Catheter with anchor mechanism

Abstract

The catheter includes a catheter body and a distal tip section including an elongate member extending along a longitudinal axis. In a first configuration, the anchor mechanism can be disposed along an outer surface of and / or within the elongate member. In a second configuration, the anchor mechanism can be configured to extend radially outward relative to the longitudinal axis and surround at least a portion of the distal tip section.

Description

[Technical Field]

[0001] The present disclosure relates to systems and techniques for anchoring a catheter within a patient's blood vessel. [Background technology]

[0002] Catheter technology is widely utilized to diagnose many abnormalities, treat vascular disease, perform vascular interventions, deliver devices for vascular occlusion, and locally deliver pharmaceutical agents to tissue, among other uses. Catheter tip stability can be important to the success of certain procedures associated with any of the aforementioned types of catheters.

[0003] For example, in coronary angioplasty, stent placement using a guide catheter can lead to catheter back-out due to resistance offered by the lesion when a guidewire or interventional device catheter is advanced through, or when an attempt is made to advance through, a stenotic lesion. Lack of adequate fixation can necessitate repeated attempts to cross the lesion, among other problems.

[0004] Furthermore, in carotid lesions, the sharp angles can complicate stent delivery as the guide catheter tends to back out of the vessel opening.

[0005] Finally, electrode catheters have been used to stimulate and map electrical activity within the heart and to ablate sites of abnormal electrical activity. In use, an electrode catheter is inserted into a major vein or artery, such as the femoral vein, and then guided into the atrium / ventricle of interest. Within the heart, the ability to control the precise position and orientation of the catheter tip is important. Thus, instability of the electrode catheter can affect the outcome of the associated procedure (e.g., unreliable results from cardiac mapping) and, therefore, can be critical to the success of certain procedures. Summary of the Invention [Problem to be solved by the invention]

[0006] The solutions of the present disclosure solve these and other problems in the art. [Means for solving the problem]

[0007] Accordingly, the inventors of the present disclosure have recognized a need for a catheter that can effectively anchor to a vessel wall, such as a coronary sinus wall. In some examples, a catheter is disclosed. In some examples, the catheter can include a catheter body and a distal tip section comprising an elongated member extending along a longitudinal axis. In a first configuration, the anchor mechanism can be disposed along an outer surface of and / or within the elongated member. In a second configuration, the anchor mechanism is configured to extend radially outward relative to the longitudinal axis to surround at least a portion of the distal tip section.

[0008] In some examples, one or more wires may be included that exit the distal end of the catheter on or adjacent the distal tip section to form one or more wire anchors. The distal ends of the one or more wires may be fixedly attached to the distal tip section. A puller wire may be configured to pull on the one or more wires and / or the distal tip section to transition the anchor mechanism from a first configuration to a second configuration.

[0009] In some examples, the anchor mechanism is actuated by a puller wire that pulls on one or more wires, effectively reducing the distance between the distal and proximal ends of the corresponding one or more wires.

[0010] In some instances, when the puller wire is in a neutral position, one or more wires are aligned axially along the catheter body.

[0011] In some examples, the anchoring mechanism transitioning from the first configuration to the second configuration causes the catheter to curve or bend outward in the second configuration to deliver a predetermined force to the vessel wall.

[0012] In some examples, one or more wires of one or more wire anchors are shape-set.

[0013] In some instances, one or more wires are asymmetrically positioned on only one side of the exterior surface of the catheter for anchoring against the vessel wall.

[0014] In some instances, the one or more wires in the second configuration include a diameter that is at least two times greater than the outer diameter of the catheter.

[0015] In some instances, the one or more wires in the second configuration comprise a diameter that is at least four times greater than the outer diameter of the catheter.

[0016] In some instances, the one or more wires in the second configuration include an atraumatic surface that contacts the vessel wall.

[0017] In some instances, the one or more wires may be retractable back into the catheter from the second configuration.

[0018] In some instances, one or more wires are configured to exit the distal end of the catheter multiple times and are anchored at or adjacent the tip section.

[0019] In some instances, the one or more wires are deployed into the second configuration by advancing them from a proximal handle operably coupled to the puller wire.

[0020] In some examples, the anchoring mechanism includes a sheath that exits an opening in the catheter on or adjacent to the distal tip section, and can include an extendable member that extends in and out of the sheath between a first configuration and a second configuration to form one or more wire anchors, the distal end of the extendable member being securely attached to the distal tip section.

[0021] In some instances, the sheath includes a lumen having an inner diameter that is greater than the outer diameter of the expandable member.

[0022] In some examples, moving the sheath proximally a first distance and / or moving the expandable member distally causes the expandable member to expand radially outward between one or more expanded states of corresponding diameters greater than the outer diameter of the catheter.

[0023] In some instances, the opening comprises a slit forming a one-way valve on the outer surface of the catheter.

[0024] In some examples, the opening comprises an oval shape.

[0025] In some examples, the opening comprises a rectangular shape.

[0026] In some examples, the anchoring mechanism in the second configuration includes a diameter that is at least two times greater than the outer diameter of the catheter.

[0027] In some examples, the anchoring mechanism in the second configuration comprises a diameter that is at least four times greater than the outer diameter of the catheter.

[0028] In some examples, the anchoring mechanism includes a plurality of expandable members adjacent the distal tip section. A gap can be positioned between each of the expandable members. In this regard, moving a portion of the catheter body proximal to the expandable members while the distal tip section remains relatively stationary causes each of the expandable members to expand radially outward to a second configuration larger than the outer diameter of the catheter body.

[0029] In some instances, each of the expandable members can be disposed radially consecutively about the longitudinal axis.

[0030] In some examples, each of the expandable members is independently movable to the second configuration.

[0031] In some examples, each of the expandable members includes a respective push wire configured to be independently translated distally to the second configuration.

[0032] In some examples, each of the expandable members includes the same or similar diameter in the second configuration.

[0033] In some examples, each of the expandable members expands outward in a balloon-like manner in the second configuration to form a porous, fixed balloon.

[0034] In some examples, each of the expandable members includes a different diameter in the second configuration.

[0035] In some instances, the expandable members collectively form a substantially planar or flat shape.

[0036] In some instances, the expandable members collectively form a non-circular shape.

[0037] In some examples, one or more of the expandable members include multiple electrodes separately positioned therealong, the multiple electrodes configured to be read simultaneously at different vascular depths and radial locations.

[0038] In some examples, the anchoring mechanism includes a plurality of wire members extending axially distally from the convergence along the catheter body and terminating in one or more variable loop lassos fixedly wrapped at or adjacent the distal tip section, wherein pushing on the plurality of wire members causes the wire members to expand outwardly into the second configuration.

[0039] In some examples, a pusher wire extending proximally from the convergence through an opening within the lumen of the catheter body is included, the pusher wire being configured to actuate the anchor mechanism between the first and second configurations.

[0040] Some examples include a pusher wire that extends generally proximally along the exterior surface of the catheter body.

[0041] In some examples, the plurality of wire members in the second configuration are configured to expand outwardly between a plurality of different orientations and / or diameters.

[0042] In some examples, in the second configuration, at least two of the plurality of wire members are generally orthogonal to the others.

[0043] In some examples, in the second configuration, at least two of the plurality of wire members form a generally obtuse angle with respect to the others.

[0044] In some examples, the anchor mechanism includes multiple wire members extending axially distally along the catheter body and fixedly attached and terminating at or adjacent the distal tip section, wherein pushing the multiple wire members causes the wire members to expand outwardly and away from one another into the second configuration.

[0045] In some examples, a pusher wire is included that extends proximally from the proximal ends of the multiple wire members.

[0046] Some examples include a pusher wire that extends proximally from within the catheter body through an opening in the lumen of the catheter body.

[0047] In some examples, each of the plurality of wire members delivers an outward radial force to the vessel wall in the second configuration, and each of the plurality of wire members is radially disposed about the catheter body.

[0048] In some examples, the plurality of wire members are curved away from one another in a generally oval first configuration.

[0049] In some examples, the catheter body includes at least two inner lumens, at least one of the two inner lumens configured to fixedly receive the distal ends of the plurality of wire members.

[0050] In some examples, the elongate member includes a circumferential opening disposed on an outer surface of the elongate member, and the anchor mechanism is configured to extend radially outward from the circumferential opening of the elongate member.

[0051] In some examples, a catheter can include a catheter body and a distal tip section including an elongated member extending along a longitudinal axis, the elongated member having a circumferential opening disposed on an outer surface of the elongated member. An anchoring mechanism is disposed within the elongated member in the first configuration. The anchoring mechanism is configured to extend outwardly relative to the longitudinal axis from the circumferential opening of the elongated member to surround at least a portion of the distal tip section in the second configuration.

[0052] In some examples, the anchoring mechanism can include at least one of a first configuration within the lumen, the first configuration being coextensive with the lumen of the catheter, and a second configuration external to the catheter for anchoring against the vessel wall.

[0053] In some instances, the catheter includes one or more electrodes, and the catheter is an electrode catheter.

[0054] In some examples, the anchoring mechanism includes a variable loop lasso.

[0055] In some examples, the anchoring mechanism is extendable from the lumen of the catheter through an opening in the exterior surface of the catheter when moving from the first configuration to the second configuration.

[0056] In some examples, the variable loop lasso includes one or more wires that are movable from a first configuration to a second configuration by translating distally through an opening.

[0057] In some examples, the Variable Loop Lasso is actuatable from a first configuration to a second configuration by expanding and / or contracting the Variable Loop Lasso around the catheter body like a python or bore.

[0058] In some examples, the variable loop lasso includes one or more wires with variable diameter loops and configured to compress against the vessel wall in the second configuration.

