Catheter with anchoring mechanism

Abstract

A catheter includes a catheter body and a distal tip segment including an elongate member extending along a longitudinal axis. An anchoring mechanism is disposable along an outer surface of the elongate member and / or disposed within the elongate member when in a first configuration. The anchoring mechanism is configurable to extend radially outward relative to the longitudinal axis to encompass at least a portion of the distal tip segment when in a second configuration.

Description

Technical Field

[0001] This disclosure relates to systems and methods for anchoring catheters into a patient's blood vessels. Background Technology

[0002] Among other uses, catheter technology is widely used to diagnose many abnormalities, treat vascular diseases, perform vascular interventions, deliver devices to occlude blood vessels, and focus medication delivery to tissues. The stability of the catheter tip can be crucial to the success of any procedure associated with any of the aforementioned types of catheters.

[0003] For example, in coronary angioplasty, when advancing a guide filament or interventional device catheter through a narrowed lesion, or attempting to do so, stent placement with the guide catheter may cause catheter dislodgement due to resistance caused by the lesion. Without sufficient anchorage, repeated attempts to pass through the lesion may be necessary, among other problems.

[0004] In addition, for carotid artery lesions, acute angles may complicate stent delivery because the guiding catheter tends to exit the vessel ostium.

[0005] Finally, electrode catheters have been used to stimulate and map electrical activity in the heart, as well as to ablate sites of abnormal electrical activity. In use, the electrode catheter is inserted into a major vein or artery (e.g., the femoral artery) and then guided into the chamber of the heart of interest. Within the heart, the ability to control the precise position and orientation of the catheter tip is crucial. Therefore, any instability in the electrode catheter can affect the outcome of the associated procedure (e.g., unreliable results from cardiac mapping) and is thus significant to the success of a particular surgical procedure.

[0006] The solutions disclosed herein address these and other problems in the art. Summary of the Invention

[0007] Therefore, the inventors of this disclosure have recognized the need for a catheter capable of effectively anchoring to the wall of a blood vessel, such as the coronary sinus wall. In some examples, a catheter is disclosed. In some examples, the catheter may include a catheter body and a distal terminal segment, the distal terminal segment including an elongated member extending along a longitudinal axis. In a first configuration, an anchoring mechanism may be disposed along the outer surface of the elongated member and / or disposed within the elongated member. In a second configuration, the anchoring mechanism is configured to extend radially outward relative to the longitudinal axis to surround at least a portion of the distal terminal segment.

[0008] In some examples, one or more wires may be included, which are withdrawn from the distal end of the conduit at or near the distal end section to form one or more wire anchors. The distal end of the one or more wires may be securely attached to the distal end section. A pull wire may be configured to pull the one or more wires and / or the distal end section, thereby causing the anchoring mechanism to change from the first configuration to the second configuration.

[0009] In some examples, the anchoring mechanism is activated by pulling the wires of one or more wires, thereby effectively reducing the distance between the distal and proximal ends of the corresponding one or more wires.

[0010] In some examples, when the pull wire is in the neutral position, the one or more wires are aligned axially along the conduit body.

[0011] In some examples, the anchoring mechanism changes from a first configuration to a second configuration, causing the catheter to bend or fold outward when in the second configuration and deliver a predetermined force to the vessel wall.

[0012] In some examples, one or more wires of the one or more wire anchors are shaped.

[0013] In some examples, one or more wires are asymmetrically positioned on only one side of the outer surface of the catheter to anchor against the vessel wall.

[0014] In some examples, the diameter of one or more wires in the second configuration is at least twice the outer diameter of the conduit.

[0015] In some examples, the diameter of one or more wires in the second configuration is at least four times the outer diameter of the conduit.

[0016] In some examples, the one or more wires in the second configuration include a damage-resistant surface that contacts the blood vessel wall.

[0017] In some examples, one or more wires can retract from the second configuration back into the conduit.

[0018] In some examples, the one or more wires are configured to be repeatedly pulled out of the distal end of the conduit and secured at or near the end section.

[0019] In some examples, the one or more wires are extended into a second configuration by advancing a handle on the proximal side of the pull wire from the operating ground.

