.g., oriented so that the flat surface faces the circumference of rotation) has the potential advantage of providing a uniform surface for distributing torsional forces. A circular cross-section has the potential advantage of avoiding concentrations of ablation energy when the needle also serves as an electrode. The needles may optionally have a uniform or non-uniform cross-section. Regions of non-uniform cross-section may provide advantages for puncture (e.g., providing a tapered needle tip with a sharp tip). In some embodiments, the needle's taper may be relatively short (e.g., less than the distal 25%, 20%, or 10% of the total needle length). Alternatively, the needle's taper may be longer (e.g., 30%, 40%, 50%, or more of the total needle length). This could allow the base of the needle to be significantly widened while still being able to puncture easily enough. This in turn offers the potential advantage of redistributing the contact surface area around a larger needle circumference to avoid tearing when forces are applied to the tissue, either during rotation to deform the tissue or during the application of structural damage energy. The taper may also enhance the strength of the needle itself. The taper need not be radially isotropic, for example, the taper can change from a first cross-sectional shape to a second cross-sectional shape, without the second cross-sectional shape being merely scaled from the first cross-sectional shape.

[0209] All or any needles may be straight, without particular limitation; for example, they may be curved (e.g., hook-shaped). In certain embodiments, a curved needle may be advanced into tissue along a path consistent with its curvature, or there may be some deviation between the needle shape and the needle advancement path. This may simply result from some deformation of the needle during penetration (e.g., compression), but resistance to penetration by the needle tip may be increased.

[0210] Even for straight needles, there is no particular limitation, i.e., any or all needles (which are positioned against tissue) must be advanced into the tissue while moving parallel to the longitudinal (proximal to distal) axis of the device. For example, the needles may be advanced into the tissue at an angle, and may optionally be advanced in different directions from one another, such that the needle tips converge or diverge during advancement.

[0211] The mutually non-parallel paths of needle / hook advancement provide potential advantages for maintaining penetration attachment during further tissue manipulation, for example, where force can be applied to pull tissue on the tissue, for example, pulling tissue against a superficial electrode surface, for example, as explained with respect to some embodiments of attachment to tissue using vacuum, for example, as explained below.

[0212] One aspect of some embodiments of the present disclosure relates to annuloplasty devices that combine the use of structure-destroying energy with mechanical manipulation using a vacuum.

[0213] In some embodiments, mechanical contraction of the tissue is achieved by vacuuming the tissue surface prior to applying structurally disruptive energy. A vacuum port is positioned over the tissue in the area to be contracted, and the vacuum is activated. In some embodiments, the resulting pressure drop is, for example, at least about 50 mmHg, 75 mmHg, 100 mmHg, 150 mmHg, or other pressure values.

[0214] As a result, the tissue is drawn into the orifice. At the same time, the planar equivalent area of ​​the drawn tissue effectively shrinks simultaneously. For example, for a planar equivalent area defined as the cross-sectional area of ​​the vacuum orifice, the actual surface area is equal to that area plus the area required to allow the tissue to expand inward to the low-pressure vacuum orifice. After the structural destruction energy is applied, the deformation is fixed and the tissue shrinks. In some embodiments, the structural destruction energy is delivered in the form of radio frequency (RF) energy (e.g., at a power of 8-12 watts for a duration of 12-24 seconds). In some embodiments, the power is 8 watts.

[0215] A potential advantage of this mechanical fixation method is that fixation can be confirmed by changes in vacuum pressure and / or evacuated volume. For example, in some embodiments, a pressure sensor can be placed (e.g., at the tip of the device) where the stability of the vacuum joint is determined based on the ambient pressure.

[0216] In some embodiments, the vacuum orifice is configured as a rectangle. This may increase the shrinkage ratio of the tissue in the shorter direction of the vacuum orifice. For example, if the convex shape is approximated as a hemisphere divided in the middle by a straight line segment, the ratio d1 of the actual surface length to the effective plane length in the short distance of the straight line segment can be (for example) about In the orthogonal direction, considering only the two hemispherical ends, the surface area along the longest distance d2 can increase the ratio, while the ratio of the intermediate straight segments remains unchanged, thereby reducing the overall ratio. In some embodiments, the ratio of the height (major axis) to the width (minor axis) of the vacuum orifice is about 1.5:1, 2:1, 2.5:1, 3:1, or other ratios.

[0217] The vacuum orifice can optionally be rounded in profile to avoid sharp internal corners. For example, it can be circular, oval, elliptical, or square or rectangular with rounded corners. For example, the minimum radius of curvature can be equal to or greater than about 0.25 mm, or about 0.5 mm. This offers the potential advantage of avoiding excessive stress on the tissue at the corners (which could easily hinder inward tissue traction and / or cause mechanical damage to the tissue).

[0218] In some embodiments, for example, electrodes or other transducers that deliver structurally destructive energy (e.g., radiofrequency energy, acoustic energy, and / or thermal energy) to the tissue itself constitute part or all of the vacuum orifice. For example, the electrodes can form the vacuum orifice. It should be understood that, particularly for embodiments in which a vacuum is used to mechanically deform tissue, the electrodes used as transducers for introducing structurally destructive energy into the tissue can optionally be replaced with other types of transducers, for example, transducers that convert electrical energy from an electrical energy source into a structurally destructive energy form.

[0219] In some embodiments, the vacuum port and the electrode (or other energy transducer) are separately defined elements; for example, the electrode can apply RF energy through an electrical connection formed outside of and / or behind the vacuum port. In some embodiments, mechanical contraction of the tissue prior to fixation by energy application depends not only on entry of the tissue vacuum port but also on further mechanical movement of the vacuum port.

[0220] For example, in some embodiments, the vacuum port is advanced to adhere the tissue by suction contact and then withdrawn, pulling the tissue into a further deformed shape. Deformation can be limited by a spacer (e.g., a protrusion that remains in more distal contact with the tissue when the vacuum port is withdrawn). In some embodiments, the protrusion is a tube into which the vacuum port is withdrawn. In some embodiments, the tube has a slit, which may result in folds or wrinkles defined by the closed slit on one axis, while on the other axis, it may extend beyond the tube / slit boundary. This may allow a particularly large shrinkage rate to be applied to each lesion formed along one direction (e.g., periphery), while maintaining a relatively low shrinkage rate in the other direction. For example, the maximum shrinkage rate in one direction can be as high as 2:1, 3:1, 4:1 or higher. The maximum shrinkage rate in the vertical direction may be at least 25%, 50%, 75% or other fractions lower than this value.

[0221] One potential advantage of vacuum-formed mechanical deformation is that the electrodes (or other energy transducers) are operated from a superficial position. This can make the thickness of the ablated tissue somewhat more uniform than with needle electrodes (at least ignoring the "bumps" caused by vacuum stretching). For example, a continuous sheet of healthy collagen tissue may remain beneath the lesion. Additionally or alternatively, this may also reduce the likelihood of introducing local defects (such as shape distortions or weak spots).

[0222] However, optionally or alternatively, the needle is operable to mechanically deform the tissue prior to providing energy via one or more surface-acting electrodes (or other energy transducers other than the needle itself) to plastically fix the tissue into a new shape. It will be appreciated that, particularly with respect to the embodiments described in which exposed surface-contact electrodes are provided (i.e., electrodes separate from the needle or other element for mechanically deforming the tissue), the electrodes used as transducers for introducing structurally destructive energy into the tissue may optionally be replaced with other types of transducers, for example, transducers that convert electrical energy from an electrical energy source into structurally destructive energy (e.g., acoustic energy, light energy, thermal energy, or other forms of energy).

[0223] In some embodiments, needles can be provided that can clamp together, slide linearly past each other, rotate, or otherwise move to compress and / or otherwise deform the tissue. Additionally or alternatively, the tissue is secured for deformation by one or more releasable hooks (e.g., hooks with reversibly expandable barbs and / or that enter the tissue along a path that curves at least partially proximally). When two or more hooks are bent in opposite directions, the minimum angle of curvature of each hook can optionally be reduced, for example, because when the hooks are pulled, the tissue resists deformation to a degree sufficient to slide over the hook ends. In some embodiments, straight hooks (which can be straight needles) are driven into the tissue in non-parallel directions (e.g., converging or diverging directions). For example, tissue is hooked by trapping a wider surface area of ​​tissue at a deeper, narrower point where the needles converge. Regardless of the degree of hooking and / or capture, the punctured tissue is mechanically pulled into a deformed position that is configured to contact an electrode that delivers structurally damaging energy. For example, the hook draws the tissue into a depression whose inner surface at least partially comprises the electrode surface area. Structural damaging energy is delivered through the tissue surface in contact with the superficially acting electrode surface area while the needle and / or hook acts on the tissue to mechanically deform it.

[0224] Guidance components and methods

[0225] According to some embodiments of the present disclosure, one aspect of some embodiments of the present disclosure relates to positioning and operating guide components of annuloplasty devices, and / or methods of using such components. In some embodiments, annuloplasty devices operate on the principle of tissue contraction by twisting / torsing (e.g., as described herein in conjunction with Figure 5A-11 Complete annuloplasty generally involves mechanical deformation and energy application at multiple sites around the annulus (referred to as treatment locations).

[0226] A potential advantage of annuloplasty devices operated via minimally invasive catheters is the inclusion of features that help the operator gain and / or maintain a clear understanding of the current state of the annuloplasty device itself and / or the positional relationship of the annuloplasty device to the treated annulus. Related tasks include, for example, one or more of the following:

[0227] • Bringing the annuloplasty device to the selected location around the annulus to initiate treatment, including ensuring the device is correctly positioned, eg, in the correct initial orientation and / or offset relative to the annulus.

[0228] • Moving the annuloplasty device between multiple treatment locations where it will be mechanically deformed and subjected to structurally damaging energies.

[0229] • At each such location, the annuloplasty device is appropriately positioned so that it is ready to begin at a predictable angle of insertion and / or to a predictable degree of mechanical engagement with the tissue of the annulus.

[0230] • Mechanical deformation by actually mechanically engaging the device with the tissue, optionally including verifying that the device is properly engaged.

[0231] • Performing mechanical deformation, for example by twisting and / or applying a vacuum, optionally including verification that the mechanical deformation occurred as expected.

[0232] • Applying structure-destroying energy to tissue, optionally including verifying that the tissue received the energy as intended, and / or that the tissue was destroyed as intended.

[0233] • Withdraw the device from the tissue and proceed to the next of multiple treatment locations.

[0234] Minimizing the complexity and / or uncertainty of each task has potential advantages. For example, task complexity can be minimized by reducing the number of degrees of freedom (e.g., degrees of freedom of device motion and / or device state) that are manipulated during the task. Other aspects that can reduce task complexity include narrowing the range of available degrees of freedom that need to be adjusted, sequencing the manipulation of degrees of freedom (e.g., one at a time), and / or "quantizing" one or more available degrees of freedom.

[0235] In this context, the term "quantified" should be understood to indicate that the implementation and / or sensing of device degrees of freedom allows the operator to select at least one clearly defined state; for example, needle fully retracted, needle fully advanced, needle unrotated, and / or needle fully rotated. Partial states can also be quantified through the use of sensing and / or mechanical methods (e.g., actuators). For example, a semi-rotated and / or semi-advanced needle state can be defined.

[0236] Quantification can be achieved by imposing physical constraints on the degrees of freedom themselves, such as by mechanical interference with stops and / or brakes (brakes define a region of increased resistance to motion, but not necessarily complete obstruction of further motion, which region is optionally transient). In this case, the operator does not need to make delicate judgments, such as whether sufficient twisting or longitudinal propulsion force is being applied. Instead, reaching the stop / brake (e.g., sensing an increased resistance to further twisting / propulsion) may be sufficient to provide an indication. Additionally or alternatively, sensing and / or indication (e.g., electronic sensing and / or indication) can be used to detect and / or indicate to the operator the state of the device degrees of freedom.

[0237] In some embodiments, the annuloplasty device is configured so that it tends to follow a path around the annulus when advanced using a certain degree of control freedom. For example, as the device is advanced from the constraint of an outer sleeve, its distal portion can bend in a predetermined manner. The curvature can be selected so that the tip of the device is directed to different areas around the circumference of the annulus as the control freedom is activated. In some embodiments, the degree to which the tip of the device bends toward the plane of the annulus can also be preconfigured, for example, starting from a position outside of that plane (e.g., from the insertion point at the fossa ovalis of the atrial septum into the left atrium). With this configuration, the problem of positioning the device relative to three-dimensional space can be greatly simplified to a problem of advancement or retraction. However (e.g., to allow for fine-tuning), one or more additional operable controls can be provided to modify the path (position) of the device tip.

[0238] The sensing itself need not be quantified. However, it is potentially advantageous to have at least a "yes / no" type indication (e.g., a light that is on or off) to assist in immediate decision making. Additionally or alternatively, a graded indication of the sensed state is provided, for example, a gradual change in intensity and / or color of light as the sensed attribute changes. The sensed attribute may include the distance and / or angle at which the device is actuated; for example, by using electrical contacts and / or sensing a resistance that varies with movement. Additionally or alternatively, the sensor may be configured to measure local electrical impedance, which has potential use in confirming whether the needle head is inserted into tissue and / or the state of the tissue when providing structurally damaging energy to the tissue.

[0239] In some embodiments, the annuloplasty device includes one or more elements that facilitate visualization via imaging modalities such as X-ray and / or ultrasound. For example, the annuloplasty device may be provided with one or more radiopaque markers whose shape and position assist in determining the orientation of the annuloplasty device tip. This may help ensure that the annuloplasty device tip is inserted at a preferred angle. For example, the preferred angle may include two needles of the device defining an axis therebetween that is oriented at an angle of inclination to the circumference of the annulus. The angle of inclination is approximately half the total amount of angular change that the needles undergo when deforming the annulus by twisting the tissue. For example, the needles are first twisted by the amount of the inclination angle until the needles and the axis therebetween are oriented perpendicular to the circumference of the annulus; and then twisted again by approximately the same angle.

[0240] In some embodiments, the tip of the device is rotated in situ (e.g., when positioned within a cardiac chamber, adjacent to the valve to be treated) until two radiopaque markers mounted on opposite sides of the tip of the device reach a maximum or minimum distance apart (depending on the viewpoint and / or how the device is configured). This can be the operating direction of the device; or it can be used to calibrate the orientation of the device, from which an offset can be added to select a target operating direction. In some embodiments, when the operating direction is set, the direction of the axis extending between the needles of the device is at the aforementioned oblique angle to the circumferential direction of the valve annulus. Optionally, the needles change operating direction for different treatment positions, for example, to adjust the amount of contraction applied at each treatment position, and / or to adjust the overall shape of the valve annulus (e.g., to bend it more or less in a particular direction over a series of treatment positions). Optionally, the position of the needles relative to the radiopaque markers can also be visualized using fluoroscopy. This can be used to verify their relative state of advancement or retraction from the tip of the device, and / or their rotational state.

[0241] In some embodiments, one or more portions of the device tip are provided with structures that alter (e.g., increase) its ultrasound detectability; for example, acoustic scattering structures such as raised and / or embedded striations and / or indentations. Optionally, these structures vary on different portions of the device, e.g., varying along its elongated longitudinal extent and / or varying around certain portions of its periphery. Contrasting structures may help distinguish (by ultrasound) the orientation of the device (e.g., relative to the ultrasound transducer, and the transitional orientation relative to the valve annulus by knowing the position of the ultrasound relative to the heart). They may help distinguish, for example, the device housing and / or needle from the rest of the device.

[0242] Optionally, the device tip is configured to enhance ultrasound ("echo") visualization based on the extrusion of fluid into the surrounding blood. In some embodiments, the device tip is supplied with fluid (e.g., infusate) from the proximal end through the lumen. The flow of droplets at the device tip can be discerned by ultrasound, thereby enabling visualization of the position of the device tip.

