Transcatheter or minimally invasive surgical systems and methods of use thereof

Abstract

The present disclosure relates to transcatheter surgical systems and methods for performing mitral annuloplasty and other surgical procedures. In one aspect, the transcatheter system includes: a drive catheter configured to drive one or more anchors into tissue; a tightening conduit configured to tighten a wire extending through the one or more anchors; and a cutting conduit configured to cut a portion of the wire. The present disclosure also relates to an implant kit comprising: a helical anchor defining an anchor channel extending therethrough; a bead wire defining longitudinally spaced beads; the stop piece is larger than the central channel so as to prevent the stop piece from penetrating through the central channel; and a lacing element larger than the central channel to prevent passage therethrough, the lacing element defining a one-way gap that allows the thread to pass therethrough in only one direction.

Description

[0001] Cross - reference

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 378,866, filed Oct. 8, 2022, which is incorporated herein by reference. Field of the Invention

[0003] The present disclosure relates generally to the field of surgical and medical devices, and more particularly to transcatheter or minimally invasive surgical systems and methods of using the same. Background Art

[0004] Many medical conditions can be treated by joining two pieces of tissue together or by reducing the size of an opening. Examples of such conditions include heart valve regurgitation and wounds where two pieces of tissue need to be maintained in contact with each other until the natural healing process is complete. To perform these procedures, access to the surgical site is required, which is problematic in many cases due to space limitations. For example, open - heart surgery is extremely risky for patients. Although some surgeries are performed via catheter, laparoscopy, endoscopy, and the like, these devices require rapid mastery in a short period of time because they are both complex and challenging for the operator.

[0005] Accordingly, there is a need in the market for improved devices and methods for performing surgical treatments that avoid the above - mentioned drawbacks while being simple, robust, and reproducible. Accordingly, it is an object of the present disclosure to provide such improved devices and methods. Summary of the Invention

[0006] In a broad aspect, there is provided a cutting catheter for cutting a suture, the cutting catheter comprising: an elongate suture receiving member provided at its suture receiving member distal end with a suture receiver for receiving the suture; an elongate cutting member provided at its cutting member distal end with an annular blade, the annular blade being positionable adjacent to the suture receiver; the cutting member being longitudinally movable relative to the suture receiving member and axially rotatable relative thereto such that the blade can simultaneously translate and rotate relative to the suture received in the suture receiver.

[0007] In another broad aspect, there is provided a method of cutting a suture using a tubular cutting member provided with a distal annular blade, the method comprising: positioning the annular blade to abut against the suture at the contact position where the suture enters the cutting member; and axially rotating the annular blade to cut the suture.

[0008] In yet another broad aspect, a cinching system is provided that can be used in conjunction with a beaded wire that defines beads, the cinching system comprising: a cinching element, the cinching element including an attachment; and a stopper, the stopper being configured to allow the beaded wire to move therethrough in a distal-to-proximal direction and to prevent the beaded wire from moving therethrough in a proximal-to-distal direction; and a cinching catheter, the cinching catheter including a cinching element retainer provided distally for receiving the attachment; and a cinching element lock, the cinching element lock being used to reversibly lock the attachment and the cinching element retainer to each other.

[0009] In yet another broad aspect, a tightening element defining a proximal end and a distal end is provided, the tightening element being capable of being used in conjunction with a tightening catheter and a beaded thread, the tightening element comprising: a proximally located attachment, the proximally located attachment being capable of being selectively attached to the tightening catheter; and a distally located stopper, the distally located stopper being configured to allow the beaded thread to move therethrough in a distal-to-proximal direction and to prevent the beaded thread from moving therethrough in a proximal-to-distal direction.

[0010] In yet another broad aspect, a cryoadhesion procedure catheter assembly is provided, comprising: a tubular body supporting a hollow thermally transmissive element distally relative thereto, the thermally transmissive element comprising a flexible portion capable of bending to conform to a predetermined shape; a pull assembly distally secured to the thermally transmissive element and comprising a pull wire extending along the body, the pull assembly being configured to bend the flexible portion; and a cooling fluid supply for supplying cooling fluid to the thermally transmissive element.

[0011] In yet another broad aspect, a transcatheter system is provided, comprising: a drive catheter configured to drive one or more anchors into tissue; a tightening catheter configured to tighten a wire extending through the one or more anchors; and a cutting catheter configured to cut a portion of the wire.

[0012] In yet another broad aspect, an implant kit is provided that includes: a screw anchor defining an anchor channel extending therethrough; a beaded suture defining longitudinally spaced beads; a stopper larger than the central channel to prevent passage therethrough; and a cinching element larger than the central channel to prevent passage therethrough, the cinching element defining a one-way gap that permits passage of the suture therethrough in only one direction.

[0013] In yet another broad aspect, an implant kit is provided that includes: at least two screw anchors each defining an anchor channel extending therethrough; a beaded suture defining longitudinally spaced beads; and a cinching element defining a one-way gap that permits passage of the suture therethrough in only one direction.

[0014] In yet another broad aspect, a wound closure device is provided that includes: a cryo-adhesion device including a hollow heat conducting element and a cooling fluid supply for supplying a cooling fluid thereto; and an anchor driver for driving a screw anchor onto the heat conducting element.

[0015] Aspects of the present disclosure provide a cutting catheter for cutting a suture, the cutting catheter including: a suture receiving member including a suture receiver at a distal end of the suture receiving member, the suture receiver configured to receive the suture; a cutting member including an annular blade at a distal end of the cutting member, the annular blade being positionable adjacent to the suture receiver and the cutting member being longitudinally movable relative to the suture receiving member and axially rotatable relative thereto, wherein the annular blade is configured to translate and rotate relative to the suture simultaneously. In some embodiments, the cutting member is biased in a distally directed direction relative to the suture receiver.

[0016] In some embodiments, the longitudinal movement and axial rotation of the cutting member relative to the wire receiving member are independent of each other. In some embodiments, the wire receiving member and the cutting member are flexible. In some embodiments, the wire receiving member and the cutting member are bendable so as to be able to follow the patient's vasculature. In some embodiments, the wire receiver includes a wire aperture extending transversally therethrough, the wire aperture being configured to receive the wire passing therethrough. In some embodiments, the wire receiving member defines a wire receiving member channel that extends longitudinally therethrough and opens into the wire aperture; and wherein the wire receiving member and the cutting member are concentric. In some embodiments, the system further includes a tensioner configured to apply tension to the wire. In some embodiments, the cutting member further includes a tubular member surrounding at least a portion of the wire receiving member.

[0017] In some embodiments, the system further includes an actuation assembly including: a body to which the wire receiving member is mounted; and a cutting member actuator operably coupled to the cutting member for selectively and independently rotating and longitudinally moving the cutting member relative to the body. In some embodiments, the cutting member is movable relative to the body between a proximal position and a distal position, and the cutting member is lockable in the proximal position when translating relative to the body. In some embodiments, the system further includes a biasing element provided between the cutting member and the body for biasing the cutting member toward the distal position.

[0018] In some embodiments, the cutting member actuator includes: a cutting member mount through which the cutting member is configured to extend and be axially rotatable therewith; and a knob mounted to the body so as to be axially rotatable relative thereto, the knob defining an axially extending knob aperture that receives the cutting member mount such that the cutting member mount is axially movable along the knob and is axially rotatable therewith.

[0019] Aspects of the present disclosure provide methods of cutting a suture using a tubular cutting member provided with a distal annular blade, the method comprising: positioning the annular blade to abut against the suture at the contact location where the suture enters the tubular cutting member; and axially rotating the annular blade to sever the suture. In some embodiments, the method further comprises pushing the annular blade towards the suture. In some embodiments, the method further comprises pushing the annular blade towards the suture, including biasing the annular blade with a biasing element. In some embodiments, the annular blade is rotated at least one full turn before the suture is cut. In some embodiments, the suture is sandwiched between the cutting blade and a member fixed relative to the annular blade. In some embodiments, the method further comprises applying a tension to the suture. In some embodiments, the method is performed within a patient's body.

[0020] Aspects of the present disclosure provide a tightening system capable of being used in conjunction with a beaded suture defining bead members, the tightening system comprising: a tightening element including an attachment and a stop, the stop being configured to allow the beaded suture to move therethrough in a distal-to-proximal direction and prevent the beaded suture from moving therethrough in a proximal-to-distal direction; and a tightening catheter including a tightening element retainer provided distally for receiving the attachment; and a tightening element lock for reversibly locking the attachment and the tightening element retainer to each other.

[0021] In some embodiments, the stop includes a tubular body and lobes provided within the tubular body and converging towards each other in a proximally directed direction within the stop, the lobes being movable between a narrow configuration and a wide configuration, a central gap between the lobes being smaller in the narrow configuration than in the wide configuration such that the bead members can move through the gap in the wide configuration but are prevented from moving through the gap in the narrow configuration. In some embodiments, the lobes extend integrally from the tubular body as a single piece of material. In some embodiments, the lobes are made of a nickel-titanium shape memory alloy. In some embodiments, the lobes are biased towards the narrow configuration in the wide configuration.

[0022] In some embodiments, the cinch catheter is adapted to selectively open the gap to allow the beaded wire to be directed therethrough in both distal and proximal directions. In some embodiments, the tubular body includes circumferentially spaced sectors that are deformable between an undeformed configuration and an open configuration, wherein in the open configuration, the gap is larger than in the undeformed configuration, and the cinch catheter includes a sector actuator for selectively moving the sectors to the open configuration.

[0023] In some embodiments, the tensioning element holder and the attachment are complementarily shaped such that relative longitudinal and circumferential movement between the tensioning element holder and the attachment is prevented when the tensioning element holder and the attachment are mounted on one another, and the attachment is free to move laterally in at least one direction relative to the tensioning element holder unless the attachment is locked to the tensioning element holder. In some embodiments, the attachment and the tensioning element holder are both hollow, and the tensioning element lock comprises an elongated member selectively movable between an extended position and a retracted position, wherein in the extended position the tensioning element lock extends through the tensioning element holder and the attachment, and in the retracted position the tensioning element lock is proximally retracted relative to the attachment such that the attachment is free to move laterally relative to the tensioning element holder.

[0024] In some embodiments, the attachment and the lacing element holder are both internally threaded and the lacing element lock is externally threaded, such that in the extended position, the lacing element lock threadably engages the attachment and the lacing element holder. In some embodiments, the stopper is hollow and includes an internally extending deformable leaflet configured to allow the bead to pass through the stopper in a proximally directed direction while preventing the bead from passing through the stopper in a distally directed direction.

[0025] In some embodiments, the stopper includes a tubular stopper body defining circumferential sectors separated from one another by slits, each leaf extending from a single sector, and the tightening element lock is hollow and movable distally to engage the sectors to splay the sectors outward and separate the leafs from one another to create a gap allowing the bead to move distally therethrough.

[0026] In some embodiments, the cinching element lock is tubular and is movable selectively between an extended position and a retracted position, wherein in the extended position, the cinching element lock surrounds at least a portion of both the cinching element retainer and the attachment member to prevent lateral movement therebetween, and in the retracted position, the cinching element lock is retracted proximally relative to the attachment member such that the attachment member is free to move laterally relative to the cinching element retainer. In some embodiments, the lobes together form a proximally tapering conical shape.

[0027] Aspects of the present disclosure provide a cinching element defining a proximal end and a distal end, the cinching element being usable in conjunction with a cinching catheter and a beaded suture thread, the cinching element including: a proximal attachment member that is selectively attachable to the cinching catheter; and a distal stop configured to permit the beaded suture thread to move therethrough in a distal-to-proximal direction and to prevent the beaded suture thread from moving therethrough in a proximal-to-distal direction.

[0028] In some embodiments, the stop includes a tubular body and lobes provided within the tubular body and converging toward each other in a proximally directed direction within the stop, the lobes being movable between a narrow configuration and a wide configuration, a central gap between the lobes being smaller in the narrow configuration than in the wide configuration such that the beaded member can move through the gap in the wide configuration but is prevented from moving through the gap in the narrow configuration.

[0029] In some embodiments, the lobes extend integrally from the tubular body as a single piece of material. In some embodiments, wherein in the wide configuration, the lobes are biased toward the narrow configuration. In some embodiments, the tubular body defines circumferentially spaced sectors, each of the lobes being supported by one of the sectors, the sectors being deformable into an open configuration in which the gap is enlarged to permit the beaded member to move in a proximal-to-distal direction.

[0030] Aspects of the present disclosure provide a cryoadhesion catheter assembly including: a tubular body that supports a hollow heat transfer element distally thereof, the heat transfer element including a flexible portion that is bendable to conform to a predetermined shape; a pull assembly that is fixed distally to the heat transfer element and includes a pull wire extending along the body, the pull assembly being configured to bend the flexible portion; and a cooling fluid supply for supplying cooling fluid to the heat transfer element.

[0031] In some embodiments, the system further includes a guiding member extending within the flexible portion, the guiding member being stiffer when bent in a first plane than when bent in a second plane orthogonal to the first plane, both the first plane and the second plane extending along the bellow, wherein when the pulling wire is pulled, the guiding member restricts bending in the first plane while allowing bending in the second plane. In some embodiments, the guiding member includes a plate that extends laterally across the flexible member and longitudinally along at least a portion of the flexible member. In some embodiments, the plate is perforated.

[0032] In some embodiments, the cooling fluid supply defines a fluid outlet, and the cooling fluid supply is movable relative to the heat transfer portion such that the cooling fluid outlet can be positioned at different longitudinal positions along it. In some embodiments, an anchor drive conduit is included for driving a screw anchor on the heat transfer portion.

[0033] In some embodiments, the tubular body defines an anchor engagement portion proximal to the heat transfer portion, the anchor engagement portion being configured to engage the anchor and constrain movement of the anchor along it to a helical movement. In some embodiments, the anchor engagement portion prevents the anchor drive conduit from advancing further distally than the anchor engagement portion. In some embodiments, the anchor engagement portion includes at least two protrusions extending radially outward from the tubular body, the at least two protrusions being circumferentially and longitudinally offset from each other. In some embodiments, the anchor engagement portion includes a helical flange extending radially outward from the tubular body.

[0034] In some embodiments, the system further includes an anchor conduit actuator for selectively advancing and rotating the anchor drive conduit relative to the tubular body. In some embodiments, the advancement and rotation of the anchor drive conduit are independent of each other. In some embodiments, the advancement and rotation of the anchor drive conduit can be locked independent of each other. In some embodiments, the anchor conduit actuator includes a housing and a knob, the knob being mounted to the housing, the knob defining an axial knob channel that receives the drive conduit passing therethrough, the drive conduit being fixed to the knob to be axially movable and rotatable relative to it together. In some embodiments, the knob is mounted to a knob mount to be longitudinally movable therewith and axially rotatable relative to it, the knob mount being mounted to the housing to be longitudinally movable along it and axially rotatably fixed relative to it.

[0035] In some embodiments, the system further includes a rotation lock for selectively locking relative rotation between the knob mount and the knob and a translation lock for selectively locking relative translation between the housing and the knob mount. In some embodiments, the housing defines: a longitudinally elongated mount cavity that receives the knob mount therein; and a pair of slots that longitudinally extend therebetween along an outer side of the housing and the mount cavity, the translation lock and the rotation lock respectively including a translation lock threaded fastener and a rotation lock threaded fastener, each radially extending through a respective one of the slots so as to be longitudinally movable therein and engage respective threaded orifices formed in the knob mount, wherein translation and rotation of the knob relative to the housing are respectively locked when the translation and rotation lock threaded fasteners are fully screwed into their respective threaded orifices.