[0020] In some examples, the anchoring mechanism includes a sheath that extends out of the conduit opening on or near the distal end section. An extendable member may be included that retracts and extends from the sheath between the first and second configurations to form one or more wire anchors, the distal end of which is securely attached to the distal end section.

[0021] In some examples, the sheath includes a lumen whose inner diameter is larger than the outer diameter of the extendable member.

[0022] In some examples, the sheath is moved proximally and / or the extendable member is moved distally by a first distance, causing the extendable member to expand radially outward between one or more expansion states with a corresponding diameter greater than the outer diameter of the conduit.

[0023] In some examples, the opening includes a slit forming a one-way valve in the outer surface of the conduit.

[0024] In some examples, the opening has an elliptical shape.

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

[0026] In some examples, the anchoring mechanism in this second configuration has a diameter that is at least twice the outer diameter of the conduit.

[0027] In some examples, the anchoring mechanism in this second configuration has a diameter that is at least four times the outer diameter of the conduit.

[0028] In some examples, the anchoring mechanism includes multiple expandable members adjacent to the distal end section. A gap can be positioned between the respective expandable members. In this respect, when the distal end section is relatively stationary, moving the portion of the conduit body proximal to the expandable member causes the respective expandable member to expand radially outward into a second configuration larger than the outer diameter of the conduit body.

[0029] In some examples, each expandable member in the expandable structure can be arranged in series radially about the longitudinal axis.

[0030] In some examples, each expandable component in the expandable structure can move independently to the second configuration.

[0031] In some examples, each expandable member in the expandable member includes a corresponding propulsion line configured to independently translate distally into a second configuration.

[0032] In some examples, in the second configuration, each expandable member in the expandable member has the same or similar diameter.

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

[0034] In some examples, in the second configuration, each expandable member has a different diameter.

[0035] In some examples, the expandable components together form a substantially planar or flat shape.

[0036] In some examples, expandable components together form a non-circular shape.

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

[0038] In some examples, the anchoring mechanism includes multiple wire members that extend axially distally from a convergence point along the conduit body and terminate in one or more variable annular loops fixedly wound around or near the distal end section. Pushing these multiple wire members causes them to expand outward into a second configuration.

[0039] In some examples, a thruster wire is included, which extends proximally from the convergence point through an opening in the lumen of the conduit body. The thruster wire is configured to actuate an anchoring mechanism between a first configuration and a second configuration.

[0040] In some examples, this includes a thruster wire that typically extends proximally along the outer surface of the conduit body.

[0041] In some examples, multiple wire components in the second configuration are configured to expand outward between multiple different orientations and / or diameters.

[0042] In some examples, in the second configuration, at least two of the multiple wire components are approximately orthogonal to the other.

[0043] In some examples, in the second configuration, at least two of the multiple wire members form an approximately obtuse angle relative to the other.

[0044] In some examples, the anchoring mechanism includes multiple wire members that extend axially distally along the conduit body and terminate at or near a fixedly attached distal end segment. Pushing these multiple wire members causes them to expand outward from another into a second configuration.

[0045] In some examples, a thruster wire is included, which extends proximally from the proximal end of a plurality of wire components.

[0046] In some examples, a thruster wire is included, which extends proximally from within the conduit body through an opening in the lumen of the conduit body.

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

[0048] In some examples, when in the first configuration, the multiple wire components are positioned in a generally elliptical shape away from another bend.

[0049] In some examples, the conduit body includes at least two internal lumens, wherein at least one of the two internal lumens is configured to permanently receive the distal ends of the plurality of wire components.

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

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

[0052] In some examples, the anchoring mechanism may include at least one of a first configuration within the lumen, a first configuration extending together with the catheter lumen, and a second configuration outside the catheter, for anchoring against the vessel wall.

[0053] In some examples, 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 sling.

[0055] In some examples, when moving from the first configuration to the second configuration, the anchoring mechanism is able to extend from the lumen of the conduit through an opening in the outer surface of the conduit.

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

[0057] In some examples, the variable annular lasso can be actuated from a first configuration to a second configuration by expanding and / or contracting around the catheter body in a python-like or serpentine manner.