[0243] In some embodiments, bioimpedance is measured during the procedure. This can be used, for example, to assess device contact with the annular tissue, needle penetration of the annular tissue, and / or tissue damage caused by application of structurally damaging energy. Alternatively, it can be used to confirm that the tissue being contacted, penetrated, and / or damaged is indeed annular tissue (e.g., as long as the bioimpedance of the tissue is different from that of other nearby tissues (e.g., leaflet tissue and / or myocardium)).

[0244] Angle of approach

[0245] One aspect of some embodiments of the present disclosure relates to operating an annuloplasty device using needle puncture followed by mechanical deformation and structure-destructive energy application, such that the needle approaches (and then punctures) the valve annulus from a direction directed largely outward from the center of the annulus, and possibly to a lesser extent from a position above or below the periphery of the annulus.

[0246] As a reference frame, the direction from the location where the needle penetrates the annulus to the geometric center of the annulus can be set to 0° (the "shallowest" angle). The orthogonal direction at 90° / -90° (the "steepest" angle) represents the direction pointing "upward" or "downward" away from the valve periphery. The "upward" or "downward" direction can be orthogonal or nearly orthogonal to the mean plane of the annulus (or more specifically, the mean plane of the valve periphery). The mean plane is optionally defined as having the shortest average distance from the annulus periphery (e.g., measured from the middle of the annulus thickness or other reference position). For example, in the case of the mitral valve, "upward" typically points to the left atrium and "downward" points to the left ventricle. In some embodiments, the needle is oriented relative to the angular axis so that it punctures tissue within a range of ±55°. For example, when approaching the mitral valve from within the left atrium (e.g., after insertion into the left atrium from the fossa ovalis and the atrial septum), the needle punctures tissue within a range of 0° to 55°. In practice, there may be a lower limit to the approach angle, for example, a lower limit within the range of about 20°-30°. Alternatively, other angle ranges are used, for example, a range limited to shallower angles (for example, within the range of ±50°, ±45°, or ±40°), or a range that includes steeper angles, for example, within the range of ±60°. In some embodiments, the approach angle varies slightly depending on the circumferential position of the treatment location, with the shallowest angle not exceeding about 15°, 20°, 25°, or 30°. The slope of the steepest angle optionally does not exceed 45° and / or 60°. The range of 30°-40° can be considered "typical", for example, in some embodiments, at least half of the treatment area is approached at an angle within this range.

[0247] A potential advantage of using a shallower approach angle is that the device is less likely to accidentally slide off the periphery of the annulus as it is pressed into the annulus. In addition, a shallower approach direction may help ensure that the puncture enters a relatively thick portion. This may reduce the risk of damaging other tissues and / or allow more annular tissue to participate in the changes caused by the annuloplasty. In addition, a potential advantage may be that a shallower approach direction (e.g., from the atrial side of the mitral valve) may make it easier to slide over the leaflets rather than end up being inadvertently pressed against the leaflets. This may reduce changes that damage the leaflets.

[0248] In certain embodiments (e.g., as described elsewhere herein), the needle may also engage the valve annulus so that the axis extending therebetween is in an oblique orientation to the valve periphery, for example, at an angle of approximately 45° in a direction extending up and down the valve periphery. In this case, a 90° rotation would result in a final orientation also tilted by approximately 45°, preferably after passing a position perpendicular to the axis of the valve periphery and in a direction extending up and down the periphery. This is typically not a vertically upward and downward orientation, as the inclination of the axis in the radial direction depends on the shallowness of the approach angle as described above. Other explanations herein relate to these same considerations, but employ different descriptive approaches. These explanations should be understood as involving mutually consistent conditions, at least insofar as one of the explanations can clarify how to understand the other explanation in the event of substantial doubt about some aspect of the latter. Furthermore, these descriptions may be combined (e.g., with respect to the specific angular ranges mentioned and / or entities defined).

[0249] Optionally, the tilt angle can be selected to be greater or less than 45° relative to the periphery (i.e., before the total rotation is greater or less than 90°). Optionally, the arc of rotation is not equal on either side of the periphery's perpendicular axis, i.e., the midpoint is not necessarily perpendicular to the valve periphery. "Asymmetric" rotation in this sense can be selected to potentially adjust how annuloplasty affects the planar curvature of the valve, for example, to bend it toward a more or less planar configuration.

[0250] Similarly, the direction of twisting, either clockwise or counterclockwise, is not necessarily chosen equally at all treatment positions. For example, opposite directions may optionally be chosen, particularly for pairs of treatment positions located on either side of the (expected) leaflet coaptation site. For example, although the tissue on opposite sides may be slightly stretched, the leaflet roots below the treatment position are still pushed toward each other. Even then, as long as some tension may remain on the "stretched" side even after plastic remodeling due to the application of structurally destructive energy, and / or tension may be generated during later recovery, there is still a potential advantage of further improving the mechanical stability of the coaptation (particularly at the site marking the boundary between the leaflets). It is also not excluded that in certain embodiments, effects associated with the (at least initially) "stretched" side may be optionally induced on one side of the leaflet root. For example, this may reduce expansion deformation, and / or help smooth the root region near the site where coaptation occurs (or almost occurs). Potentially, controlling the pattern of clockwise or counterclockwise twisting may promote expansion and / or contraction of the leaflet shape, and / or the degree of fluctuation around the valve periphery (i.e., the degree of fluctuation of the valve circumference within and outside the mean valve plane). Larger fluctuations may be selected to potentially increase effective circumference shortening, but any such distortions should generally be controlled so as not to compromise overall function (eg, valve coaptation).

[0251] In some embodiments, the treatment location is positioned relatively toward the outer or inner edge of the annular periphery of one or more leaflets (i.e., toward or away from their coaptation edges). This may help to tailor the effect of the annuloplasty on the shape (and coordinated coaptation) that the leaflets assume during the cardiac cycle. In this regard, it is noteworthy that the specific positioning of the needle relative to the periphery midpoint and / or the shallowness of the angle of approach to the annulus can modulate the extent to which the leaflet roots are recruited to the torsion zone and, therefore, may also be expected to have an effect on coaptation. The discussion of the potential effects of treatment site selection, torsion arc (amount and / or orientation of twist), and / or direction of twist on coaptation and / or other therapeutic effects should not be viewed as a commitment to a particular theory, but rather should be viewed in conjunction with (i.e., for some embodiments of the present disclosure, built upon) other discussions of the effects of annuloplasty presented herein, without necessarily being limited or restricted by the teachings of such discussions.

[0252] Before explaining at least one embodiment of the present disclosure in detail, it should be understood that the application of the present disclosure is not necessarily limited to the construction and arrangement details of the components and / or methods described in the following description and / or shown in the accompanying drawings. The features described in the present disclosure (including the features of the present invention) can be applied to other embodiments or can be implemented or carried out in various ways.

[0253] Vacuum-attached annuloplasty device

[0254] Reference Figure 1A , which is a schematic diagram of a cardiac annuloplasty device 100 operable to shape annular valve tissue using vacuum, according to some embodiments of the present invention. In some embodiments, the annuloplasty device 100 includes a tip 13 (which includes an electrode 10) and a chamber 12. The chamber 12 is open at the distal end. In addition, the chamber 12 can be selectively pressure-connected to a vacuum source 35 through a lumen of a catheter 15. For example, the selection can be made by operating an (optional) valve 34, by operating a valve (not shown) of the vacuum source 35, and / or by activating the vacuum source 35 itself. In some embodiments, the valve 34 is part of the handle 25. In some embodiments, the handle 25 includes appropriate through-conduits and valves to allow independent guidance of electricity and vacuum.

[0255] An electrode 10 is also disposed at the distal end of the tip 13. The electrode 10 is in electrical communication with a radio frequency (RF) generator 33 via a conductive wire 17 and an optional impedance matching module 31 (ie, receives electrical energy for inducing fibrosis formation).

[0256] In some embodiments, steering of the catheter 15 (ie, steering the tip 13 into apposition with the target region of the annulus prior to inducing fibrosis) is accomplished via a steerable guide sheath 19 .

[0257] Alternatively or in addition, the catheter 15 itself includes a steering mechanism. Optionally, the guide sheath 19 is omitted in such embodiments. The handle 25 optionally includes controls for steerable guide sheath 19 and / or catheter 15.

[0258] Optionally, one or more sensors 11 are located at the tip, which can be connected back to an optional sensor controller 36, for example, via additional wires 17. In some embodiments, the sensor 11 comprises a pressure sensor that can be used to detect positive engagement with tissue. Optionally, the RF generator is controlled (e.g., an interlock control) based on sensing the pressure generated at the tip 13 (which corresponds to positive vacuum engagement with tissue). The pressure and / or flow sensor can be located at another location in pressure communication with the vacuum compartment; for example, along the catheter 15, in the handle 25, with the valve 34, and / or as a component of the vacuum source 35.

[0259] In some embodiments, sensor 11 comprises a temperature sensor, the output of which can also be used to assist in controlling the operation of RF generator 33 to activate electrode 10. In some embodiments, sensor 11 comprises an impedance sensing electrode (and / or electrode 10 itself functions as an impedance sensing electrode), and the sensed impedance is used to assist in controlling the operation of RF generator 33. For example, when the sensed impedance does not reach or approach the expected level for collagenous annular tissue, RF power generation may be locked out and / or the device may enter a warning state. In some embodiments, the expected impedance is different from, for example, blood impedance and / or leaflet impedance. Furthermore, it should be noted that an applied vacuum can draw relatively thin, freely moving leaflets into cusps 13 to a greater extent than relatively thick, fixed annular tissue. In some embodiments, one or more sensors 11 within chamber 12 are used to detect this condition; for example, the sensors are placed in locations accessible to the leaflets but not to the annular tissue.

[0260] Now refer to Figure 1B , which according to some embodiments of the present disclosure, uses Figure 1A Schematic flow chart of a method for performing annuloplasty using the device 100 in FIG. Figures 1C to 1E , which schematically shows some embodiments of the present invention, Figure 1A Operation of the device 100 in.

[0261] In some embodiments, at block 110, the apex 13 of the annuloplasty device 100 is pressed against target tissue (eg, heart valve annulus tissue 200) to induce fibrosis and contraction. Figure 1C The situation shown corresponds to Figure 1CThe tip 13 is shown (in cross section) against the tissue 8. In the example shown, the electrode 10 is located within the cavity 12. In certain embodiments, another relative positioning of the electrode 10 and the cavity 12 is provided, e.g., as in combination with Figure 4A and 4B As stated.

[0262] The pressure need not be high, or even constant (eg, to account for the motion of the heart), as long as it is sufficient at some point to allow for the operation of block 112, as described next.

[0263] Positioning of the tip 13 can also include adjusting its orientation relative to the circumferential and / or axial height axis of the valve annulus. When the electrode 10 (and / or the orifice passing therethrough) is relatively slender in one direction, the contraction produced in the treatment area may be greater (and / or more uniform or less uniform) in one direction than in another direction. This is potentially important for achieving predictable results. It can also be used for potential uses to adjust the outcome of the procedure. Directional adjustment helps to control this difference. In some embodiments, the adjustment is controlled by rotating the entire handle of the device. In some embodiments, the adjustment includes rotating a knob or other control element. It is important to note that the same fixed orientation of the device may be suitable for treating one area of ​​the valve annulus, but (depending on how the steering is performed) may not necessarily be suitable for areas away from that area along the periphery of the valve annulus, for example 90°. Providing specific controls to manage the rotation can help the operator track the status of the device. In some embodiments, a preferred steering method is selected to ensure that the tip maintains the same orientation regardless of which side of the valve the catheter is guided to. For example, it may be preferable to guide the catheter to the center of the valve, introduce a predetermined bend in the shape of the distal end of the apex, and then rotate the entire catheter while maintaining the same steering angle to select different peripheral regions. Then, by rotating the catheter a certain amount (e.g., by twisting its handle and / or operating controls thereon), the direction can be predictably adjusted to achieve its use, for example, as a means of controlling the amount of contraction produced along the circumference of the valve annulus.

[0264] In some embodiments, at block 112, a vacuum is applied to the cavity 12, for example, by the vacuum source 35 through the lumen of the catheter 15. This causes the tissue of the heart valve annulus 200 to be appropriately drawn toward the opening of the cavity 12, for example, as Figure 1D As shown in . Figure 1D , the vacuum force in cavity 12 is represented by arrow 35A, as a result of which the greater pressure existing outside cavity 12 forces tissue portion 8A of tissue 8 into cavity 12.

[0265] It may be noted that the resulting raised surface area of ​​tissue portion 8A is greater than the surface area previously located beneath cavity 12 (e.g., as shown in FIG. Figure 1C). This is not entirely due to deformation of the tissue beneath lumen 12; rather, the deformation is caused by tissue 8 beneath lumen 12 and in the vicinity thereof. Consequently, the surface of the vicinity of tissue 8 undergoes at least slight contraction, which in some embodiments constitutes part of the shape change caused by the ongoing annuloplasty procedure.

[0266] At block 114, in some embodiments, RF power is delivered through the annuloplasty device. More specifically, in some embodiments, RF generator 33 is activated; and / or a switch connecting RF generator 33 to electrode 10 via lead 17 is closed. In some embodiments, impedance module 31 is configured to match the impedance of RF generator 33 to the impedance of the subcircuit comprising lead 17 and electrode 10.

[0267] Radiofrequency energy is provided at a frequency that interacts with, and heats, tissue portion 8A and / or surrounding portions of tissue 8. The energy applied is sufficient to denature the tissue, having the effect of producing plastic deformation and / or contraction that remains in place after the vacuum is released and tip 13 is removed.

[0268] During the entire valvuloplasty procedure, Figure 1B Operations in (e.g., combining Figures 1C-1E The lesions in the row may be repeated multiple times, for example, to form a row or line of lesions 6 along the extent of the valve annulus 200 being reshaped and / or pliable. The lesions in the row may extend partially or completely around the valve annulus 200. Optionally, the lesions in the row are divided into multiple row segments, marked by relatively large lesion gaps between the row segments. Examples of lesions in the row are combined with (for example) Figures 2H-2J Described.

[0269] Now briefly refer to Figure 1F , which is according to some embodiments of the present disclosure, consisting of Figure 1A Schematic diagram of injury 6 produced by device 100. Figures 1D-1E The vacuum-induced bulge of the tissue portion 8A shown is retained in the form of an upward bulge 6E occupying the center of the lesion 6. A region 6F "outlining" the bulge 6E may also be produced, corresponding to where the distal surface of the tip 13 contacts the tissue 8. In addition, the lesion 6 generally extends outwardly along the surface 6C beyond the lesion 6. Figures 1D-1E The electrode contact area shown, for example, has a depth profile corresponding to area 6D. In some embodiments, the diamond-shaped protrusions of lesion 6 correspond to the shape of the lesion formed by the annuloplasty device 100, such as Figures 3A-3CAlthough contraction may occur in and / or toward the center of the lesion 6 from all directions, greater relative contraction may occur by tissue moving in the direction of arrow 201 toward either long side of the protrusion 6E. Potential reasons for this have been discussed (e.g.) Figures 3A-3C Described.

[0270] Reference Figure 2A , which is a photograph of a lesion 6 created in vitro in the tricuspid valve of a porcine heart using the device 100 according to certain embodiments of the present disclosure. More specifically, the lesion was created using the annuloplasty device 100 with the cusp 13, as combined with Figures 3A-3C As described. Damage 6 is based on Figure 1B 2. The method of FIG. 2 produces a pattern in tissue 8, more specifically in the region of annular tissue 200, which is part of a heart valve 202. The shape corresponding to protrusion 6E and the surrounding contour 6F is clearly visible.

[0271] Now refer to Figures 2B-2E , which is a pre-lesion image of the lesion 6 region created in vitro in a porcine tricuspid valve using the device 100 according to some embodiments of the present disclosure ( Figure 2B 、 2D ) and after injury ( Figure 2C 、 2E ) photos. Figure 2B The 4mm scale bar shown also applies to Figures 2C-2E The fiducial marker 207 itself in each figure spans 4 mm. Figure 2B 、 2D In the figure, the dotted lines 208A represent Figure 2C 、 2E The surface width of the pre-injury tissue is shown in . Figure 2C 、 2E In FIG. 6 , dotted line 208B shows the corresponding post-lesion width of the area marked by line 208A. Lesion 6 occupies the middle of the contraction region and its features can be seen similar to those of Figure 1F The illustrated protrusion 6E (approximately 2.3 mm wide and 4.3 mm high) corresponds to the contour 6F. The damage range corresponding to the surface range 6C of the damage 6 can be determined as the range of the area around the central protrusion where the glossiness is reduced and the color is slightly changed.