[0036] Aspects of the present disclosure provide a transcatheter system that includes: a drive catheter configured to drive one or more anchors into tissue; a cinch catheter configured to cinch a filament extending through the one or more anchors; and a cutting catheter configured to cut a portion of the filament. In some embodiments, the system further includes a cooling catheter and a cooling system for providing a cooling fluid to the cooling catheter, wherein the cooling catheter is configured to freeze a portion of the tissue adhered thereto. In some embodiments, the cooling catheter includes a heat transfer portion having a flexible portion that is capable of bending to conform to the shape of a valve annulus. In some embodiments, when bent, the flexible portion extends over between about 135 degrees and about 225 degrees.

[0037] In some embodiments, the system further includes a tensioning device for applying tension to the suture. In some embodiments, the suture defines longitudinally spaced-apart beads. In some embodiments, the system further includes at least one helical anchor that can be mounted to the drive catheter for driving into the tissue. In some embodiments, the system further includes a stopper and a cinching element, both of which are larger than the central channel of the helical anchor, the suture can be fixed to the stopper and the cinching element is configured to allow the suture to pass therethrough in only one direction. In some embodiments, the at least one anchor is configured to be implanted at the mitral annulus along a portion of the mitral valve selected from: the portion from the P1 region to the A1 region, the portion from the P2 region to the A3 region, the portion from the P1 region to the P3 region, the portion in the P1 region, the portion in the P2 region, the portion in the P3 region, the portion from the P3 to the A3 region. In some embodiments, the at least one anchor includes 2 to 30 coils. In some embodiments, the at least one anchor is configured to span between about 45 degrees and about 225 degrees along the mitral annulus. In some embodiments, the at least one anchor is configured to span between about 225 degrees and about 315 degrees along the mitral annulus.

[0038] In some embodiments, the cinching catheter includes a double-shell construction that includes two layers that can rotate axially relative to each other and is configured to receive the suture therebetween.

[0039] In some embodiments, the cooling and drive catheter is the cryoadhesion catheter assembly defined in any of the above embodiments, the cutting catheter is the cutting catheter in any of the above embodiments, and the cinching catheter is the cinching catheter defined in any of the above embodiments.

[0040] Aspects of the present disclosure provide an implant kit that includes: a helical anchor that defines an anchor channel extending therethrough; a beaded suture that defines longitudinally spaced-apart beads; a stopper that is larger than the central channel to prevent passage therethrough; and a cinching element that is larger than the central channel to prevent passage therethrough, the cinching element defining a one-way gap that allows the suture to pass therethrough in only one direction. In some embodiments, the stopper can be fixed to the beaded suture. In some embodiments, the kit is assembled to form an implant, wherein the stopper and the cinching element abut the helical anchor at their opposite longitudinal ends, and the suture extends therebetween under tension.

[0041] In some embodiments, the kit further includes another screw anchor, wherein the kit is assembled to form an implant, wherein the screw anchors extend from one another with a space therebetween, and the stop and the tightening element abut against a respective one of the screw anchors opposite the space, and the suture extends therebetween under tension. In some embodiments, the anchors are straight when undeformed and bent when the implant is assembled with the suture under tension. In some embodiments, the stop can be fixed to the suture, and the implant kit further includes another stop, another screw anchor, and another beaded suture that can be fixed to the suture.

[0042] In some embodiments, the kit is assembled to form an implant, wherein the screw anchors extend from one another with a space therebetween, the stop abuts against a respective one of the screw anchors opposite the space, and each suture extends from a respective one of the stops through a respective screw anchor and to the tightening element provided adjacent the space, and the sutures all extend under tension through the gap.

[0043] Aspects of the present disclosure provide an implant kit comprising: at least two screw anchors, each defining an anchor channel extending therethrough; a beaded suture defining longitudinally spaced beads; and a tightening element defining a one-way gap that permits the suture to pass therethrough in only one direction.

[0044] In some embodiments, the kit is assembled to form an implant, wherein the suture forms a loop extending through two screw anchors and closed by the tightening element. In some embodiments, the loop forms an 8 shape. In some embodiments, in the implant, the two screw anchors are laterally spaced from one another by generally parallel anchor channels.

[0045] An implant assembled from an implant kit according to any of the above embodiments.

[0046] Aspects of the present disclosure provide a wound closure device comprising: a cryo-adhesion device including a hollow heat-conductive element and a cooling fluid supply for supplying a cooling fluid thereto; and an anchor driver for driving a screw anchor onto the heat-conductive element. In some embodiments, the anchor driver supports the anchor at the distal end of a rigid member.

[0047] Aspects of the present disclosure provide methods of using a transcatheter system to cut suture threads, the methods comprising: advancing a transcatheter system comprising a catheter and a cutting member having a distal annular blade through at least one body vessel of a subject to a location at or near a target tissue; driving one or more anchors into the target tissue using a drive catheter; tightening a suture thread extending through the one or more anchors; and cutting at least a portion of the suture thread using the cutting member. In some embodiments, the annular blade is configured to translate and rotate simultaneously relative to the suture thread. In some embodiments, the method further comprises cryoadhering at least one of the one or more anchors to a portion of the tissue. In some embodiments, the method further comprises biasing the annular blade towards the suture thread.

[0048] Advantageously, the proposed system and its various components can be used to effectively perform a variety of different types of surgical procedures.

[0049] Other objects, advantages and features of the present disclosure will become more apparent after reading the following non-limiting description of some of its embodiments, which is given by way of example only with reference to the accompanying drawings.

[0050] Incorporation by reference

[0051] All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference into this application to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference into this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The novel features of the present disclosure are set forth specifically in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description, which sets forth illustrative embodiments that utilize the principles of the invention, and in the accompanying drawings in which:

[0053] Figure 1 A transcatheter surgical system according to an embodiment of the present disclosure is shown in schematic form;

[0054] Figure 2 Shown in perspective form is a Figure 1 cooling catheter portion of the system according to an embodiment of the present disclosure;

[0055] Figure 3 and Figure 4 and Figure 5 and Figure 6 and Figure 7 and Fig. 8A and Figure 8B and Fig. 9 and Fig.10 and Fig.11 , Fig.12 , Fig.13 , Fig.14 , Fig.15 , Fig.16 , Fig.17 , Fig.18 , Fig.19 , Fig. 20 and Fig.21 show various aspects of a cooling conduit and some of its variations according to an embodiment of the present disclosure in side elevation and perspective views; Figure 1

[0056] Fig. 22 show, in side elevation view, an actuator capable of being used in conjunction with Figure 2 the cooling conduit and Fig.23 the drive conduit shown;

[0057] Fig.23 show, in side elevation view, Figure 1 the drive conduit portion of the system, which is shown here sliding on Figure 1 the cooling conduit;

[0058] Fig.24 , Fig.25 , Fig.26 , Fig.27A , Fig.27B and Fig.28 show various aspects of Fig.23 the drive conduit and Fig. 22 the actuator in various views;

[0059] Fig.29 show, in longitudinal cross - sectional view, Figure 1 the cinching conduit portion of the system;

[0060] Fig.30 , Fig.31 , Fig.32 , Fig.33 , Fig.34 , Fig.35 , Fig.36 , Fig.37 , Fig.38 , Fig.39 and Fig.40 show various aspects of Fig.29 the cinching conduit and some of its variations in various views;

[0061] Fig.41 show, in perspective cross - sectional view, an actuator according to an embodiment of the present disclosure capable of being used in conjunction with Fig.29 the cinching conduit;

[0062] Fig.42 show, in perspective view, Fig.40 ​Actuator;

[0063] Fig.43 The cutting catheter portion of the system according to an embodiment of the present disclosure is shown in an exploded view; Figure 1 of the system;

[0064] Fig.44 and Fig.45 and Fig.46 and Fig.47 show various aspects of the cutting catheter in various views; Fig.43 of the cutting catheter;

[0065] Fig.48A and Fig.48B and Fig.48C A flowchart shows the annuloplasty procedure using the system according to an embodiment of the present disclosure; Figure 1 of the system;

[0066] Fig.49 A flowchart shows the use of the system according to an embodiment of the present disclosure; Figure 1 An alternative annuloplasty procedure of the system;

[0067] Fig.50 A flowchart shows the use of the system according to an embodiment of the present disclosure; Figure 1 Another alternative annuloplasty procedure of the system;

[0068] Figure 50-2 A flowchart shows the use of the system according to an embodiment of the present disclosure; Figure 1 Yet another alternative annuloplasty procedure of the system;

[0069] Fig.51 A flowchart shows the use of the system according to an embodiment of the present disclosure; Figure 1 Yet another alternative annuloplasty procedure of the system;

[0070] Fig.52 A flowchart shows the use of the system according to an embodiment of the present disclosure; Figure 1 AP reduction procedure of the system;

[0071] Fig.53 A flowchart shows the use of the system according to an embodiment of the present disclosure; Figure 1 An alternative AP reduction procedure of the system;

[0072] Fig.54A and Fig.54B A flowchart shows the use of the system according to an embodiment of the present disclosure; Figure 1 suturing procedure of the system;

[0073] Fig.55 A flowchart shows the use of the system according to an embodiment of the present disclosure; Figure 1A systematic edge-to-edge valve repair procedure;

[0074] Fig.56 , Fig.57 , Fig.58 , Fig.59 , Fig.60 , Fig.61 , Fig.62 , Fig.63 , Fig.64 , Fig.65 , Fig.66 , Fig.67 , Fig.68 , Fig.69 , Fig.70 , Fig.71 , Fig.72 , Fig.73 and Fig.74 The schematic diagram shows the embodiment of the present invention. FIG. 48A to FIG. 48C The various steps of the method;

[0075] Fig.75 , Fig.76 , Fig.77 and Fig.78 The schematic diagram shows the embodiment of the present invention. Fig.49 The various steps of the method;

[0076] Fig.79 , Fig.80 , Fig.81 and Fig.82 The schematic diagram shows the embodiment of the present invention. Fig.50 The various steps of the method;

[0077] Fig.83 and Fig.84 The schematic diagram shows the embodiment of the present invention. Figure 50-2 The various steps of the method;

[0078] Fig.85 , Fig.86 and Fig.87 The schematic diagram shows the embodiment of the present invention. Fig.51 The various steps of the method;

[0079] Fig.88 and Fig.89 The schematic diagram shows the embodiment of the present invention. Fig.52 The various steps of the method;

[0080] Fig.90 and Fig.91 The schematic diagram shows the embodiment of the present invention. Fig.53 The various steps of the method;

[0081] Fig.92 、 Fig.93 、 Fig.94 、 Fig.95 、 Fig.96 、 Fig.97 、 Fig.98 、 Fig.99 、 Fig.100 、 Fig.101 、 Fig.102 、 Fig.103 and Fig.104 show in schematic form Fig.54A and Fig.54B each step of the method and its variations;

[0082] Fig.105 and Fig.106 show in schematic form Fig.55 each step of the method and its variations;

[0083] Fig.107 show in perspective view an optional actuator that can be used in Figure 1 the system;

[0084] Fig.108 show in side elevation view the cooling supply actuator in a first configuration;

[0085] Fig.109 show in side elevation view the cooling supply actuator in a second configuration where the cooling fluid supply has been moved relative to the first configuration;

[0086] Fig.110 show in schematic form the manner of suturing by connecting both sides of the wound;

[0087] Fig.111 show in schematic form another manner of suturing by connecting both sides of the wound;

[0088] Fig.112 show in perspective view an optional drive catheter;

[0089] Fig.113 show in exploded perspective view an optional cutting catheter actuator that can be used in conjunction with an optional cutting catheter according to an embodiment of the present disclosure;

[0090] Fig.114 show in perspective view Fig.113 the knob portion of the cutting catheter assembly;

[0091] Fig.115 show in perspective view Fig.113 the distal end of the support member portion of the cutting catheter that can be used in conjunction with

[0092] Fig.116 Shown in the form of a side partial cross-sectional view is a cutting catheter of a cutting catheter assembly including Fig.113 a cutting catheter;

[0093] Fig.117 Shown in the form of a side elevation view is Fig.116 detail CXVII;

[0094] Fig.118 Shown in the form of a side partial cross-sectional view is the Fig.116 cutting catheter in a second configuration;

[0095] Fig.119 Shown in the form of a side elevation view is Fig.118 detail CXIX;

[0096] Fig.120 Shown in the form of a side partial cross-sectional view is the Fig.116 cutting catheter in a third configuration;

[0097] Fig.121 Shown in the form of a side elevation view is Fig.120 detail CXXI; and

[0098] Fig.122 Shown is a tightening wire forming a loop through one or more anchors according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0099] The terms "substantially" and "about" are used in this document to denote variations of the terms so qualified. These variations are variations that do not materially affect the way the present disclosure works and may be due, for example, to uncertainties in the manufacturing process or to minor deviations from the nominal value or ideal shape that do not cause a significant change to the invention. In addition, the terms "proximal" and "distal" refer to the orientation relative to the operator using the present disclosure on a patient. Distal elements are closer to the intervention site within the patient, while proximal elements are closer to the operator (e.g., a surgeon) using the proposed invention.

[0100] Reference Figure 1, schematically shows a transcatheter surgical system 100, hereinafter simply referred to as system 100. System 100 may include a cooling catheter 200, a drive catheter 300, a tightening catheter 400, a cutting catheter 500, and a wire tensioning device 600. The cooling catheter 200, the drive catheter 300, the tightening catheter 400, and the cutting catheter 500 can be used respectively to perform various transcatheter procedures or other minimally invasive surgical procedures, several examples of which are described below. System 100 may also include a cooling system 102 for providing a cooling fluid, a cooling and drive catheter actuator 104 for moving the respective components of the cooling catheter 200, and a tightening catheter actuator 106 for operating the tightening catheter 400. In some embodiments, a cutting catheter actuator 122 similar to the tightening catheter actuator 106, or a similar actuator, can also be used to actuate the cutting catheter 500. For example, the cooling fluid can be a pressurized gas, which is configured to expand at a suitable lower pressure position in the cooling catheter 200 to cool a part of the cooling catheter 200. The cooling system 102 can thus include any components required to provide the pressurized gas in a controlled manner. However, in alternative embodiments, any other suitable cooling fluid can be provided, such as, for example, a compressed or liquefied gas cylinder or a mixed-phase gas and liquid. Benches 118 and 120 can be used to support the respective actuators used in system 100.

[0101] Reference Figure 2 , the cooling catheter 200 may include a traction assembly 202, a wire guide 204, a bellows 206, an inner tube 208, an outer tube 210, a sleeve 212, and a cooling fluid supply 214. The traction assembly 202 and the wire guide 204 can be used to selectively bend the cooling catheter 200 to allow steering through the patient's vasculature and set the shape of the bellows 206 such that the bellows 206 can cool the tissue adjacent thereto and ultimately adhere to this tissue by cryo-adhesion. The cooling fluid supply 214 receives the cooling fluid from the cooling system 102 ( Figure 2 not shown in the figure) to cool the bellows 206. In the figures, only the distal end of the cooling catheter 200 is shown, and it should be understood that the cooling catheter 200 can be long enough to be inserted through a conventional surgical catheter or sheath to perform surgery at the site of interest (such as within the heart). The respective components of the cooling catheter 200 that need to be accessed externally to perform the surgery thus have sufficient length to provide such access. In some embodiments, the diameter of the bellows 206 can be adjusted using a traction wire.