[0059] In some examples, the variable loop lasso is movable between a plurality of different second configurations having different diameters.

[0060] In some examples, the anchor mechanism includes one or more wires shaped in the form of a circle, a spiral, or a helix and extending from an opening in the distal end of the catheter in the second configuration.

[0061] In some instances, in the second configuration, the anchor mechanism is axially aligned with the longitudinal axis of the catheter.

[0062] In some instances, in the second configuration, the anchoring mechanism is attached to only one side of the exterior surface of the catheter that presses against the vessel wall.

[0063] In some examples, the catheter includes a coiled wire attached to a Variable Loop Lasso, the coiled wire being twistable so that the Variable Loop Lasso can be deployed through the opening and secured to the vessel wall.

[0064] In some instances, the coiled wire is attached to the proximal end of the variable loop lasso.

[0065] In some instances, the coiled wire is axially connected to the catheter lumen of the catheter body.

[0066] In some instances, the coiled wire is axially connected to the catheter, and the coiled wire is wrapped around the exterior of the catheter body. In some instances, the coiled wire includes one or more twists.

[0067] In some examples, the anchoring mechanism includes one or more strips connected to the outer surface of the catheter, the one or more strips configured to bunch together and extend outward when one or more portions of the distal tip section are withdrawn towards one or more portions of the catheter proximally.

[0068] In some instances, the one or more strips are configured to extend outward to a diameter at least twice the outer diameter of the catheter.

[0069] In some instances, the one or more strips are configured to extend outwardly on at least two opposing sides of the catheter in a balloon-like manner.

[0070] In some instances, the one or more strips are configured to extend outwardly through a plurality of slits in the exterior surface of the catheter.

[0071] In some examples, the one or more strips are actuated into the second configuration by one or more pull members actuable by an end user operably connected to the one or more strips.

[0072] In some instances, one or more strips are positioned on only one side of the catheter and are configured to be pushed into the blood vessel on only that side.

[0073] In some examples, the one or more strips are positioned between the plurality of electrodes of the distal tip section. In some examples, the plurality of electrodes includes at least an ablation electrode. In some examples, the plurality of electrodes includes at least a recording electrode. In some examples, the plurality of electrodes includes at least a sensing electrode.

[0074] In some examples, the area surrounding one or more strips comprises a soft, flexible plastic, including an elastomer.

[0075] In some instances, the area surrounding one or more strips comprises a soft, flexible plastic (polyether block amide), including Pebax®.

[0076] In some examples, one or more strips comprise polyetheretherketone (PEEK).

[0077] In some examples, the catheter is withdrawn a predetermined distance to move the strip to the second configuration, hi some examples, the predetermined distance comprises a 1:1 ratio with the radial expansion of the strip in the second configuration.

[0078] In some examples, the anchoring mechanism includes a plurality of strips connected to the outer surface of the catheter, the plurality of strips configured to bunch together and extend outward when one or more portions of the distal tip section are withdrawn toward one or more portions of the catheter proximally. In some examples, the plurality of strips are radially separated (e.g., evenly separated radially about the longitudinal axis of the catheter). In some examples, the plurality of strips are configured to extend outward to a diameter at least twice the outer diameter of the catheter. In some examples, the plurality of strips are configured to extend outward to at least two opposing sides of the catheter in a balloon-like manner. In some examples, the plurality of strips are configured to extend outward through a plurality of slits in the outer surface of the catheter. In some examples, the plurality of strips are actuated to the second configuration by one or more end-user-actuable pull members operably connected to the strips.

[0079] In some examples, the plurality of strips are positioned between the plurality of electrodes of the distal tip section. In some examples, the plurality of electrodes includes at least an ablation electrode. In some examples, the plurality of electrodes includes at least a recording electrode. In some examples, the plurality of electrodes includes at least a sensing electrode.

[0080] In some examples, the region surrounds the plurality of strips and comprises a soft, flexible plastic that includes an elastomer.

[0081] In some examples, the region surrounds the plurality of strips and comprises a soft, flexible plastic (eg, polyether block amide), including Pebax®.

[0082] In some examples, the plurality of strips comprises polyetheretherketone (PEEK).

[0083] In some examples, the catheter is withdrawn a predetermined distance to move the plurality of strips to the second configuration, hi some examples, the predetermined distance comprises a 1:1 ratio with the radial expansion of the plurality of strips in the second configuration.

[0084] In some examples, the distal tip section of the catheter is retractable to move the anchoring mechanism to the second configuration. The anchoring mechanism in this embodiment includes multiple walls, a first wall of the multiple walls being flexible and a second wall of the multiple walls being formed as a strip that is more rigid than the first wall, the strip being expandable outward when the distal tip section is withdrawn and the first wall collapses upon itself.

[0085] In some examples, the walls are positioned between the electrodes of the distal tip section.

[0086] In some examples, the first wall comprises a soft, flexible plastic having an elastomer.

[0087] In some examples, the first wall comprises a soft, flexible plastic (eg, polyether block amide) with Pebax®.

[0088] In some examples, the second wall comprises polyetheretherketone (PEEK).

[0089] In some examples, the catheter includes a sensor for detecting movement of the catheter.

[0090] In some examples, the catheter includes a sensor for detecting whether the anchoring mechanism is secured to the vessel wall.

[0091] In some examples, the anchoring mechanism is a balloon expandable to a radial extent greater than the outer diameter of the catheter in the second configuration, the balloon configured to expand and anchor to the vessel wall without occluding the vessel.

[0092] In some examples, the balloon is collapsible within the catheter in the first configuration.

[0093] In some examples, the balloon includes an expandable section formed by the wall of the catheter within or adjacent to at least one distal tip section, the expandable section being softer than the surrounding wall section of the catheter and configured to expand outward to apply pressure to the vessel wall in the second configuration.

[0094] In some examples, the balloon is positioned within or adjacent to the distal tip section and is in fluid communication with a pressure lumen within the catheter.

[0095] In some instances, the balloon is configured to expand outward from only one side of the catheter.

[0096] In some instances, the balloon is configured to expand outwardly to a radial extent of at least two times the outer diameter of the catheter.

[0097] In some examples, the anchoring mechanism is expandable along the length of the distal tip section.

[0098] In some examples, the anchor mechanism includes one or more wires that exit the distal end of the catheter on or adjacent the distal tip section to form one or more wire anchors.

[0099] In some examples, one or more wires of one or more wire anchors are shape-fixing.

[0100] In some instances, one or more wire anchors are positioned on only one side of the exterior surface of the catheter for anchoring against the vessel wall.

[0101] In some examples, the one or more wire anchors include one or more wires bulged with at least one anchor bump. In some examples, the at least one anchor bump in the second configuration includes a diameter at least two times greater than the outer diameter of the catheter. In some examples, the at least one anchor bump includes an atraumatic surface that contacts the vessel wall. In some examples, the at least one anchor bump includes a fishhook-shaped surface for anchoring to the vessel wall.

[0102] In some examples, the one or more wires can be retractable back into the catheter from the second configuration. In some examples, the one or more wires are configured to exit the distal end of the catheter multiple times and are anchored at or adjacent to the tip section. In some examples, the one or more wires are deployed to the second configuration by being advanced from a proximal shaft or proximal handle operably coupled to the proximal end of the catheter. In some examples, the one or more wires are deployed to the second configuration from a single puller mechanism that is retractable into the catheter body of the catheter during use.

[0103] In some examples, a method for anchoring a catheter to a blood vessel at a treatment site is disclosed. The method can include delivering a catheter to the treatment site, the catheter including a catheter body and a distal tip section with an anchor mechanism deployable from the distal tip section, the anchor mechanism including a first configuration within or coextensive with a lumen of the catheter and a second configuration external to the catheter for anchoring against a blood vessel wall, deploying the anchor mechanism and securing the anchor mechanism to the blood vessel wall. In some examples, the blood vessel wall is a coronary sinus wall. In some examples, the catheter of the method includes one or more electrodes and is an electrode catheter.

[0104] In some examples, the anchoring mechanism of the present methods includes one or more wires shaped in the form of a circle, a spiral, or a helix and extending from an opening in the distal end of the catheter in the second configuration.

[0105] In some examples, the anchoring mechanism of the present method includes a variable loop lasso.

[0106] In some examples, the method includes extending the anchor mechanism from the catheter lumen through an opening in the exterior surface of the catheter when deploying the anchor mechanism from the first configuration to the second configuration.

[0107] In some examples, the anchor mechanism of the method includes an adjustable loop lasso with one or more wires. In this embodiment, the method includes translating the anchor mechanism distally through the opening, thereby moving the anchor mechanism from a first configuration to a second configuration.

[0108] In some examples, the anchoring mechanism of the method includes a variable loop lasso having one or more wires with variable diameter loops. The method of this embodiment includes pressing against the vessel wall with the variable loop lasso in the second configuration.

[0109] In some examples, the method includes moving the variable loop lasso between a plurality of different second configurations having different diameters.

[0110] In some examples, the method includes axially aligning the anchoring mechanism with a longitudinal axis of the catheter.

[0111] In some examples, the method includes positioning an anchoring mechanism on only one side of an exterior surface of the catheter and pressing against the vessel wall with the anchoring mechanism in the second configuration.

[0112] In some examples, the method includes attaching a coiled wire attached to a Variable Loop Lasso and twisting the coiled wire, thereby causing the Variable Loop Lasso to be deployed through the opening and anchored to the vessel wall.

[0113] In some examples, the method includes attaching a coiled wire at the proximal end of the variable loop lasso.

[0114] In some examples, the method includes axially connecting a coiled wire to a catheter lumen of the catheter body.

[0115] In some examples, the method includes axially connecting and wrapping a coiled wire to the catheter body, the coiled wire being wrapped around an exterior surface of the catheter body. The coiled wire can include one or more twists and / or loops.