[0058] In some examples, the variable loop sling includes one or more wires, each including a variable diameter loop and configured to push against the vessel wall when in a second configuration.

[0059] In some examples, the variable loop lasso is able to move between multiple different second configurations with different diameters.

[0060] In some examples, the anchoring mechanism includes one or more wires in the form of circles, spirals, or helices, and extends from an opening in the distal end of the conduit in the second configuration.

[0061] In some examples, in this second configuration, the anchoring mechanism is axially aligned with the longitudinal axis of the conduit.

[0062] In some examples, in the second configuration, the anchoring mechanism is attached to only one side of the outer surface of the catheter to be pushed against the vessel wall.

[0063] In some examples, the catheter includes a coiled filament attached to a variable looped sling, which is twistable such that the variable looped sling unfolds through the opening and anchors to the vessel wall.

[0064] In some examples, coiled wire is attached to the proximal end of a variable loop sling.

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

[0066] In some examples, the coiled wire is axially connected to the conduit, and the coiled wire is wound around the outer surface of the conduit body. In some examples, the coiled wire includes one or more twists.

[0067] In some examples, the anchoring mechanism includes one or more strips attached to the outer surface of the conduit, the strips being configured to converge and extend outward as one or more portions of the distal end segment retract toward one or more portions of the conduit located proximal to the distal end segment.

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

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

[0070] In some examples, one or more strips are configured to extend outward through multiple slits on the outer surface of the catheter.

[0071] In some examples, the one or more strips are actuated to the second configuration by one or more pull members that can be actuated by an end user operatively connected to the one or more strips.

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

[0073] In some examples, the one or more strips are positioned between multiple electrodes in the distal segment. In some examples, the electrodes include at least an ablation electrode. In some examples, the electrodes include at least a recording electrode. In some examples, the electrodes include at least a sensing electrode.

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

[0075] In some examples, the area surrounding the one or more strips comprises a flexible plastic, which includes... (Polyether block amide).

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

[0077] In some examples, the conduit is retracted a predetermined distance, causing the strip to move into the second configuration. In some examples, this predetermined distance has a 1:1 ratio to the radial length of the strip in the second configuration.

[0078] In some examples, the anchoring mechanism includes one or more strips attached to the outer surface of the conduit, the strips being configured to converge and extend outward as one or more portions of the distal end segment retract toward one or more portions of the conduit located proximal to the distal end segment. In some examples, the strips are radially spaced (e.g., radially equidistantly spaced about the longitudinal axis of the conduit). In some examples, the strips are configured to extend outward to at least twice the outer diameter of the conduit. In some examples, the strips are configured to extend outward in a balloon-like manner to at least two opposite sides of the conduit. In some examples, the strips are configured to extend outward through a plurality of slits on the outer surface of the conduit. In some examples, the strips are actuated to this second configuration by one or more pulling members capable of being actuated by an end user operatively connected to the strips.

[0079] In some examples, the strip is positioned between multiple electrodes in the distal segment. In some examples, the electrodes include at least an ablation electrode. In some examples, the electrodes include at least a recording electrode. In some examples, the electrodes include at least a sensing electrode.

[0080] In some examples, the area surrounds the strip and includes a soft, flexible plastic that includes an elastomer.

[0081] In some examples, the area surrounds the strip and includes a flexible plastic comprising... (For example, polyether block amide).

[0082] In some examples, the strips include polyetheretherketone (PEEK).

[0083] In some examples, the conduit is retracted a predetermined distance, causing the strip to move into the second configuration. In some examples, this predetermined distance has a 1:1 ratio to the radial length of the strip in the second configuration.

[0084] In some examples, the distal end section of the conduit is retractable, causing the anchoring mechanism to move to a second configuration. The anchoring mechanism in this embodiment includes a plurality of walls, the first of which is flexible, and the second of which is formed as a strip that is more rigid than the first wall, which can expand outward when the distal end section is retracted, thereby causing the first wall to wrinkle itself.

[0085] In some examples, the multiple walls are positioned between multiple electrodes, which are positioned on the distal end segment.