[0102] Figure 3The retraction assembly 202 is shown. The retraction assembly 202 can include an end cap 216 and a retraction wire 218 extending therefrom. The end cap 216 can include a dome 220 and a cap sleeve 222 extending therefrom, the dome 220 having a substantially atraumatic shape (such as hemispherical). In some embodiments, when the cooling catheter 200 is used, an external wire attachment 224 extends from the dome 220 to the outside of the cooling catheter 200 opposite the retraction wire 218. The wire attachment 224 can be used to attach an external wire thereto, which can be used, for example, to cinch in valvuloplasty. In a particular embodiment, the wire attachment 224 takes the form of a loop.

[0103] Figure 4 The wire guide 204 is shown. The wire guide 204 can be elongate and is generally manufactured by removing a suitable portion of a tubular member. The wire guide 204 defines longitudinally opposed proximal 226 and distal 228 wire guide ends. In a first embodiment, the wire guide 204 can include a longitudinally extending backbone 230, and a plurality of longitudinally spaced cylindrical tubes 232 extend from the backbone 230. The backbone 230 defines a plurality of notches 234 (seen more clearly, for example, in Figure 5 ), the notches 234 extending transversely therethrough midway and longitudinally spaced from each other. The notches 234 facilitate bending of the backbone 230 in a plane perpendicular to the notches 234. When the wire guide 204 and the retraction assembly 202 can be assembled, the tubes 232 receive the retraction wire 218 therethrough.

[0104] In some embodiments, during manufacture, a pair of slits 236 opposite the backbone 230 can be formed in each of the tubes 232. The slits 236 each circumferentially surround a portion of the tube 232 and together define a tab 238 therebetween. As Figure 6 shown, during manufacture, the tab 238 can be pushed inwardly into the tube. This allows the retraction wire 218 to be inserted between the outer wall of the tube 232 and the inwardly pushed tab 238 to provide a relatively narrow passage through which the retraction wire 218 can extend, as Figure 7 shown. This maintains the retraction wire 218 spaced from the backbone 230, thereby creating a uniform pull along the tip, replicating a multi-lumen tube therearound to facilitate bending of the cooling catheter and maintaining the bending plane using the retraction wire 218. Generally, the retraction wire 218 can slide relatively easily relative to the tubes 232 while still remaining relatively close to the perimeter of the tubes 232. Thus, when the retraction wire 218 is pulled, the wire guide 204 is configured to bend in a plane perpendicular to the backbone 230 and the notches 234, or in other words, in a plane extending through both the backbone 230 and the tab 238.

[0105] Once assembled, the backbone 230 longitudinally overlaps the sleeve 222. This effectively transfers the forces and torques generated when the draw wire 218 is pulled to the remainder of the cooling conduit 200. In the illustrated embodiment, releasing the draw wire 218 causes the backbone 230 to passively return to its straight, undeformed shape. In an alternative embodiment, a bi-wire or multi-wire (e.g., 3-wire or 4-wire) counteracting system may instead be used to effect such deformation.

[0106] In an alternative embodiment, as Figure 6 shown, the backbone 230' may be tubular and provided with slits 234' configured to allow the backbone 230' to bend in a predetermined plane.

[0107] Fig. 8A and Figure 8B illustrates the bellows 206. The bellows 206 is configured to transfer heat relatively easily such that when the interior of the bellows 206 is cooled by a cooling fluid, any tissue adjacent to which the bellows 206 abuts is cooled relatively quickly. Eventually, this tissue will be cooled below the freezing point and the bellows 206 and the tissue will adhere to each other. For example, the bellows 206 is formed from a relatively thin metal tube having sufficient thickness to withstand a pressurized cooling fluid.

[0108] The bellows 206 is a heat transfer section configured to adhere to tissue once the bellows 206 is internally cooled. The bellows 206 may include longitudinally opposed bellows proximal section 240 and bellows distal section 242 and a bellows intermediate section 244 extending therebetween. The bellows proximal section 240 and the bellows distal section 242 may be more rigid than the bellows intermediate section 244, which defines a convolution that allows the bellows intermediate section 244 to bend when the backbone 230 is deformed by pulling on the draw wire 218. In some embodiments, the bellows 206 may include a braided tubing flexible enough to withstand high pressure. In some embodiments, the bellows 206 is multi-lumen. In some embodiments, the cooling conduit may be constructed to withstand a relatively high (e.g., up to 3000 psi) internal pressure.

[0109] When assembling the cooling conduit 200, the bellows 206 may be positioned around the wire guide 204, which itself receives the draw wire 218, and the bellows 206 abuts the cover 216. The cover 216 may generally be fixed to the bellows distal section 242, for example by welding. The bellows intermediate section 244 and the backbone 230 at least partially overlap such that they can deform together to deform the cooling conduit 200 from a stress-free configuration as shown in Fig. 8A to a configuration as shown in Figure 8BThe curved configuration shown. For example, in the curved configuration, the intermediate section 244 of the bellows may be generally arcuate. In some embodiments, the bellows 206 may be relatively long, e.g., long enough to extend along a major portion of the cardiac annulus or other tissue.

[0110] In an alternative embodiment, as shown together in Fig. 9 and Fig.10 the wire guide 204' takes the form of a perforated plate fixed inside the bellows 206. As Fig.10 shown, the pull wire 218 may be provided between the pull wire and the bellows 206, and the size of the gap between the pull wire 218 and the bellows 206 is adapted to receive the pull wire 218 relatively closely while allowing the pull wire 218 to slide slightly relative thereto. The perforated plate bends mainly in a plane perpendicular to it and includes perforations 205 extending therethrough, allowing the cooling fluid to fill the bellows 206 while also facilitating the bending of the wire guide 204'.

[0111] Referring to Fig.11 and Fig.12 the inner tube 208 may fit inside the proximal section 240 of the bellows, a little shy of the wire guide 204. The pull wire 218 exits the bellows 206 to outside the inner tube 208. The inner tube 208 may be fixedly mounted inside the bellows 206, e.g., using an adhesive, while allowing the pull wire 218 to be more relative thereto.

[0112] Referring to Fig.13 and Fig.14 the inner tube 208 and the pull wire 218 may fit inside the outer tube 210, and in a typical transcatheter procedure, all three components extend outside the patient's body. As Fig.15 shown, the outer tube 210 may take the form of a multi-lumen catheter, including a main lumen 246 and an auxiliary lumen 248. The inner tube 208 and the pull wire 218 extend through the main lumen 246, and accessories such as thermocouples can be inserted through the auxiliary lumen 248. As Fig.16 shown, in some embodiments, a relatively rigid sleeve 212 may fit over the proximal section 240 of the bellows and the outer tube 210 (the outer tube 210 tapers distally to allow such a fit).

[0113] Finally, referring to Fig.17, the cooling fluid supply member 214 may take the form of a tube extending from within the bellows 206 to outside the outer tube 210. The cooling fluid supply member 214 may be configured, for example, to deliver pressurized gas through a relatively small opening at its distal tip such that when the gas expands, the gas can be cooled, thereby cooling the bellows 206. The expanded gas then exits the bellows 206 through the outer tube 210. In some embodiments, the cooling fluid supply member 214 may be fixed relative to the bellows 206. In other embodiments, the cooling fluid supply member 214 is capable of longitudinal movement along the remainder of the cooling conduit 200. In some embodiments, the cooling fluid supply member 214 can have a plurality of openings or outlets spaced along its distal end such that the cooling effect is diffused over a distance. Once the cooling gas flows within the conduit, the polymer, polyamide, or plastic tubing is configured to expand and press against this stainless steel sleeve, thereby making it leak-proof.

[0114] Reference Fig.18 , in some embodiments, the cooling conduit 200a may include a section that can assume a predetermined non-straight configuration when no force is applied thereto. For example, the cover 216a may include a tubular section 221a having an arcuate configuration or a D-shaped configuration, for example, whose shape and size match a similar shape of the annulus section. This cover 216a can be shaped or pre-bent. In such embodiments, the tubular section 221a can help the user locate the bellows 206 more quickly by guiding the surgeon to the correct position with minimal trial and error, as Fig.19 shown. In other embodiments, the tubular section 221 may be replaced by a preformed wire.

[0115] Reference Fig. 20 , in some embodiments, one or more auxiliary pull wires 250 may be fitted within one of the auxiliary cavities 248 of the outer tube 210 and fixed to the outer tube 210 at its distal end. This auxiliary pull wire 250 may be, for example, approximately 90 degrees around the outer tube 210 relative to the pull wire 218, and can further assist in positioning the cooling conduit 200 by better controlling its deformation in various planes, as Fig.21 shown. In other embodiments, certain sections of the cooling conduit 200 may be pre-bent to assume a predetermined shape to facilitate the positioning and manipulation of the cooling conduit when no external force is applied to the cooling conduit 200.

[0116] Reference Fig. 22 , the drive conduit 300 is shown. The drive conduit 300 can be used in conjunction with the cooling and drive conduit actuator 104 and one or more anchors 302. Reference Fig.23 , the drive conduit 300 is capable of sliding over the cooling conduit 200 such that the anchor 302 can be inserted into the tissue to which the bellows 206 can adhere ( Fig.23into (not shown in FIG. 1). This sliding movement can also be used to load the anchor 302 into the drive catheter. The drive catheter 300 is also capable of rotating relative to the cooling catheter 200. The drive catheter 300 can be an elongate tube that is flexible enough for use in catheter-based surgery while still being able to transmit sufficient torque to drive the helical anchor 302 into tissue.

[0117] As Fig.24 shown, the anchor 302 can be fixed to the distal end 306 of the drive catheter 300. The anchor 302 is generally capable of being removed from the drive catheter 300. For example, the anchor 302 takes the form of an elongate helical member that terminates at a point that can be screwed into a suitable thread 308 formed internally in the distal end 306 of the drive catheter 300. When the anchor 302 abuts against tissue and the drive catheter 300 can be rotated in the driving direction, the anchor 302 is configured to be driven into the tissue. When the anchor 302 is anchored past the distal tip of the drive catheter 300, the anchor 302 is configured to be released and the drive catheter 300 can be released. When the drive catheter 300 is removed, the anchor 302 will be left behind. Alternative anchors 302 and drive catheters 300 that can be used in the present disclosure are described in PCT patent application PCT / IB2018 / 060073, filed Dec. 14, 2018, the contents of which are hereby incorporated by reference in their entirety.

[0118] Referring Fig.23 to FIG. 10, in some embodiments, the sleeve 212 can be small enough to fit within the anchor 302 and is provided with an anchor engagement portion 309 that is configured to engage the anchor 302 and ensure that the anchor 302 is driven into the tissue according to its pitch. For example, the anchor engagement portion 309 takes the form of one, two, or more pins 305 that project radially outward from the sleeve 212 and are longitudinally and angularly spaced from each other to match the pitch of the helical anchor 302. As Fig.25 shown in FIG. 11, in other embodiments, the engagement portion 309' takes the form of a helical flange extending from the sleeve 212, still having a pitch that matches the pitch of the helical anchor 302. Additionally, the engagement portions 309 and 309' prevent the anchor 302 from being released without rotation and prevent the drive tube 306 from extending beyond the positions of the engagement portions 309 and 309', such that this would prevent the drive tube from elongating for better control.

[0119] The actuator 104 can be used to rotate the drive catheter 300. For example, with continued reference Figure 26 to Figure 28, the actuator 104 may include a housing 310, and a knob 312 defining an axial knob passage 314 may be mounted to the housing 310. A drive conduit 300 extends through the knob passage 314 and may be fixed relative to the knob passage 314 using a set screw 316 that engages a tubular threaded insert 317 fixedly mounted in a suitable mounting aperture 319 formed in and extending radially through the knob 312.

[0120] In some embodiments, the knob 312 can be removed from the housing 310 of the actuator 104 to facilitate the assembly of the actuator 104 with the cooling and drive conduits 200 and 300. For example, the housing 310 may include two portions 318 and 320, each extending the entire length of the housing 310 and fixed to each other using screws 321, thereby allowing the housing 310 to be split in half to allow access to its interior. When the two portions 318 and 320 are separable from each other, a knob mount 322 to which the knob 312 can be mounted can be removably mounted to the housing 310. The knob 312 can rotate freely relative to the knob mount 322 unless locked thereto.

[0121] For example, the knob mount 322 may be generally annular and define a central aperture 323 through which a proximal mounting shaft 325 portion of the knob 312 can be mounted. A split pin 324 can be used to engage a circumferential groove 326 formed in the mounting shaft 325. The split pin 324 can be inserted into a suitable slit 327 formed in the knob mount 322 and extending toward the central aperture 323. In some embodiments, the knob mount 322 may be provided with one or more threaded inserts 328 mounted thereon and opening radially outwardly therefrom. The housing 310 may be provided with a pair of longitudinally extending elongated slits 330 positioned such that when the knob mount 322 is properly rotated, screws 332a and 332b can be used to engage the threaded inserts 328 to fix the knob mount 322 relative to the housing 310. (See Fig.28 ) When mounted to the housing 310, the knob mount 322 can be received in a cylindrical cavity 327 formed inside the housing 310 for rotation and sliding along it.

[0122] The screws 332a and 332b engage the knob mount 322 through the slots 330 to rotationally lock the knob mount 322 relative to the housing 310. In one aspect, one of the screws 332a can be too short to extend to the mounting shaft 325 such that when this screw 332a is fully screwed in, frictional engagement prevents longitudinal movement of the knob mount 322 and the housing 310 relative to each other because the housing 310 is then sandwiched between and compressed between the screw 332a and the knob mount 322. In one aspect, the other screw 332b can be long enough to extend into the central aperture 323 when fully screwed in, at which time it engages the mounting shaft 325 to prevent rotation of the mounting shaft 325 relative to the knob mount 322 and thus relative to the housing 310. Accordingly, each of rotation and translation of the knob 312 relative to the housing can be locked independently, which allows the drive catheter 300 to be as well because the drive catheter 300 can be fixedly mounted to the knob 312.

[0123] As Fig.112 shown, in some embodiments, the cinching catheter 300 can include a dual-shell construction including two layers that are axially rotatable relative to each other and configured to receive a cinching filament 402 (described further below) therebetween to prevent filament entanglement during anchor actuation. This dual-shell construction is achieved by adding an outer drive catheter sheath 301 outside the drive catheter 300. The outer drive catheter sheath 301 can be manipulated using the secondary steerable catheter actuator 104”, and multiple steerable concentric sheaths that can be independently manipulated and moved relative to each other can be added to enhance steerability.

[0124] The cinching catheter 400 can be used to tighten a loop of filament inserted into a patient. For example, as detailed below, valvuloplasty can be performed by anchoring two or more helical anchors 302 around the annulus of a valve while filaments are inserted through the anchors 302. When the filaments are tightened, the diameter of the annulus can be reduced, thereby reducing the size of the orifice that the valve leaflets must cover. This cinching action can also be performed in many other surgical procedures.

[0125] With common reference Fig.29 and Fig.30 , the cinching catheter 400 can be used in conjunction with a cinching filament 402. The cinching filament 402 generally can include a plurality of bead-like members 404 at longitudinally spaced positions therealong. The bead-like members 404 can be formed, for example and without limitation, by tying knots in the cinching filament 402. The cinching filament 402 extends proximally from outside the cinching catheter 400 and exits the cinching catheter 400 at its cinching catheter distal end 406. The cinching filament 402 can be anchored distally (to tissue or to an implant) within the patient and can also loop outside the cinching catheter 400 back out of the patient.