[0272] In such Figures 2A-2F In the example performed, the relative shrinkage of the area corresponding to line 208A was determined to be in the range of 20.5% to 26.5%, corresponding to an absolute nominal shrinkage of 1.2-2.1 mm (also depending on the overall size of the affected area). The ablation power used was 8 watts and the duration was 18 seconds.

[0273] Now refer to Figure 2F, which is a photograph of an incisional lesion 6 created in vitro in the tricuspid valve of a porcine heart using the apparatus 100 according to some embodiments of the present invention. Further reference is now made to Figure 2G , which schematically depicts a schematic diagram of a circuit according to some embodiments of the present invention. Figure 2F For clarity, Figure 2F Only the contour lines 210 and 212 are shown. These contour lines can be used to help locate and identify Figure 2G Features marked in .

[0274] The tricuspid valve element shown in the photograph corresponds more generally to heart valve 202 .

[0275] Lesion portion 6B comprises approximately half of the raised portion of lesion 6 located on one side of a slit 216 made through lesion 6 (as shown, on the upper side) roughly along a line corresponding to line 208B in 2C and 2E. Lesion portion 6A corresponds to the other half of the raised portion of the lesion. Looking down at slit 216, the relatively dark and / or shiny slit walls 214 correspond to areas of undamaged tissue. The lighter and / or less shiny area 6D shows a profile of the depth of the lesion through the exposed cross section, which has a width of approximately 7.2 mm and a depth of approximately 1.5 mm from surface 2C. The raised portion of lesion 6B is approximately 1.5 mm above surface 2C. Contour lines 212, 212 roughly outline (on either half of the cut lesion) the surface extent of the lesion, corresponding to Figure 1F Surface 6C of the overall damage 6 is shown in FIG. 215 . Region 215 includes the exposed bottom of slit 216 .

[0276] Reference Figures 2H to 2I , which is a photograph of a row of lesions 6 created in vitro in the mitral valve of a porcine heart using some embodiments of the present disclosure. See also Figure 2J , which is a cross-sectional photograph of a row of lesions 6 created in vitro in the mitral valve of a porcine heart using the device 100 according to some embodiments of the present disclosure.

[0277] The mitral valve element shown in the photograph more generally corresponds to a heart valve 202, for example, annulus 200 is an annulus of the mitral valve. Lesion 6 corresponds to a lesion formed at a power of 8-12 watts within 12-18 seconds. Typically, shorter times correspond to higher powers, such that the total energy used is approximately constant, ranging from about 144 joules to about 162 joules.

[0278] In the example shown, the long axis of each lesion 6 is along the axis of blood flow through the valve. Optionally, the lesions are placed side by side with the raised protrusions having a spacing of about 2 mm (e.g., about 85% of the width of a single protrusion). Alternatively, larger or smaller spacings may be used.

[0279] The depth of the damage can again be seen at the depth of the relatively shallow region 6D extending laterally above the darker region 215, which itself is at Figure 2J Shown above the slit bottom 215.

[0280] However, there is no particular requirement that the resulting lesion be continuous.

[0281] In this example, the lesion region 6C is substantially continuous. Placing the lesion region 6 at least close enough to allow the affected tissue areas to come into contact helps ensure that the greatest degree of contraction occurs in a specific circumferential portion of the annulus 200. However, this is optional, depending, for example, on whether the full extent of available annular remodeling is required to ensure coaptation. It is important to note that annuloplasty can be intended to specifically reduce the annular circumference in the area bridging the two malapposed leaflets, while reducing the annular circumference in other areas may not be effective in reducing regurgitation.

[0282] Diminishing benefits are expected for lesions that are located close enough to produce "double lesions" (multiple exposures to heating levels sufficient to induce fibrosis) with areas shared between lesions. The benefits are diminishing, at least currently, because lesion shrinkage is a function of changes, including shrinkage of the tissue itself, that do not add up with repeated treatments. However, as lesions are spaced closer together, vacuum-induced shape changes (e.g., shrinkage of the surface area represented by the bulge) may lead to further reductions in valve circumference.

[0283] Now refer to Figure 3A , which is a schematic diagram of the distal end of the heart valve annuloplasty device 100 according to some embodiments of the present invention. Figure 3B , which is a schematic diagram of a distal end view of the tip of a heart valve annuloplasty device 100 according to some embodiments of the present invention. Figure 3C , which is a schematic diagram of a handle and connection area of ​​a heart valve annuloplasty device 100 according to some embodiments of the present invention.

[0284] use Figures 3A-3C Designed annuloplasty device to produce Figures 2A-2J The damage shown and / or described in. Figure 3A, the distal end of the catheter 15 is shown, along with the adhesive 14 used to secure it to the tip 13. The tip 13 is generally frustoconical in shape, with an initially circular cross-section that narrows slightly in diameter from proximal to distal. Furthermore, toward the distal side, the cross-section flattens on two opposing sides so that the tip 13 terminates with a rectangular cross-section having completely rounded corners (i.e., the rounded portions of the perimeter meet each other on the short sides of the rectangle). In some embodiments, the tip 13 is made of PEEK or other materials (e.g., other polymers) that provide good electrical insulation and heat resistance. Improving the properties of one or both of the materials can result in a relatively thin wall for the tip 13, thereby potentially reducing its overall size.

[0285] Embedded within the distal cross-section of tip 13 is a similarly shaped (but smaller) electrode 10, which is open at its center to provide access to chamber 12. The internal bore through electrode 10 is approximately 2 x 4 mm. In some embodiments, electrode 10 has a wall thickness of, for example, approximately 0.5 mm and a wall height (extending proximally) of approximately 1 mm.

[0286] The inner hole may be slightly smaller than the actual lesion bulge 6E (e.g., 2.3 x 4.3 mm), possibly due to slight relaxation of the injured tissue after the vacuum is released. The wall thickness of the electrode 10, together with the surrounding wall thickness of the tip 13, helps determine the size of the perilesion region 6F.

[0287] Figure 3A The inner hole shape of the middle electrode 10 has an elliptical aspect ratio (aspect ratio > 1, e.g., approximately 2). An aspect ratio greater than 1 may help promote greater relative shortening of the annulus in the short dimension compared to the long dimension. For example, in the short dimension, if the penetration depth of tissue portion 8A through a circular cross section under vacuum is approximately 2 mm, the ratio of the bulge circumference to the bulge width is approximately 1.6. Along the long dimension, this ratio (assuming a quarter-turn circle at either end) is closer to 1.3. As a result, less remodeling is required per unit length in the longitudinal direction to produce a given shape. This can be helpful, for example, when the long axis of the inner hole of the electrode 10 is oriented along the direction of blood flow through the valve, in which case the annulus is shorter than its length around its circumference. This may help, for example, to reduce deformation in this direction due to uneven contraction, where the overall distance is smaller to "smooth out" such differences. It should be noted that the actual overall contraction ratio achieved may be somewhat less than just described, for example due to post-treatment relaxation and / or the presence of portions of the lesion outside the bulge.

[0288] The rounded corners of the inner hole of the electrode 10 provide the potential advantage of allowing tissue to be smoothly pulled into the cavity 12 under suction. For example, the cutting and / or compression of the invading tissue at the corners of the hole can be reduced.

[0289] Figure 3BIn the proximal end view of the tip 13 shown, a portion of the lead 17 is shown as comprising a coiled multi-strand cable; this cable is connected (e.g., crimped, welded, and / or welded) to the remainder of the lead 17 at the proximal end via a connector 17A. Distally, the lead 17 is attached (e.g., crimped, welded, and / or welded) to an extension 10B, which may be integrally formed with the electrode 10 (e.g., cast together with the electrode 10 and / or cut from the same billet). Alternatively, the extension 10B itself is attached to the electrode 10 but is formed separately.

[0290] Figure 3C The proximal portion of the annuloplasty device 100 is shown, including the handle 25. The handle body 300 is sized to fit in the hand. The knob 301 can be used to adjust (e.g., with a finger) an adjustable valve that controls whether a vacuum is currently being applied to the cavity 12. In some embodiments, the vacuum is received from the vacuum source 35 via a conduit 35B. An isolation valve 302 attaches the conduit 35B to the handle body 300; for example, to the proximal side of the handle, or other convenient location that does not obstruct the conduit when operating the handle 25. The isolation valve 302 also allows the wire 17 to pass through on its way to connecting the wire 17 to the RF generator 33 (e.g., via the impedance module 31). A handle having these (and optionally additional) features is optionally provided with the annuloplasty device 100 (e.g., Figures 4A-4B Any embodiment of the device).

[0291] Now refer to Figures 4A-4B , which schematically illustrates the distal end of the annuloplasty device 100 according to some embodiments of the present disclosure, wherein the vacuum attachment element 403 is in an advanced ( Figure 4A ) and retraction ( Figure 4B )Location.

[0292] Generally speaking, Figures 4A-4B The annuloplasty device 100 includes Figure 1A The features of the annuloplasty device 100 are generally described and described in accordance with Figure 1B The method is usually used as described. However, with (for example) Figures 3A-3C In contrast to the embodiment of the present invention, the electrode 10 and the cavity 12 are movable relative to each other. In the example shown, the cavity 12 is defined by a movable element 403 that can be longitudinally translated relative to the electrode 10 along the proximal to distal axis.

[0293] When advanced distally, the vacuum applied to the cavity 12 will hold the adjacent tissues in place. Figure 1BAs described in block 110 in FIG. 1 . An additional operation may then be performed, whereby the element 403 is withdrawn proximally. As a result, the secured tissue will be pulled deeper into the tip 13, into the recess 402 which is slightly larger than the element 403. In fact, withdrawing the element 403 may allow for a greater pull than the tip 13. Figures 3A-3C The grooves 402 can optionally be in the form of slits so that the tissue shape along one axis is relatively less constrained even if the tissue shape deforms more along another axis.

[0294] In some embodiments, the electrode 10 extends from the distal region where it contacts the tissue to the groove 402. Thus, lesions can be made along the contact of the electrode 10 with the deformed tissue, which contacts are located substantially anywhere outside of the cavity 12. This can result in the formation of lesion protrusions that appear like squeezed wrinkles or folds in the tissue, e.g., when moving along the periphery of the valve, the protrusion protrudes relatively steeply above (and above) the base surface, but when moving along the axis of blood flow, the protrusion protrudes more gradually, e.g., as shown in FIG. Figure 4C shown.

[0295] Now refer to Figure 4C , which schematically illustrates some embodiments of the present disclosure. Figures 4A-4B The damage 6 caused by the device 500.

[0296] Damage 6 may be more Figure 1F 10. It is shown slightly higher in the fold. It may be covered by a nodule 6G formed by tissue that has completely withdrawn into the chamber 12 itself, and even though the tissue is not in direct contact with the electrode 10, it may still be damaged (and therefore plastically deformed). The surface of region 6H (surrounded by surround 6I) is mostly in direct contact with the electrode 10 when damaged; the tissue in nodule 6G is subject to traction, which pulls it into contact with the electrode 10, but it is not itself directly subjected to the vacuum. Region 6I constitutes the rest of the fold. It may include a mixture of damaged tissue (closer to the center) and non-damaged tissue (periphery), the latter of which is passively pulled into a new shape due to the traction of other collapsed areas. Region 6C shows that the damaged surface may extend significantly beyond the range of direct contact with the electrode 10. Cross-sectional views of the front and side of region 6D show the depth of the damage.

[0297] This "folded" shape of the lesion shape has the potential advantage of allowing for greater changes in the annular circumference overall and / or concentrating changes in the valve circumference in particularly important areas, such as at and / or around the junctions between the leaflets.

[0298] Annuloplasty device utilizing rotational deformation

[0299] Now refer to Figure 5A, which is a schematic illustration of a heart annuloplasty device 500 operable to shape annular tissue using needle puncture and twisting, according to some embodiments of the present disclosure.

[0300] In some embodiments, annuloplasty device 500 includes a tip 501 including a needle electrode 20, which is optionally recessed until it extends from tip 501. Needle electrode 20 is in electrical communication with (i.e., receives RF power from) a radiofrequency (RF) generator 33 via a conductive wire 17 and an optional impedance matching module 31. In some embodiments, needle electrode 20 is stabilized to allow it to exert a torque sufficient to deform annular tissue without excessively deforming itself. For example, needle electrode 20 is mounted on a mounting block 21. Mounting block 21 can maintain a fixed distance between the needle electrodes while allowing them to rotate about a common axis. In some embodiments, needle electrode 20 rotates under the control of control member 18 (e.g., a controller on handle 25). For example, control member 18 can pull on mounting block 21 to rotate it. Alternatively, the functions of control member 18 and wire 17 can be combined. Driving needle 20 to rotate can utilize mechanical advantage, such as through a gear, lever, and / or pulley mechanism. The mechanism may be embedded in the tip 501 itself, may be embedded in a mechanism of the handle 25, and / or may be distributed; for example, a pulley mechanism may be provided that includes a multi-section control member 18 that moves up and down the catheter 15 to obtain a mechanical advantage.

[0301] In some embodiments, handle 25 includes appropriate controls to mechanically manipulate the needle electrode, eg, to extend or retract the electrode, and / or to rotate the electrode about the longitudinal (proximal-distal) axis of tip 501 .

[0302] In some embodiments, the catheter 15 is steered (i.e., the tip 501 is oriented to align the tip 501 with the target area of ​​the valve annulus prior to treatment) by the steerable guide sheath 19. Alternatively or in addition, the catheter 15 itself includes a steering mechanism. Optionally, in such embodiments, the guide sheath 19 is omitted. The handle 25 optionally includes controls for steering the steerable guide sheath 19 and / or the catheter 15.

[0303] Optionally, one or more sensors 11 are provided on the tip 501 and are optionally connected to a sensor controller 36. The sensor controller 36 is operable to assist in controlling the operation of the RF generator 33 to deliver power to the needle electrode 20. The sensors 11 can, for example, sense temperature and / or impedance. The control of the operation of the RF generator 33 can be influenced, for example, by combining Figure 1A As stated.

[0304] Now refer to Figure 5B, which is according to some embodiments of the present invention, using Figure 5A Schematic flow chart of a method for performing annuloplasty using the device 500. Figures 5C to 5F , which schematically illustrates some embodiments according to the present disclosure, Figure 5A Operation of the device 500 in.

[0305] In some embodiments, at block 510, the tip 501 of the annuloplasty device 500 is pressed against the tissue to be contracted (eg, heart valve annulus tissue 200). This corresponds to, for example, Figure 5C The situation shown, Figure 5C The tip 501 is shown (in cross-section) positioned against tissue 8. In the example shown, the electrode 20 is recessed within the housing of the tip 501, for example, mounted on a retractable mounting block 21. In some embodiments, the mounting block 21 can also be rotated under the control of the handle 25. This tip configuration can be combined with other tip configurations (for example) Figures 7A-7E , 8A-8B and 10A-10C are described.

[0306] Optionally, in some embodiments, at block 512, the needle electrode 20 is extended into the tissue 8. In some embodiments, this corresponds to Figure 5D The situation shown, where the needle electrode 20 is inserted into the tissue at position 20A (for Figure 5D-5G For clarity, the rest of the annuloplasty device is omitted). In some embodiments (e.g., as in combination with Figure 11 The inserted element manipulates the tissue mechanically but does not itself deliver RF energy, e.g. in combination with Figure 11 In some embodiments and / or uses, the needle electrode 20 is not retracted or remains extended, and block 512 is optional. However, there are potential advantages to having the needle electrode retractable during guidance and / or positioning (e.g., positioning of block 510).