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

[0087] In some examples, the first wall includes having Soft and flexible plastics (e.g., polyether block amides).

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

[0089] In some examples, the catheter includes sensors to detect catheter movement.

[0090] In some examples, the catheter includes sensors to detect whether the anchoring mechanism is anchored to the vessel wall.

[0091] In some examples, the anchoring mechanism is a balloon that, in a second configuration, can expand to a radial length greater than the outer diameter of the catheter. This balloon is configured to expand and anchor together with the vessel wall without obstructing the vessel.

[0092] In some examples, when in the first configuration, the balloon can collapse within the catheter.

[0093] In some examples, the balloon includes an expandable segment that forms the wall of the catheter at at least in or near the distal terminal segment. The expandable segment is more flexible than the peripheral wall segment of the catheter and is configured to expand outward and apply pressure to the vessel wall when in a second configuration.

[0094] In some examples, the balloon is positioned in or near the distal end segment and is in fluid communication with the pressure lumen within the catheter.

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

[0096] In some examples, the balloon is configured to expand outward to a radial length at least twice the outer diameter of the catheter.

[0097] In some examples, the anchoring mechanism is able to extend along the length of the distal end segment.

[0098] In some examples, the anchoring mechanism includes one or more wires that extend from the distal end of a conduit at or near the distal end section to form one or more wire anchors.

[0099] In some examples, one or more wires of the one or more wire anchors are shaped.

[0100] In some examples, the one or more wire anchors are positioned on only one side of the outer surface of the catheter to anchor against the vessel wall.

[0101] In some examples, the one or more wire anchors comprise one or more wires raised with at least one anchoring bump. In some examples, the at least one anchoring bump in a second configuration has a diameter at least twice the outer diameter of the catheter. In some examples, the at least one anchoring bump includes a damage-resistant surface that contacts the vessel wall. In some examples, the at least one anchoring bump includes a hook-shaped surface for anchoring to the vessel wall.

[0102] In some examples, the one or more wires are retractable from the second configuration into the catheter. In some examples, the one or more wires are configured to be repeatedly withdrawn from the distal end of the catheter and secured at or near the distal segment. In some examples, the one or more wires are deployed into the second configuration by advancing from a proximal shaft or proximal handle operatively connected to the proximal end of the catheter. In some examples, the one or more wires are deployed into the second configuration between uses from a single puller mechanism that allows them to retract into the catheter body.

[0103] In some examples, a method for anchoring a catheter to a blood vessel at a treatment site is disclosed. The method may include: delivering a catheter to the treatment site, wherein the catheter includes a catheter body and a distal terminal segment, the distal terminal segment including an anchoring mechanism deployable from the distal terminal segment, the anchoring mechanism including a first configuration extending within or common to the lumen of the catheter and a second configuration anchored externally to a vessel wall; deploying the anchoring mechanism; and anchoring the anchoring mechanism to the vessel wall. In some examples, the vessel wall is the coronary sinus wall. In some examples, the catheter of this method includes one or more electrodes and is an electrode catheter.

[0104] In some examples, the anchoring mechanism of the method includes one or more wires in the form of circles, spirals or helices, which extend from an opening in the distal end of the conduit when in the second configuration.

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

[0106] In some examples, the method includes extending the anchoring mechanism from the conduit lumen through an opening in the outer surface of the conduit when the anchoring mechanism is deployed from the first configuration to the second configuration.

[0107] In some examples, the anchoring mechanism of the method includes a variable annular sling with one or more wires. The method in this embodiment includes translating the anchoring mechanism distally through an opening, thereby causing the anchoring mechanism to move from a first configuration to a second configuration.

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

[0109] In some examples, the method involves moving a variable annular lasso between multiple different second configurations with different diameters.

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

[0111] In some examples, the method includes positioning the anchoring mechanism on only one side of the outer surface of the catheter and pushing it against the vessel wall in a second configuration of the anchoring mechanism.

[0112] In some examples, the method includes attaching a coiled wire to a variable looped lasso and twisting the coiled wire, thereby causing the variable looped lasso to unfold through an opening and anchor to the vessel wall.