[0116] In some examples, the anchoring mechanism of the method includes one or more strips connected to the outer surface of the catheter. In this embodiment, the method includes retracting one or more portions of the distal tip section toward one or more portions of the catheter proximal thereto, thereby bunching and extending one or more strips outward. The method can also include extending the one or more strips outward to a diameter at least twice the outer diameter of the catheter. The method can also include extending the one or more strips outward in a balloon-like manner on at least two opposing sides of the catheter. The method can also include extending the one or more strips outward through multiple slits in the outer surface of the catheter. The method can also include actuating the one or more strips into the second configuration by pulling or translating one or more pull members operably connected to the one or more strips.

[0117] In some examples, the method can include positioning one or more strips on only one side of the catheter and pressing the one or more strips of the anchor mechanism in the second configuration against the vessel wall on only that side.

[0118] In some examples, the method can include positioning one or more strips between the plurality of electrodes of the distal tip section.

[0119] In some examples, the method can include positioning an area surrounding one or more strips with a soft, flexible plastic that includes an elastomer.

[0120] In some examples, the method can include positioning an area surrounding one or more strips with a soft, flexible plastic (polyether block amide), including Pebax®.

[0121] In some examples, the method can include withdrawing the catheter a predetermined distance to move the one or more strips to the second configuration. The predetermined distance can include a 1:1 ratio with a radial extent of the one or more strips in the second configuration.

[0122] In some examples, the anchoring mechanism of the method includes a plurality of strips connected to the outer surface of the catheter. The method can include retracting one or more portions of the distal tip section toward one or more portions of the catheter proximal thereto, thereby bunching and extending the plurality of strips outward. The method can also include radially separating the plurality of strips along the outer surface of the catheter. The plurality of strips can be evenly radially separated. The method can also include extending the plurality of strips outward to a diameter at least twice the outer diameter of the catheter. The method can also include extending the plurality of strips outward in a balloon-like manner on at least two opposing sides of the catheter.

[0123] In some examples, the method includes extending a plurality of strips outward through a plurality of slits in the exterior surface of the catheter. The method can also include actuating the plurality of strips into a second configuration by pulling or translating one or more pull members operably connected to the plurality of strips. The method can also include positioning the plurality of strips on only one side of the catheter and pressing the plurality of strips against the vessel wall on only that side with the plurality of strips of the anchor mechanism in the second configuration. The method can also include positioning the plurality of strips between a plurality of electrodes on the distal tip section.

[0124] In some examples, the method includes positioning an area surrounding the plurality of strips with a soft, flexible plastic that includes an elastomer.

[0125] In some examples, the method includes moving the plurality of strips to the second configuration by withdrawing the catheter a predetermined distance, where the predetermined distance can include a 1:1 ratio with a radial extent of the plurality of strips in the second configuration.

[0126] In some examples, the method includes detecting movement of the catheter by a sensor in the catheter.

[0127] In some examples, the method includes detecting, with a sensor on the catheter, whether the anchoring mechanism is secured to the vessel wall.

[0128] In some examples, the method includes determining a position and orientation of the anchor mechanism by generating a plurality of AC magnetic fields, each AC magnetic field at a different frequency; sensing the AC magnetic fields at a plurality of sensors proximal to the distal tip section; and calculating dimensions of the position and orientation of a portion of the distal tip section in response to signals representing the generated and sensed magnetic fields.

[0129] In some examples, the method includes determining a position and orientation of the distal tip section by generating a plurality of AC magnetic fields, each AC magnetic field at a different frequency, sensing the AC magnetic fields at a plurality of sensors proximal to the distal tip section, and calculating dimensions of the position and orientation of a portion of the distal tip section in response to signals representing the generated and sensed magnetic fields.

[0130] In some examples, the method includes generating, by at least one magnetic field generator, an externally applied magnetic field to establish a frame of reference; positioning a plurality of sensors comprising single-axis coils around the distal tip section, each single-axis coil being fixed at a different respective point around the distal tip section; and determining dimensional, translational, and orientation coordinates of the single-axis coils by processing signals from the single-axis coils.

[0131] In some examples, the method includes positioning one or more electrodes on the distal tip section at known, fixed locations relative to at least one of the single-axis coils, the location of each electrode being derived from the dimensional, translational, and orientational coordinates of the single-axis coil.

[0132] In some examples, the method includes deflecting the tip section in response to moving one or more puller wires.

[0133] In some examples, the method includes moving one or more puller wires with a steering assembly.

[0134] In some examples, the method includes deflecting the tip section in the direction of an off-axis lumen through which each puller wire extends.

[0135] In some examples, the method includes assembling the catheter with a control handle including a deflection knob, and adjusting a tip deflection orientation of the tip section by rotating the deflection knob.

[0136] In some examples, the method includes extending one or more puller wire segments pulled by a pulley to deflect relative to the longitudinal axis at an angle of less than about 7 degrees.

[0137] In some examples, the anchoring mechanism of the method includes a balloon, wherein the anchoring step further includes expanding the balloon to a radial extent greater than the outer diameter of the catheter in the second configuration, thereby anchoring the anchoring mechanism to the vessel wall without occluding the vessel.

[0138] In some examples, the method can include collapsing a balloon within the catheter in the first configuration.

[0139] In some examples, the method can include forming a balloon in an expandable section of the wall of the catheter within or adjacent to the distal tip section, the expandable section being softer than the surrounding wall section of the catheter and configured to expand outward in the second configuration to apply pressure to the vessel wall.

[0140] In some examples, the method can include positioning a balloon within or adjacent the distal tip section and in fluid communication with a pressure lumen within the catheter.

[0141] In some examples, the method can include outwardly expanding the balloon from only one side of the catheter.

[0142] In some examples, the method can include outwardly expanding the balloon to a radial extent of at least twice the outer diameter of the catheter.

[0143] In some examples, the method can include outwardly expanding a balloon along the length of the distal tip section.

[0144] In some examples, the anchor mechanism of the method includes one or more wires. In this embodiment, the method includes one or more wires exiting the distal end of the catheter on or adjacent the distal tip section to form one or more wire anchors of the anchor mechanism. In some examples, the method can include shape-setting one or more wires of the one or more wire anchors. In some examples, the method can include positioning one or more wire anchors on only one side of the exterior surface of the catheter for anchoring against the vessel wall.

[0145] In some examples, the method can include expanding one or more wire anchors to form at least one anchor bump. The at least one anchor bump can include a diameter in the second configuration that is at least two times greater than an outer diameter of the catheter. The at least one anchor bump can include an atraumatic surface that contacts the vessel wall. The at least one anchor bump can include a fishhook surface for anchoring to the vessel wall.

[0146] In some examples, the method can include retracting the one or more wires from the second configuration into the catheter.

[0147] In some examples, the method can include one or more wires exiting and retracting back into the catheter multiple times.

[0148] In some instances, the step of deploying the anchor mechanism includes advancing one or more wires from a proximal shaft or proximal handle operably coupled to the proximal end of the catheter.

[0149] In some examples, the step of deploying the anchor mechanism includes advancing one or more wires from a single puller mechanism that is retractable within the catheter body of the catheter during use to the second configuration.

[0150] A more complete understanding of the present disclosure will be obtained from the following detailed description of the embodiments of the present invention when read in conjunction with the drawings. [Brief explanation of the drawings]

[0151] While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter described herein, the subject matter will be better understood from the following description taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements in the various drawings. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the present disclosure. The figures depict one or more implementations of devices of the present disclosure, by way of example only and not by way of limitation. [Figure 1A] FIG. 1 is a side view of one embodiment of an exemplary catheter of the present disclosure. [Figure 1B] FIG. 1B is an enlarged side view of the tip section of FIG. 1A taken along section AA. [Figure 2] FIG. 2 is an enlarged front plan view of the exemplary catheter of FIGS. 1A-1B. [Figure 3A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 3B] FIG. 3B is another enlarged side view of a portion of the tip section of FIG. 3A. [Figure 4A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 4B] FIG. 4B is another enlarged side view of a portion of the tip section of FIG. 4A. [Figure 5A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 5B] FIG. 5B is another enlarged side view of a portion of the tip section of FIG. 5A. [Figure 6A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 6B] FIG. 6B is another enlarged side view of a portion of the tip section of FIG. 6A. [Figure 7A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 7B] FIG. 7B is another enlarged side view of a portion of the tip section of FIG. 7A. [Figure 8A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 8B] FIG. 8B is another enlarged side view of a portion of the tip section of FIG. 8A. [Figure 9A] FIG. 8B is an enlarged side view of an alternative portion of the tip section of FIG. 8A. [Figure 9B] FIG. 9B is an enlarged cross-sectional view of the tip section of FIG. 9A. [Figure 10A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 10B] FIG. 10B is another enlarged side view of a portion of the tip section of FIG. 10A. [Figure 11A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 11B] FIG. 11B is another enlarged side view of a portion of the tip section of FIG. 11A. [Figure 12A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 12B] FIG. 12B is another enlarged side view of a portion of the tip section of FIG. 12A. [Figure 13A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 13B] FIG. 13B is another enlarged side view of a portion of the tip section of FIG. 13A. [Figure 14] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure expanded in an exemplary blood vessel. [Figure 15A] FIG. 10 is an enlarged side view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 15B] FIG. 15B is an enlarged perspective view of a portion of the tip section of FIG. 15A. [Figure 15C]15B is an enlarged plan view of a portion of the tip section of FIG. 15A in a first orientation. [Figure 15D] FIG. 15B is an enlarged plan view of a portion of the tip section of FIG. 15A in a second orientation. [Figure 16] 1 depicts an enlarged side view of a portion of the anchor mechanism. [Figure 17A] FIG. 10 is an enlarged top view of a portion of the tip section of another exemplary catheter of the present disclosure. [Figure 17B] FIG. 17B is an enlarged side view of a portion of the tip section of FIG. 17A. [Figure 17C] FIG. 17B is an enlarged perspective view of a portion of the tip section of FIG. 17A. [Figure 17D] 17B is an enlarged plan view of a portion of the tip section of FIG. 17A in a first orientation. [Figure 17E] FIG. 17B is an enlarged plan view of a portion of the tip section of FIG. 17A in a second orientation. [Figure 18] FIG. 10 is a front plan view of an anchor mechanism in a second configuration within an exemplary vessel. [Figure 19] FIG. 1 is a flow diagram illustrating an exemplary method for tissue ablation. [Figure 20A] 1 shows a partial perspective view of the tip section of another exemplary catheter of the present disclosure. [Figure 20B] FIG. 20B is another enlarged side view of a portion of the tip section of FIG. 20A. [Figure 21] 1 shows a perspective view of a portion of the tip section of another exemplary catheter of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0152] As used herein, the term "about" or "approximately" in connection with any numerical value or range of values indicates a suitable dimensional tolerance that enables a portion of a component or a collection of components to function in accordance with its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of values of ±20% of the recited value; for example, "about 90%" may refer to a range of values of 71% to 99%.