[0126] The cinching catheter 400 may include a cinching element 410, a cinching element retainer 412, an elongate tube 414, and a cinching element lock 416. The cinching element 410 may be left in place after the cinching procedure to maintain the cinching wire 402 in a relatively taut state within the patient, generally by mechanical interference with an implant such as the anchor 302 or, in some embodiments, with tissue. Generally, the cinching element 410 also acts as a ratchet to allow the cinching wire 402 to be tightened unidirectionally at regular intervals determined by the spacing of the beads 404. To this end, the cinching element 410 may include a stop 418 that allows the bead 404 to move proximally therethrough but prevents the bead 404 from moving distally therethrough. When the cinching element lock 416 is in the locked configuration, the cinching element retainer 412 may be fixed to the elongate tube 414 and the cinching element 410. When the cinching element lock 416 is moved to the unlocked configuration, the cinching element 410 may be released and the remainder of the cinching catheter 400 can be removed, leaving the cinching element 410 behind.

[0127] More specifically, the cinching element 410 may include a tubular body 420 that terminates distally in an annular cap 422 fixed thereto. The stop 418 may be mounted within the tubular body 420 and abut against the cap 422. The stop 418 may be provided between an attachment 421 fixed to the tubular body 420 and the cap 422. The attachment 421 may be configured to mechanically interfere with the cinching element retainer 412 to fix the cinching element 410 to the remainder of the cinching catheter 400.

[0128] The stopper 418 may include, for example, a tubular stopper body 424 that fits snugly within a tubular body 420, with lobes 426 extending proximally from the tubular body 420. For example, four lobes are provided, but any other suitable number of lobes 426 may be used. The lobes 426 taper in a proximally directed direction and define therebetween a proximally located gap 428. The tightening filament 402 extends through the gap 428. The gap 428 may be large enough to allow the tightening filament 402 to move longitudinally therealong, but small enough to prevent the bead 404 from moving distally therethrough. The lobes 426 are capable of deforming independently of one another such that the gap 428 can be enlarged when the bead 404 is directed by the lobes 426 toward and through the gap 428. For example, the lobes 426 may be notched at their tips to create the gap 428 and longitudinally spaced from one another to allow the lobes 426 to move relative to one another and, when a suitable force is applied to the lobes 426, to separate from one another. Thus, in this embodiment, the lobes 426 and the stopper body 424 extend integrally as a single piece of material and may be hinged at the stopper body 424 by living hinges such that they can spread apart from one another by elastic deformation. When the tightening filament 402 is pulled proximally and the bead 404 approaches the gap 428, the bead engages the inner surfaces of the lobes 426, thereby pushing the lobes 426 apart from one another, from a narrow configuration (e.g., as shown in Fig.31 ), to a wide configuration (e.g., as shown in Fig.29 ) to allow the bead 404 to pass through. Once the bead 404 has passed through the gap 428, the lobes 426 elastically rebound toward one another such that pulling the tightening filament distally relative thereto will cause the bead to abut against the tips of the lobes 426 and be stopped, as shown in Fig.31 . In some embodiments, the lobes 426 may be made of a nickel-titanium alloy that exhibits a shape memory effect and superelasticity and is commercially available under the name Nitinol, TM.

[0129] The attachment 421 and the tightening element retainer 412 can be complementary shaped. For example, the attachment 421 and the tightening element retainer 412 are formed by cutting a tubular member along the interface curve 432. The shape of the interface curve 432 is such that the attachment 421 and the tightening element retainer 412 can only move laterally relative to each other. If such lateral movement is blocked, longitudinal and rotational movement of the attachment 421 and the tightening element retainer 412 relative to each other is not possible. For example, the interface curve 432 starts at the vertex 434 and terminates at the lowest point 436. The interface curve 432 follows an S-shape that extends longitudinally along two laterally opposite sides of the attachment 421 and the tightening element retainer 412 assembly, following the profile of the tube from which this assembly is made. The S-shape monotonically extends from the vertex 434 at its furthest lateral position to the lowest point 436 at its closest lateral position such that no lateral plane intersects the S-shape at spaced apart positions along it. This allows the attachment 421 and the tightening element retainer 412 to move freely laterally relative to each other when unlocked. The S-shape prevents longitudinal movement because there are certain longitudinal lines along the attachment 421 and the tightening element retainer 412 assembly that intersect the S-shaped curve at longitudinally spaced apart positions, creating mechanical interference. Finally, since the S-shape can be formed by cutting a cylinder, rotation is blocked because the S-shape does not exhibit rotational symmetry that would allow rotation. In some embodiments, the attachment 421 and the tightening element retainer 412 are substantially similar to each other such that they look the same when one is flipped relative to the other.

[0130] The tightening element tube 414 can be long enough to extend outside the patient's body when a transcatheter procedure is to be performed. The tightening element retainer 412 can be mounted distally on the tightening element tube 414, for example, by a tubular coupler 440 that extends therebetween and is fixed thereto. The outer diameter of the tightening element retainer 412 and the attachment 421 is approximately the same as the outer diameter of the tightening element tube 414.

[0131] The tightening element lock 416 takes the form of an elongated tube that surrounds the tightening element tube 414 and extends towards the tightening element 410. In the locked configuration, as Fig.29 shown, the tightening element lock is moved such that the attachment 421 engages therein. As detailed above, this prevents the tightening element 410 from detaching from the tightening element tube 414. When the tightening element lock 416 is moved proximally until the attachment 421 can be completely outside the tightening element lock 416, as Fig.32 shown, the tightening element 410 is released and the remainder of the tightening catheter 400 can be withdrawn, with the tightening element 410 remaining, mounted to the silk thread 402.

[0132] Figures 34 to 40An optional tightening catheter 400a is shown. In this tightening catheter 400a, the tightening element lock 416a takes the form of a tube that extends through the interior of the elongate tube 414a and includes a distal external thread section 442a, and the attachment 421a and the tightening element retainer 412a can be internally threaded such that when the thread section 442a engages the attachment 421a and the tightening element retainer 412a, the tightening element lock 416a locks the two of them to each other. Once the tightening element lock 416a is unscrewed from the attachment 421a, as Fig.39 and Fig.40 shown, the attachment 421a disengages from the tightening element retainer 412a.

[0133] In some embodiments, the stop 418a may include a tubular body 424a in which the lobes 426a extend internally, forming a proximally tapered conical shape, as described above. A slit 444a may be formed in the tubular body 424a and extend longitudinally therefrom partially from its distal end 446a. The slit 444a thus defines a tubular body sector 448a that supports the respective lobes 426a. The slit 444a thus extends further proximally than the lobes 446a. The inner surface of the tubular body 424a may be curved such that the diameter of the tubular body 424a tapers in a distally directed direction. The tubular body sectors 448a may be configured such that they can elastically deform outwardly, and the tightening catheter 400a may be adapted to selectively open the gap between the lobes 426a to allow the beaded wire 402 to pass therethrough and move distally and proximally. To this end, when the tightening element lock 416 can be screwed in such that it projects into the interior of the tubular body 424a and engages the tubular body sectors 448a, the tubular body sectors 448a may deform such that the gap 428a between the lobes 446a can be enlarged. If sufficient deformation is allowed, one can thus enlarge the gap 428a enough to allow the beaded member 404 to move distally and, through the gap 428a, proximally, as Fig.38 shown. This allows one to correct for over-tightening of the tightening wire 402 - if such over-tightening occurs.

[0134] Fig.41 and Fig.42Shown is a cinching catheter actuator 106 that can be used to operate a cinching catheter 400. The cinching catheter actuator 106 can include a housing 450 to which a slider 452 and a spool 454 can be mounted. The slider 452 is capable of longitudinal movement along the housing 450. In some embodiments, a notch or other suitable feature can be provided to be engaged by the slider 452 such that the slider 452 does not move along the housing 450 too easily. Other ways of preventing accidental movement of the slider 452 are possible. The spool 454 can be located within the housing 450 and can be rotated by an external knob 456. In some embodiments, a releasable ratchet mechanism 458 can also be provided such that the spool 454 is only allowed to move in a predetermined direction unless released.

[0135] A cinching element lock 416 can be mounted to the slider 452 to be capable of co-moving therewith along the housing 450. An elongate tube 414 can be mounted to the housing 450 to be fixed relative thereto. A cinching filament 402 ( Fig.41 and Fig.42 not shown in) can be wound around the spool 454. Thus, moving the slider 452 relative to the housing 450 moves the cinching element lock 416 between a locked configuration and an unlocked configuration, while rotating the knob 456 allows a person to draw the cinching filament 402 into the housing 450. Releasing the ratchet mechanism 458 allows a person to remove a portion of the cinching filament 402 from the spool 454. A ratchet mechanism can be used in addition to or in place of the beaded member 404, and in some embodiments the ratchet mechanism can be omitted.

[0136] Referring Fig.43 and Fig.44 , a cutting catheter 500 - sometimes referred to as a release catheter - can be used to remotely cut the cinching filament 402 or any other wire (such as a suture) within a patient from outside the body. The cutting catheter 500 can include a cutting catheter inner tube 502 and a cutting catheter outer tube 504 that are capable of longitudinal movement relative to each other. Each of the cutting catheter inner tube 502 and the cutting catheter outer tube 504 can be manufactured as two parts that are joined to each other by a tubular coupler to allow replacement of worn parts each time, or relatively short parts can be made of metal, while the main parts of the inner tube 502 and the outer tube 504 can be made of a flexible polymer. The diameter of the inner tube 502 is generally relatively small compared to the outer tube 504.

[0137] The outer tube 504 may be provided with a laterally extending outer tube orifice 506 that is a short distance from the distal end 508 of the outer tube. The outer tube orifice 506 has, for example, a generally rectangular configuration and extends around the outer tube 504 for approximately 45 to 180 degrees. In some embodiments, two diametrically opposed outer tube orifices 506 may be provided. The V-shaped blade 510 may be mounted in the outer tube orifice 506 of the outer tube 504. The V-shaped blade 510 tapers in a distally directed direction and includes a pair of cutting edges 512 that converge distally and face proximally.

[0138] The cutting catheter 500 can be used as follows. Initially, as Fig.44 shown, the inner tube 502 can be positioned to extend from the outer tube orifice 506, and the suture 402 to be ultimately cut extends through the inner tube 502. To cut the suture 514, the inner tube 502 can be withdrawn into the outer tube 504, which causes the suture 402 to abut against the blade 510, as Fig.46 shown. The suture 402 can be maintained under slight tension, and then the inner tube 502 can be pushed. The inner tube 502 can be rigid enough to continue to be pushed through the outer tube orifice 506 within the outer tube 504, which creates a fold in the suture 402. This fold abuts against the cutting edge 512, and with the appropriate tension in the suture 402 combined with sufficient force applied to the inner tube 502, the suture 402 can be cut by the blade 510, as Fig.47 shown, and the cutting catheter 500 can be removed from the patient. The cutting catheter actuator 122 can be similar to the cinching catheter actuator 106, except that the slider 452 can be coupled to the inner tube 502 to slide the inner tube 502 along the outer tube 502. In some embodiments, like the components described in this document, the cutting and cinching catheters can be integrated in a single cutting / cinching device, while the actuators are integrated in a single handle.

[0139] With common reference Figures 113 to 121 there is shown an alternative cutting catheter 500' for cutting a suture 402, such as a cinching suture, a stitch, or any other similar suitable structure. The cutting catheter 500' can include a cutting catheter actuator 532 or actuation assembly, on which an elongate suture receiving member 520 can be mounted. The elongate suture receiving member 520 is provided at its suture receiving member distal end 523 with a suture receiver 522 for receiving the suture 402. An elongate cutting member 524 provided with an annular blade 526 at its cutting member distal end 528 can be mounted on the suture receiving member 520 such that the annular blade 526 can be positioned adjacent to the suture receiver 522. The cutting member 524 can move longitudinally relative to the suture receiving member 520 and can rotate axially relative thereto such that the blade 526 can translate and rotate relative to the suture 402 while the suture 402 is received in the suture receiver 522.

[0140] In some embodiments, the wire receiving member 520 and the wire cutting member 524 can both be flexible and can be concentric, with the cutting member 524 being tubular and surrounding at least a portion of the wire receiving member 520. In such embodiments, the wire receiving member 520 and the wire cutting member 524 can be bendable so as to be able to conform to the patient's vasculature to perform a transcatheter procedure. It should be noted that performing a cutting operation via a transcatheter procedure is notoriously difficult because the flexibility required to position the cutting catheter near the suture in the patient's body complicates the cutting operation, as the required force may not be fully transmitted from outside the patient to the cutting site due to the flexibility of the device.

[0141] Advantageously, the proposed cutting catheter 500 solves this problem by combining rotation of the cutting member 524 relative to the wire holder 522 with biasing the cutting member 524 in a distally-directed direction relative to the wire receiver 522. Thus, using the flexible cutting member 524, a rotational force, which can be more easily transmitted compared to a longitudinal force, can be used to cut the wire 402 by rotating the cutting member 524, without the need for a large longitudinal force. Generally, the cutting member 524 flips at least one full turn before the cutting wire 402 can be cut, and in some embodiments about 10 to 15 turns may be required. The ability to rotate the cutting member 524 through multiple complete turns helps reduce the longitudinal force that must be applied, thus enabling a successful cutting action. Generally, the longitudinal movement can be an axial rotation of the cutting member 524 relative to the wire receiving member 520 and can be independent of each other.

[0142] The wire receiving member 520 can be any suitable element capable of fixing the wire 402 relative to the cutting member 524. For example, the wire receiving member 520 can be elongate and hollow, with the wire receiver 522 being in the form of a wire orifice that extends laterally through the wire receiving member at its distal end. The wire receiving member 520 defines a wire receiving member channel 530 that longitudinally extends therethrough and opens into the wire orifice.

[0143] The cutting catheter actuator 532 can include a body 534 to which the wire receiving member 520 is mounted. The cutting catheter actuator 532 can also include a cutting member actuator 536 that is operably coupled to the cutting member 524 for selectively and independently rotating and longitudinally moving the cutting member 524 relative to the body 534. The cutting member 524 is capable of moving relative to the body 534 between a proximal position and a distal position, as shown respectively in Fig.116 and Fig.120As shown. In some embodiments, the cutting member 524 can be locked in the proximal position when translated relative to the body 534 such that inadvertent cutting action does not occur when the cutting catheter 500' is advanced within a patient.

[0144] More specifically, the cutting member actuator can include a cutting member mount 538 and a knob 540. The cutting member 524 extends through the cutting member mount 538 and is capable of co-axial rotation therewith, such as by being adhered thereto or integrally formed therewith, among other possible arrangements. The knob 540 can be mounted to the body 534 to be axially rotatable relative thereto and defines a knob aperture 542 extending axially therethrough, receiving the cutting member mount 538 therein such that the cutting member mount 538 can axially move along the knob 540 and can rotate therewith. This can be achieved in the actuation assembly 532 by having the cutting member mount 538 and the knob aperture 542 with a similar configuration and size (e.g., having a generally square transverse cross-sectional configuration).

[0145] The cutting member mount 538 can itself be mounted to a mounting element 544 to be rotatable relative thereto, and the mounting element 544 can longitudinally move along a suitably shaped cavity 546 extending along the body 534. The body 534 also defines a slit 548 extending into the cavity 546 such that a slider 550 fixed to the mounting element 544 through the slit 548 allows an intended user to move the mounting element 544 along the cavity 546 to manually position the cutting member. The slit 548 generally extends longitudinally, where a proximal notch 549 allows the slider 550 to be positioned therein to lock the cutting member 534 in the proximal position by rotating the slider into the notch 549. A biasing element 552 can be provided between the cutting member 524 and the body 534 for biasing the cutting member 524 toward the distal position. For example, the biasing element 552 can be a helical spring, abutting against the mounting element 544 and biasing against an internal structure within the body 534 such that the biasing element 552 pushes the cutting member 534 distally. Similar to the knob 446 described above, a tensioner 556 can also be provided for applying tension to the wire 402.