[0113] In some examples, the method involves attaching a coiled wire to the proximal end of a variable annular sling.

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

[0115] In some examples, the method includes axially connecting and winding a coiled wire around a catheter body, the coiled wire being wound around the outer surface of the catheter body. The coiled wire may include one or more twists and / or loops.

[0116] In some examples, the anchoring mechanism of the method includes one or more strips attached to the outer surface of the catheter. The method in this embodiment includes retracting one or more portions of the distal distal segment toward one or more portions of the catheter located proximal to the distal distal segment, thereby converging and extending the one or more strips outward. The method may also include extending the one or more strips outward by at least twice the outer diameter of the catheter. The method may also include extending the one or more strips outward in a balloon-like manner to at least two opposite sides of the catheter. The method may also include extending the one or more strips radially outward through a plurality of slits on the outer surface of the catheter. The method may also include actuating the one or more strips into a second configuration by pulling or translating one or more pulling members operatively attached to the one or more strips.

[0117] In some examples, the method may include positioning the one or more strips on only one side of the catheter and pushing the one or more strips against the vessel wall on that only side by means of the anchoring mechanism in a second configuration.

[0118] In some examples, the method may include positioning the one or more strips between multiple electrodes in the distal end segment.

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

[0120] In some examples, the method may include using... The soft, flexible plastic (polyether block amide) is positioned to surround the area of ​​one or more strips.

[0121] In some examples, the method may include retracting the catheter a predetermined distance, thereby causing the one or more strips to move into a second configuration. In the second configuration, the predetermined distance may have a 1:1 ratio to the radial length of the one or more strips.

[0122] In some examples, the anchoring mechanism of the method includes multiple strips attached to the outer surface of the catheter. The method may include retracting one or more portions of the distal distal segment toward one or more portions of the catheter located proximal to the distal distal segment, thereby converging and extending the strips outward. The method may also include radially separating the strips along the outer surface of the catheter. The strips may be radially equally separated. The method may further include extending these strips outward by at least twice the outer diameter of the catheter. The method may also include extending these strips outward in a balloon-like manner to at least two opposite sides of the catheter.

[0123] In some examples, the method includes extending strips through multiple slits on the outer surface of the catheter. The method may also include actuating the strips into a second configuration by pulling or translating one or more pulling members operatively attached to the strips. The method may also include positioning the strips on only one side of the catheter and pushing them against the vessel wall on that only side by an anchoring mechanism in the second configuration. The method may also include positioning the strips between multiple electrodes in the distal segment.

[0124] In some examples, the method involves positioning the areas surrounding these strips with a soft, flexible plastic including an elastomer.

[0125] In some examples, the method includes retracting the catheter a predetermined distance, thereby causing the strips to move into a second configuration. In the second configuration, the predetermined distance may have a 1:1 ratio to the radial length of the strips.

[0126] In some examples, the method includes detecting catheter movement via sensors on the catheter.

[0127] In some examples, the method includes detecting whether the anchoring mechanism is anchored to the vessel wall via sensors on the catheter.

[0128] In some examples, the method includes determining the position and orientation of the anchoring mechanism by generating multiple AC magnetic fields, each AC magnetic field at a different frequency, sensing the AC magnetic fields at multiple sensors near the distal end segment, and calculating the size and orientation of a portion of the distal end segment in response to signals representing the generated and sensed magnetic fields.

[0129] In some examples, the method includes determining the location and orientation of the distal end segment by generating multiple AC magnetic fields, each AC magnetic field at a different frequency, sensing the AC magnetic fields at multiple sensors near the distal end segment, and calculating the size and orientation of a portion of the distal end segment in response to signals representing the generated and sensed magnetic fields.

[0130] In some examples, the method includes generating an externally applied magnetic field to establish a reference frame by means of at least one field generator, positioning multiple sensors including single-axis coils around a distal end segment, each single-axis coil being fixed at a different corresponding point around the distal end segment, and determining the dimensional translation 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 at known fixed positions on the distal end segment relative to at least one of the single-axis coils, the positions of the respective electrodes being derived from the dimensional translation and orientation coordinates of the single-axis coil.