[0307] In particular, once the needle electrode 20 is inserted into the tissue, any outer shell of the tip 501 is not necessarily required to remain in direct contact with the target area; for example, it can be slightly withdrawn while at least a portion of the needle electrode 20 remains in place. This can be used, for example, to adjust the depth of the lesion.

[0308] At block 514, a torsion (twist) is applied to the tissue 8 by the needle electrodes 20, for example, causing portions of the tissue 8 to rotate up to about 60°-120° about the proximal-distal axis of the tip 501. In some embodiments, the needle electrodes 20 themselves also rotate; for example, they can rotate about a common center. Alternatively, in some embodiments, the needle electrodes 20 do not rotate, but rather translate (e.g., relative to each other). However, they translate in a manner that induces torsion in the tissue, for example, as combined with Figures 10A-10C As stated.

[0309] For example, the operation of block 514 corresponds to Figure 5E , wherein the needle electrode 20 moves from position 20A to position 20B, generally around a circular path as indicated by arrow 520. This creates distortions and "vortices" in the tissue 8 that tend to compress the tissue, e.g., as combined with Figure 5G A planar (eg, square) cross-sectional geometry of the needle electrode may aid in clamping the tissue to impart torsion, however, circular or other cross-sections may alternatively be used in some embodiments of the present disclosure.

[0310] In some embodiments, RF power is provided at block 516. RF power may include RF energy applied through the needle electrodes. In some embodiments, this corresponds to Figure 5F Figure 5 shows a situation where field lines 531 indicate RF transmission within an area where the RF transmission is sufficiently focused to induce damage. Dashed line 530 indicates the extent of the damage. The effects of the damage include converting transient deformations caused by distortion into more permanent plastic deformations (and net contraction). The damage itself may also cause volumetric contraction of the tissue.

[0311] The damaging energy used can be, for example, in the range of about 100-200 joules, such as 140-160 joules. Example power and time combinations within this range include, for example, 8 watts for 18 seconds, 10 watts for 15 seconds, and 12 watts for 12 seconds. Using relatively high powers may help to focus the damaging effect (e.g., to avoid energy loss due to thermal conduction). Conversely, using relatively low powers may increase the area of ​​effect without causing scorching.

[0312] Now briefly refer to Figure 5G , which is according to some embodiments of the present disclosure, consisting of Figure 5A Schematic diagram of lesion 7 produced by device 500 in FIG. The boundary of the lesion is delineated by dashed line 530. Punctures 20C represent damage left by needle electrode 20. In the figure, they are positioned to match needle electrode position 20B, but in reality, some recoil may occur as uninjured tissue attempts to return to its equilibrium state.

[0313] Arrow 535 indicates the direction of compression due to distortion. In most cases (but not limited to), compression may be manifested as wrinkled tissue surface. Volumetric effects of injury on tissue structure may also increase shrinkage. Arrow 535 is drawn transverse to the local direction of wrinkle 532, which is in the Figure 5G The indications are provided to illustrate how tissue can be deformed by torsion.

[0314] As the advancing tissue near each needle electrode 20 is compressed relative to the immobile tissue, some tissue "bunches" into wrinkles 532 in front of the rotating needle electrode 20. At this location, the longitudinal direction of the peaks and valleys of wrinkles 532 tends to be close to a tangent to a circle centered at the nearby needle electrode 20. Tissue stretched behind the needle electrode 20, while experiencing tension along the axis in the direction of the needle electrode 20, also compresses along a (roughly) orthogonal axis as it is partially stretched inward as it follows. At these locations, the orientation of wrinkles 532 tends to be more radial. It is noteworthy that the tension mechanism plays a significant role in shaping the deformation pattern generated by twisting (torsion); even some compression in the pattern may be attributed to tissue being subjected to tension in one direction, "pushing together" (e.g., wrinkling) along an orthogonal direction when tension forces it to realign. Even within the limits of material integrity, the compression mechanism is prone to unstable buckling (e.g., a slight bend may result in a larger structural weakness, leading to a greater degree of bending), whereas the tension mechanism does not suffer from this failure mode. This potentially improves the repeatability of torsional mode results and may help avoid "jumping" (and potentially disrupting control and / or "feel") that can occur when, for example, compressed tissue abruptly buckles into a new configuration.

[0315] The deformations produced in the tissue may favor torsional contraction (e.g., manifesting as tissue wrinkling) along a particular axis (anisotropy). This is particularly true locally and is more pronounced if the number of turns of the electrode needle is much less than a full circle (e.g., about 90° or less). For example, in some embodiments, wrinkle fans that "pull back" tend to distribute tension over a large area, which may include areas outside the ultimate injury. Wrinkles that "push forward" may tend to concentrate tissue distortion more locally. Thus, in some embodiments (e.g., for a twist of about 90°), the axis of greatest contraction is roughly parallel to an axis drawn between the start and end positions of each needle electrode. For example, in Figure 5G In this case, the horizontally extending axis may experience more contraction than the vertically extending axis.

[0316] Now refer to Figures 6A-6B , which according to some embodiments of the present disclosure, uses Figure 5A The device 500 was used to generate an in vitro injury in the pig heart 7 area before the injury ( Figure 6A) and after injury ( Figure 6B ) photos.

[0317] In this example, two dye-stained markers 612 and 611 are made on tissue 8 before the lesion is formed. Line 603 ( Figure 6A ) represents the distance between the dye-stained markers 612 and 611 before the damage is formed, and line 604 ( Figure 6B ) represents the distance between dye-stained markers 612 and 611 after lesion formation. A size difference of approximately 41%, or approximately 1.5 mm, was determined. This compares favorably, both relative and absolute, to contraction induced by, for example, vacuum traction, and may result in a lower-profile lesion (less protruding relative to surrounding tissue). A lower-profile lesion has potential advantages, for example, by reducing concerns about disrupting blood flow through the valve.

[0318] exist Figure 6B In the example, lesion 7 is located at the center of punctures 601 and 602, which are approximately 2.0 mm apart. The ablation was performed at a power of 8 watts for 18 seconds. The reference mark 207 indicates a scale of 4 mm (e.g., when combined with the Figure 6A when drawing a scale bar).

[0319] Figure 6B In an example, one of the electrode needles 20 that shapes the tissue before inducing fibrosis is stationary, while the other moves around the electrode needle along the periphery; for example, as combined with Figures 8A-8B This pattern of motion can help a user predict the eventual contraction pattern, since in actual use, users often rely on indirect visualization methods, such as X-ray and / or ultrasound images, which provide unclear and / or incomplete information about what is occurring. For example, one needle electrode can be visualized as if moving along a substantially straight line between its start and end points (even though it may actually be curved), while another needle can be visualized while stationary. This can give the device operator a clearer understanding in advance of how tissue will be dragged behind the moving needle electrode along a distance roughly equal to the start / end point distance, while tissue in front of it is compressed.

[0320] However, the final deformation mode may be combined with Figure 5G The wrinkle patterns described for the symmetrical distortions are so similar that they may be indistinguishable. For example, there is a relatively small wrinkle (alternating light and dark bands) extending out the top of the image. Closer to electrode puncture 601, a large wrinkle with a "push forward" compression characteristic appears to the lower right, extending to the left and between punctures 601 and 602 to connect with the compression wrinkle associated with puncture 602. The distorted tissue motion patterns that may occur in some embodiments of the present disclosure are also (for example) combined with Figures 6H-6Idescribe.

[0321] Brief Reference Figures 6C-6D , which are some embodiments according to the present disclosure, Figure 6B Before the incision of injury 7 ( Figure 6C ) and after incision ( Figure 6D )'s exterior photos.

[0322] Figure 6C Roughly reproduced Figure 6B , but the fiducial marker 207 has been removed from the frame. Cut line 613 indicates the resulting Figure 6D The depth of the lesion 6 can be determined by the depth of the less glossy portion of the tissue extending downward (eg, starting from approximately the location of the puncture 602).

[0323] Reference Figures 6E-6F , which is according to some embodiments of the present invention, using Figure 5A The device 500 was used to generate an in vitro injury in the pig heart 7 area before the injury ( Figure 6E ) and after injury ( Figure 6F ) photos. See also Figure 6G , which is according to some embodiments of the present invention, Figure 6F Photograph of injury 7 after incision.

[0324] Line 623( Figure 6E ) marks the distance before treatment between the dye colored markers 612, 611; the distance is also proportional to the 4mm wide reference mark 217. Figure 6E The relevant 4mm scale bar indicates the Figure 6F In the figure, line 624 indicates that the position indicated by puncture holes 601 and 602 is followed by Figure 5B After the same distance reduction, punctures 601 and 602 were approximately 1.8 mm apart. The average shrinkage across six such tests was approximately 2.5 mm, or 46% of the lesion width. The ablation power used was 8-10 watts, and the duration was 18-20 seconds.

[0325] exist Figure 6G , the slit opening area 615 separating the dye colored markings 611 and 612 indicates the depth of the lesion made in the tissue 8, in this case a dark area 614 visible at the center lower edge of the orifice of the slit opening area 615. The fibrotic area itself is slightly lighter in color than the surrounding darker areas, which are only partially affected by the treatment.

[0326] Now refer to Figure 6H , which indicates that according to some embodiments of the present disclosure, superimposed on Figure 6B Estimation of tissue motion and needle electrode position on lesion images.

[0327] Figure 6B The features shown in FIG6 (except that line 604 is hidden) are shown with an overlay. The overlay shows the original needle electrode position 602A, which moves along the connecting arc shown (dashed line) to the puncture position 602 during the rotation. Also shown are dashed outlines representing the original positions 611A and 612A of the dye-colored markers 611 and 612, respectively; the final positions of the dye-colored markers are also outlined.

[0328] Arrows 650 connect the multiple anterior and posterior positions. The reference frame for the rotation is the position of the puncture hole 601. For the purpose of assigning the relative arrangement of the anterior and posterior positions, the two images are aligned as if all rotations were performed around this point. Another rotation center is selected as the reference frame (e.g., Figure 6I ) are compatible with the same needle electrode position and the same anterior-posterior state, but the attribution distribution of motion differs.

[0329] Figure 6H The reference frame selection in is not the only one available (e.g., in combination with Figure 6I 602A, 602A.

[0330] In contrast, the tissue at outline 612 moves primarily upward and to the left in this reference frame. This can be partially explained by the tissue being compressed to the left by the needle electrode's movement, while the tissue further to the left is well supported, resisting its own movement. The tissue also undergoes some rotation here (explaining the upward movement), resulting in a partial contraction component orthogonal to the movement from 611A to 611. Tissue closer to the top (e.g., above dye-stained mark 612) remains relatively fixed (in this reference frame) due to the presence of the needle at puncture 601.

[0331] Now refer to Figure 6I , which means that according to some embodiments of the present disclosure, a needle is used to Figure 6B The motion of different reference frames is used to estimate tissue motion and needle electrode position.

[0332] In this case, the rotation center 651 selected for the before and after image alignment is the +-marked midpoint of the line segment connecting puncture holes 601 and 602. After rotating approximately 90° from positions 601B and 602B in the direction indicated by curved arrow 652, puncture holes 601 and 602 are shown in their final positions.

[0333] Profiles 611A and 612A with Figure 6H , and are reproduced rotated 180° for ease of explanation and visualization. Contours 611B and 612B are contours of dye-colored marks 611 and 612, according to their positions in (e.g.) Figure 6B The arrows 650 connect the front and back positions of the various points of the dye-colored marker outline. These arrows indicate the Figure 6H The specific motion directions and distances are different in the , which is due to the different reference frames chosen; the starting and ending states are the same.

[0334] In this reference frame, the motion is symmetrical, such that both needle electrodes are considered to move in the same clockwise direction about their common midpoint. Because the motion of the needle electrodes is symmetrical, the original positions of outlines 612A, 611A, 612B, and 611B (bottom) can be considered to be approximately repeated in a manner similar to that described above. In practice, deviations from symmetry may occur due to, for example, uneven distribution of forces exerted by tissue 8 itself.

[0335] The pattern shown particularly emphasizes how the tissue moves relative to the axis 653 that intersects the original needle electrode positions 601B, 602B. In the lower right quadrant, the tissue moves primarily to the left (and symmetrically, in the upper left quadrant, the tissue moves to the right). There is some (but relatively little) inward radial movement. In contrast, in the lower left corner, the movement is upward and to the right (slightly more upward), with radial movement dominating the circumferential deflection. The reverse movement is repeated in the upper right to complete the view. Considering the resulting net effect, there is significant inward movement toward the center of rotation 651 in all quadrants, but in the lower right / upper left quadrants, the movement is almost entirely horizontal, while in the lower left / upper right quadrants, the movement is approximately equally horizontal and vertical (with vertical slightly dominating). This suggests that tissue compression is strongest in the horizontal direction and weaker in the vertical direction.

[0336] In some embodiments, the resulting contraction anisotropy is controlled so that the maximum contraction occurs along the periphery of the annulus; for example, axis 653 is set so that rotation from positions 601B and 602B to positions 601 and 602 is symmetric about a vertical axis. In the case shown, for a movement through approximately 90°, there is an angle of approximately 45° from the vertical axis.

[0337] Now refer to Figure 7A 、 7Band 7D, which schematically illustrate the distal end of a heart valve annuloplasty device 500 in different operating states according to some embodiments of the present invention. Figure 7C and 7E , which schematically illustrate some embodiments of the present invention. Figure 7B and 7D The end view of the operating status of

[0338] In this embodiment of the annuloplasty device 500, the tip 501 includes a housing 505 that is attached to the proximal end of the catheter 15 and terminates in a frustoconical shape at the distal end. The distal surface of the tip 501 includes two slotted openings 702. Each slotted opening 702 extends along a portion of the outer circumference of the distal surface of the tip 501 and is wide enough to accommodate a needle electrode 20, such as Figure 7B shown.

[0339] exist Figure 7A In the embodiment, the needle electrode 20 is retracted, which can help guide the device to the treatment site, optionally up to and including placing the device against the target treatment site (i.e., corresponding to the Figure 5B 510).

[0340] exist Figure 7B In the embodiment, the needle electrode 20 extends (eg, corresponding to Figure 5B Each needle electrode 20 passes through its respective slot opening 702 and is located near the counter-clockwise edge of its slot opening 702 (the top needle electrode 20 is located on the left and the bottom needle electrode 20 is located on the right when viewed from the distal end). This also corresponds to Figure 7C The configuration is shown in a view looking proximally along the proximal-distal axis of the tip 501, which also shows the bracket 703 within the housing 505 of the tip 501, to which each needle electrode 20 is attached.

[0341] like Figure 7D As shown, the bracket 703 can be driven to rotate in the housing 505 (for example, under the control of the handle 25) to move the needle electrodes 20 to the opposite sides (clockwise edges) of their corresponding slot openings 702, which correspond to the views viewed from the proximal end along the proximal-distal axis of the tip 501. Figure 7E middle.

[0342] Figure 5B During the operation of frame 514, the support 703 and the needle electrode 20 supported by it are Figures 7B-7C and Figures 7D-7E This can cause the tissue to distort, for example by Figure 6B and 6FThe slit orifice 702 limits the range of rotational motion to approximately 90°, which has the potential advantage of providing repeatable effects, for example, reliable geometric effects (e.g., degree of contraction), and / or reliable performance (e.g., reduced likelihood of tearing, slipping, and / or excessive deformation).

[0343] In some embodiments, multiple annuloplasty devices 500 are provided (e.g., as a kit), each having a slot orifice 702 extending through a different full range of angles (e.g., to allow movement of the needle electrode 20 to be limited to approximately 45° to approximately 120°). Any suitable number of options may be provided, for example, between 4 and 8 options. This may facilitate tailoring the procedure to achieve a certain amount of annular contraction at each treatment site; for example, the surgeon may calculate the product of the number of treatment sites and the amount of contraction at each treatment site to arrive at a surgical plan that is both feasible and likely to produce the desired amount of remodeling. Additionally or alternatively, in some embodiments, the slot orifices 702 themselves are adjustable, for example, by rotating the two slotted plates relative to each other. Precise alignment of their slots may produce the maximum available slot orifice, or the slots may be slightly misaligned to limit the available range of motion. Optionally, slot alignment is set before the catheter is inserted into the target area. In some embodiments, slot alignment is performed by operation of a controller remote from the tip 501 (e.g., a controller that may be provided on the handle 25).