[0146] In operation, the slider 550 can initially be in the notch 552, and the cutting member can be in the proximal position, as Fig.116 and Fig.117 shown. The wire 402 extends from the tensioner 556 into a wire receiving member 520 and exits through a wire holder 522. The wire 402 can be attached to other structures or tissues such that when the tensioner 556 can be used to pull the wire 402, the latter will be relatively tightened.

[0147] Once it is desired to begin the cutting procedure, the slider 550 can be moved outside the notch 548 such that the slider 550 and the mounting element 544 can be pushed distally, thereby moving the cutting member 524 distally until the blade 526 abuts against the suture 402. Accordingly, the suture 402 can be clamped between the blade 526 and the distal end of the orifice 522. This configuration can be seen in Fig.118 and Fig.119 . In this configuration, the knob 540 can be rotated axially and is configured to gradually cut the suture 402. Once the suture 402 is cut, the cutting member 424 can be moved to its distal position, as shown in Fig.120 and Fig.121 , and the slider 550 can be used to retract the blade 526 such that the cutting catheter 500' can be removed from the patient.

[0148] The cooling catheter 200, the drive catheter 300, the cinching catheter 400, and the cutting catheter 500 can be used in various surgical procedures, several examples of which will be described in detail below.

[0149] In still other embodiments, for example, as shown in Fig.122 , the cinching suture 402 can form a loop passing through one or more anchors 302, the ends of which enter a single cinching element 410 such that a stop 613 is not required. In the embodiment of Fig.122 , four anchors 302 are shown.

[0150] Referring to FIG. 48A to FIG. 48C , in a first example, a valve repair procedure is performed, and more specifically, a method 600 for mitral valve 609 repair can be carried out. Similar procedures can be used to perform tricuspid valve repair.

[0151] First, a sheath 603 can be inserted into the patient's vasculature in a conventional manner and driven through the septum 605 to the left atrium 607 (step 602), as shown in Fig.56 . Then, the cooling catheter 200 can be driven through the sheath 603 (step 604) and bent such that the bellows 206 are positioned along respective portions of the annulus 611 of the mitral valve 609 to insert the anchors 302 around the annulus 611, followed by cinching.

[0152] More specifically, the cinching suture 402 can be attached to the suture attachment 224, and the cooling catheter 200 is first inserted through the sheath 603 and advanced and deformed until the bellows 206 are adjacent to the P2 and P3 sectors (steps 606 and 608), and then cooling fluid is delivered through the cooling fluid supply 214 (step 610). The resulting configuration can be seen in Fig.57is shown. Thereafter, the tissue can be cooled until the bellows 206 adheres to the surrounding tissue by cryo-adhesion (steps 612 and 614). This can be tested, for example, by attempting to slightly move the cooling catheter 200. When there is adhesion, there will be no significant movement with little force. In alternative embodiments, other anchoring sites around the mitral valve can also be used.

[0153] Then an anchor 302 can be delivered through the sheath 603. To this end, the drive catheter 300 with the anchor 302 fixed distally can slide on the cooling catheter 200 until it cannot be further advanced due to the anchor reaching the cryo-adhesion site (steps 616 and 618), as Fig.58 shown. Then, the drive catheter 300 can be rotated to suture the anchor 302 to the annulus 311 using a corkscrew motion. This can be carried out until the anchor 302 can be disengaged - in the Fig.59 configuration shown - by rotating the drive catheter 300 in the direction opposite to the direction used to drive the anchor 302 (steps 618 and 620). Then, the anchor 320 can be fully driven into the tissue while the cooling catheter is in its central channel. Thus, the longitudinal extension of the anchor 302 remains outside the tissue while the mating portion is inserted into the tissue. Once the anchor 302 is disengaged from the drive catheter 300, the drive catheter 300 can be fully retracted (step 624), as Fig.60 shown, and the cooling can be stopped (step 626). This causes the bellows 206 to disengage from the annulus. Then, at that time, the bellows 206 can be retracted a little until it clears the anchor 302 (step 628), as Fig.61 shown.

[0154] Then the sheath 603 can be reoriented to better access other parts of the valve annulus 611, as Fig.62 shown, and the same process can be repeated with the bellows 206 adjacent to the P1 sector to insert a second anchor 302 that is generally axially aligned with the first anchor 302 (steps 630 to 654), as Fig.63 and Fig.64 in the order shown. Once these two anchors 302 are sutured, the cooling catheter 200 can be fully retracted from the sheath (step 656), as Fig.65 shown, and the tightening wire 402 can be detached from the wire attachment 224 (step 658). These two anchors 302 can be very close to each other, adjacent to each other, or have a gap between them. Note that once the cooling catheter 200 is removed, the tightening wire 402 can be looped through the anchors 302 while the two opposite ends of the tightening wire 402 extend outside the sheath 603.

[0155] Then a cinching procedure can be performed. Before cinching, one needs to deliver a member that will abut against the opposite ends of the two anchors 302. To this end, a stopper 613 can be fixed to one end of the cinching wire 402 (step 660). The stopper 613 can be larger than the diameter of the anchor, but small enough to be delivered through the sheath 603. In some embodiments, the cinching wire 402 can be tied into a relatively large knot, and the stopper 613 is thus a segment of the cinching wire. When the end of the cinching wire 402 opposite the stopper 613 is pulled, the stopper 613 is configured to travel through the sheath 603 until it abuts against one of the anchors 302, such as the anchor adjacent to the P2 - P3 site (step 662), as Fig.66 shown. Then, the portion of the cinching wire 402 that remains outside the sheath 603 can be inserted through the cinching catheter 400 (step 664), and the cinching catheter 400 can be advanced through the sheath 603 until the cinching catheter cannot be advanced further (steps 664 to 668), as Fig.67 shown. In this configuration, the cinching element 410 abuts against the anchor 302 opposite the stopper 613.

[0156] Then an appropriate cinching can be performed. To this end, the actuator 104 can be used to pull on the cinching wire 402 until the regurgitation is reduced or there is no regurgitation (steps 670 and 672), as Fig.68 shown. During this process, the stopper 613 and the cinching element 410 are configured to compress the two anchors 302 clamped therebetween, causing the tissue connected thereto to also contract. This is configured to cause a reduction in the circumference of the annulus 611, helping the leaflets of the mitral valve 609 to close properly, thereby stopping, or at least reducing, the regurgitation. Then, the cinching element lock 416 can be moved to its unlocked position to release the cinching element 410 (step 674), as Fig.69 and Fig.70 shown, and the cinching catheter 400 can be removed from the sheath 603 (step 676), as Fig.71 shown.

[0157] To complete this procedure, the cinching wire 402 can be cut at the cinching element 410. To this end, the cinching wire 402 can be inserted through the cutting catheter 500 (step 678), and the cutting catheter 500 can be advanced as far as possible towards the cinching element 410 (steps 680 and 682), as Fig.72 shown. Then, the cutting catheter 500 can be used to cut the cinching wire 402, as described above (step 684), and the cutting catheter 500 and the sheath 603 can be retracted (steps 686 and 688), as Fig.73 and Fig.74in the order shown. The cinching procedure can now be completed, and the cinching element 410, the stopper 613, the anchor 302, and a short section of the cinching suture 402 extending through the stopper 613 and the cinching element 410 remain in the patient's body. Although the process shown uses two anchors 302, similar processes using more anchors 302 also fall within the scope of the present disclosure. Additionally, as detailed below, in some embodiments, a single longer anchor 302 can be used.

[0158] Reference Fig.49 , method 600 can be slightly modified to perform alternative method 700. In method 700, a cooling catheter 200 with a relatively long corrugated tube 206 can be used. For example, the corrugated tube 206 can be long enough to cover most of the target circumference of the annulus 611, meaning it will only need to be positioned once. This makes the procedure faster and more efficient. In this embodiment, the cooling fluid supply 214 can take the form of a tube capable of moving along the bellows 206 to selectively cool its various parts.

[0159] Initially, method 700 can be similar to method 702, except that the corrugated tube 206 can now be positioned and bent to be adjacent to a larger portion of the mitral valve 609, e.g., covering from sector P1 to segment A3 before cooling (steps 702 to 708, similar to steps 602 to 608, but with different positioning of the corrugated tube 206), as Fig.75 shown.

[0160] Then, the anchors 302 can be inserted one by one from the most distal to the most proximal. To do this, the cooling fluid supply 214 can be moved to the section of the corrugated tube 206 corresponding to the position of the drivable anchor 302 (step 710) and cooling can be performed until adhesion occurs (steps 712 to 716, similar to steps 610 to 614), as Fig.76 shown. Now one of the anchors 302 can be driven on the adhered portion of the corrugated tube 206, as Fig.77 shown, and then cooling is terminated (steps 718 to 728, similar to steps 616 to 626). If more anchors 302 are needed (step 730), steps 710 to 728 can be repeated at other positions along the corrugated tube 206 until all the anchors 302 are sutured, as Fig.78 shown. This only requires moving the cooling supply 718 along the corrugated tube 206, rather than having to move the entire cooling catheter 200. Thereafter, the procedure can be completed (step 732), similar to steps 656 to 688.

[0161] Reference Fig.50, in yet another method 800 of using the long bellows 206, a single long anchor 302 can be used instead of multiple small anchors to perform the valve repair procedure. In method 800, the bellows 206 is positioned as in method 700 (steps 802 to 808, similar to steps 702 to 708). Once this is done, the cooling fluid supply 214 is positioned to cool the proximal portion of the bellows 206 (step 810) and cryo-adhesion can be performed (steps 814 and 816), such as adhering adjacent sectors P1.

[0162] Now the anchor 302 can be sutured as described above (steps 818 to 826, corresponding to steps 718 to 724), except that when the drive catheter is advanced, the cooling supply 718 is also advanced, thereby adhering the bellows 206 to the tissue into which the anchor 302 is driven at its tip, as Fig.79 and Fig.80 shown in the sequence. As Fig.81 shown, once the anchor 302 is fully inserted, the cinching procedure can be performed as described above (steps 826 to 830, similar to steps 726 to 732), as Fig.82 shown.

[0163] Figure 50-2 Figure 900 shows yet another method of performing an annuloplasty procedure. This procedure is the reverse of the sequence in which the anchor 302 can be implanted relative to method 600. After the sheath 603 has been inserted and has traversed the septum (step 902, similar to step 602), one anchor 302 is anchored at sector P1 (step 904), as Fig.83 shown. The sub-steps of step 904 can be similar to steps 604 to 626, except for the position where the anchor 302 is inserted. Then, the cooling catheter 200 is fully retracted from the sheath (step 906) and the cinching wire 402 is detached from the wire attachment 224 (step 908) such that the opposite end of the cinching wire 402 (which was outside the patient in step 904) can be attached to the wire attachment 224 (step 910). Then, the cooling catheter 200 is inserted back into the sheath 603 such that another anchor 302 can be inserted at sectors P2 and P3 (step 912), similar to step 904, but at a different position. Note that in step 910, as Fig.84 shown, the anchor 302 is driven in the opposite direction to the anchors that have been driven so far. That is, the driving direction of the anchor is from sector P3 towards sector P1, whereas it was the opposite in the other anchoring steps described above. Finally, the procedure is completed by cinching using the stop 613 and the cinching element 410 (step 914), similar to steps 656 to 688.

[0164] Fig.51 The method 1000 shown is an alternative to method 900. In method 1000, the anchor 302 can be sutured in the same order as in method 900, but two stoppers 613 can be used. More specifically, as in steps 902 and 904, the anchor at the sector P1 is anchored and the cooling catheter 200 is fully retracted from the sheath 603 (step 1002). Then, the tightening thread 402 is detached from the thread attachment 224 (step 1004) and instead attached to the stopper 613 (step 1006), after which the stopper is pulled through the sheath 603 to the anchor 302, as Fig.85 shown. Then the second tightening thread 402 is attached to the thread attachment 224 (step 1010) and another anchor 302 is anchored at sectors P2 and P3 as described above (steps 1012 and 1014), but this time in the direction from sector P2 towards sector P3. During this process, the first tightening thread 402 remains in the sheath 603. After this, the cooling catheter 200 is withdrawn and the second stopper 613 is inserted (steps 1016 to 1022). After this is performed, there are two stoppers 613 in the heart, each adjacent to one of the corresponding anchors 302 at opposite ends of the anchor chain, as Fig.86 shown.

[0165] Two tightening threads 402 protrude from the sheath 603 and can be used to perform the tightening process. These two threads exit the anchor 302 between the anchors 302. To tighten, the two tightening threads 402 can be inserted through the tightening catheter 400 (step 1024). Then, the tightening and cutting of the tightening threads 402 can be performed as described above, but in a way that works on both tightening threads 402 simultaneously (step 1026) to ultimately obtain Fig.87 the configuration shown.

[0166] Fig.52Another method 1100 for reducing valvular regurgitation - referred to as AP reduction - is shown. Instead of using the anchors anchored along sectors P1, P2, and P3 as described above, this method uses an anchor 302 anchored at segment A2 and sector P2, and the anchors 302 face each other across the mitral valve 609. By reducing the distance between these two anchors 302, the AP distance is reduced, thereby reducing or eliminating regurgitation. In this method 1100, after the sheath is inserted through the septum (step 1102), relatively short anchors 302 are successively anchored at segment A2 (step 1104) and segment P2 (step 1106), similar to steps 604 to 656, but at different positions. Then, both ends of the tightening wire 402 can be inserted through the tightening catheter 400 (step 1108) and tightening can be performed by pulling both ends of the tightening wire 402, and then both ends of the tightening wire 402 are cut simultaneously (step 1110), similar to that described above. By sufficiently pulling both ends of the tightening wire, the length of the loop passing through the two anchors 302 is reduced, which causes the valve leaflets to move closer to each other, as Fig.88 shown. In one variant, a stop can be used, making method 1100 very similar to method 600, except for the positions where the anchors can be inserted, as Fig.89 shown.

[0167] Referring Fig.53 , in another variant, method 1200 can be performed. In this variant, the initial steps 1202 and 1204 can be the same as steps 1102 and 1104. Then, the cooling catheter 200 is fully retracted from the sheath 603 (step 1206) so that the tightening wire 402 can be detached from the wire attachment 224 to attach the opposite ends of the tightening wire 402 to the wire attachment 224 (steps 1208 and 1210). Then, the second anchor 302 can be anchored using the cooling and drive catheters 200 and 300 similar to step 1106 (step 1212), as Fig.90 shown. Thereafter, the tightening element 410 can be used as described above, with both ends of the tightening wire 402 passing through it, and the tightening wire is cut (step 1214), similar to step 1110. In some embodiments, the tightening element 410 is positioned near the second anchor 302 (the anchor anchored near sector P2). As can be seen from Fig.91 , doing so forms a crossing of the tightening wire 402 across itself in the gap between the anchors 302, which can help fix the tightening wire 402.

[0168] The components of system 100 can be used in other surgical procedures, including for suture applications, for endoscopic gastroscopy, and for other possible scenarios such as closing internal or external wounds. The drive catheter 300' is used, for example, to manipulate the anchor 302', and the suture thread 1309 can be mounted on the anchor 302'. The suture thread 1309 is generally barbed, but in some embodiments a non-barbed suture thread 303 can be used, which may require tying a knot on the suture thread 1309 at the end of the process to prevent the suture thread 1309 from unraveling. The termination of the suture thread 1309 can be the mounting tip 1313, which can be removably mounted at the distal end of the anchor 302'. In such an embodiment, the drive catheter 300' can be modified with respect to the above drive catheter 300, since the anchor 302' is then permanently fixed to it.