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

[0133] In some examples, the method involves moving one or more pull wires via a steering component.

[0134] In some examples, the method includes deflecting the end section in the direction of the off-axis lumen of the corresponding draw wire extension.

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

[0136] In some examples, the method involves extending a section of one or more pull lines pulled by pulleys to deflect at an angle of less than about 7 degrees relative to the longitudinal axis.

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

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

[0139] In some examples, the method may include forming a balloon in or near the distal terminal segment with an expandable segment having a catheter wall that is more flexible than the peripheral wall segment of the catheter and configured to expand outward and apply pressure to the vessel wall when in a second configuration.

[0140] In some examples, the method may include positioning the balloon in or near the distal end segment and communicating it with a pressure lumen within the catheter.

[0141] In some examples, the method may include expanding a balloon outward from only one side of the catheter.

[0142] In some examples, the method may include expanding the balloon outward to a radial length at least twice the outer diameter of the catheter.

[0143] In some examples, the method may include expanding the balloon outward along the length of the distal segment.

[0144] In some examples, the anchoring mechanism of this method includes one or more wires. The method in this embodiment includes one or more wires that are drawn from the distal end of the catheter at or near the distal distal segment to form one or more wire anchors for the anchoring mechanism. In some examples, the method may include shaping one or more wires of one or more wire anchors. In some examples, the method may include positioning one or more wire anchors on only one side of the outer surface of the catheter to anchor against the vessel wall.

[0145] In some examples, the method may include protruding from the one or more wire anchors to form at least one anchoring bump. The at least one anchoring bump in the second configuration may have a diameter at least twice the outer diameter of the catheter. The at least one anchoring bump may include a damage-resistant surface that contacts the vessel wall. The at least one anchoring bump may include a hook-shaped surface for anchoring to the vessel wall.

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

[0147] In some examples, the method may include repeatedly pulling out one or more wires and retracting the one or more wires back into the conduit.

[0148] In some examples, the steps of deploying the anchoring mechanism include advancing one or more wires from the operating location to a proximal shaft or proximal handle at the proximal end of the conduit.

[0149] In some examples, the steps of deploying the anchoring mechanism include advancing one or more wires from a single puller mechanism that can retract into the conduit body to a second configuration between uses.

[0150] This disclosure will be more fully understood through the following detailed description of embodiments thereof, taken in conjunction with the accompanying drawings. Attached Figure Description

[0151] Although a claim that specifically points out and clearly claims protection for the subject matter described herein is provided after the specification, it is believed that the subject matter will be better understood from the following description taken in conjunction with the accompanying drawings, wherein similar reference numerals in the respective drawings indicate similar structural elements and features. The drawings are not necessarily drawn to scale, but rather focus on illustrating the principles of this disclosure. The drawings depict one or more specific embodiments of the apparatus of the invention by way of example only and not by way of limitation.

[0152] Figure 1A This is a side view of an embodiment of an exemplary catheter of this disclosure.

[0153] Figure 1B It is cut along section AA. Figure 1A A close-up side view of the end section.

[0154] Figure 2 yes Figures 1A to 1B A close-up frontal plan view of an exemplary catheter.

[0155] Figure 3A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0156] Figure 3B yes Figure 3A Another close-up side view of this part of the end section.

[0157] Figure 4A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0158] Figure 4B yes Figure 4A Another close-up side view of this part of the end section.

[0159] Figure 5A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0160] Figure 5B yes Figure 5A Another close-up side view of this part of the end section.

[0161] Figure 6A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0162] Figure 6B yes Figure 6A Another close-up side view of this part of the end section.

[0163] Figure 7A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0164] Figure 7B yes Figure 7A Another close-up side view of this part of the end section.

[0165] Figure 8A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0166] Figure 8B yes Figure 8A Another close-up side view of this part of the end section.

[0167] Figure 9A yes Figure 8A A close-up side view of an alternative portion of the end section.

[0168] Figure 9B yes Figure 9A A close-up cross-sectional view of the end section.

[0169] Figure 10A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0170] Figure 10B yes Figure 10A Another close-up side view of this part of the end section.

[0171] Figure 11A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0172] Figure 11B yes Figure 11A Another close-up side view of this part of the end section.