[0344] In some embodiments, the slotted aperture 702 is configured so that it is always sufficiently large, and the range of motion is selected to be smaller by other means. For example, a controller can be provided on the handle 25 that can be rotated to a specific position before insertion. After the needle is inserted into tissue at that angle, whatever rotational range remains in the slotted aperture 702 sets the available range of motion.

[0345] The slot opening does not necessarily have to participate in setting the rotation range, for example, as in conjunction with Figures 8A-8BThe type of embodiment described is described. Movement can be entirely determined by the operator's selection during rotation, or movement can be limited by stops on the control element and / or the controlled element. Using a stop that directly limits the movement of the needle electrode 20 (by contacting the needle electrode and / or the bracket 703 to which it is rigidly attached) has potential advantages, for example, as long as the distance allowed is not affected by the clearance that may be generated by the control linkage. In some embodiments, in addition to and / or in place of the slotted aperture, another stop element can be provided as part of the tip 501; for example, one or more internal protrusions that interfere between the housing 505 and the bracket 703, one or more internal protrusions of the housing 505 that directly interfere with the needle electrode 20, or other stop devices. The stop device can also provide tactile feedback to enable the operator to sense when the limit is reached. In some embodiments, one or more intermediate brakes are provided that allow tactile perception of the partial rotation state and / or provide confirmation that rotation is occurring.

[0346] It is important to note that the needle electrode 20 is electrically conductive and its movement can be verified by one or more electrical contacts made of sensing conductors electrically connected to the proximal side of the device, thereby providing a sensor switch that can be directly or indirectly coupled to the activation of an audible and / or visual indicator such as an LED. In some embodiments, rotation is sensed with a resolution capable of distinguishing one or more intermediate rotational states, for example, using a Hall effect sensor, multiple encoder contacts, a potentiometer (rotational variable resistor), or other methods.

[0347] It is worth noting that applying torque to the entire handle 25 may result in the transmission of distortion along the catheter 15; therefore, if additional torque is required in a particular situation, this option is still available, at least in principle, by bypassing the self-limiting mode of operation.

[0348] It should also be noted that the relative orientation of the axes extending through the two needles and the circumferential and / or axial height orientation of the annulus may optionally be adjusted in this manner, for example as part of adjustment thereof.

[0349] Now refer to Figures 8A-8B , which schematically illustrates the distal end of a heart valve annuloplasty device 500 in different operating states according to some embodiments of the present invention. Figure 9 , which is used in the process of in vitro injury of porcine heart valves according to some embodiments of the present invention Figures 8A-8B A photograph of a heart valve annuloplasty device 500 is shown.

[0350] In this example, the tip 901 comprises a cylindrical housing 905 that is proximally attached to the catheter 15 and is open distally. The electrode needle 20 has been shown extended, but may be retracted; for example, as in conjunction with Figure 5B Box 512 and / or Figures 7A-7E As described in the implementation method.

[0351] In some embodiments, rotation of the housing 905 relative to the support 902 (eg, under the control of the handle 25 ) changes the relative positions of the two needle electrodes 20 , optionally to any relative angle.

[0352] Figure 8A and 8B The difference between the configurations shown is a rotation of approximately 180°; alternatively, a different rotation may be performed, for example, a rotation within a range of 60°-120° (e.g., approximately 90°). In some embodiments, the needle electrode 20 within the lumen of the stent 902 is rotationally fixed; it is constrained by the lumen of the stent 902, but not necessarily rotated about its own axis through the lumen. The external needle electrode 20 (occupying the space between the stent 902 and the housing 905) can be attached to the housing 905 and move with its rotation (e.g., as shown), or the external needle electrode 20 can be attached to the stent 902. In the latter case, the housing 905 can be configured to rotate relative to the catheter 15 when the stent 902 rotates, so that the stent 902 and the housing 905 rotate together. Alternatively, the housing 905 can be designed as a cylinder without a raised portion for accommodating the external needle electrode 20, thereby allowing the stent 902 to be rotated eccentrically within the housing 905 to change the relative position of the needle electrode 20. Alternatively, the housing 905 may be rotated relative to the catheter 15 while the support 902 (and the needle 20 it supports) remains stationary.

[0353] It can be noted that in Figures 8A-8B In the embodiment, the center around which the needle electrode 20 rotates is actually also the center of one of the needle electrodes 20. For example, this embodiment is used to form Figure 6B Therefore, Figures 5D-5G In contrast to the example shown in , one needle electrode 20 (e.g., occupying puncture 601) can remain in place while another needle electrode 20 (e.g., occupying lesion 602) surrounds it, appearing as if the tissue is "wrapped" around the fixed needle. Because this causes different tissue movement relative to the reference frame of the fixed tissue, the appearance of the resulting wrinkle pattern may vary. For example, with puncture 601 as the center reference, puncture 602 appears to rotate around it counterclockwise.

[0354] Figure 9 A portion of an annuloplasty device 500 is shown, including the distal end and tip 901 of the catheter 15, with the needle electrode 20 extended and partially inserted into tissue 8, ready for twisting and lesioning. Several lesions 6 with diamond-shaped protrusions can also be seen nearby, each of which was formed individually by a different annuloplasty device 100.

[0355] Now refer to Figures 10A-10C , which schematically illustrates the distal end of a cardiac annuloplasty device 500 in different operating states according to some embodiments of the present disclosure.

[0356] In this example, the tip 1001 of the annuloplasty device 500 includes a housing 1005 that is proximally attached to the catheter 15 and has two straight slotted openings 1003 on its distal side through which the electrode needles 20 can be selectively retracted ( Figure 10A ) or stretch out ( Figures 10B-10C If not retracted, the electrode needle 20 remains extended. The two electrode needles 20 are located on opposite sides of their respective slot openings 1003.

[0357] Actuation of the device (e.g., by handle 25) swaps the two sides of the electrode needle 20. Although the movement of the electrode needle 20 is linear, the effect on the tissue is torsion. As the electrode needles 20 pass each other, an intermediate segment of linear compression combined with torsion occurs. Optionally, actuation is stopped at the intermediate position before applying structural damage energy.

[0358] Annuloplasty devices using surface electrodes

[0359] Reference Figure 11 , which schematically illustrates the distal end of a cardiac annuloplasty device 1100 according to some embodiments of the present disclosure. This example has a tip 1101 that separates the electrical energy conduction and tissue alignment functions. A needle 1102 moves within a slotted orifice 1104 of a tip housing 1105 (e.g., when a needle electrode is embedded in tissue, as described herein for needle electrodes). The needle 1102 closes from its initial separated position (the needle is positioned at the outer edge of the slotted orifice 1104) to Figure 11 The tissue into which they are inserted is also compressed and retains the compressed shape after the treatment-induced plastic deformation.

[0360] However, RF energy is delivered separately through the tissue via electrodes 1103. During operation, these electrodes maintain contact with the tissue surface adjacent to needle 1102. This separation has the potential advantage of avoiding the generation of the highest temperatures at the locations of greatest mechanical stress (which could weaken the tissue). This can allow for the application of greater compressive force; for example, shrinking a 5 mm wide area to 2.0-2.5 mm wide.

[0361] Another potential advantage of this approach is the decoupling of lesion geometry design from the design of the tissue-forming device. For example, the electrode needle creates a lesion along its penetration depth, while the surface electrode can be manipulated to create a more superficial lesion. This may also help the deeper tissue surrounding the inserted needle maintain its mechanical integrity during treatment, thereby inducing fibrosis more superficially.

[0362] Because surface electrodes do not need to bear mechanical stress, they can be very narrow (e.g., less than half a mm wide), which may produce correspondingly narrower lesions. Additionally or alternatively, the surface electrodes can be larger in width than the width that the needle electrodes are suitable for (together occupying half or more of the width of the probe-like object, their overall width can be (e.g.,) 4-7 mm). This may cause the current to be more evenly distributed over the area to be treated. This in turn may help to reduce damage caused by excessive local heating, and / or improve the uniformity of the damage produced. Hopefully, the energy applied (e.g., power or operating time) can be shorter. For example, this may be because (e.g.,) the contact surface is wider, the energy distribution is more uniform, and / or because there is less need to ensure that areas farther away from the probe-like object (e.g., 1 mm or so) are reached.

[0363] Constructing annuloplasty devices using rotational deformation

[0364] Now refer to Figures 12A-12B , which schematically illustrates a sheath 1200 of the tip 1300 of the annuloplasty device 500 according to some embodiments of the present disclosure. For example, the sheath 1200 may be used as Figures 7A-7E The components of the annuloplasty device 500 are provided and used in conjunction with a stent 702 .

[0365] In some embodiments, the housing 1200 includes a generally cylindrical body 1205 having a wall having an opening 1209 along one side that is open to a range of angles corresponding to the range of angles through which the needle 20 (e.g., a needle electrode) can rotate when installed (e.g., as in combination with Figure 13A The body 1205 comprises a non-conductive and preferably heat-resistant material, such as PEEK or other polymer materials.

[0366] In some embodiments, a sensing electrode 1206 is also provided that is electrically coupled to the annuloplasty device 500 (e.g., in conjunction with Figure 13A ) proximal sensing circuitry (e.g., Figure 5A12. The sensor controller 36 in FIG. In some embodiments, the sensing electrode 1206 is formed in the shape of a C-ring. In some embodiments, the sensing electrode 1206 is electrically coupled to the conductive strip 1207 (bridge) and the connector 1204 extending therefrom via a connector 1208. The connector 1208 can be secured, for example, using laser welding. Optionally, the sensing electrode 1206 and the conductive strip 1207 comprise stainless steel. The conductive strip 1207 can be positioned within a slot in the body 1205.

[0367] In some embodiments, sensing electrode 1206 includes one or more portions 1206A, 1206B, each portion having a surface positioned to contact needle 20 at certain locations within the range of rotation and / or longitudinal travel of needle 20 .

[0368] In some embodiments, the sheath 1200 includes one or more cavities 1210 sized and shaped to receive a portion of a radiopaque marker 1311 (e.g., Figure 13D In some embodiments, two cavities 1210 are diametrically positioned on the periphery of the housing 1200 .

[0369] Reference Figure 12C , which schematically illustrates a sheath 1200 of the tip 1300 of the annuloplasty device 500 according to some embodiments of the present disclosure. For example, the sheath 1200 may be used as Figures 7A-7E The annuloplasty device 500 of the embodiment of the present invention is provided with a component (corresponding to the housing 505) that includes a curved slot opening 1222 on the distal end face 1223 corresponding to the slot opening 702. The curved slot opening 1222 defines a track along which the needle 20 of the needle element 1301 moves. The width of the slot opening 1222 can be sized to the width of the needle 20 (e.g., approximately 0.4 mm), thereby providing some mechanical support to the needle 20 and helping to prevent it from breaking due to stress concentration at its connection to the base 1307 ( Figure 13A However, the slot aperture 1222 is preferably long enough so as not to restrict rotational movement by applying force to the needle 20 when the needle 20 is in the fully rotated position. Instead, the force is absorbed by the interference of a portion of the base 1307 (e.g., the contact area 1305) with the housing 1200.

[0370] Also shown are a distally tapered body portion 1224, a cylindrical body portion 1226, and a cavity 1228. Optionally, cavity 1228 is one of a plurality of cavities 1228 (e.g., two cavities) diametrically located on the outer circumference of sheath 1200. In some embodiments, cavity 1228 is positioned such that a radiopaque marker 1311 inserted into cavity 1228 is also inserted into cavity 1210 of sheath 1200, thereby acting as a pin to secure them to each other.

[0371] In some embodiments, the housing 1200 comprises a polymeric and electrically insulating material, preferably one that is heat resistant; for example, PEEK.

[0372] Now refer to Figure 13A , which schematically illustrates a partially assembled apex 1300 of an annuloplasty device 500 according to some embodiments of the present disclosure. For example, the apex 1300 corresponds to Figures 7A-7E The tip 501 of the annuloplasty device 500 is shown.

[0373] The partially assembled assembly shown includes a housing 1200, a needle holder 1303 (e.g., corresponding to Figures 7A-7E The embodiment includes a support 703 in FIG. 1 ), a needle element 1301, and a connecting cable 1302. Connecting cable 1302 is flexible; for example, outer casing 1302A of connecting cable 1302 is provided with grooves 1302B to enhance its flexibility. In some embodiments, outer casing 1302A comprises stainless steel and is optionally provided with an electrically insulating sleeve, such as a polymer shrink tubing.

[0374] In some embodiments, the needle element 1301 comprises a plurality of needles 20, each needle 20 comprising a needle body 1304 and a sharpened tip 1306. The needle body 1304 can have a quadrilateral cross-section (e.g., a square). The needles 20 can be connected together by a base 1307, which connects the needles 20 to the needle support 1303. The base 1307 is electrically connected to the proximal side of the annuloplasty device 500 via one or more electrical conductors connected to the cable 1302.

[0375] The needles 20 can be electrically connected to each other, or can be independently electrically connected via a connecting cable 1302. Optionally, the connection is made through the (conductive) body of the shell 1302A, for example, by a connection made by laser welding. Through the electrical connection of the needle 20, the needle 20 can be optionally configured as a needle electrode 20 to deliver (for example) radio frequency, microwave frequency and / or electroporation orifice energy (for example) to the tissue in a monopolar or bipolar configuration. As shown, the needle element 1301 also includes a contact area 1305. Optionally, the entire needle element 1301 is made of a single metal piece, for example, a piece stamped or laser cut from a sheet, or a 3D printed component. In some embodiments, the needle element 1301 contains tantalum, which has both electrical conductivity and the property of being opaque to fluorescence.

[0376] The needle support 1303 can rotate relative to the housing 1200 and can also move relative to the housing 1200 along the proximal-distal axis; for example, by moving the connecting cable 1302 and / or mechanical elements extending into the outer housing 1302A. Because contact is prevented by mechanical interference with the base 1307 of the needle element 1301, the more fragile tip region of the needle element (e.g., the needle body 1304) can be protected from excessive torsion, which can cause the tip region to bend, slip out of tissue, and / or other adverse events.

[0377] These movements change the nature of the electrical contact of contact region 1305 with sensing electrode 1206. In the example shown, contact region 1305 makes electrical contact with sensing electrode 1206 when needle 20 is fully advanced and rotated maximally to one side or the other of opening 1209.

[0378] This allows the sensor controller 36 to detect these specific conditions and optionally indicate these specific conditions, such as by LED lighting and / or other indications (e.g., sound, tactile, and / or other types of visually presented indications). Optionally, one or more other locations on the housing 1200 are electrically interconnected with the sensing electrodes 1206, thereby allowing detection of other positions, such as one or more fully retracted positions of the needle element 1301. Of the multiple positions that can be detected by the same sensing device (and indicated in the same manner), the operator can determine which position is actually relevant because the operator knows (for example) which side they have turned the needle element 1301 and / or whether they are retracting or advancing the needle element 1301.

[0379] In some embodiments, the sensing device itself is configured to distinguish between different positions. For example, different contact areas on the housing 1200 are connected to the sensor controller 36 via resistors of different values. Alternatively, a variable resistor type configuration is provided, wherein the electrical contact between the needle element 1301 and the housing 1200 is achieved through a resistive element (e.g., the inner lining of the housing 1200, which contains carbon particles embedded in a polymer, a resistive paste, or other material). This is expected to allow for graded detection of responses to input motion commands, for example, allowing for differentiation and / or assessment of partial rotation and / or distance of advancement of the needle along the proximal / distal axis.

[0380] Now refer to Figures 13B-13C , which schematically illustrates a partially assembled tip 1300 of annuloplasty device 500 with housing 1220 added, according to some embodiments of the present disclosure. As shown, needle 20 of needle element 1301 is fully extended. Figure 13B As can be seen from the close-end view, connector 1204 is exposed in a position where it can be connected during final assembly.