[0153] As used herein, a "subject" or "patient" includes a subject or a blood vessel from a subject or patient, and may refer to any relevant human patient, as well as any mammal, veterinary animal, livestock animal, or companion animal, etc. In one example, the animal may be a laboratory animal (e.g., rat, dog, pig, rabbit, monkey, etc.) specifically selected to have certain characteristics similar to humans.

[0154] As used herein, "operator" may include a doctor, surgeon, or any other person or instrument associated with a medical procedure that is used in conjunction with a device of the present disclosure.

[0155] The present disclosure generally relates to a catheter having one or more anchoring mechanisms for stabilizing the distal tip section of the catheter during use. Referring to FIGS. 1A-1B, a steerable bidirectional electrode catheter 10 is shown. The catheter 10 may include an elongated catheter body 12 having a proximal end and a distal end, a tip section 14 at the distal end of the catheter body 12, and a control handle 16 at the proximal end of the catheter body 12. FIG. 1B is an enlarged side view of the tip section 14 taken along section AA. The body 12 may include an elongated tubular structure having a single axis or central lumen 18. The catheter body 12 may be flexible (e.g., bendable but substantially incompressible along its length). The catheter body 12 may have any suitable structure and may be made of any suitable material.

[0156] The tip section 14 comprises a longitudinal axis 25 and can be deflected unidirectionally or bidirectionally from that axis. The tip section 14 can also include one or more electrodes 19 selectively positioned and / or separated about the tip section 14. The tip section 14 can also include a deployable anchoring mechanism 50 positioned therealong. While an electrode catheter is shown in the figures provided herein, it is understood that other types of catheters are contemplated for use with the anchoring mechanisms disclosed herein. The mechanism 50 can be disposed within and / or along the body 12 in a first configuration (e.g., a collapsed configuration). The mechanism 50 can be configured to extend outward relative to the longitudinal axis from a circumferential opening in the elongate member to surround at least a portion of the distal tip section in a second configuration (e.g., an expanded configuration).

[0157] In the depicted example of FIGS. 1A-1B, the mechanism 50 may be positionable within the body 12, including at or around the tip section 14 (e.g., within a lumen therein), and when deployed, may comprise one or more wires 52. FIG. 2 is an enlarged front plan view of the catheter 10 of FIGS. 1A-1B. As shown, the wires 52 may be in a shape-fixed configuration, such as a variable lasso shape or a circular, spiral, or helical form. As shown, the one or more wires 52 may include one or more curved sections or loops 53, which may be generally thin and flexible. The one or more loops 53 may be positioned around the section 14, but leave spaces between them through which blood can flow, even if the wires 52 contact the corresponding vessel wall. In this regard, the wires 52 forming one or more loops 53 facilitate anchoring to the vessel wall while avoiding occluding blood flow in the vessel itself. One or more loop segments 53 of mechanism 50 may be axially aligned with axis 25 or may be otherwise oriented.

[0158] One or more loop segments 53 can be connected to an elongate base segment 55 proximate to the one or more loop segments 53. The curvature of the one or more loop segments 53 formed by one or more wires 52 can be adjustable using a steering mechanism and / or a control mechanism (not shown) (e.g., the diameter of mechanism 50, the distance between loops, the length of mechanism 50 in a second configuration, etc.). The radius of any loop segment 53 of mechanism 50 can be adjustable (e.g., 7 - 25 mm). In some examples, one or more loops of mechanism 50 can be sized to conform to a structure such as the ostium of a pulmonary vein or the coronary sinus. One or more loop segments 53 can include an elasticity generally constant over at least a portion of its length, for example, by internally reinforcing the curved portion with an elastic longitudinal member so as to sufficiently secure mechanism 50 to a blood vessel wall in a second configuration. One or more loop segments 53 can generally be made thicker and / or stiffer than the remaining portion of the one or more wires proximal thereto.

[0159] More or fewer loops than depicted in FIGS. 1A - 1B can be provided as needed or requested. One or more loops of the depicted mechanism 50 can also include variable diameter loops configured to press against a blood vessel wall in a second configuration. The depicted mechanism 50 can also be configured to move between or otherwise adjust among a plurality of different second configurations having different diameters (e.g., move between different diameters to accommodate different sized vascular systems).

[0160] The wire 52 depicted in FIGS. 1A-2 can be spiraled or bounded in a predetermined manner. The wire 52 can be oriented at an angle relative to the axis 25 of the catheter 10. Throughout this disclosure, the term "at an angle" is intended to mean a plane in space that best accommodates the shaped wire(s) 52 and is angled relative to the axis 25. The angle θ between the plane P and the axis 25 can range from about 45 degrees to 105 degrees, preferably about 75 degrees to 105 degrees, and more preferably about 90 degrees. The section 14 can include an elongated member extending along a longitudinal axis (e.g., axis 25), the elongated member having a circumferential opening 22 disposed on an outer surface of the elongated member. As can be seen more clearly in FIG. 1B, the opening 22 can be provided from which the mechanism 50 can be translated distally until it expands to a second configuration. Once expanded, the mechanism 50 can be secured against (e.g., pressed into) a vessel wall, such as the coronary sinus wall. In some examples, one or more of the wires 52 can include a sensor that detects the force of contact with the vessel wall during the fixation process to ensure that a predetermined force is achieved for fixation, or the sensor can be used to ensure that a predetermined force is not exceeded to avoid rupturing the corresponding vessel wall.

[0161] Prior to deployment, mechanism 50 can be in a first configuration housed within a lumen of catheter 10. For example, one or more wires 52 of mechanism 50 can be positioned within a lumen (e.g., lumen 22) of catheter 10. One or more wires 52 can also extend with catheter 10. In certain examples, the lumen associated with opening 22 can be formed by a slit selectively positioned in the outer surface of catheter body 12 at tip section 14, thereby providing spacing for one or more wires 52 to be deployed therefrom. In some examples, mechanism 50 can be attached to only one side of the outer surface of catheter 10, or otherwise in a second configuration, thereby pressing against the vessel wall on one side.

[0162] FIG. 3A is an enlarged side view of a portion of the tip section 114 of another exemplary catheter. FIG. 3B is another enlarged side view of a portion of the tip section 114 of FIG. 3A in a second configuration. In this example, a mechanism 150 similar to mechanism 50 is extendable and / or deployable via an opening 122 positioned on or adjacent to the exterior surface of section 114. Mechanism 150 can include one or more segments 152 (e.g., wire or other biocompatible material) that form one or more loop segments 153 similar to mechanism 50 described above. As can be seen, one or more segments 152 can be, but are not necessarily, thicker than one or more wires 52. In some examples, one or more segments 152 can include a catheter structure with a smaller diameter than the lumen of catheter 110.

[0163] As can be seen, the coiled wire 154 can be attached proximally to the mechanism 50 and any corresponding one or more loop segments 153. The coiled wire 154 can be configured such that twisting or otherwise moving the wire 154 can cause the mechanism 150 to extend and / or deploy through the opening 122. In some examples, twisting or otherwise moving the wire 154 can also secure the mechanism 150, including any of its one or more loops 153, to the vessel wall in a second configuration, as in FIG. 3B , allowing a user to adjustably and precisely push the mechanism 150 against the vessel wall. The wire 154 can include one or more twists on or around the catheter 110 and can be axially connected to the catheter 110 (e.g., wrapped around the exterior surface of the catheter 110). However, the wire 154 is not so limited and can be attached elsewhere or in a different manner to the exterior and / or interior surfaces of the catheter 110, as needed or desired. Additionally, in some examples, mechanism 150 can be deployed through the opening by adding or removing twist from the elongated wire in a first configuration to the coiled wire 154 in a second configuration (e.g., by twisting or otherwise moving wire 154), and then actuating mechanism 150 to form one or more loops 153 and / or otherwise secure to the vessel wall.