[0173] Figure 12A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0174] Figure 12B yes Figure 12A Another close-up side view of this part of the end section.

[0175] Figure 13A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0176] Figure 13B yes Figure 13A Another close-up side view of this part of the end section.

[0177] Figure 14 This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure, which is dilated in an exemplary blood vessel.

[0178] Figure 15A This is a close-up side view of a portion of the distal segment of another exemplary catheter of this disclosure.

[0179] Figure 15B yes Figure 15A A close-up perspective view of this part of the end section.

[0180] Figure 15C It is the first choice Figure 15A A close-up plan view of this part of the end section.

[0181] Figure 15D It is in the second orientation Figure 15A A close-up plan view of this part of the end section.

[0182] Figure 16 A close-up side view of a portion of the anchoring mechanism is depicted.

[0183] Figure 17A This is a close-up top view of a portion of the distal section of another exemplary catheter of this disclosure.

[0184] Figure 17B yes Figure 17A A close-up side view of this part of the end section.

[0185] Figure 17C yes Figure 17A A close-up perspective view of this part of the end section.

[0186] Figure 17D It is the first choice Figure 17A A close-up plan view of this part of the end section.

[0187] Figure 17E It is in the second orientation Figure 17A A close-up plan view of this part of the end section.

[0188] Figure 18 This is a front view of an anchoring mechanism in a second configuration within an exemplary blood vessel.

[0189] Figure 19 This is a flowchart illustrating an exemplary method for ablating tissue.

[0190] Figure 20A A perspective view of a portion of the distal segment of another exemplary catheter of this disclosure is shown.

[0191] Figure 20B yes Figure 20A Another close-up side view of this part of the end section.

[0192] Figure 21 A perspective view of a portion of the distal segment of another exemplary catheter of this disclosure is shown. Detailed Implementation

[0193] As used herein, the term “about” or “approximately” for any numerical value or range indicates appropriate dimensional tolerances that allow a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of values ​​±20% of the listed values; for example, “about 90%” may refer to a range of values ​​from 71% to 99%.

[0194] As used herein, “subject” or “patient” including blood vessels from a subject or patient can refer to any applicable human patient as well as any mammal, veterinary animal, livestock, or pet. For example, an animal can be a laboratory animal specifically selected to have certain characteristics similar to humans (e.g., rats, dogs, pigs, rabbits, monkeys, etc.).

[0195] As used herein, “operator” may include a physician, surgeon, or any other individual or device associated with a medical procedure used with the device disclosed herein.

[0196] This disclosure generally relates to a catheter having one or more anchoring mechanisms to stabilize the distal end segment of the catheter during use. (Go to...) Figures 1A to 1B The diagram shows a steerable bidirectional electrode catheter 10. The catheter 10 may include an elongated catheter body 12 having a proximal end and a distal end, an end section 14 located at the distal end of the catheter body 12, and a control handle 16 located at the proximal end of the catheter body 12. Figure 1B This is a close-up side view of the distal segment 14 taken along section AA. The body 12 may comprise an elongated tubular structure having a single axial 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 construction and may be made of any suitable material.

[0197] The distal segment 14 may include a longitudinal axis 25 and be deflected unidirectionally or bidirectionally from this axis. The distal segment 14 may also include one or more electrodes 19 selectively positioned and / or separated around the distal segment 14. The distal segment 14 may also include an anchoring mechanism 50 positioned thereal and / or deployable thereto. It should be understood that while electrode conduits are shown in the accompanying drawings, other types of conduits are contemplated for use with the anchoring mechanisms disclosed herein. The mechanism 50 may be disposed within and / or along the body 12 in a first configuration (e.g., a collapsed configuration). The mechanism 50 may be configured to extend outward from a circumferential opening of an elongated member relative to the longitudinal axis to surround at least a portion of the distal distal segment in a second configuration (e.g., an expanded configuration).