[0381] Reference Figure 13D , which schematically illustrates the tip 1300 of the annuloplasty device 500, now with the addition of a catheter sheath 1310, according to some embodiments of the present disclosure. Optionally, a radiopaque element 1311 acts as a needle to interconnect the housing 1220 and sheath 1200, and optionally to the catheter sheath 1310 (e.g., via an orifice in the sheath material). Where appropriate, the catheter sheath 1310 can be adhered to the housing 1220 and / or sheath 1200, for example, using adhesive and / or melting. It should be noted that the illustrated assembly allows the connecting cable 1302 and the catheter sheath 1310 to rotate relative to each other, and thus the needle element 1301 can rotate relative to the housing 1220. In some embodiments, the assembly includes a steering element (e.g., a longitudinally elongated element, not shown) connected to one or more sides of the assembly and capable of being shortened or otherwise manipulated to divert the direction of the device tip.

[0382] Now refer to Figure 14 , which shows a fluoroscopic (X-ray) image of the distal tip 1300 of the annuloplasty device 500 in situ (i.e., within a chamber of the heart), according to some embodiments of the present invention. Specifically indicated in the image are the location of the needle assembly 1301, radiopaque markers 1311 (e.g., two), the housing 1220, and the passage of the connecting cable 1302 through the catheter hub 1310 and the introducer sheath 1401.

[0383] In order to effectively perform annuloplasty procedures, it is potentially advantageous to include device features and / or methodologies that allow the operator to develop and maintain a clear and unambiguous understanding of the relative position of the device to the tissue target. For example, the position of the radiopaque markers 1311 can be adjusted by rotation until they are displayed at their widest (as shown) or narrowest distance, thereby allowing the orientation of the distal tip 1300 to be calibrated relative to one or more known and / or predefined fluoroscopic perspectives (views). Optionally, the reference perspective changes depending on which region of the annulus is being manipulated. For example, the needle selects different angles for different circumferential regions on the mitral valve annulus (e.g., different positions of the fluoroscopic "C" arm); for example, the needle selects different views for the P1, P2, and / or P3 regions posterior to the annulus.

[0384] Using rotational deformation to manipulate annuloplasty devices

[0385] Now refer to Figure 15A and 15C , which schematically illustrates a horizontal (transverse) section 16 through the left side of the heart (including the left atrium 41 and the left ventricle 43) according to some embodiments of the present disclosure. Also shown is ( Figure 15A) The location of the foramen ovale 42 (typically used as a passage between the left and right atria in minimally invasive cardiac surgery), the mitral valve 200, and the mitral valve annulus 202. Figure 15C A more complete view of this is provided by icon 1501 in FIG, where plane 16 passes through heart 50 near the bottom of left atrium 41 (which is shaded and hidden behind heart 50 from this perspective).

[0386] Further references Figure 15B , which shows a 3D reconstructed ultrasound image of the valve 200 and a horizontal (transverse) section 16, viewed from a vantage point above the valve 200, according to some embodiments of the present invention. Also seen is the distal tip 1300 of the annuloplasty device 500 in a generally cylindrical form.

[0387] Now refer to Figure 15D and 15F , which schematically illustrate a coronal (frontal) section 17 through the left side of the heart (including the left atrium 41 and the left ventricle 43) according to some embodiments of the present disclosure. Also shown is ( Figure 15D ) The location of the foramen ovale 42, the mitral valve 200 and the mitral valve annulus 202. Figure 15F Icon 1502 in provides a more comprehensive view of how plane 17 passes through heart 50.

[0388] Further references Figure 15E , which presents a planar ultrasound image of a coronal cross-section (corresponding to coronal section 17) of valve 200 (e.g., showing leaflet 200A) according to some embodiments of the present invention. Also seen in a generally cylindrical form is the distal tip 1300 of annuloplasty device 500, which traverses the valve to position housing 1220 in contact with annulus 202.

[0389] Now refer to Figures 16A-16H , which presents a series of 3D reconstructed ultrasound images obtained at different positions and / or articulations of the tip 1300 as it moves the needle element 1301 around the periphery of the mitral valve annulus 202, according to some embodiments of the present disclosure. The tip 1300 has entered the left atrium from the location of the foramen ovale 42. In each image, the approximate position and longitudinally elongated shape of the tip 1300 are indicated by a white outline and black lines. See also Figure 16I , it will Figures 16A-16H The individual positions of the MRI scans are superimposed in a single image.

[0390] At each such location, the probing device tip 1300 inserts the needle 20 into the tissue of the annulus 202, distorts the annulus, and then induces plastic deformation by delivering energy (in this case, radiofrequency energy through the needle 20 acting as a needle electrode; microwave and / or electroporation energy may alternatively be provided).

[0391] It can be recognized that although Figure 14-16I While the general situation is understood from the various ultrasound and / or fluoroscopic images shown and / or explained in the figures, potential problems still exist: how to accurately determine the location of the target valve annulus tissue and how to operate the tip 1300 to appropriately manipulate the target valve annulus tissue and deliver structural damaging energy through the tip 1300.

[0392] Operational characteristics of annuloplasty devices using rotational deformation

[0393] Now refer to Figures 17A-17B , which illustrates an in situ (i.e., within a chamber of the heart) fluoroscopic (X-ray) image and schematic diagram of a needle assembly 1301 (which may include a radiopaque material such as tantalum) relative to a radiopaque marker 1311, according to some embodiments of the present disclosure. Figure 17B The needle assembly 1301 is imaged to be fully retracted into the housing (eg Figure 12C This configuration is identified by the relative position of the radiopaque marker 1311 directly next to the needle 20. Figure 17A Needle 20 is imaged in an extended position, well beyond the longitudinal position of radiopaque marker 1311.

[0394] Now refer to Figure 18A , which schematically illustrates views of a needle assembly 1301 and a radiopaque marker 1311 at different rotational positions according to some embodiments of the present disclosure. Figures 18B-18D , which shows an X-ray image of the distal tip 1300 according to some embodiments of the present disclosure, including views of the needle 1301 from different rotation angles.

[0395] exist Figure 18A , the view at angle 1701 shows the needle assembly 1301 and the radiopaque marker 1311 at their maximum spacing (flat view). The view associated with rotation angle 1702 increases the rotation by 45°, and the view associated with rotation angle 1703 increases the rotation by 90°. After another rotation of 45°, the view will return to a view similar to the rotation angle 1702.

[0396] In some embodiments, the view at angle 1702 corresponds approximately to Figure 18B and 18D The oblique view shown in , while the view at angle 1703 corresponds to a rotation of angle 1703. Thus, from Figures 18B to 18DThe image sequence corresponds to a rotation of approximately 90° from side to side. Although difficult to discern in a static image, the two 45° rotation angles can be distinguished by observing the transition time, and / or by understanding how much control is applied and in which direction to produce the position shift. It is noteworthy that in this embodiment, the position of the opaque marker 1311 relative to the needle assembly 1301 is shown to be closer than Figures 18A-18D The position shown in is slightly more distal.

[0397] Now refer to Figures 19A-19B , which schematically illustrates an outer sleeve 1901 according to some embodiments of the present disclosure, which is pre-set to exhibit a compound bend with both curvature and out-of-plane displacement added. In some embodiments, when the restriction of outer sleeve 1901 (e.g., by another outer tube (e.g., tube 1900)) is removed, the pre-set bend is exhibited. Alternatively, in some embodiments, the shape shown is the "limit" bend of outer sleeve 1901 when steering is fully actuated. When steering is not actuated (or reversed), outer sleeve 1901 will straighten. Optionally, outer sleeve 1901 is biased to bend, and steering actuation causes it to bend further, or alternatively, to straighten it away from the biased bend. The minimum radius of curvature can be (for example) radius 1903. In some embodiments, the catheter device itself is configured to be steerable in the same manner as described for outer sleeve 1901.

[0398] Figure 19AThe view of outer sleeve 1901 in FIG. 1 represents an end view of the curling portion (including section 1905), which is pre-configured to bend out of plane (i.e., deviate from the curling plane or assume a spiral shape) when curled a distance 1902. Optionally, outer sleeve 1901 may at least partially exhibit curling and / or out-of-plane displacement as it extends from the confines of section 1900 (which may be provided as another outer sleeve). Optionally, additional (or reduced) curling and / or out-of-plane displacement may be provided by a steering input. Alternatively, section 1900 may be provided as part of outer sleeve 1901, with curling substantially entirely controlled by the steering input. For example, the steering input may be provided by, for example, a longitudinally elongated element (not shown) attached to tip 1904, extending along the body of tube 1901 and returning along section 1900. Attaching the element to tip 1904 allows tension applied to the element to induce the steering motion shown. In particular, as the elongated element extends toward the apex 1904, it may partially wrap around the periphery of segment 1905 such that as it shortens longitudinally, it pulls the apex 1904 out of plane by a distance 1902 and causes curling to the main radius of curvature 1903. It should also be noted that the gradual coordination of the main curvature with the out-of-plane curvature has potential advantages for treating valve annuli that are generally saddle-shaped, such as the mitral valve, for example, in conjunction with Figure 19C As discussed.

[0399] In some embodiments, the tip 1904 of the outer sleeve 1901 can also be steered at least partially independently of the overall curvature, for example, to allow adjustment of the out-of-plane distance 1902 .

[0400] It should be noted that, combined Figures 19A-19B The curvatures shown and discussed may be well suited for shallow approach angles (relative to angles above or below the (local) plane of the valve) on the periphery of the valve annulus. For example, the angle may be within 60° of the plane, within 45° of the surface, within 35°, within 30°, or within 25°. In some embodiments, the angle is within 30°-50° of the local plane of the valve, optionally lower, and preferably not higher. As long as the shape of the valve can be non-planar (e.g., saddle-shaped), the "local" plane of the valve refers to the plane that contains (e.g., contains with minimal error) some omitted portion of the entire valve annulus. Shallow approach angles provide potential advantages in avoiding leaflet damage and / or repeatable positioning and / or engagement with valve annulus tissue.

[0401] Now refer to Figures 19C-19D , which schematically illustrates the relationship of an outer sleeve 1901 (or the catheter itself, similarly configured for steering) relative to the generally saddle-shaped valve annulus 200, according to some embodiments of the present disclosure. Figure 19CIn the embodiment of the present invention, a slight steering input (tensioning) away from the location of the orifice oval 42 results in a relatively slight circular bending, as well as a relatively slight out-of-plane bending. For example, 10-20 mm of out-of-plane displacement may be required to reach the valve tissue. Figure 19D In some embodiments, a strong steering input (greater tension) away from the orifice oval 42 results in a relatively tight circular bend, and a relatively large amount of out-of-plane bending. For example, 35-45 mm of out-of-plane displacement may be required to reach the valve tissue. Figure 19C In some embodiments, the portion of the mitral valve annulus corresponding to the arrival area P1 (the distal portion of the posterior valve annulus) for treatment is treated. Figure 19D The position corresponds to the arrival area P3 of the mitral valve annulus for treatment (the proximal part of the posterior valve annulus).

[0402] Bioimpedance heuristics

[0403] Now refer to Figure 20 , which is a schematic flow chart illustrating target and / or expected thresholds and / or ranges of bioimpedance (in Ohms (Ω)) at various stages and / or conditions during annuloplasty surgery, according to some embodiments of the present disclosure.

[0404] The values ​​shown are experimentally derived using a needle 20 (also an electrode that delivers structurally destructive energy at radiofrequency frequencies). The needle electrode is constructed of stainless steel with a square cross-sectional area of ​​approximately 0.4 mm x 0.4 mm. However, similar values ​​are expected for other (conductive) electrode materials (e.g., tantalum). These values ​​apply to an inter-electrode distance of approximately 1-2 mm and a tissue penetration distance of approximately 4 mm. In addition, the values ​​shown are optionally used in conjunction with operating parameters that include delivering 8-10 watts of radiofrequency power over a period of approximately 8-25 seconds. In some embodiments, impedance measurements are made within a frequency range of 25-75 kHz (e.g., 50 kHz). Frequency sampling is preferably performed above the corresponding Nyquist frequency (e.g., approximately 2 MHz). For example, at a measurement frequency of 50 kHz, this allows for capturing three complete waveforms using (e.g.,) 60 microseconds of data (120 samples), which helps filter out noise. In some embodiments, results are displayed at intervals of approximately 1 second; optionally faster or slower.

[0405] Box 2000 shows the period of time when the electrode is in contact with blood but not in contact with tissue in the pre-exposed state (eg, retracted into housing 1220). Typical bioimpedance measured under these conditions is greater than about 750Ω.

[0406] In box 2002, the device tip is brought into contact with the tissue and electrode insertion is initiated, resulting in a decrease in measured bioimpedance, which is typically determined to be within the range of approximately 220Ω to 500Ω during the ongoing insertion. In some embodiments, this range is used to indicate that the device tip is positioned at a location where a needle (e.g., a needle electrode) can be extended to insert into the annular tissue. Optionally, the upper limit of this expected range can be lowered (for example) to 400Ω; this is expected to improve the repeatability of the procedural results, but is also expected to increase the need for longer times and / or repeated attempts to position the device tip. If the expected range is not typically achieved and / or maintained during the insertion process, it may indicate a failed and / or lost penetration.

[0407] In block 2004, the final loop penetration (as the needle 20 is extended into the tissue) with alignment suitable for initiating structural disruption typically (but not always) results in a narrowing of the bioimpedance from the more general range associated with the insertion itself. Depending on the initial conditions, this has been observed to result in a variably slight rise or fall from the initial range, typically within the range of 240Ω-360Ω. In some embodiments, the impedance is within the range of 200Ω-400Ω. Optionally, achieving an impedance within this range serves as a gating condition for further manipulation and / or as confirmation of "good alignment" of the device and tissue after needle insertion, allowing manipulation of the tissue (e.g., by rotational deformation) without loss of electrical contact and / or damage to the device needle. In particular, when the impedance is low, this may indicate that the extended needle is contacting each other through an open space filled with blood, rather than penetrating the tissue. Pressing the device forward may cause the impedance to rise, which may indicate that alignment is correct. Alternatively, the upper limit of the range for "good alignment" can be lowered, for example, to 320Ω; and / or the lower limit of the range can be raised, for example, to 280Ω. This reduction in the range is expected to improve the reproducibility of the procedure, but may also increase the need for longer times and / or repeated attempts to position the device tip.

[0408] Box 2006 (along with its subboxes) represents some potential bioimpedance states that may result from the application of structure-destructive energy. Box 2007 indicates a target range of approximately 1000Ω-2250Ω, corresponding to a bioimpedance range that corresponds to successful application of structure-destructive energy. In the illustrated example, above 2250Ω (box 2008), the application of structure-destructive energy is optionally stopped, even if the planned power delivery time (e.g., within the range of 15-30 seconds) has not been reached. Optionally, the stop threshold is selected from a value within the range of 1800-2500Ω. The upper limit of this range is optionally lowered to, for example, 2400Ω, which is expected to increase the safety margin. Additionally or alternatively, the lower limit of this range is optionally raised to, for example, 2000Ω, thereby potentially reducing the occurrence of unnecessary system self-shutdowns. In some embodiments, automatic stopping occurs upon reaching the selected stop threshold. Optionally, the automatic stopping is correlated to a temporal characteristic of the impedance change. For example, impedance changes that occur abruptly relative to the normal time course of structural damage (hundreds of milliseconds rather than seconds) are optionally filtered from triggering cessation until a more physiologically plausible period of time has passed. Block 2009 indicates that during the delivery of structurally destructive energy, bioimpedance remains at (or abruptly recovers to) a level below approximately 400Ω. This is optionally considered an indication of malalignment or loss of alignm ent, regardless of what the historical record of other bioimpedance indicators may indicate.

[0409] In some embodiments, bioimpedance measurements are used in conjunction with imaging and / or other measurement types to verify that device operation is proceeding according to the expected sequence of events.