[0164] Figure 4A is an enlarged side view of a portion of the tip section 214 of another exemplary catheter 210 of the present disclosure in a first configuration prior to fixation. Figure 4B is another enlarged side view of a portion of the tip section 214 in a second configuration, in which a mechanism 250 is configured for fixation. The mechanism 250 as shown can include one or more strips extendable and / or deployable through slits 222 in the exterior surface of the catheter 210. In some examples, one or more electrodes can be included with the one or more strips 252. The one or more strips 252 can be configured to bunch and extend outward when one or more portions of the distal tip section 214 are withdrawn toward one or more portions of the catheter proximally, as seen between Figures 4A and 4B, where the section 214 is shortened by a distance D. The distance D can range, including being selected by a predetermined ratio (e.g., a 1:1 ratio, a 1:2 ratio, etc.) with the radial extent of the one or more strips 252 in the second configuration. It is understood that any ratio can be used, as needed or desired, to select the distance D that corresponds to the outer diameter desired for the second configuration. The one or more strips 252 can be actuated into the second configuration by one or more pull members actuable by an end user operably connected to the one or more strips 252. In some examples, the one or more wires 252 and / or slits 222 can be radially equally spaced strips to center the catheter 210.

[0165] In some examples, one or more strips 252 can be outwardly extendable to a diameter at least twice the outer diameter of the catheter 210. The one or more strips 252 can be positioned on only one side of the catheter 210 and configured to be pushed into the blood vessel on only that side, as shown. However, it is contemplated that the one or more strips 252 can be designed to extend outward from multiple sides of the catheter 210, similar to a balloon. The one or more strips 252 can be positioned between the electrodes 19, which can be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, and / or the like. In some examples, one or more sensing electrodes can be included to detect movement of the catheter 210 and / or whether the mechanism 250 is secured to the blood vessel wall. Such sensing by the electrodes 19 can be particularly advantageous in informing the end user whether the mechanism 250 is sufficiently secured or is moving undesirably.

[0166] The area surrounding one or more strips 252 can include a relatively soft and / or flexible plastic, including an elastomer. Acceptable materials for the peripheral area can include one or a combination of polyether block amide, polyether ether ketone (PEEK), Pebax®, which can include an elastomer as a block copolymer consisting of hard polyamide blocks and soft polyether blocks.

[0167] Referring to FIG. 5A, the catheter body 12 is shown in a first configuration, while FIG. 5B shows it in a second configuration. The mechanism 350 is more clearly shown in FIG. 5B, deployed through the exterior surface of the catheter body 12, with one or more strips 352 bunched and extending outward after one or more sections of the catheter body 12 are withdrawn a distance D toward one or more sections of the catheter proximal thereto. In some examples, the anchor mechanism 350 can include multiple walls 352, 358. The first wall 358 can be flexible, and the second wall 352 of the multiple walls can be formed as a strip that is more rigid than the first wall 358. For example, the less rigid, flexible first wall 358 can be made from any low-durometer Pebax, urethane, other polymer, and / or the like. In other examples, the first wall 358 can be made from a thin-walled extrusion that allows the first wall 358 to collapse and / or crumple upon itself. Rigid materials can be made from PEEK, plastics with relatively high durometers, shaped metals such as Nitinol, regular urethane, Pebax, and / or the like.

[0168] Wall 352 can comprise a relatively soft and / or flexible plastic, including an elastomer. In some examples, wall 352 is designed with a softer material to allow catheter 310 to contract a distance D, thereby buckling the strip of wall 352. The strip of wall 352 can be expandable outward when a section around it is withdrawn the distance D, causing first wall 358 to collapse in on itself. Acceptable materials for wall 352 can include one or a combination of polyether block amide and Pebax®, which can include an elastomer as a block copolymer consisting of a rigid polyamide block and a soft polyether block. Wall 358 can be more rigid, including polyether ether ketone (PEEK). Similar to mechanism 250, mechanism 350 can be positioned between electrodes 19, which can be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, and / or the like.

[0169] Referring to FIG. 6A, feature 450 is shown in a first configuration, collapsed within the catheter body 12. Conversely, FIG. 6B shows feature 450 in a second, expanded configuration. Feature 450 can be provided through a relatively soft section, region 452, such that pressure applied thereto can cause said soft section 452 to expand outward and become balloon-like. In some examples, the expandable section of region 452 can be formed in a wall of the catheter body 12 that is softer than the surrounding wall section of the catheter body 12. In some examples, pressure can be applied directly through a lumen 454 that is in fluid communication with feature 450's region 452. Applying pressure to region 452 through lumen 454 can cause feature 450 to expand outward to the depicted balloon-like configuration of FIG. 6B. In some examples, a hard or other more rigid material can be added around region 452 to prevent expansion at a certain radial percentage or extent, as shown, to achieve expansion on only one side. In some instances, region 452 may extend outward from only one side of catheter body 12, although it is contemplated that region 452 may extend outward from more than one side.

[0170] Referring to FIG. 7A, an enlarged side view of the anchor mechanism 550 is shown in a pre-deployed first configuration, while FIG. 7B shows the mechanism 550 in a second configuration, capable of being deployed from the catheter body 12 and anchored to a vessel wall. The mechanism 550 can include one or more wires 552, which are shaped and configured to exit distally through one or more slits 522 or openings in the catheter body 12. In the second configuration of FIG. 7B, the one or more wires 552 can be seen in the form of a fishhook anchor configured to be pushed into and anchored in the vessel wall after being moved or translated distally a predetermined distance. The one or more wires 552 can be retractable back into the catheter body 12 from the second configuration after being deployed. The one or more wires 552 can also exit their respective slits 522 or openings in the catheter body 12 multiple times and be anchored at or adjacent the tip section. In some examples, the one or more wires 552 are deployed into the second configuration by being advanced from a proximal shaft or handle operably coupled to the proximal end of the catheter 10.

[0171] The one or more wires 552 may be shape-locked and connected, directly or indirectly, to a pull wire mechanism configured to store the one or more wires 552 within the catheter body 522 when not in use and deploy them from the slit 522 or opening for use. While the one or more wires 552 are shown in a fish hook shape, alternative wire shapes are contemplated for less traumatic fixation. As shown in FIG. 7B, the one or more wires 552 can be positioned on only one side of the exterior of the catheter body 12 for fixation against the vessel wall or multiple sides.

[0172] Referring to FIG. 8A, an enlarged side view of the anchor mechanism 650 is shown in a pre-deployed first configuration, while FIG. 8B shows the mechanism 650 in a second configuration deployed from the catheter body 12 and capable of anchoring to a vessel wall. The mechanism 650 can include one or more wires 652 that are shaped and configured to exit distally through one or more slits 622 or openings in the catheter body 12. In the second configuration of FIG. 8B, after being moved or translated distally a predetermined distance, the one or more wires 652 can be seen to be bulging with at least one fixation bump. The at least one fixation bump of the one or more wires 652 in the second configuration of FIG. 8B can include a collective diameter at least two times greater than the outer diameter of the catheter body 12.

[0173] At least one anchoring bump of the one or more wires 652 can include an atraumatic surface configured to contact the vessel wall during anchoring. After being deployed, the one or more wires 652 can be retracted into the catheter body 12 from the second configuration. The one or more wires 652 can also exit respective slits 622 or openings in the catheter body 12 multiple times and be anchored at or adjacent the tip section. In some examples, the one or more wires 652 are deployed to the second configuration by being advanced from a proximal shaft or proximal handle operably coupled to the proximal end of the catheter 10.

[0174] Referring to FIG. 9A, an enlarged side view of anchor mechanism 650' is shown. In particular, mechanism 650' in FIG. 9A is shown in a deployed and expanded second configuration. One or more electrodes 19 are disposed between slits or openings 622, thereby asymmetrically deploying 650' on only one side of catheter body 12. In the depicted configuration, wire 652' is shown being urged outward by distally moving its proximal end (not shown), thereby buckling outer wire 652' into the second configuration. Wire 652' can be anchored at one or more points (e.g., at distal slits or openings 622). When moving between the first and second configurations, part or all of wire 652' can be configured to contact and anchor within a corresponding vessel wall. The expanded diameter of wire 652' can also be manipulated by distally or proximally translating wire 652' as needed or desired.

[0175] Advantageously, by providing the exit point and distal fixation point of the wire 652′ oriented at approximately a 90-degree angle A relative to one another in the second configuration, the amount of force required to push the wire out is significantly reduced, which is desirable because it requires less force to actuate between configurations, resulting in improved deployment control with reduced force transmitted to the patient. While a mechanism 650 oriented in an orthogonal configuration, as defined by angle A, may not necessarily be preferred or optimal, it should be understood that having the exit and termination points in line, as shown, creates a more generally axial force transmission pushing down on the wire 652′ while making off-axis buckling easier. Furthermore, having a plane that coincides with the parabolic shape formed by the extended wire 652 more parallel to the catheter axis can provide more effective fixation. FIG. 9B is a cross-sectional view taken at the distal fixed end at or adjacent to the distal slit 622, illustrating an exemplary orthogonal angle A defined between the elongated wire 652′ and the fixed distal end at or adjacent to the distal slit 622.

[0176] Referring to FIG. 10A, an enlarged side view of a portion of the distal tip section 714 of another exemplary catheter is shown. FIG. 10B is an enlarged side view of a portion of the tip section 714 of FIG. 10A in a second configuration. In this example, a mechanism 750, similar to previous mechanisms 50 and 150, can be deployed and undeployed by expanding and contracting its one or more adjustable lasso loops around the body 12, similar to a python and a boa constrictor. A distal end 756 of mechanism 750 can be a free end not attached to the catheter body 12, while a proximal end 757 can be attached to and sealed to the body 12. Mechanism 750 can still use a side exit, but need not necessarily include an open passageway. Similar to mechanisms 50 and 150 described above, mechanism 750 can include one or more segments 752 (e.g., wire or other biocompatible material) forming one or more loop segments 753. Outside the patient, an operator (e.g., a surgeon) can use an actuation mechanism, such as a pull wire, configured to tighten the spiral or loop, seen more clearly between Figures 10A-10B, as adjustably moving anchor mechanism 750 against a corresponding vessel wall. The configuration of Figure 10A can be expandable from a corresponding delivery mechanism upon release therefrom at the treatment site.