[0169] In such an embodiment, Fig.107 The actuator 104' shown in is similar to the actuator 104, except that it has a gun shape including a handle 112 with a trigger 114 adjacent thereto. The trigger 114 can be used to control the supply of cooling fluid. For example, the operation of the trigger 114 can selectively actuate a valve that allows a pressurized or liquefied gas (e.g., CO2) to discharge from a canister housed in the handle 112. In addition, a drive device 300' similar to the drive catheter 300 can also be used. The drive device 300' is generally rigid enough to be freely standing for external suturing, or rigid enough for various other minimally invasive access surgical procedures such as laparoscopy, gastroscopy, and gynecology. The actuator 104' can also be provided with a slider 126 for performing a function similar to the cutting slider 452 and a spool for applying tension to the suture.

[0170] In addition, the use of such a system can also be in a deployable manner for wounds on the skin, such as for wound incisions. In addition to being able to be used for wound closure, cooling also advantageously provides a temporary relief of bleeding and pain at that time.

[0171] In another embodiment, the tip of the drive device 300' can be attached to, for example, a hernia patch and used to advance a helical anchor 302 along tissue to attach the patch or other fabric material to the tissue.

[0172] It should be noted that the cooling temperature can be selected to sometimes kill tissue, for example, in cases where bleeding can be stopped or when there is an appropriate need. When used externally, the cooling temperature can be reduced, for example, to a lower temperature than when used internally, such as down to -150°C.

[0173] Fig.54A and Fig.54BAn example of a method 1300 for closing a wound 1301 is shown. First, a cooling device 200’ (similar to the cooling conduit 200) is brought close to the wound 1301 and positioned such that the bellows 206 abuts a first side 1303 of the wound 1301 (steps 1304 and 1306), as Fig.92 shown. Then, the bellows 206 is cooled until the bellows 206 adheres to the tissue on the first side 1303 of the wound 1301 (steps 1310 and 1312). Subsequently, the bellows 206 is manipulated until it contacts and adheres to a second side 1305 of the wound 1301 (steps 1314 and 1316), as Fig.93 shown. Then the bellows 206 is moved to align with the centerline of the wound 1301 (step 1318). It should be noted that in this application, the bellows 206 can be replaced by any suitable similar tubular structure, such as a tube made of plastic or braided metal, and other possible alternatives. The first side 1303 and the second side 1305 can be positioned side by side in a common plane, or their free ends can overlap, as Fig.110 and Fig.111 shown.

[0174] Then an anchor 302’ is driven into the wound using a drive device 300’ until the anchor 302’ is fully sutured into the wound 1301 (steps 1320 to 1326), as Fig.94 shown. To remove the anchor from the wound 1301, the drive device 300’ is rotated in a direction opposite to the direction used to drive the anchor 302’ into the tissue (steps 1328 and 1330). This is configured to cause the mounting tip 1313 to disengage from the anchor 302’, since the mounting tip 1313 is only pinned to the distal end of the anchor 302’. Since the mounting tip 1313 is shaped to be blunt relative to its drive tip, the suture thread 1309 is left behind due to this process, as Fig.95 shown. Then the cooling can be stopped (step 1332) such that the cooling and the drive devices 200 and 300’ can be removed (step 1334). The barbed suture thread 1309 is pulled, as Fig.96 shown, and then the wound 1301 is fully closed (steps 1336 and 1338). Since the barbs penetrate the tissue and do not allow the thread to lose tension, the wound 1301 will remain closed even after the tension in the thread 1301 is released. Finally, the suture thread 1309 can be cut flush with the wound 1301 to obtain a fully sutured wound 1301, as Fig.97 shown. If a non-barbed suture thread 1309 is used, a knot may have to be tied at one end of the suture thread 1309 before cutting to prevent the suture thread 1303 from unraveling.

[0175] If the wound 1301 is deep and narrow rather than shallower and longer, one can instead insert the bellows 206 along the depth of the wound and perform the same steps. This process is shown in Figures 98 to 102 and Figures 98 to 102 respectively corresponding to those described above Figure 93 to Figure 97 , the difference between them being due to the different orientations of the anchor 302.

[0176] In some embodiments, as shown in Fig.103 and Fig.104 , a hollow anchor 302” defining an internal channel 313 can be used. The internal channel is formed inside the helical structure of the hollow anchor 302” and is thus helical. The suture thread 1313’ extends through the internal channel 313 and can terminate at a hook 1315 that is configured to engage tissue when the anchor 302” is retracted. The hook 1315 can be larger than the diameter of the internal channel 313 such that when the anchor 302” is driven, the hook 1315 remains at the tip of the anchor 302”. The anchor 302” can also be only partially hollow.

[0177] As shown in Figure 1 , in some embodiments, when the cooling and drive catheters 200 and 300 can be used, the tensioning device 116 can be used to adjust the tension of the tightening thread 400. The tensioning device can include a spool and operate in a manner similar to the spool 454 of the tightening catheter 400.

[0178] As shown in Fig.108 and Fig.109 , in some embodiments, the cooling fluid supply 214 can be mounted on the fluid supply actuator, allowing for precise positioning of the cooling fluid supply 214. For example, the cooling fluid supply 214 can be clamped to a fixture that can move along a guide relative to the actuator 104. The movement of the fixture along the guide can be controlled, for example, by a worm drive operated by a knob or other possible means.

[0179] Another way to reduce mitral valve 609 regurgitation is to perform an edge-to-edge valve repair. Referring to Fig.55 , a method 1400 for performing this procedure is shown. The system 100 can be used to achieve an effect similar to the above-described suturing process, except that suture threads may not be used. Instead, the anchor 302 can be used to join the central portions of the two leaflets of the mitral valve 609.

[0180] More specifically, the sheath 603 can be inserted through the septum (step 1402). Then, the cooling catheter 200 can be slid within the sheath 603 and the bellows 206 can be bent and positioned at the center of the posterior leaflet 1401 (steps 1404, 1406, and 1408). When a sufficient position is reached, the cooling gas flow can be turned on to reduce the temperature of the bellows, thereby allowing it to adhere to the leaflet by cryo-adhesion (steps 1410, 1412, and 1414). The cooling gas flow can continue until the anchor 302 is fully positioned in place.

[0181] The cooling catheter 200 and the sheath 603 can then be manipulated such that the bellows 206 contacts the center of the anterior leaflet 1403 (while still adhered to the posterior leaflet 1401) (steps 1416 and 1418). This will enable the bellows 206 to also adhere to the anterior leaflet 1413. Then, the drive catheter 300 can be advanced and the anchor 302 can be driven through both the anterior leaflet 1403 and the posterior leaflet 1401 simultaneously, similar to the above-described anchoring procedure, thus suturing the two leaflets to each other (steps 1420, 1422, 1424, and 1426). Once the anchor 302 is fully deployed, the drive catheter 300 can be removed (step 1428) and the cooling can be stopped (step 1430) to allow the cooling catheter 200 to retract, and then the sheath 603 to retract (step 1432), thereby obtaining Fig.105 the result shown.

[0182] A similar procedure can be followed to insert the anchor perpendicular to the plane of the mitral valve 609. In this variant, the bellows 206 is inserted perpendicular to the mitral valve 609 and adhered to the anterior leaflet 1403 and the posterior leaflet 1401 to allow the anchor 302 to be driven through them to obtain Fig.106 the result shown. In another variant, as described above, the anchor can be inserted perpendicular to the mitral valve 609, but the anchor can include a suture thread. Retracting the anchor - similar to method 1200 - sutures the anterior leaflet 1403 and the posterior leaflet 1401 to each other, after which the thread can be cut. This procedure can thus be similar to a wound closure method, but is performed within the heart to attach the anterior and posterior leaflets to each other.

[0183] Although a manually operated actuator has been shown, a power actuator including an electric motor or other power actuation mechanism can also be used.

[0184] The foregoing discussion has disclosed and described only exemplary embodiments of the present disclosure. Those skilled in the art will readily recognize, from such discussion, as well as from the accompanying drawings and claims, that various changes, modifications, and variations can be made therein without departing from the spirit and scope of the present disclosure as defined in the following embodiments and claims.

[0185] Embodiment 1. A cutting catheter for a cutting wire, the cutting catheter comprising: an elongate wire receiving member provided at its distal wire receiving member end with a wire receiver for receiving the wire; an elongate cutting member provided at its distal cutting member end with an annular blade that can be positioned adjacent to the wire receiver; the cutting member being longitudinally movable relative to the wire receiving member and axially rotatable relative to it such that the blade can translate and rotate simultaneously relative to the wire received in the wire receiver.

[0186] Embodiment 2. The cutting catheter as defined in Embodiment 1, wherein the cutting member is biased relative to the wire receiver in a distally directed direction.

[0187] Embodiment 3. The cutting catheter as defined in Embodiment 1, wherein the longitudinal movement and axial rotation of the cutting member relative to the wire receiving member are independent of each other.

[0188] Embodiment 4. The cutting catheter as defined in Embodiment 1 or 2, wherein the wire receiving member and the cutting member are flexible.

[0189] Embodiment 5. The cutting catheter as defined in Embodiment 1, 2 or 3, wherein the wire receiving member and the cutting member are bendable so as to be able to conform to the patient's vasculature.

[0190] Embodiment 6. The cutting catheter as defined in Embodiments 1 to 5, wherein the wire receiver may include a wire orifice extending transversely therethrough for receiving the wire therethrough.

[0191] Embodiment 7. The cutting catheter as defined in Embodiment 6, wherein the wire receiving member defines a wire receiving member channel that extends longitudinally therethrough and opens into the wire orifice; and the wire receiving member and the cutting member are concentric.

[0192] Embodiment 8. The cutting catheter as defined in Embodiment 6 or 7, further comprising a tensioner for applying tension to the wire.

[0193] Embodiment 9. The cutting catheter as defined in Embodiments 1 to 8, wherein the cutting member may include a tubular member that surrounds at least part of the wire receiving member.

[0194] Embodiment 10. The cutting catheter defined in Embodiments 1 to 9 further includes an actuation assembly, and the actuation assembly includes: a body, and the wire receiving member is mounted on the body; a cutting member actuator, which is operably coupled to the cutting member for selectively and independently rotating and longitudinally moving the cutting member relative to the body.

[0195] Embodiment 11. The cutting catheter defined in Embodiment 10, wherein the cutting member is capable of moving between a proximal position and a distal position relative to the body, and the cutting member can be locked in the proximal position when translating relative to the body.

[0196] Embodiment 12. The cutting catheter defined in Embodiment 11 further includes a biasing element provided between the cutting member and the body for biasing the cutting member towards the distal position.

[0197] Embodiment 13. The cutting catheter defined in Embodiments 10, 11 or 12, wherein the cutting member actuator includes: a cutting member mount, the cutting member extends through the cutting member mount and is capable of co-axially rotating therewith; and a knob, the knob is mounted on the body so as to be axially rotatable relative thereto, the knob defines a knob orifice extending axially therethrough, and the knob orifice receives the cutting member mount such that the cutting member mount can axially move along the knob and can co-rotate with the cutting member mount.

[0198] Embodiment 14. A method of cutting a wire using a tubular cutting member provided with a distal annular blade, the method comprising: positioning the annular blade to abut against the wire at a contact position where the wire enters the cutting member; and axially rotating the annular blade to cut the wire.

[0199] Embodiment 15. The method defined in Embodiment 14 further includes pushing the annular blade towards the wire.

[0200] Embodiment 16. The method defined in Embodiment 15, wherein pushing the annular blade towards the wire may include biasing the annular blade with a biasing element.

[0201] Embodiment 17. The method defined in Embodiments 14, 15 or 16, wherein the annular blade can be rotated at least one full turn before the wire is cut.

[0202] Embodiment 18. The method defined in Embodiments 14 to 17, wherein the wire can be clamped between the cutting blade and a member fixed relative to the annular blade.

[0203] Embodiment 19. The method defined in Embodiments 14 to 18 further includes applying a tension to the wire.

[0204] Embodiment 20. The method defined in Embodiments 14 to 19, wherein the method can be performed inside a patient's body.

[0205] Embodiment 21. A tightening system capable of being used in combination with a beaded wire defining beaded elements, the tightening system including: a tightening element including an attachment; and a stopper configured to allow the beaded wire to move therethrough in a direction from distal to proximal and prevent the beaded wire from moving therethrough in a direction from proximal to distal; and a tightening catheter including a tightening element retainer provided distally for receiving the attachment; and a tightening element lock for reversibly locking the attachment and the tightening element retainer to each other.

[0206] Embodiment 22. The tightening system defined in Embodiment 21, wherein the stopper may include a tubular body and lobes provided within the tubular body and converging towards each other in a proximally directed direction within the stopper, the lobes being movable between a narrow configuration and a wide configuration, a central gap between the lobes being smaller in the narrow configuration than in the wide configuration such that the beaded elements can move through the gap in the wide configuration but are prevented from moving through the gap in the narrow configuration.

[0207] Embodiment 23. The tightening system defined in Embodiment 22, wherein the lobes integrally extend from the tubular body as a single piece of material.

[0208] Embodiment 24. The tightening system defined in Embodiment 22 or 23, wherein the lobes are made of a nickel-titanium shape memory alloy.

[0209] Embodiment 25. The tightening system defined in Embodiment 23 or 24, wherein, in the wide configuration, the lobes are biased towards the narrow configuration.

[0210] Embodiment 26. The tightening system defined in Embodiments 23 to 25, wherein the tightening catheter is adapted to selectively open the gap to allow the beaded wire to move therethrough in both distal and proximal directions simultaneously.

[0211] Embodiment 27. The tightening system defined in embodiment 26, wherein the tubular body includes circumferentially spaced fan-shaped bodies, which are capable of deforming between an undeformed configuration and an open configuration, wherein in the open configuration, the gap is larger than the gap in the undeformed configuration; and the tightening catheter may include a fan-shaped body actuator for selectively moving the fan-shaped bodies to the open configuration.

[0212] Embodiment 28. The tightening system defined in embodiments 21 to 27, wherein the tightening element holder and the attachment are complementarily shaped so that when the tightening element holder and the attachment are mounted on each other: relative longitudinal and circumferential movement between the tightening element holder and the attachment is prevented; and unless the attachment is locked to the tightening element holder, the attachment can move freely laterally in at least one direction relative to the tightening element holder.

[0213] Embodiment 29. The tightening system defined in embodiment 28, wherein the attachment and the tightening element retainer are both hollow; and the tightening element lock may include a slender member capable of selectively moving between an extended position and a retracted position, wherein in the extended position, the tightening element lock extends through the tightening element retainer and the attachment; and in the retracted position, the tightening element lock is retracted proximally relative to the attachment so that the attachment is free to move laterally relative to the tightening element retainer.

[0214] Embodiment 30. The tightening system defined in embodiment 29, wherein the attachment and the tightening element retainer both have internal threads and the tightening element lock may have external threads, so that in the extended position, the tightening element lock threadingly engages the attachment and the tightening element retainer.

[0215] Embodiment 31. The tightening system defined in embodiment 30, wherein the stopper may be hollow and may include a deformable leaf-shaped member extending internally and configured to allow the bead-shaped member to pass through the stopper in a proximally directed direction while preventing the bead-shaped member from passing through the stopper in a distally directed direction.

[0216] Embodiment 32. The tightening system defined in embodiment 31, wherein the stop may include a tubular stop body defining circumferential sectors separated from one another by slits, each leaf extending from a single sector; the tightening element lock may be hollow and capable of moving distally to engage the sectors to open the sectors outward and separate the leafs from one another to create a gap allowing the bead to move distally therethrough.