[0410] Methods of operating annuloplasty devices

[0411] Reference Figure 21 , which is a schematic flow chart of a method of operating an annuloplasty device according to some embodiments of the present invention. In some embodiments, the annuloplasty device operates based on the principle of tissue contraction by a combination of: twisting / torsion (e.g., as described herein in conjunction with Figure 5A-11 as described) and applying structural destruction energy.

[0412] In summary, the method includes operations of the larger block diagram indicated below: Block 2101 includes initial device positioning and optional positioning calibration; Block 2109 includes engaging the annuloplasty device to the treatment site; Block 2115 includes deformation and structural failure (plastic deformation) of the treatment site; and Block 2121 includes evaluation of the results and, if relevant, proceeding to the next treatment site. The various sub-blocks are provided as non-limiting examples of activity categories (more examples are described below) that can be performed within each larger block diagram.

[0413] In block 2100, in some embodiments, an annuloplasty device is inserted into a body cavity adjacent to the valve to be treated (e.g., through the fossa ovalis of the atrial septum into the left atrium) for treating the mitral valve. In some embodiments, other heart valves, such as the tricuspid valve, are treated.

[0414] In block 2102, in some embodiments, the rotational orientation of the annuloplasty device is calibrated. This is particularly relevant to Figures 5A to 11 The needle twisting embodiment in FIG. 1 is relevant, but is also optionally applicable to (for example) Figures 1A to 4C This is also true for embodiments of vacuum use when the lesion formed is longer in one dimension than another and / or is configured to preferentially compress tissue along a particular axis.

[0415] In some embodiments, calibrating the rotational orientation of the annuloplasty device comprises rotating the annuloplasty device under imaging visualization until the configuration of the device (as viewed from the visualization) matches a known rotational state. In some embodiments, this comprises rotating a portion of the device comprising at least two radiopaque markers until the markers are at a maximum or minimum distance apart in a fluoroscopic image in which they are visualized. Optionally, the radiopaque marker comprises a needle that is itself used to mechanically manipulate and / or energy-alter tissue for analysis. Optionally, the radiopaque marker comprises an element added to the tip of the device in a known and / or determinable relationship to the orientation of the needle.

[0416] In some embodiments, calibration uses another method; for example, ultrasound scattering and / or reflection patterns that return unique signals when oriented toward the location of the ultrasound detector and / or ultrasound energy source.

[0417] Where fluoroscopic and / or ultrasound visualization techniques are readily available, direct imaging of the annuloplasty device itself may provide a preferred method for determining device orientation because it has the potential advantage of providing a direct, intuitive understanding of how the annuloplasty device is positioned. However, there are potential advantages to using non-imaging methods to calibrate and / or monitor device orientation, for example to reduce procedural complexity and / or radiation exposure.

[0418] Using such methods, the orientation of the annuloplasty device itself can optionally be detected directly. Furthermore, the orientation of other components (e.g., an outer sleeve or a dedicated measurement device) can also be determined, and this information transferred to the annuloplasty device via known spatial and / or additional measurement constraints. Indirect methods have the potential advantage of not requiring sensors to be added directly to the annuloplasty device itself, with the caveat that the sensing elements can optionally be placed slightly proximal to the apex itself, where more space may be available. As long as the annuloplasty device itself is directly sensing and / or being sensed, there is the potential advantage of real-time and / or more clearly localized sensing of the device's orientation and / or position.

[0419] Non-imaging sensing principles for determining device orientation may optionally include one or more of: magnetic field direction sensing, acceleration sensing (e.g., gravity sensing), pressure sensing (e.g., blood pressure, e.g., pressure differential across a sensing tip), flow sensing (e.g., blood flow sensing), and strain sensing (e.g., for determining twisting along the device). Additionally or alternatively, physical constraints may be used to aid in determining orientation and / or to facilitate transfer of known orientation information about an element to the annuloplasty device. For example:

[0420] In some embodiments, magnetic field emitters and / or detectors are associated with a known and / or determinable orientation relative to the needle of an annuloplasty device, and corresponding detectors / emitters are placed at other locations to sense / activate the emitters / detectors associated with the needle. For example, a guidewire comprising one or more micromagnets and / or electromagnets can be optionally placed in the circumflex artery and / or coronary sinus around the annulus. This can be detected by the device tip (e.g., using a MEMS Hall effect detector) and may even be used to magnetically attract the device tip to the annulus.

[0421] In some embodiments, the direction is determined at least in part by observing the direction of flexion when the tip is moved (i.e., bent) by manipulating the steering degree of freedom. The direction can be determined based on changes in measured parameters (e.g., the direction of acceleration determined with respect to gravity) and / or in association with the physical constraints of the motion itself (e.g., steering may be more distance-constrained in some directions than in others).

[0422] In some embodiments, it is more convenient to determine the orientation of the overtube directly, rather than determining the orientation of the annuloplasty device itself. For example, the orientation of the overtube can be determined by imaging and / or tracking used to manipulate the overtube into position, followed by optional cessation or reduction of imaging, at least to the extent that the overtube orientation can be translated into information about the orientation of the annuloplasty device (e.g., as described below). In some embodiments, a history of how the overtube has been manipulated into position (e.g., by steering and / or twisting) can be tracked. The overtube may be relatively resistant to twisting about its longitudinal axis (e.g., due to its large size), its approximate position within the body and path through the body are known, and the orientation of the proximal portion of the overtube is known. Alternatively, the overtube is actually susceptible to twisting, but the amount of twisting can be determined using calibrated sensing (e.g., by a strain gauge device, such as a fiber optic strain gauge).

[0423] As a means of conveying directional information, in some embodiments, an overtube used with an annuloplasty device is provided with an obstruction (e.g., at its distal orifice and / or at another location proximal to its distal orifice) that creates a non-circular ("keying" or "guide") shape (e.g., a shape that is indented from a circle on one or more sides) through which the annuloplasty device can be passed. The non-circular shape is selected so that the cross-sectional profile of the annuloplasty device can only be passed through the constriction in one or more specific matching orientations. Optionally, a detent-type interaction is used between the overtube and the annuloplasty device (e.g., a protrusion on the lumen of the overtube and a receiving recess on the annuloplasty device) resulting in a mechanical "stop" that can be felt by the operator in certain directions or directions, but not at other angles. In some embodiments, electrical sensing (e.g., based on contact and / or resistive films) is used to determine the relative orientation of the overtube (serving as a reference system) and the annuloplasty device.

[0424] Optionally, prior to use of the annuloplasty device, a sensing probe advanced through the outer cannula determines the orientation of the outer cannula (e.g., based on any of the sensing principles described above). This information is transmitted to help determine the orientation of the annuloplasty device during insertion, e.g., via a "keying" or detent mechanism to the outer cannula orientation and then to the annuloplasty device itself.

[0425] In block 2104, in some embodiments, the orientation of the annuloplasty device is adjusted from the known / calibrated position to the target position, optionally and appropriately adjusted based on the expected orientation of the device needle relative to the annulus. This is optionally done "blindly" by offsetting the calibrated orientation by a fixed amount. Optionally, sensory feedback is continuously provided during the adjustment. The preferred orientation of the target position may depend on the device type. For example, a vacuum-type device that produces diamond-shaped lesions (e.g., Figures 1A-4C ) can be preferably oriented so that the long axis of the diamond is perpendicular to the circumference of the valve annulus. Regardless of the orientation of the damaged diamond portion (if any), the clamping vacuum type device can be preferably oriented so that the direction of the shortest clamping is the circumference. Figure 5A-11 The needle-like "twisting" device in the embodiment is preferably oriented in such a way that the axis extending between the two needles (e.g., their tips) is tilted relative to the circumference of the valve annulus. For embodiments that combine vacuum attachment and twisting deformation, the preferred orientation can be tilted as for the needle-like twisting device. This also applies to embodiments that operate by vacuum attachment, in which the needles also serve as energy delivery electrodes to (e.g.) prevent slippage and / or facilitate deeper lesion puncture.

[0426] In some embodiments, once the rotational orientation is calibrated in block 2102 by a first method, device, and / or principle, the rotational position can be further tracked by another method, device, and / or principle. For example, the rotation of the electrode relative to the resistive film can be measured. In some embodiments, the electrode is placed on a surface of the annuloplasty device (here, the surface contacts a portion of the lumen of an outer sleeve lined with the resistive film), and changes in resistance are used to track changes in orientation. Additionally or alternatively, the operator can at least approximately determine the orientation by placing a marker on the handle of the annuloplasty device at a "calibrated" position and then noting the offset relative to that position (e.g., relative to the sleeve or the surrounding environment).

[0427] The rotational adjustment operation optionally includes adjusting the angle of entry of the annuloplasty device above or below the valve plane relative to the annular tissue.

[0428] In block 2106, in some embodiments, the annuloplasty device is brought to a first selected position around the annulus to initiate treatment. Optionally, during the operations of this block diagram, an operation for assessing the orientation of the device is determined (e.g., as described in conjunction with blocks 2102-2104).

[0429] In some embodiments, the operations of block 2106 are performed under real-time image-assisted (e.g., ultrasound and / or fluoroscopic) guidance; for example, in combination with Figures 14 to 18D Additionally or alternatively, in some embodiments, non-imaging measurements are performed to determine and / or confirm device positioning. For example, bioimpedance measurements are performed, for example, as combined with Figure 20 As stated.

[0430] In some embodiments, the shape of the relevant anatomy of the valve to be treated is known from prior imaging (e.g., preoperative imaging or imaging during the early stages of the current procedure). The anatomical shape can be determined, for example, by segmenting a (3D) MRI or CT image. Alternatively, the shape can be determined from a two-dimensional fluoroscopic image (e.g., based on a distribution image of an injected contrast agent), and optionally, the 3D shape can be reconstructed by applying stereo constraints to images taken from different directions. The insertion position of the annuloplasty device near the valve can be determined, for example, by image-based detection of the position of the fossa ovalis relative to the valve and / or by recording the position of the annuloplasty device during surgery using brief imaging.

[0431] As long as the annuloplasty device assumes a predictable shape in response to steering inputs and / or longitudinal device advancement, the amount of such control input (optionally measured by suitable encoders in some embodiments) can optionally be used to infer the position of the device. In some embodiments, the general results of these inferences can optionally be confirmed and / or corrected with guidance from other measurements. Again, for example, such corrections can be made in accordance with a combination of Figure 20 The method is based on a bioimpedance heuristic approach as described in . Monitoring the course of bioimpedance measurements over time while operating the annuloplasty device is also expected to optionally assist in finding the treatment location, for example, the device can be operated to position itself at a local minimum or maximum in the measured bioimpedance. Other sensing options that can assist in positioning the device relative to the anatomy near the annulus include, for example, force sensing (e.g., contact force sensing), flow sensing, and / or pressure sensing. Flow and pressure sensing are expected to indicate characteristic states of blood flow near the valve edge (and annulus) compared to characteristic states of high blood flow areas closer to the center of the valve. Potentially, flow and / or pressure sensing can distinguish regions between the leaflets (i.e., find and / or confirm the location of the leaflet boundaries).

[0432] In some embodiments, a device comprising one or more electrodes placed within (e.g., along) the coronary sinus is used to assist in positioning an annuloplasty device. This can operate in the context of an electric field transmitted by / to the electrodes within the coronary sinus based on electrical induction by and / or an electrode configuration element of the annuloplasty device (e.g., a needle and / or another electrode at the tip of the annuloplasty device).

[0433] Optionally, the anatomical scene model is adjusted and / or recalibrated based on sensed information (e.g., based on imaging and / or other data). For example, adjustments are made based on the location of detected forces (e.g., by contact force sensors at the tips of the annuloplasty device), bioimpedance measurements, and / or sensed changes in fluid flow and / or pressure. Optionally, the anatomical scene is adjusted and / or recalibrated based on changes resulting from the ongoing annuloplasty procedure, based on one or both of imaging changes, changes indicated by non-imaging sensors, and / or the anticipated effects of the procedure on valve shape, thereby reshaping the annulus.

[0434] In block 2108, in some embodiments, the annuloplasty device is appropriately positioned so that it is ready to begin mechanical engagement with the tissue of the annulus from a predictable insertion angle and / or a predictable degree. This block emphasizes a refinement of the overall goal of block 2106 to find a starting treatment position and can be performed simultaneously therewith. Figure 5A-11In the twisted needle embodiment, at least two parameters should be emphasized. First, proper alignment with the valve annulus tissue (contact with the distal plane) should be achieved so that the needle 20 can be punctured at the desired depth (e.g., 4 mm puncture depth) when actuated. Figure 20 The bioimpedance heuristics in provide an example of a measurement that can be used to assess proper alignment. Second, the alignment should be at a suitable angle. The suitable angle can be selected (e.g., pre-selected) by the operation of blocks 2102-2104. Optionally, further adjustments can be made, for example, as long as the operation of block 2106 results in a change in device orientation. In some embodiments, the suitable angle includes an axis extending between two needles of the annuloplasty device that is inclined (e.g., at about 45°, or other angle) to the circumference of the annulus, such as described herein in conjunction with the needle placement examples.

[0435] When using a vacuum-type device, it is expected that apposition will be enhanced after suction is applied.

[0436] In block 2110, in some embodiments, the needle of the annuloplasty device is advanced from its housing to engage the tissue to which the device is applied. In some embodiments, the needle has a shaft with a cross-sectional area of ​​approximately 0.4 mm x 0.4 mm, a length of approximately 4 mm, and a sharp tip to assist in piercing the tissue.

[0437] When a vacuum type device is used, suction is applied at box 2110.

[0438] At block 2112, in some embodiments, for embodiments using a needle, proper engagement of the needle with the annular tissue is optionally verified. This may include, for example, testing heuristics associated with the measurements, such as in combination with Figure 20 Additionally or alternatively, fluoroscopic imaging of the contrast agent injection can demonstrate proper insertion of the needle into an area that is inaccessible to the contrast agent. Additionally or alternatively, ultrasound imaging may be helpful in confirming needle penetration. In some embodiments, bioimpedance measurements are performed using surface electrodes (e.g., flat electrodes placed on the distal surface of the annuloplasty device apex housing) that are evaluated to confirm whether the surface maintains tissue contact. Evidence of such contact, combined with consistent evidence of penetration, is expected to increase confidence that a good penetration has been achieved.

[0439] As described above: for vacuum-type devices, suction is applied at block 2110. Simply increasing contact in this manner may have a noticeable effect on the bioimpedance measurement (if used) and / or the amount of negative pressure generated within the device, which in some embodiments will be used for verification at block 2112.

[0440] At block 2114, in some embodiments, the needle of the rotating annuloplasty device (e.g., as in combination with Figure 5A-11 The needles are thin and fragile, so it is potentially advantageous to support and / or protect them by the device in various ways (e.g., using stops, sensing devices, and / or appropriately sized slots), such as in combination with Figures 12A-13D The expected amount of rotation (twist applied to the valve annulus) can be about 90°. In some embodiments, the expected amount of rotation is an angular value within the range of about 80°-115°.

[0441] In some embodiments, the correct amount of rotation is achieved when the needle of the device rotates through its full available range, e.g., from a starting position near a first stop to a final position near a second stop. In some embodiments, sensing (e.g., electrical sensing) at the tip is used to electrically identify at least one of these stop positions, e.g., as in combination with Figures 12A-13A Optionally, more positions are sensed and / or discriminated, optionally discretely or continuously. Optionally, for certain treatment positions, the rotation is submaximal. This may allow, for example, lower local introduction of deformation and the need for more treatment position compromises to achieve the same overall level of reduction in valve circumference.

[0442] For pure vacuum type embodiments, the operation of block 2114 is not necessarily performed, but additional mechanical deformation may be introduced, for example, by pulling on the stent in contact with the tissue, e.g., as combined with Figures 4A-4C In some embodiments, the vacuum type embodiment can be twisted (with or without needles). This is expected to fuse Figures 1A-4C and Figure 5A-11 Characteristics of the damage produced by the implementation method.