[0177] 11A-11B, another exemplary anchoring mechanism 750 is shown. Figure 11A is an enlarged side view of a portion of the tip section 14 of another exemplary catheter body 12 in a first configuration prior to anchoring and the corresponding mechanism 750. Figure 11B is another enlarged side view of a portion of the tip section 14 in a second configuration, in which the mechanism 750 is radially expanded and configured to anchor to a vessel wall, similar to Figure 9. The mechanism 750 as shown can include one or more wires 752 that are expandable and / or deployable through slits or openings 722 in the exterior surface of the catheter body 12.

[0178] The one or more wire members 752 can be bundled and configured to extend outward through one or more portions of the catheter body 12, such as one or more holes, elongated strips, or cutouts, or flexible valves formed on the exterior surface of the catheter body 12 through which the one or more wire members 752 can be deployed. In some examples, the one or more wire members 752 can exert an outward force on the blood vessel. In one example, the force exerted on the blood vessel by the one or more wire members 752, and generally by friction between the corresponding catheter 10 and tissue, can secure the catheter 10 in place and resist movement within the blood vessel.

[0179] One or more wire members 752 can be configured to deliver a specific force to ensure a predetermined force is achieved for fixation, and / or include a sensor to detect the contact force with the vessel wall during the fixation process. Alternatively, a sensor can be used to ensure that a predetermined force is not exceeded to avoid rupturing the corresponding vessel wall. A contact force sensor particularly suitable for use with mechanism 750 is described in U.S. Patent Application No. 16 / 036,710, filed July 16, 2018, which is incorporated herein by reference in its entirety.

[0180] In some examples, one or more electrodes 19 can be included with one or more wire members 752. The one or more electrodes in this example positioned on one or more wire members 752 can allow multiple signals to be acquired around the inner circumference of the vessel and at the same or similar depths within the vessel. In one example, deployment can be achieved by withdrawing section 14 toward one or more portions of catheter 10 proximal to it, as shown in FIGS. 11A-11B, where section 14 is withdrawn, causing section 14 to curve or otherwise bend.

[0181] In one example, one or more wire members 752 are deployed by actuating a puller wire, which effectively reduces the distance between the distal and proximal ends of the corresponding one or more wire members 752 (e.g., the shortest distance, not the length of the wire members). In some examples, the puller wire may be connected to the distal end of one or more wire members 752. Then, when pulled or otherwise actuated, the one or more wire members 752 expand outward and are deployed. In some examples, the proximal portion of the one or more wire members 752 may be fixed to the catheter body 12. In this regard, when the puller wire is in a neutral position, the one or more wire members 752 may include a profile similar to (e.g., be axially aligned with) the catheter body 12. In some examples, the one or more wire members 752 may be outwardly extendable to a diameter at least four times the outer diameter of the catheter body 12.

[0182] In one example, one or more wire members 752 extend through the catheter body 12 and may be deployed by a pusher wire coupled to the one or more wire members 752. The distal end of the pusher wire may be secured to the distal ends of the one or more wire members 752, and the proximal end may control the axial translation of the mechanism 750 in a corresponding handle. Securing the mechanism 750 in this example may be achieved by pushing the proximal end of the pusher wire distally, which causes the length of the pusher wire and the one or more wire members 752 within the catheter body 12 to expand radially outward.

[0183] The one or more wire members 752 may be positioned on only one side of the catheter body 12, as shown, and may be configured to be pushed into the blood vessel on only that side. However, it is contemplated that the one or more wire members 752 may extend outward from multiple sides of the catheter body 12, similar to a balloon. The one or more wire members 752 may be positioned between and / or around the electrodes 19, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, or the like. In some examples, one or more sensing electrodes may be included to detect movement of the catheter 10 associated with the catheter body 12 and / or to determine whether the mechanism 750 is secured to the blood vessel wall. Such sensing by the electrodes 19 may be particularly advantageous in communicating to the end user whether the mechanism 750 is sufficiently secured or is moving undesirably.

[0184] Referring to Figure 12A, a catheter body 12 having a mechanism 850 is shown in a first configuration, while Figure 12B shows the catheter body 12 having the mechanism 850 in a second configuration. In some embodiments, the mechanism 850 can include an expandable member 852B that can extend and retract the sheath member 852A between the first and second configurations. In this regard, the member 852A can have a lumen with an inner diameter that is larger than the outer diameter of the member 852B. Each of the members 852A, 852B can comprise the same or different materials, and each can be separately actuable.

[0185] In particular, feature 850 is shown in Figure 12B as being deployed through an opening 822 positioned on the exterior surface of catheter body 12. Opening 822 may be a slit that forms a one-way valve on the exterior surface of catheter 12. In other embodiments, opening 822 may be substantially oval, rectangular, or any other shape to accommodate the first and second configurations of feature 850.

[0186] In some examples, member 852A can be moved proximally (e.g., pulled), while the distal end of member 852B can be fixedly attached at the distal end of opening 822. Moving member 852A proximally and / or moving member 852B distally a first distance can cause member 852B to expand radially outward between one or more expanded states of corresponding diameters larger than the outer diameter of catheter 12. In some examples, a length of member 852B previously housed with member 852A and / or catheter 12 can be released radially outward through opening 822 and into the corresponding vessel wall.

[0187] In some examples, the diameter of the second configuration of feature 850 can be the same size as or larger than the diameter of the corresponding vessel diameter. One or both of members 852A, 852B can be formed with a predetermined bias (e.g., heat set, with a spring-like element configured therewith, etc.) that causes the feature to expand radially outward when member 852A is withdrawn proximally.

[0188] Acceptable materials on or adjacent to opening 822 can include one or a combination of polyether block amides and Pebax®, which can include elastomers as block copolymers consisting of hard polyamide blocks and soft polyether blocks. Similar to previous anchor mechanisms of the present disclosure, mechanism 850 can be positioned between electrodes 19, which can be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, etc. Although not shown, members 852A, 822B can also include electrodes 19 selectively positioned and / or spaced therealong. Similarly, the portion of catheter 12 adjacent opening 822 can also include one or more electrodes 19 selectively positioned and / or spaced therealong.

[0189] Referring to FIG. 13A, a catheter body 12 having a mechanism 950 is shown in a first configuration, while FIG. 13B shows the catheter body 12 having the mechanism 950 in a second configuration. In some examples, the mechanism 950 can include flexible and / or expandable members 952A, 952B, 952C, and 952D. While four expandable members are shown here, fewer or more expandable members can be included with the mechanism 950 as needed or desired. The members 952A, 952B, 952C, and 952D can be formed integrally with or separately from the catheter body 12. Gaps, voids, or spaces can be positioned between the respective members 952A, 952B, 952C, and 952D. Each of the members 952A, 952B, 952C, and 952D can be arranged radially in series about the longitudinal axis of the body 12. In some examples, portions of body 12 proximal to members 952a, 952B, 952C, 952D can be moved (e.g., pushed) distally while distal tip 14 can remain relatively stationary. Pushing body 12 distally causes members 952A, 952B, 952C, 952D to deploy radially outward between one or more expanded states of corresponding diameters larger than the outer diameter of catheter 12.

[0190] In some examples, each of the members 952A, 952B, 952C, and 952D can include an internal push wire (not shown) that is separately pushed by an end user. The distal end members 952A, 952B, 952C, and 952D can remain fixed or can include an internal stop that prevents the corresponding push wire from translating distally, such that further distal pushing causes the respective member 952A, 952B, 952C, and 952D to expand outward. In this case, rather than pushing all of the body 12, each of the members 952A, 952B, 952C, and 952D can be separately actuated by distally moving the push wire associated with the respective member 952A, 952B, 952C, and 952D. This can be advantageous for accommodating vessels of various sizes and shapes, increasing the amount of surface area in contact with the vessel wall.

[0191] The members 952A, 952B, 952C, and 952D can be radially arranged about the longitudinal axis of the catheter body 12. Each of the members 952A, 952B, 952C, and 952D can have a different diameter in the second configuration. In another example, each of the members 952A, 952B, 952C, and 952D can have the same or substantially similar diameter and can be expanded in a balloon-like manner to form a porous anchor balloon due to gaps or voids formed between each of the members 952A, 952B, 952C, and 952D. In another example, the members 952A, 952B, 952C, and 952D can be spaced apart, but not necessarily radially apart. For example, the feature 950 formed by the members 952A, 952B, 952C, and 952D can be substantially planar or otherwise non-circular, or can have a shape that is different from the shape of the catheter body 12. Members 952A, 952B, 952C, 952D can also include one or more electrodes, which can be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, and / or the like. Similar to previous anchor mechanisms of the present disclosure, mechanism 950 can be positioned between electrodes 19, which can be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, and / or the like.

[0192] FIG. 14 shows mechanism 950 asymmetrically deployed in a second configuration, in which member 952A contacts blood vessel BV. It can be seen that member 952A in the illustrated configuration can contact blood vessel BV along a relatively increased surface area. Furthermore, the electrodes on member 952A (and other expandable members, not shown) allow multiple radial positions per electrode for each expandable member to be read simultaneously, thereby increasing the precision and accuracy of the sensing information, in contrast to existing catheters that record only one radial position at a given blood vessel depth. For ease of reference, but not by way of limitation, FIG. 14 shows an exemplary definition of what may be meant by "vascular depth" for purposes of this disclosure.