[0217] Embodiment 33. The tightening system defined in Embodiment 28, wherein the tightening element lock can be tubular and is capable of selectively moving between an extended position and a retracted position, wherein in the extended position, the tightening element lock surrounds at least part of both the tightening element retainer and the attachment member to prevent lateral movement therebetween; while in the retracted position, the tightening element lock can be retracted proximally relative to the attachment member such that the attachment member is free to move laterally relative to the tightening element retainer.

[0218] Embodiment 34. The tightening system defined in Embodiments 28 to 33, wherein the lobes together form a proximally tapering conical shape.

[0219] Embodiment 35. A tightening element defining a proximal end and a distal end, the tightening element being capable of being used in combination with a tightening catheter and a beaded suture line, the tightening element comprising: a proximal attachment member capable of selectively attaching to the tightening catheter; and a distal stop configured to allow the beaded suture line to move therethrough in a direction from the distal side to the proximal side and to prevent the beaded suture line from moving therethrough in a direction from the proximal side to the distal side.

[0220] Embodiment 36. The tightening element defined in Embodiment 35, wherein the stop may include a tubular body and lobes provided within the tubular body and converging towards each other in a proximally directed direction within the stop, the lobes being capable of moving between a narrow configuration and a wide configuration, the central gap between the lobes being smaller in the narrow configuration than in the wide configuration such that the beaded member can move through the gap in the wide configuration but is prevented from moving through the gap in the narrow configuration.

[0221] Embodiment 37. The tightening element defined in Embodiment 36, wherein the lobes extend integrally from the tubular body as a single piece of material.

[0222] Embodiment 38. The tightening element defined in Embodiment 37, wherein the lobes are made of a nickel-titanium shape memory alloy.

[0223] Embodiment 39. The tightening element defined in Embodiments 36 to 38, wherein, in the wide configuration, the lobes are biased towards the narrow configuration.

[0224] Embodiment 40. The tightening element defined in Embodiment 36, which defines circumferentially spaced sectors, each of the lobes being supported by one of the sectors, the sectors being capable of deforming into an open configuration in which the gap can be enlarged to allow the beaded member to move in a direction from the proximal side to the distal side.

[0225] Embodiment 41. A cryoadhesion catheter assembly, comprising: a tubular body that distally supports a hollow heat transfer element relative thereto, the heat transfer element including a flexible portion that can be bent to conform to a predetermined shape; a traction assembly that is distally fixed to the heat transfer element and includes a traction wire extending along the body, the traction assembly being configured to bend the flexible portion; and a cooling fluid supply for supplying cooling fluid to the heat transfer element.

[0226] Embodiment 42. The cryoadhesion catheter assembly defined in Embodiment 41, further comprising a guiding member extending within the flexible portion, the guiding member being stiffer when bent in a first plane than when bent in a second plane orthogonal to the first plane, both the first plane and the second plane extending along the bellows, wherein when the traction wire is pulled, the guiding member restricts bending in the first plane while allowing bending in the second plane.

[0227] Embodiment 43. The cryoadhesion catheter assembly defined in Embodiment 42, wherein the guiding member includes a plate that laterally extends across the flexible member and longitudinally extends along at least a portion of the flexible member.

[0228] Embodiment 44. The cryoadhesion catheter assembly defined in Embodiment 43, wherein the plate may be perforated.

[0229] Embodiment 45. The cryoadhesion catheter assembly defined in Embodiments 41 to 44, wherein the cooling fluid supply defines a fluid outlet, and the cooling fluid supply is movable relative to the heat transfer portion such that the cooling fluid outlet can be positioned at different longitudinal positions along it.

[0230] Embodiment 46. The cryoadhesion catheter assembly defined in Embodiments 41 to 45, further comprising an anchor drive catheter for driving a screw anchor on the heat transfer portion.

[0231] Embodiment 47. The cryoadhesion catheter assembly defined in Embodiment 46, wherein the tubular body defines an anchor engagement portion proximal to the heat transfer portion, the anchor engagement portion being configured to engage the anchor and constrain the movement of the anchor along it to a helical movement.

[0232] Embodiment 48. The cryoadhesion catheter assembly defined in Embodiment 47, wherein the anchor engagement portion prevents the anchor drive catheter from advancing further distally than the anchor engagement portion.

[0233] Embodiment 49. The cryoadhesion catheter assembly as defined in Embodiment 48, wherein the anchor engagement portion may include at least two protrusions extending radially outward from the tubular body, and the at least two protrusions are circumferentially and longitudinally offset relative to each other.

[0234] Embodiment 50. The cryoadhesion catheter assembly as defined in Embodiment 48, wherein the anchor engagement portion may include a helical flange extending radially outward from the tubular body.

[0235] Embodiment 51. The cryoadhesion catheter assembly as defined in Embodiments 46 to 50, further comprising an anchor catheter actuator for selectively advancing and rotating the anchor drive catheter relative to the tubular body.

[0236] Embodiment 52. The cryoadhesion catheter assembly as defined in Embodiment 51, wherein the advancement and rotation of the anchor drive catheter are independent of each other.

[0237] Embodiment 53. The cryoadhesion catheter assembly as defined in Embodiment 52, wherein the advancement and rotation of the anchor drive catheter can be locked independently of each other.

[0238] Embodiment 54. The cryoadhesion catheter assembly as defined in Embodiment 53, wherein the anchor catheter actuator includes a housing and a knob, the knob is mounted to the housing, the knob defines an axial knob channel, and the drive catheter passes through the axial knob channel, and the drive catheter is fixed to the knob to be able to move axially and rotate relative to it jointly.

[0239] Embodiment 55. The cryoadhesion catheter assembly as defined in Embodiment 54, wherein the knob can be mounted to a knob mount to be able to move longitudinally jointly with it and be able to rotate axially relative to it, and the knob mount is mounted to the housing to be able to move longitudinally along it and be fixed against axial rotation relative to it.

[0240] Embodiment 56. The cryoadhesion catheter assembly as defined in Embodiment 55, further comprising a rotation lock for selectively locking the relative rotation between the knob mount and the knob and a translation lock for selectively locking the relative translation between the housing and the knob mount.

[0241] Embodiment 57. The cryoadhesion catheter assembly as defined in Embodiment 56, wherein the outer housing defines: a longitudinally elongated mounting member cavity that receives the knob mounting member therein; and a pair of slits that longitudinally extend therebetween on an outer side of the outer housing and the mounting member cavity, the translation lock and the rotation lock respectively include a translation lock threaded fastener and a rotation lock threaded fastener, each radially extending through a respective one of the slits so as to be longitudinally movable therein and engage corresponding threaded orifices formed in the knob mounting member, wherein when the translation and rotation lock threaded fasteners are fully screwed into their corresponding threaded orifices, translation and rotation of the knob relative to the outer housing are respectively locked.

[0242] Embodiment 58. A transcatheter system, comprising: a drive catheter configured to drive one or more anchors into tissue; a cinching catheter configured to cinch a filament extending through the one or more anchors; and a cutting catheter configured to cut a portion of the filament.

[0243] Embodiment 59. The transcatheter system as defined in Embodiment 58, further comprising a cooling catheter and a cooling system for providing a cooling fluid to the cooling catheter, wherein the cooling catheter can be configured to cryoadhere to a portion of the tissue.

[0244] Embodiment 60. The transcatheter system as defined in Embodiment 59, wherein the cooling catheter can include a heat transfer portion having a flexible portion that is capable of bending to conform to the shape of a valve annulus.

[0245] Embodiment 61. The transcatheter system as defined in Embodiment 59, wherein when bent, the flexible portion extends through between about 135 degrees and about 225 degrees.

[0246] Embodiment 62. The transcatheter system as defined in Embodiments 58 to 61, further comprising a tensioning device for applying tension to the filament.

[0247] Embodiment 63. The transcatheter system as defined in Embodiments 58 to 62, wherein the filament defines longitudinally spaced beads.

[0248] Embodiment 64. The transcatheter system as defined in Embodiments 58 to 63, further comprising at least one helical anchor that can be mounted to the drive catheter for being driven into the tissue.

[0249] Embodiment 65. The transcatheter system defined in Embodiment 64 further includes a stopper and a tightening element, both the stopper and the tightening element being larger than the central channel of the helical anchor, the wire being fixable to the stopper and the tightening element being configured to allow the wire to pass through only in one direction.

[0250] Embodiment 66. The transcatheter system defined in Embodiment 64, wherein the at least one anchor is configured to be implanted at the mitral valve annulus along a portion of the mitral valve selected from the following: the portion from the P1 region to the A1 region, the portion from the P2 region to the A3 region, the portion from the P1 region to the P3 region, the portion in the P1 region, the portion in the P2 region, the portion in the P3 region, the portion from the P3 to the A3 region.

[0251] Embodiment 67. The transcatheter system defined in Embodiment 64, wherein the at least one anchor may include 2 to 30 coils.

[0252] Embodiment 68. The transcatheter system defined in Embodiment 64, wherein the at least one anchor is configured to span between about 45 degrees and about 225 degrees along the mitral valve annulus.

[0253] Embodiment 69. The transcatheter system defined in Embodiment 64, wherein the at least one anchor is configured to span between about 225 degrees and about 315 degrees along the mitral valve annulus.

[0254] Embodiment 70. The transcatheter system defined in Embodiments 58 to 69, wherein the tightening catheter may include a double-shell configuration including two layers that are axially rotatable relative to each other and are configured to receive the wire therebetween.

[0255] Embodiment 71. The transcatheter system defined in Embodiment 59, wherein the cooling and driving catheter is a cryoadhesion catheter assembly defined in any one of Embodiments 41 to 57, the cutting catheter may be a cutting catheter in any one of Embodiments 1 to 20, and the tightening catheter may be a tightening catheter defined in any one of Embodiments 21 to 40.

[0256] Embodiment 72. An implant kit, comprising: a helical anchor defining an anchor channel extending therethrough; a beaded wire defining longitudinally spaced bead-like members; a stopper larger than the central channel to prevent passage therethrough; and a tightening element larger than the central channel to prevent passage therethrough, the tightening element defining a one-way gap allowing the wire to pass through only in one direction.

[0257] Embodiment 73. The implant kit defined in Embodiment 72, wherein the stopper can be fixed to the beaded wire.

[0258] Embodiment 74. The implant kit defined in Embodiment 72, wherein the kit can be assembled to form an implant, wherein the stopper and the tightening element abut against the helical anchor at their opposite longitudinal ends, and the wire extends therebetween under tension.

[0259] Embodiment 75. The implant kit defined in Embodiment 72, further comprising another helical anchor, wherein the kit can be assembled to form an implant, wherein the helical anchors extend from each other with a space therebetween, and the stopper and the tightening element abut against a corresponding one of the helical anchors opposite to the space, and the wire extends therebetween under tension.

[0260] Embodiment 76. The implant kit defined in Embodiment 72, wherein the anchor can be straight when undeformed and can be bent when the implant is assembled with the wire under tension.

[0261] Embodiment 77. The implant kit defined in Embodiment 72, wherein the stopper can be fixed to the wire, and the implant kit further comprises another stopper, another helical anchor and another beaded wire that can be fixed to the wire.

[0262] Embodiment 78. The implant kit defined in Embodiment 77, wherein the kit can be assembled to form an implant, wherein the helical anchors extend from each other with a space therebetween, the stopper abuts against a corresponding one of the helical anchors opposite to the space, each wire extends from a corresponding one of the stoppers through a corresponding helical anchor and reaches the tightening element provided adjacent to the space, and the wires all extend through the gap under tension.

[0263] Embodiment 79. An implant kit, comprising: at least two helical anchors, each defining an anchor channel extending therethrough; a beaded wire, the beaded wire defining longitudinally spaced beads; a tightening element, the tightening element defining a one-way gap allowing the wire to pass therethrough only in one direction.

[0264] Embodiment 80. The implant kit defined in Embodiment 79, wherein the kit can be assembled to form an implant, wherein the wire forms a loop extending through two helical anchors and closed by the tightening element.

[0265] Embodiment 81. The implant kit defined in Embodiment 80, wherein the loop forms a figure-eight.

[0266] Embodiment 82. The implant kit defined in Embodiment 81, wherein in the implant, the two helical anchors are laterally spaced apart from each other by substantially parallel anchor channels.

[0267] Embodiment 83. An implant assembled from the implant kit of any one of Embodiments 72 to 83.

[0268] Embodiment 84. A wound closure device, comprising: a cryo-adhesion device including a hollow heat conduction element and a cooling fluid supply for supplying a cooling fluid thereto; and an anchor driver for driving a helical anchor on the heat conduction element.

[0269] Embodiment 85. The wound closure device defined in Embodiment 84, wherein the anchor driver supports the anchor at a distal end of a rigid member.

[0270] Although it has been described above by way of the exemplary embodiments of the present disclosure, it will be readily understood that various modifications of these exemplary embodiments are possible without substantially departing from the novel teachings and advantages of the present disclosure. Therefore, the scope of the claims should not be limited by these exemplary embodiments, but should be given the broadest interpretation consistent with the description as a whole. Thus, the present disclosure can be modified without departing from the spirit and essence of the invention defined in the appended claims.

[0271] Although the preferred embodiments of the present disclosure have been shown and described herein, it is apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, changes and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The following claims are intended to define the scope of the invention and thereby cover the methods and structures within the scope of these claims and their equivalents.

Claims

1. A cutting catheter for cutting a silk thread, the cutting catheter comprising: A filament receiving member, the filament receiving member including a filament receiver at a distal end of the filament receiving member, the filament receiver being configured to receive the filament; A cutting member, the cutting member including an annular blade at a distal end of the cutting member, the annular blade being positionable adjacent to the filament receiver; And The cutting member is longitudinally movable relative to the filament receiving member and axially rotatable relative thereto, wherein the annular blade is configured to translate and rotate relative to the filament simultaneously.

2. The cutting catheter according to claim 1, wherein the cutting member is biased in a distally directed direction relative to the silk thread receiver.

3. The cutting catheter according to claim 1, wherein the longitudinal movement and axial rotation of the cutting member relative to the silk thread receiving member are independent of each other.

4. The cutting catheter according to claim 1, wherein the silk thread receiving member and the cutting member are flexible.

5. The cutting catheter according to claim 1, wherein the silk thread receiving member and the cutting member are bendable so as to be able to conform to the patient's vasculature.

6. The cutting catheter according to claim 1, wherein the silk thread receiver includes a silk thread orifice extending transversely therethrough, the silk thread orifice being configured to receive the silk thread passing therethrough.

7. The cutting catheter according to claim 6, wherein the silk thread receiving member defines a silk thread receiving member channel that longitudinally extends therethrough and opens into the silk thread orifice; and wherein the silk thread receiving member and the cutting member are concentric.

8. The cutting catheter according to claim 1, further comprising a tensioner configured to apply tension to the silk thread.

9. The cutting catheter according to claim 1, wherein the cutting member further includes a tubular member that surrounds at least a portion of the silk thread receiving member.

10. The cutting catheter according to claim 1, further comprising an actuation assembly, the actuation assembly including: A body, the filament receiving member being mounted to the body; And A cutting member actuator, the cutting member actuator being operably coupled to the cutting member for selectively and independently rotating and longitudinally moving the cutting member relative to the body.

11. The cutting catheter according to claim 10, wherein the cutting member is movable relative to the body between a proximal position and a distal position, and the cutting member can be locked in the proximal position when translating relative to the body.

12. The cutting catheter according to claim 11, further comprising a biasing element provided between the cutting member and the body for biasing the cutting member towards the distal position.