[0443] At block 2116, in some embodiments, structurally destructive energy is delivered while the needle mechanically distorts the tissue into which it is inserted. For example, approximately 120 joules of energy are delivered over a period of approximately 8-25 seconds. In some embodiments, the energy delivery rate is in the range of 6-12 watts. Energy delivery may optionally be performed using superficial and / or puncturing (needle) electrodes. In some embodiments, the total energy delivered is in the range of approximately 40 joules to approximately 300 joules. In animal studies, the inventors have found that these power and energy levels are apparently effective and safe, for example, at least to the extent that they do not damage the circumflex sinus or coronary sinus near the lesion. The inventors have also found that changes in the acoustic impedance of the tissue can be detected during the ablation process under ultrasound imaging. Thus, the ablation area may appear in an ultrasound image as, for example, a "white spot" of enhanced acoustic reflection, thereby allowing judgment not only of the effectiveness of a single lesion location, but also of the lesion spacing and / or overall shrinkage. For example, two initial lesions can be placed a certain distance apart from each other, with additional lesions placed in between, gradually reducing the distance between lesions that are placed further apart.

[0444] In some embodiments, the annuloplasty device is detached from the tissue at block 2118. Optionally, this includes fully withdrawing the needle (if present) into its housing in preparation for further removal.

[0445] At block 2120, in some embodiments, the results obtained at block 2116 are optionally evaluated, for example, using a bioimpedance heuristic, such as in combination with Figure 20 Additionally or alternatively, a thermometer sensor (e.g., placed on the anterior surface of the apical housing of the annuloplasty device) is used to verify that the energy delivery has produced the expected amount of heating. This assessment is optionally performed before release at block 2118, and / or both before and after release. The vacuum-applied lesion may acquire a characteristic convex shape, which can be detected as a bioimpedance or other electrical signal by slightly withdrawing the electrode from the annular surface and moving the apex back and forth over the convexity. Mechanical interference with movement may also be noteworthy.

[0446] At block 2122, in some embodiments, the annuloplasty device is moved to the next target area for lesion. Optionally, this movement is performed under full image guidance (e.g., fluoroscopy and / or ultrasound guidance). In some embodiments, this movement is simplified by the design of the device, e.g., requiring only a small amount of advancement or retraction of the device to reach the new treatment location. Optionally, additional steering functionality is provided to allow for fine-tuning (which may be informed by sensing and / or modeling information), e.g., as described in conjunction with block 2106. Changes in device orientation may be introduced, e.g., as described and / or referenced in conjunction with block 2104.

[0447] Upon re-twisting (e.g., twisting of a needle) in the same direction as before (clockwise or counterclockwise), the device rotation is reset. Alternatively, the twisting directions may be alternated. Optionally, the movement between treatment sites is initially planned using dry run reconnaissance moves of the device around the valve annulus, thereby confirming at each stage of advancement (during the reconnaissance period) that conditions appear suitable for operation and are consistent with the plan. Optionally, these moves are replicated during the actual annuloplasty treatment. Since the valve is expected to change shape (e.g., shrink) during the actual treatment, the replication of the moves may include adjustments (optionally predetermined shortening adjustments) to compensate.

[0448] If surgery at a treatment location is determined to be unsuccessful, the treatment plan can be adjusted. For example, if the problem is a sudden loss of anastomosis, treatment may need to be repeated. If anastomosis is difficult to achieve and / or if anastomosis is repeatedly lost at a particular location, the treatment plan can be adjusted to compensate for the loss of the site.

[0449] As long as the target treatment location still requires treatment, the method continues (block 2124) by repeating the operations of blocks 2108 through 2122, otherwise stops.

[0450] Overview

[0451] As used herein with respect to quantities or values, the term "about" means "within ±10%."

[0452] The terms "comprise", "include", "include", "have" and their variations mean: "including but not limited to".

[0453] The term "consisting of" means "including and limited to."

[0454] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially change the basic and novel characteristics of the claimed composition, method or structure.

[0455] As used herein, unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" include plural referents. For example, "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0456] As used herein, "example" and "exemplary" mean "serving as an example, instance, or illustration." Any embodiment described as "example" or "exemplary" should not necessarily be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0457] As used herein, “optionally” means “provided in some embodiments but not provided in other embodiments.” Any particular embodiment of the present disclosure may include multiple “optional” features, unless such features conflict with each other.

[0458] The term "method" as used herein refers to manners, means, techniques and procedures for accomplishing a given task, including but not limited to manners, means, techniques and procedures known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine, or manners, means, techniques and procedures readily developable from known manners, means, techniques and procedures.

[0459] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a disorder, substantially ameliorating the clinical or aesthetic symptoms of a disorder, or substantially preventing the appearance of clinical or aesthetic symptoms of a disorder.

[0460] Throughout this application, embodiments may be presented in range format. It should be understood that descriptions in range format are for convenience and brevity only and should not be construed as rigid limitations on the scope of the disclosure. Therefore, range descriptions should be considered to have specifically disclosed all possible subranges and individual values ​​within that range. For example, a range description such as "1 to 6" should be considered to have specifically disclosed subranges such as "1 to 3," "1 to 4," "1 to 5," "2 to 4," "2 to 6," "3 to 6," and individual values ​​within that range, such as 1, 2, 3, 4, 5, and 6. This provision applies regardless of the width of the range.

[0461] Whenever a numerical range is indicated herein (e.g., "10-15," "10 to 15," or any pair of numbers linked by these or other such range indicators), it is intended to include any number (fractional or integer) between the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases "ranging between a first indicated number and a second indicated number" and "ranging from a first indicated number "to," "up to," "up to," or "to" (or another such range-indicating term) the second indicated number" are used interchangeably herein and are intended to include the first indicated number and the second indicated number and all fractions and integers therebetween.

[0462] Although the present disclosure has been described in conjunction with specific embodiments, it is obvious that many alternatives, modifications and variations are apparent to those skilled in the art. Therefore, the present invention is intended to cover all alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0463] It should be understood that, for the sake of clarity, certain features described in the present disclosure in the context of multiple separate embodiments may also be provided in combination in a single embodiment. Conversely, for the sake of brevity, various features described in a single embodiment may also be provided individually, or in any suitable subcombination, or in any other embodiment of the present disclosure in a suitable manner. Certain features described in individual embodiments should not be considered essential features of those embodiments, unless the embodiment cannot be implemented without those elements.

[0464] It is the applicant's intention that all publications, patents, and patent applications mentioned in this specification be incorporated herein by reference in their entirety, to the same extent as if each publication, patent, or patent application were specifically and individually indicated as being incorporated herein by reference when cited. In addition, the citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present disclosure. With respect to section headings, they should not be construed as necessarily limiting. In addition, any priority documents of this application are incorporated herein by reference in their entirety.

Claims

1. An annuloplasty device configured to deliver structurally damaging energy to a tip terminating at a distal end of a catheter body of the device, the annuloplasty device comprising: a housing for the tip extending between a proximal side connected to the catheter body and a distal side; as well as Multiple needles, each needle: extends distally from a location anchored to the tip within the housing, and sized and sharp enough to penetrate the collagenous tissue of the human heart valve annulus; wherein the needle is configured to be moved by being rotated relative to the valve annulus with sufficient force to twist a portion of the collagen tissue by at least 45° while the needle is inserted into the collagen tissue; and Therein, movement of the inserted needle to twist the collagen tissue also causes the needle and the collagen tissue to rotate relative to the housing.

2. The annuloplasty device according to claim 1, wherein: The movement of the inserted needle rotates the collagen tissue extending along an axis connecting two needles of the plurality of needles.

3. The annuloplasty device of claim 2, configured to limit rotation of tissue extending along the axis to a predetermined maximum rotation of less than 180° relative to the housing.

4. The annuloplasty device according to claim 3, wherein: The predetermined maximum rotation is less than about 110°.

5. The annuloplasty device according to any one of claims 3 to 4, wherein: The predetermined maximum rotation is greater than approximately 70°.

6. The annuloplasty device according to claim 2, wherein: The plurality of needles consists of exactly two needles.

7. The annuloplasty device according to claim 2, wherein: Two needles among the plurality of needles are positioned such that the distance between their axial centers is 1-2 mm.

8. The annuloplasty device of any one of claims 1-7, comprising a controller actuatable from a proximal side of the catheter body to cause twisting of a portion of the collagen tissue and movement of the needle relative to the proximal-distal axis of the housing.

9. The annuloplasty device according to claim 8, wherein: The controller includes an element that is adjusted by manual operation, and the annuloplasty device limits rotation of the needle and the collagen tissue relative to the housing by limiting movement of the manually operable element.

10. The annuloplasty device according to claim 8, wherein: The controller operates by releasing stored energy to cause rotation, and the annuloplasty device limits rotation of the needle and the collagen tissue relative to the housing by limiting the stored energy.

11. The annuloplasty device according to any one of claims 2 to 8, wherein: The distal face of the housing includes at least one aperture through which at least one needle extends; and the annuloplasty device limits rotation of the needle and the collagen tissue relative to the housing by interference between the at least one needle and a periphery of the aperture.

12. The annuloplasty device according to claim 11, wherein: The distal face of the housing includes a plurality of apertures through each of which a corresponding needle extends; and the annuloplasty device restricts rotation of the needle and the collagen tissue relative to the housing by interference between at least one of the needles and a periphery of its corresponding aperture.

13. The annuloplasty device according to any one of claims 1 to 6, wherein: Rotation of the needle relative to the housing is limited by interference contact with a stop element within the housing.

14. The annuloplasty device according to claim 13, wherein: The interfering contact with the stop element includes interference between a component that rotates the needle and a portion of a housing of the component that serves as the stop element.

15. The annuloplasty device according to any one of claims 1 to 12, wherein: Rotation of the plurality of needles relative to the housing applies a torque of at least 0.01 N·m to the collagen tissue.

16. The annuloplasty device according to any one of claims 1 to 15, wherein: The plurality of needles apply sufficient torque to the collagen tissue to drag a portion of the collagen tissue through a rotation approximately as great as a rotation of an axis extending between two of the needles, the rotation relative to a proximal-distal axis of the housing.

17. The annuloplasty device according to any one of claims 1 to 16, wherein: The force driving the rotation is transmitted along the catheter body by rotation of the control member.

18. The annuloplasty device of claim 17, wherein: The annuloplasty device limits the rotation by limiting the rotation of the control member.

19. The annuloplasty device according to any one of claims 1 to 16, wherein: The force driving the rotation is transmitted along the catheter body by longitudinal translation of a control member through the catheter body.

20. The annuloplasty device of claim 19, wherein: The annuloplasty device limits the rotation by limiting translation of the control member.

21. The annuloplasty device according to any one of claims 1 to 18, wherein: The needles maintain a fixed distance from each other during the rotation.

22. The annuloplasty device according to any one of claims 1 to 18, wherein: The needles change their distance from each other during the rotation.

23. The annuloplasty device according to any one of claims 1 to 22, wherein: The structurally damaging energy includes radio frequency energy transmitted along a wire to the tip.

24. The annuloplasty device of claim 23, wherein: The needle is an electrode that is interconnected via the wire to a power connector on the proximal side of the annuloplasty device.

25. The annuloplasty device of claim 23, wherein: When the needle is inserted into the collagen tissue, the lead is operable to transmit the radiofrequency energy to an electrode positioned to contact tissue alongside the needle.

26. The annuloplasty device according to any one of claims 1 to 24, wherein: The needle is retractable and extendable relative to the housing.

27. The annuloplasty device of any one of claims 1-26, comprising a steering sheath, the catheter being configured to be advanced through the steering sheath to reach the target collagen tissue.

28. The annuloplasty device of claim 27, wherein: The steering sleeves are configured to move in unison to adopt a curl and bend out of a plane of the curl when the steering sleeves are actuated.

29. The annuloplasty device of claim 27, wherein: The steering sleeve is configured to bend from a straight configuration such that a section of the steering sleeve is formed into a helical shape.

30. The annuloplasty device of claim 29, wherein: The helical shape includes a distal segment of the steering sheath attached to a more proximal segment of the steering sheath, and the more proximal segment of the steering sheath bends from the straightened configuration to form a curvature while remaining substantially within a plane of the curvature.

31. An annuloplasty device configured to deliver structurally damaging energy to a tip of a distal end of a terminating catheter body, the annuloplasty device comprising: a first needle and a second needle, each of the needles: extends distally from a location anchored to the tip, and sized and sharp enough to penetrate the collagenous tissue of the human heart valve annulus; wherein the first needle-shaped object and the second needle-shaped object are fixed to the first bracket and the second bracket respectively; and The first bracket occupies an inner cavity of the second bracket, and the first bracket and the second bracket rotate relative to each other.

32. The annuloplasty device of claim 31, wherein: When the needle is inserted into the collagen tissue, the first and second scaffolds move the needle relative to each other with a force sufficient to twist a portion of the collagen tissue by at least 45°.

33. The annuloplasty device according to any one of claims 31 to 32, wherein: Rotation of the first bracket and the second bracket relative to each other is limited to a maximum value of less than 180°.

34. The annuloplasty device according to any one of claims 31 to 33, wherein: The structurally damaging energy includes radio frequency energy transmitted along a wire to the tip.

35. The annuloplasty device of claim 34, wherein: The needles are electrodes that are interconnected via the wires to a power connector on the proximal side of the annuloplasty device.

36. The annuloplasty device according to any one of claims 31 to 35, wherein: The needle is retractable and extendable relative to a sheath, and the first and second stents are configured to be advanced through the sheath to reach target collagen tissue.

37. The annuloplasty device of claim 36, wherein: The sheath includes a steering mechanism.

38. An annuloplasty device configured to deliver structurally damaging energy to a tip of a distal end of a terminating catheter body, the annuloplasty device comprising: Orifice at the tip: is configured to be in pressure communication with a controllable vacuum source through the catheter body, and shaped, sized, and positioned to rest against collagenous tissue of a human heart valve annulus and, upon activation of vacuum from said vacuum source, to attach to and deform a portion of said collagenous tissue; and Transducer: attached to a conductor configured to transmit the structurally destructive energy from an electrical energy source to the transducer, and Located within a range of the orifice sufficient to conduct the structural damage energy into the deformed portion of the collagen tissue.

39. The annuloplasty device of claim 38, wherein: The orifice is elongated.

40. The annuloplasty device according to any one of claims 38 to 39, wherein: The transducers are electrodes.

41. The annuloplasty device according to any one of claims 38 to 39, wherein: The transducer includes an acoustic energy transducer or a thermal energy transducer.

42. The annuloplasty device according to any one of claims 38 to 41, wherein: The minimum radius of curvature of the orifice is equal to or greater than about 0.25 mm.

43. The annuloplasty device according to any one of claims 38 to 42, wherein: The transducer at least partially defines a periphery of the aperture.

44. The annuloplasty device according to any one of claims 38 to 43, wherein: The transducer is positioned so that it contacts the surface of the collagen tissue portion drawn into the orifice.

45. The annuloplasty device according to any one of claims 38 to 44, wherein: The transducer is positioned so that it contacts a surface of a collagenous tissue portion adjacent at least a peripheral portion of the orifice.

46. ​​The annuloplasty device according to any one of claims 38 to 42, wherein: The transducer includes portions positioned on at least two opposing sides of the aperture.

47. The annuloplasty device according to any one of claims 38 to 42, wherein: The transducer and the aperture are configured to move relative to each other along a proximal to distal axis.

48. A steering sheath for an annuloplasty device, configured to transition between a straightened configuration and a bent configuration upon receiving steering control, wherein the bent configuration comprises a helical shape at a distal end of the steering sheath.

49. The steering sheath of claim 48, including a section distally leading to the helical shape, the helical shape exhibiting a curvature that remains substantially within the plane of the curvature in the curved configuration.

50. An annuloplasty device configured to deliver structurally damaging energy to a device tip terminating at a distal end of a catheter body, the annuloplasty device comprising: a transducer configured to deliver structure-damaging energy to a plurality of sites at locations circumferentially around a heart valve annulus; an elongated steerable body tilted by said transducer and including an elongated control member; wherein the control member is actuatable to coordinately curl the steerable body and bend the steerable body out of a curling plane.

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