[0193] 15A, an enlarged side view of a portion of an anchoring mechanism 1050 of another exemplary catheter body 12 is shown. In this example, the mechanism 1050 can be actuated by translating the mechanism 1050 distally via a pusher wire 1056 while its one or more loops 1053 are relatively stationary or fixedly wrapped on or adjacent the distal tip section 14. In another example, the mechanism 1050 can be actuated between a first configuration and a second configuration by expanding and contracting its one or more adjustable lasso loops 1053 around the body 12, similar to pythons and boa constrictors. The wire 1056 of the mechanism 1050 can be positioned within the lumen of the catheter body 12 and can exit distally from a side exit 1022 of the catheter body 12 until it reaches a convergence 1057. Distal to the convergence 1057, the pair of expandable members 1052A, 1052B can extend generally parallel distally toward the tip 14. The members 1052A, 1052B can comprise one or more wires or other biocompatible materials, with other corresponding members forming one or more loop segments 1053, similar to the previously described mechanisms 50 and 150. In another example, the mechanism 1050 may not necessarily be positioned within a lumen of the body 12 or exit through an outlet in the body 12, but instead can extend generally along the exterior surface of the catheter body 12.

[0194] Outside the patient, an operator can actuate mechanism 1050, such as by pushing or pulling mechanism 1050, thereby tightening the spiral or loop seen more clearly in FIGS. 15A-15B as it adjustably moves anchor mechanism 1050 against the corresponding vessel wall. In particular, FIG. 15B shows members 1052A, 1052B radially expanded outward such that loop 1053 is secured against tip 14, with the portion of mechanism 1050 proximal to members 1052A, 1052B being pushed distally to cause this radially outward expansion for vessel fixation. FIGS. 15C and 15D simply show members 1052A, 1052B in an exemplary front cross-sectional view taken between convergence 1057 and loop 1053 from FIG. 15B, where members 1052A, 1052B are radially expanded outward. In Figure 15C, members 1052A, 1052B can be seen to be generally perpendicular to one another, while in Figure 15D, an angle of approximately 120 degrees can be seen to be formed between members 1052A, 1052B. Such orientation between members 1052A, 1052B can be adjusted as needed or desired depending on proximal movement of members 1052A, 1052B and any corresponding actuation on loop 1053 to effect twisting.

[0195] FIG. 16 shows an enlarged side view of a portion of an anchor mechanism 1150, similar to mechanism 1050. In this example, mechanism 1150 can be deployed and undeployed by pushing or pulling mechanism 1150, with one or more adjustable lasso loops 1153 fixedly wrapped around body 12, similar to mechanism 1050. Mechanism 1150 is positioned within the lumen of catheter body 12 and can exit distally through openings 1122 in catheter body 12. Distal to openings 1122, one or more expandable members 1152 can extend generally parallel toward tip 14. The one or more members 1152 can include one or more wires or other biocompatible materials, similar to loop segment 1053 described above, with other corresponding members forming one or more loop segments 1153. The segments 1153 can then anchor the distal end of mechanism 1150 to the outer surface of tip 14. Outside the patient, an operator can actuate mechanism 1150 by pushing on mechanism 1150, causing mechanism 1150 to expand radially outward, as shown by dotted expanded member 1152' in the second configuration.

[0196] 16 shows the member 1152 (first configuration) and the member 1152' (second configuration) after it has been expanded radially outward such that the loop 1153 is fixedly wrapped around the tip 14, causing the radially outward expansion of the mechanism 1150. The members 1152, 1152' may also include electrodes selectively positioned and / or spaced therealong. Similarly, the portions of the catheter body 12 adjacent the opening 1122 and / or the loop 1153 may also include one or more electrodes 19 selectively positioned and / or spaced therealong, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, and / or the like.

[0197] Referring to FIG. 17A, an enlarged top view of a portion of an anchor mechanism 1250 of another exemplary catheter body 12 is shown, in which the solid lines of the expandable member 1252 correspond to the first configuration and the dashed lines of the expandable member 1252′ correspond to the second, expanded configuration. The upper and lower arrows between the members 1252, 1252′ are intended to indicate outward radial expansion as the mechanism moves from the first configuration to the second configuration, as described herein. FIG. 17B shows an enlarged side view of the mechanism 1250 in a first, collapsed configuration, taken along section AA of FIG. 17A. FIG. 17C shows a perspective view of the mechanism 1250 with the members 1252, 1252′ in their respective configurations.

[0198] 17A and 17C show that the feature 1250 can extend from the lumen of the catheter body 12 through an opening 1222A positioned on the exterior surface of the catheter body 12. The opening 1222A can be an opening that forms a one-way valve on the exterior surface of the catheter body 12. In other embodiments, the opening 1222A can be substantially oval, rectangular, or any other shape for accommodating the members 1252, 1252' extending therethrough. The distal ends of the members 1252, 1252' can be fixedly attached to the end 1222B of the catheter body 12.

[0199] In some examples, member 1252 can be pushed distally while its distal end is fixedly attached at end 1222B, thereby actuating member 1252 to expand radially outward to its second configuration depicted as member 1252'. FIG. 17D shows an exemplary side view taken along section AA to secure distal end 1255 of member 1252, 1252', to end 1222B. As shown, end 1255 may be oriented from the outer surface of catheter body 12 or may otherwise extend from the outer surface of catheter body 12 and ultimately be attached to and / or mounted within lumen 1243 of catheter body 12. Catheter body 12 may include multiple lumens, where lumen 1243 is configured to be fixedly attached to end 1255. Ends 1255 can be soldered, welded, glued, affixed, and / or mechanically etched into lumen 1243, although other attachments, including the use of connectors, are contemplated as needed or desired. In some examples, members 1252, 1252' can be heat set or otherwise configured with a predetermined bias such that the illustrated shape flexes radially outward into the corresponding vessel wall.

[0200] In some examples, the diameter of the second configuration of feature 1250, as shown by member 1252′, can be the same size as or larger than the corresponding vessel diameter. Members 1252, 1252′ can also include electrodes 1219 selectively positioned and / or spaced apart therealong. Similarly, portions of catheter body 12 adjacent opening 1222A and / or end 1222B can also include one or more electrodes 19 selectively positioned and / or spaced apart therealong, which can be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, and / or the like. Acceptable materials for the material on or adjacent opening 1222A include one or a combination of polyether block amide and Pebax®, which can include an elastomer as a block copolymer consisting of a rigid polyamide block and a soft polyether block. FIG. 17E shows a view of mechanism 1250 in a second configuration, also taken along section AA, where members 1252' have expanded radially outward into the exemplary shape.

[0201] Referring to FIG. 18 , a front plan view of mechanism 1250 is shown in a second configuration within an exemplary blood vessel BV having a diameter D. In some instances, the blood vessel BV may be, for example, the coronary sinus (CS), which may change shape by or through member 1252′, sometimes being tubular and sometimes being funnel-shaped, depending on the patient. The blood vessel BV may also vary in size and be relatively flexible, so the anchor device should expand larger than the native vessel diameter for adequate fixation. Preferably, mechanism 1250 can include a range of diameters D of approximately 2-15 mm, although other diameters, larger (e.g., up to 25 mm) or smaller, are contemplated as needed or desired.

[0202] Mechanism 1250 in the second configuration can be seen to have two expanded segments formed by members 1252′ and anchored to the wall of blood vessel BV. However, a greater or lesser number of expanded segments are contemplated, as needed or desired. In some instances, a portion of member 1252′ on the opposite side of catheter body 12 (e.g., the lower end opposite the “top end” of member 1252′ in FIG. 18 ) can move toward and be anchored to the wall of blood vessel BV as a result of mechanism 1250 expanding and member 1252′ moving in the opposite direction.

[0203] 19, a flow diagram illustrating an exemplary method 1900 for anchoring a catheter in a blood vessel at a treatment site is provided. Method 1900 can include step 1910 of delivering any catheter of the present disclosure to the treatment site. Step 1920 can include deploying an anchoring mechanism. Step 1930 can include anchoring the anchoring mechanism to the blood vessel wall. Other steps can be included with the method as discussed throughout this disclosure.

[0204] FIG. 20A shows a perspective view of a portion of the tip section of another exemplary catheter of the present disclosure, including an exemplary feature 1350. The feature 1350 can include printed electrodes 1319A, 1319B printed on a cover 1340, where the cover 1340 with corresponding printed electrodes can be positioned over the feature 1350. One or more traces 1370 can be provided in communication with the corresponding electrodes 1319A, 1319B. FIG. 20B shows the feature 1350 radially expanded in a second configuration. The feature 1350 as shown is particularly useful for use in printing a flex circuit on a spun cover 1340 used with the feature 1350.

[0205] 21 shows a perspective view of a portion of the tip section of another exemplary catheter of the present disclosure including an exemplary mechanism 1450. The mechanism 1450, as shown, can include multiple insulated wires 1412 (e.g., a shape memory alloy such as Nitinol) bundled together in the same shape. One or more conductor rings 1419 can also be included with both bundled wires 1412, similarly functioning in the same manner as the previously described electrodes of the other exemplary mechanisms.

[0206] In some examples, the method includes determining a position and orientation of the anchor mechanism by generating a plurality of AC magnetic fields, each AC magnetic field at a different frequency, sensing the AC magnetic fields at a plurality of sensors proximal to the distal tip section, and calculating dimensions of a position and orientation of a portion of the distal tip section in response to signals representing the generated and sensed magnetic fields. In some examples, the method includes determining a position and orientation of the distal tip section by generating a plurality of AC magnetic fields, each AC magnetic field at a different frequency, sensing the AC magnetic fields at a plurality of sensors proximal to the distal tip section, and calculating dimensions of a position and orientation of a portion of the distal tip section in response to signals representing the generated and sensed magnetic fields.