13. The cutting catheter according to claim 10, wherein the cutting member actuator includes: A cutting member mount, wherein the cutting member is configured to extend through the cutting member mount and be axially rotatable therewith; And A knob, the knob being mounted to the body so as to be axially rotatable relative thereto, the knob defining a knob aperture extending axially therethrough, the knob aperture receiving the cutting member mount such that the cutting member mount is axially movable along the knob and axially rotatable therewith.

14. A method of cutting a suture using a tubular cutting member provided with a distal annular blade, the method comprising: Position the annular blade to abut against the filament at the contact position where the filament enters the tubular cutting member; And Axially rotate the annular blade to cut the filament.

15. The method according to claim 14, further comprising pushing the annular blade toward the suture.

16. The method according to claim 15, wherein pushing the annular blade toward the suture comprises biasing the annular blade with a biasing element.

17. The method according to claim 14, wherein the annular blade is rotated at least one full turn before the suture is cut.

18. The method according to claim 14, wherein the suture is clamped between the cutting blade and a member fixed relative to the annular blade.

19. The method according to claim 14, further comprising applying a tension to the suture.

20. The method according to claim 14, wherein the method is performed within a patient's body.

21. A tightening system capable of being used in conjunction with a beaded suture defining bead members, the tightening system comprising: A tightening element, the tightening element including an attachment and a stop, the stop being configured to allow the beaded filament to move therethrough in a distal-to-proximal direction and prevent the beaded filament from moving therethrough in a proximal-to-distal direction; And A tightening conduit, the tightening conduit including a tightening element retainer provided distally for receiving the attachment, and a tightening element lock for reversibly locking the attachment to the tightening element retainer to each other.

22. The tightening system according to claim 21, wherein the stop member comprises a tubular body and lobes provided within the tubular body and converging toward each other in a proximally directed direction within the stop member, the lobes being movable between a narrow configuration and a wide configuration, a central gap between the lobes being smaller in the narrow configuration than in the wide configuration such that the bead members can move through the gap in the wide configuration but are prevented from moving through the gap in the narrow configuration.

23. The tightening system according to claim 22, wherein the lobes extend integrally from the tubular body as a single piece of material.

24. The tightening system according to claim 23, wherein the lobes are made of a nickel-titanium shape memory alloy.

25. The tightening system according to claim 23, wherein, In the wide configuration, the lobes are biased towards the narrow configuration.

26. The tightening system according to claim 23, wherein the tightening catheter is adapted to selectively open the gap to allow the beaded suture to move through it in both a distal and a proximal direction simultaneously.

27. The tightening system according to claim 26, wherein the tubular body includes circumferentially spaced sectors that are deformable between an undeformed configuration and an open configuration, wherein in the open configuration, the gap is greater than the gap in the undeformed configuration; the tightening catheter includes a sector actuator for selectively moving the sectors to the open configuration.

28. The tightening system according to claim 21, wherein the tightening element retainer and the attachment are complementary shaped such that when the tightening element retainer and the attachment are mounted on each other: relative longitudinal and circumferential movement between the tightening element retainer and the attachment is prevented; and the attachment is free to laterally move relative to the tightening element retainer in at least one direction unless the attachment is locked to the tightening element retainer.

29. The tightening system according to claim 28, wherein the attachment and the tightening element retainer are both hollow; and the tightening element lock includes an elongate member that is selectively movable between an extended position and a retracted position, wherein in the extended position, the tightening element lock extends through the tightening element retainer and the attachment; and in the retracted position, the tightening element lock retracts proximally relative to the attachment such that the attachment is free to laterally move relative to the tightening element retainer.

30. The tightening system according to claim 29, wherein the attachment and the tightening element retainer both have internal threads and the tightening element lock has external threads such that in the extended position, the tightening element lock threadedly engages the attachment and the tightening element retainer.

31. The tightening system according to claim 30, wherein the stop is hollow and includes a deformable lobe that extends internally and is configured to allow the bead to pass through the stop in a proximally directed direction while preventing the bead from passing through the stop in a distally directed direction.

32. The tightening system according to claim 31, wherein the stop includes a tubular stop body that defines circumferential sectors separated from each other by slits, and each lobe extends from a single sector; The tightening element lock is hollow and is movable distally to engage the segment to cause the segment to flare outwardly and separate the lobes from each other to create a gap allowing the bead to move distally therethrough.

33. The tightening system according to claim 28, wherein the tightening element lock is tubular and is selectively movable between an extended position and a retracted position, wherein in the extended position, the tightening element lock surrounds at least a portion of both the tightening element retainer and the attachment to prevent lateral movement therebetween; and in the retracted position, the tightening element lock is retracted proximally relative to the attachment such that the attachment is free to move laterally relative to the tightening element retainer.

34. The tightening system according to claim 28, wherein the lobes together form a proximally tapering conical shape.

35. A tightening element defining a proximal end and a distal end, the tightening element being adapted for use in combination with a tightening catheter and a beaded suture line, the tightening element comprising: A proximally located attachment, the proximally located attachment being selectively attachable to the tightening conduit; And A distally located stop, the distally located stop being configured to allow the beaded filament to move therethrough in a distal-to-proximal direction and prevent the beaded filament from moving therethrough in a proximal-to-distal direction.

36. The tightening element according to claim 35, wherein the stop comprises a tubular body and lobes provided within the tubular body and converging towards each other in a proximally directed direction within the stop, the lobes being movable between a narrow configuration and a wide configuration, a central gap between the lobes being smaller in the narrow configuration than in the wide configuration such that the bead can move through the gap in the wide configuration but is prevented from moving through the gap in the narrow configuration.

37. The tightening element according to claim 36, wherein the lobes extend integrally from the tubular body as a single piece of material.

38. The clamping element according to claim 37, wherein the lobes are made of a nickel-titanium shape memory alloy.

39. The tightening element according to claim 36, wherein, In the wide configuration, the lobes are biased towards the narrow configuration.

40. The tightening element according to claim 36, wherein the tubular body defines circumferentially spaced segments, each of the lobes being supported by one of the segments, the segments being deformable into an open configuration in which the gap can be enlarged to allow the bead to move in a proximal-to-distal direction.

41. A cryoadhesion catheter assembly, comprising: A tubular body, the tubular body supporting a hollow heat transfer element distally relative thereto, the heat transfer element including a flexible portion that is bendable to conform to a predetermined shape; A pulling assembly, the pulling assembly being fixed distally to the heat transfer element and including a pulling filament extending along the body, the pulling assembly being configured to bend the flexible portion; And A cooling fluid supply for supplying cooling fluid to the heat transfer element.

42. The cryoadhesion catheter assembly according to claim 41, further comprising a guide member extending within the flexible portion, the guide member being stiffer when bent in a first plane than when bent in a second plane orthogonal to the first plane, both the first plane and the second plane extending along the bellows, wherein when the pull wire is pulled, the guide member restricts bending in the first plane while allowing bending in the second plane.

43. The cryoadhesion catheter assembly according to claim 42, wherein the guide member comprises a plate that extends laterally across the flexible member and longitudinally along at least a portion of the flexible member.

44. The cryoadhesion catheter assembly according to claim 43, wherein the plate is perforated.

45. The cryoadhesion catheter assembly according to claim 41, wherein the coolant supply defines a fluid outlet, and the coolant supply is movable relative to the heat transfer portion such that the coolant outlet can be positioned at different longitudinal positions therealong.

46. The cryoadhesion catheter assembly according to claim 41, further comprising an anchor drive catheter for driving a screw anchor on the heat transfer portion.

47. The cryoadhesion catheter assembly according to claim 46, wherein the tubular body defines an anchor engagement portion proximal to the heat conduction portion, the anchor engagement portion being configured to engage the anchor and constrain movement of the anchor therealong to a helical movement.

48. The cryoadhesion catheter assembly according to claim 47, wherein the anchor engagement portion prevents the anchor drive catheter from advancing further distally than the anchor engagement portion.

49. The cryoadhesion catheter assembly according to claim 48, wherein the anchor engagement portion includes at least two protrusions extending radially outward from the tubular body, the at least two protrusions being circumferentially and longitudinally offset from each other.

50. The cryoadhesion catheter assembly according to claim 48, wherein the anchor engagement portion includes a helical flange extending radially outward from the tubular body.

51. The cryoadhesion catheter assembly according to claim 46, further comprising an anchor catheter actuator for selectively advancing and rotating the anchor drive catheter relative to the tubular body.

52. The cryoadhesion catheter assembly according to claim 51, wherein the advancement and rotation of the anchor drive catheter are independent of each other.

53. The cryoadhesion catheter assembly according to claim 52, wherein the advancement and rotation of the anchor drive catheter can be locked independently of each other.

54. The cryoadhesion catheter assembly according to claim 53, wherein the anchor catheter actuator includes a housing and a knob, the knob being mounted to the housing, the knob defining an axial knob passage that receives the drive catheter therethrough, the drive catheter being fixed to the knob to be axially movable and rotatable relative thereto.

55. The cryoadhesion catheter assembly according to claim 54, wherein the knob is mounted to a knob mount to be longitudinally movable therewith and axially rotatable relative thereto, the knob mount being mounted to the housing to be longitudinally movable along it and axially rotationally fixed relative thereto.

56. The cryoadhesion catheter assembly according to claim 55, further comprising a rotation lock for selectively locking the relative rotation between the knob mount and the knob and a translation lock for selectively locking the relative translation between the housing and the knob mount.

57. The cryoadhesion catheter assembly according to claim 56, wherein the housing defines: a longitudinally elongated mount cavity that receives the knob mount therein; and a pair of slits that longitudinally extend between the outer side of the housing and the mount cavity, the translation lock and the rotation lock respectively including a translation lock threaded fastener and a rotation lock threaded fastener, each radially extending through a corresponding one of the slits to be longitudinally movable along it and engage corresponding threaded orifices formed in the knob mount, wherein when the translation and rotation lock threaded fasteners are fully screwed into their corresponding threaded orifices, the translation and rotation of the knob relative to the housing are respectively locked.

58. A transcatheter system, comprising: A drive conduit, the drive conduit being configured to drive one or more anchors into tissue; A cinching catheter configured to cinch a suture extending through the one or more anchors; and A cutting catheter configured to cut a portion of the suture.

59. The transcatheter system according to claim 58, further comprising a cooling catheter and a cooling system for supplying a cooling fluid to the cooling catheter, wherein the cooling catheter is configured to cryoadhere to a portion of the tissue.

60. The transcatheter system according to claim 59, wherein the cooling catheter includes a thermally conductive portion having a flexible portion that can be bent to conform to the shape of the valve annulus.

61. The transcatheter system according to claim 59, wherein, When bent, the flexible portion extends through an angle between about 135 degrees and about 225 degrees.

62. The transcatheter system according to claim 58, further comprising a tensioning device for applying tension to the wire.

63. The transcatheter system according to claim 58, wherein the wire defines longitudinally spaced beads.

64. The transcatheter system according to claim 58, further comprising at least one helical anchor configured to be mounted on the drive catheter for driving into the tissue.

65. The transcatheter system according to claim 64, further comprising a stop and a cinching element, both of which are larger than the central channel of the helical anchor, the wire being fixable to the stop and the cinching element being configured to allow the wire to pass therethrough in only one direction.

66. The transcatheter system according to claim 64, wherein the at least one anchor is configured to be implanted at the mitral annulus along a portion of the mitral valve selected from the group consisting of: the portion from the P1 region to the A1 region, the portion from the P2 region to the A3 region, the portion from the P1 region to the P3 region, the portion in the P1 region, the portion in the P2 region, the portion in the P3 region, and the portion from the P3 to the A3 region.

67. The transcatheter system according to claim 64, wherein the at least one anchor may include 2 to 30 coils.

68. The transcatheter system according to claim 64, wherein the at least one anchor is configured to span between about 45 degrees and about 225 degrees along the mitral annulus.

69. The transcatheter system according to claim 64, wherein the at least one anchor is configured to span between about 225 degrees and about 315 degrees along the mitral annulus.

70. The transcatheter system according to claim 58, wherein the cinching catheter includes a double-shell configuration including two layers that are axially rotatable relative to each other and are configured to receive the wire therebetween.

71. The transcatheter system according to claim 59, wherein the cooling and drive catheter is a cryoadhesion catheter assembly according to any one of claims 41 to 57, the cutting catheter is a cutting catheter according to any one of claims 1 to 20, and the cinching catheter is a cinching catheter according to any one of claims 21 to 40.

72. An implant kit, comprising: A helical anchor defining an anchor passage extending therethrough; A beaded suture defining longitudinally spaced beads; A stop larger than the central passage to prevent passage therethrough; and A cinching element larger than the central passage to prevent passage therethrough, the cinching element defining a one-way gap allowing the suture to pass therethrough in only one direction.

73. The implant kit according to claim 72, wherein the stop member is capable of being fixed to the beaded wire.

74. The implant kit according to claim 72, wherein the kit is assembled to form an implant, wherein the stop member and the tightening element abut against the helical anchor at their opposite longitudinal ends, and the wire extends therebetween under tension.

75. The implant kit according to claim 72, further comprising another helical anchor, wherein the kit is assembled to form an implant, wherein the helical anchors extend from each other with a space therebetween, and the stop member and the tightening element abut against a corresponding one of the helical anchors opposite to the space, and the wire extends therebetween under tension.

76. The implant kit according to claim 72, wherein the anchor is straight when not deformed and bent when the implant is assembled with the wire under tension.

77. The implant kit according to claim 72, wherein the stop member is capable of being fixed to the wire, and the implant kit further comprises another stop member, another helical anchor, and another beaded wire that are capable of being fixed to the wire.

78. The implant kit according to claim 77, wherein the kit is assembled to form an implant, wherein the helical anchors extend from each other with a space therebetween, the stop member abuts against a corresponding one of the helical anchors opposite to the space, each wire extends from a corresponding one of the stop members through a corresponding helical anchor and reaches the tightening element provided adjacent to the space, and the wires all extend through the gap under tension.

79. An implant kit, comprising: At least two helical anchors, each defining an anchor passage extending therethrough; A beaded suture defining longitudinally spaced beads; and A cinching element defining a one-way gap allowing the suture to pass therethrough in only one direction.

80. The implant kit according to claim 79, wherein the kit is assembled to form an implant, wherein the wire forms a loop that extends through two helical anchors and is closed by the tightening element.

81. The implant kit according to claim 80, wherein the loop forms a figure-eight.

82. The implant kit according to claim 81, wherein in the implant, the two helical anchors are laterally spaced apart from each other by substantially parallel anchor channels.

83. An implant assembled from the implant kit according to any one of claims 72 to 82.

84. A wound closure device, comprising: A cryo-adhesion device including a hollow heat-conductive element and a cooling fluid supply for supplying a cooling fluid thereto; and An anchor driver for driving a helical anchor onto the heat-conductive element.

85. The wound closure device according to claim 84, wherein the anchor driver supports the anchor at a distal end of the rigid member.

86. A method of cutting a suture using a transcatheter system, the method comprising: Advance a transcatheter system including a catheter and a cutting member having a distal annular blade through at least one body vessel of a subject to a location at or near a target tissue; Drive one or more anchors into the target tissue using a drive catheter; Cinch a suture extending through the one or more anchors; and Cut at least a portion of the suture using the cutting member.

87. The method according to claim 86, wherein the annular blade is configured to translate and rotate simultaneously relative to the suture.

88. The method according to claim 86, further comprising cryo-adhering at least one of the one or more anchors to a portion of the tissue.

89. The method according to claim 86, further comprising biasing the annular blade towards the suture.

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