[0207] In some examples, the method includes generating, with at least one magnetic field generator, an externally applied magnetic field to establish a frame of reference; positioning a plurality of sensors comprising single-axis coils around the distal tip section, each single-axis coil fixed at a different respective point around the distal tip section; and determining dimensional, translational, and orientational coordinates of the single-axis coils by processing signals from the single-axis coils. In some examples, the method includes positioning one or more electrodes on the distal tip section at known fixed locations relative to at least one of the single-axis coils, the location of each electrode being derived from the dimensional, translational, and orientational coordinates of the single-axis coil. Specific implementations of these embodiments can be understood to include features more clearly described in Appendix 1 attached hereto, including U.S. Patent No. 6,690,963 and U.S. Patent No. 8,926,528.

[0208] In some examples, the method includes deflecting the tip section in response to moving one or more puller wires. In some examples, the method includes moving one or more puller wires with a steering assembly. In some examples, the method includes deflecting the tip section in the direction of an off-axis lumen through which each puller wire extends. In some examples, the method includes assembling the catheter with a control handle including a deflection knob and adjusting a tip deflection orientation of the tip section by rotating the deflection knob. In some examples, the method includes extending one or more puller wire segments pulled by a pulley to deflect the one or more puller wire segments relative to the longitudinal axis at an angle of less than about 7 degrees. Certain implementations of these embodiments can be understood to include features more specifically described in Appendix 1 attached hereto, including U.S. Patent No. 8,348,888.

[0209] Additionally, ECG signals can be separately assessed by electrodes on the electrode catheter, allowing a user or system to determine when the distal tip section has contacted tissue; those embodiments having electrodes may require a stable catheter effectively anchored to the corresponding vessel wall to determine which electrodes to activate to provide ablation therapy. Contact with tissue may be determined using a force contact sensor, such as that described in U.S. Patent Publication No. 2018 / 0256247, filed March 8, 2017, which is incorporated herein by reference in its entirety. A force contact sensor particularly suitable for use with catheters having a bifurcated tip is also described in U.S. Patent Publication No. 2020 / 0015693, filed July 16, 2018, which is incorporated herein by reference in its entirety.

[0210] In some examples, the systems and methods of use described herein can be used in conjunction with pacemaker lead technology, such as one or more fixation mechanisms for securing one or more corresponding electrodes to a blood vessel wall.

[0211] In any of the foregoing embodiments, the anchor mechanism may be included in the distal tip section of the catheter. The catheter may also include an elongate body having one or more lumens longitudinally disposed therethrough. The catheter may be used by the following methods and variations: First, the catheter may be manipulated so that one or more of its electrodes contact tissue and inserted into a subject, such as a human subject, proximate the subject's heart. The catheter may be one aspect of an ablation system that also includes a processor. Sectors and corresponding electrodes at the distal tip of the catheter may measure temperature and provide temperature data to the processor. Ablation energy may also be provided thereto, for example, as controlled by the processor. As shown and previously described, one or more electrodes may be included with any of the catheters discussed herein.

[0212] [Embodiment] (1) A catheter, A catheter body; a distal tip section comprising an elongated member extending along a longitudinal axis; an anchor mechanism disposed along an outer surface of and / or within the elongate member in a first configuration, the anchor mechanism being configured to extend radially outward relative to the longitudinal axis and to surround at least a portion of the distal tip section in a second configuration. (2) The anchor mechanism one or more wires exiting the distal end of the catheter on or adjacent the distal tip section to form one or more wire anchors, the distal ends of the one or more wires being fixedly attached to the distal tip section; and A catheter as described in embodiment 1, comprising: a puller wire configured to pull the one or more wires and / or the distal tip section and transition the anchor mechanism from the first configuration to the second configuration. (3) A catheter as described in embodiment 2, wherein the anchor mechanism transitioning from a first configuration to a second configuration causes the catheter to curve or bend outward in the second configuration and deliver a predetermined force to the blood vessel wall. (4) A catheter as described in embodiment 2, wherein the one or more wires are asymmetrically positioned on only one side of the outer surface of the catheter to secure it to the blood vessel wall. (5) The catheter of embodiment 2, wherein the one or more wires in the second configuration have a diameter at least four times greater than the outer diameter of the catheter.

[0213] (6) The anchor mechanism a sheath exiting an opening in the catheter on or adjacent the distal tip section; A catheter as described in embodiment 1, comprising an extendable member that extends and retracts in and out of the sheath between the first configuration and the second configuration to form one or more wire anchors, the distal end of the extendable member being fixedly attached to the distal tip section. (7) The catheter of embodiment 6, wherein moving the sheath proximally and / or moving the expandable member distally a first distance causes the expandable member to expand radially outward between one or more expanded states of corresponding diameters greater than the outer diameter of the catheter. (8) The catheter of embodiment 6, wherein the opening comprises a slit forming a one-way valve on the outer surface of the catheter. (9) The anchor mechanism a plurality of expandable members adjacent the distal tip section, wherein a void is positioned between each expandable member; A catheter as described in embodiment 1, wherein moving a portion of the catheter body proximal to the expandable members while the distal tip section is relatively stationary causes each expandable member to expand radially outward to the second configuration larger than the outer diameter of the catheter body. (10) The catheter of embodiment 9, wherein each of the expandable members expands outward in a balloon-like manner in the second configuration to form a porous anchor balloon.

[0214] (11) The anchor mechanism A catheter as described in embodiment 1, comprising a plurality of wire members extending axially distally along the catheter body and fixedly attached and terminating at or adjacent the distal tip section, wherein pushing the plurality of wire members causes the wire members to expand outwardly and away from one another into the second configuration. (12) The catheter of embodiment 11, wherein the plurality of wire members extend from within the catheter body through an opening within the lumen of the catheter body. (13) The catheter according to embodiment 11, wherein the catheter body comprises at least two inner lumens, and at least one of the two inner lumens is configured to fixedly receive distal ends of the plurality of wire members. (14) The catheter of embodiment 1, wherein the elongated member has a circumferential opening disposed on an outer surface of the elongated member, and the anchor mechanism is configured to extend radially outward from the circumferential opening of the elongated member. (15) A catheter as described in embodiment 1, wherein the anchor mechanism comprises a variable loop lasso, and the anchor mechanism comprises one or more wires that form the variable loop lasso and are extendable from the catheter lumen through an opening in the outer surface of the catheter when moving from the first configuration to the second configuration.

[0215] (16) The catheter of embodiment 1, wherein the anchor mechanism has a circular, spiral, or helical form and comprises one or more wires extending from an opening at the distal end of the catheter in the second configuration, thereby axially aligning the anchor mechanism with the longitudinal axis of the catheter. (17) The catheter of embodiment 1, wherein the anchor mechanism has a circular, spiral, or helical form and comprises one or more wires extending from an opening at the distal end of the catheter in the second configuration, whereby the anchor mechanism is attached to only one side of the outer surface of the catheter and pressed against the blood vessel wall. (18) The catheter of embodiment 1, wherein the anchor mechanism comprises one or more strips connected to the outer surface of the catheter, the one or more strips configured to bunch and extend outward when one or more portions of the distal tip section are withdrawn proximally toward one or more portions of the catheter. (19) The catheter of embodiment 18, wherein the one or more strips are extendable outward through a plurality of slits in the outer surface of the catheter. (20) The catheter of embodiment 18, wherein the one or more strips are actuated into the second configuration by one or more pull members actuable by an end user operably connected to the one or more strips.

Claims

1. A catheter, A catheter body; a distal tip section comprising an elongated member extending along a longitudinal axis; an anchor mechanism disposed along an outer surface of and / or within the elongate member in a first configuration, the anchor mechanism configured to extend radially outward relative to the longitudinal axis and to surround at least a portion of the distal tip section in a second configuration; The anchor mechanism is a sheath received in an opening formed in an outer surface of the catheter on or adjacent the distal tip section; an expandable member that extends and retracts in and out of the sheath between the first and second configurations to form one or more wire anchors, the distal end of the expandable member being fixedly attached to the distal end of the opening in the catheter; a catheter in which a portion of the expandable member is contained within a lumen of the sheath, and when the sheath is pulled proximally, the expandable member is not pulled proximally and a portion of the expandable member exposed from the sheath increases, causing the expandable member to expand radially outward relative to the longitudinal axis and transitioning the anchor mechanism from the first configuration to the second configuration.

2. 10. The catheter of claim 1, wherein moving the sheath proximally a first distance causes the expandable member to expand radially outward between one or more expanded states of corresponding diameters greater than an outer diameter of the catheter.

3. The catheter of claim 1 , wherein the opening comprises a slit forming a one-way valve on the outer surface of the catheter.

4. A catheter, A catheter body; a distal tip section comprising an elongated member extending along a longitudinal axis; an anchor mechanism disposed along an outer surface of and / or within the elongate member in a first configuration, the anchor mechanism configured to extend radially outward relative to the longitudinal axis and to surround at least a portion of the distal tip section in a second configuration; The anchor mechanism is a plurality of wire members extending axially distally along the catheter body and fixedly attached and terminating at or adjacent the distal tip section, wherein pushing the plurality of wire members causes the wire members to expand outwardly and away from one another into the second configuration; A catheter, wherein the plurality of wire members extend from within the catheter body through openings within the lumen of the catheter body.

5. A catheter, A catheter body; a distal tip section comprising an elongated member extending along a longitudinal axis; an anchor mechanism disposed along an outer surface of and / or within the elongate member in a first configuration, the anchor mechanism configured to extend radially outward relative to the longitudinal axis and to surround at least a portion of the distal tip section in a second configuration; the anchoring mechanism comprises one or more strips connected to an outer surface of the catheter, the one or more strips configured to bunch and extend outward when one or more portions of the distal tip section are withdrawn proximally toward one or more portions of the catheter; The one or more strips are extendable outwardly through a plurality of slits in the exterior surface of the catheter.

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