[0198] exist Figures 1A to 1BIn the illustrated example, mechanism 50 may be located inside body 12, including at or around end section 14 (e.g., in a lumen therein), and once deployed, may include one or more wires 52. Figure 2 yes Figures 1A to 1B A close-up frontal plan view of the catheter 10. As shown, the wire 52 can be a fixed configuration, such as a variable lasso shape or other circular, coiled, or spiral form. In some examples, one or more wires 52 may include one or more curved segments or loops 53, which can typically be thin and flexible. The one or more loops 53 may be positioned around the segment 14, but with spaces between them to allow blood to flow even when the wire 52 contacts the corresponding vessel wall. In this respect, the wire 52 forming the one or more loops 53 helps to anchor to the vessel wall while avoiding obstruction of blood flow in the vessel itself. The one or more loop segments 53 of the mechanism 50 may be axially aligned with axis 25 or otherwise oriented.

[0199] The one or more loop segments 53 may be connected to an elongated base segment 55 adjacent 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 may be adjustable using a steering and / or control mechanism (not shown) (e.g., the diameter of mechanism 50, the distance between the loops, the length of mechanism 50 in the second configuration, etc.). The radius of any loop segment 53 of mechanism 50 may be adjustable (e.g., adjustable between 7 mm and 25 mm). In some examples, the size of one or more loops of mechanism 50 may be set to conform to structures such as pulmonary vein ostia or coronary sinuses. The one or more loop segments 53 may include a substantially constant elasticity over at least a portion of their length, for example, by internally reinforcing the curved sections with elastic longitudinal members, thereby adequately anchoring mechanism 50 to the vessel wall in the second configuration. The one or more loop segments 53 may generally be thicker and / or stiffer than the remainder of the one or more wires adjacent to them.

[0200] We can provide more than as needed or required. Figures 1A to 1B The depicted mechanism 50 may include more or fewer rings. One or more rings of the depicted mechanism 50 may also include variable-diameter rings configured to abut against the vessel wall when in a second configuration. The depicted mechanism 50 may also be configured to move between or otherwise adjust between multiple different second configurations with different diameters (e.g., move between different diameters to accommodate a range of different sized vascular systems).

[0201] Figures 1A to 2The wire 52 depicted can be coiled or oriented in a predetermined manner. The wire 52 can be oriented obliquely relative to the axis 25 of the conduit 10. Throughout this disclosure, the term "obliquely" is intended to refer to a plane in space best suited for forming one or more wires 52 and angled relative to the axis 25. The angle θ between the plane P and the axis 25 can be in the range of about 45 degrees to 105 degrees, preferably in the range of about 75 degrees to 105 degrees, and more preferably about 90 degrees. Section 14 may include an elongated member extending along a longitudinal axis (e.g., axis 25), the elongated member having a circumferential opening 22 disposed on the outer surface of the elongated member. The opening 22 may be provided from which the mechanism 50 can be translated distally until it expands in a second configuration, such as in Figure 1B This is seen more clearly in the image. Once expanded, the mechanism 50 is able to anchor against a vessel wall such as the coronary sinus wall (e.g., push into the vessel wall). In some examples, one or more wires 52 may include sensors to detect contact forces with the vessel wall during the anchoring process, thereby ensuring that a predetermined force is achieved for anchoring. Optionally, the sensors may be used to ensure that the predetermined force is not exceeded to avoid rupture of the corresponding vessel wall.

[0202] Before deployment, mechanism 50 may be in a first configuration contained within the lumen of catheter 10. For example, one or more wires 52 of mechanism 50 may be positioned inside the lumen of catheter 10 (e.g., lumen 22). One or more wires 52 may also extend co-exist with catheter 10. In some examples, the lumen associated with opening 22 may be formed by a slit selectively positioned on the outer surface of catheter body 12 at distal segment 14 to provide spacing for one or more wires 52 deployed therefrom. In some examples, mechanism 50 may be attached to only one side of the outer surface of catheter 10 or otherwise in a second configuration, thereby being pushed against the vessel wall on a single side.

[0203] Figure 3A This is a close-up side view of a portion of the distal segment 114 of another exemplary catheter. Figure 3B It is in the second configuration Figure 3A Another close-up side view of this portion of the terminal segment 114. In this example, similar to mechanism 50, mechanism 150 is capable of extending and / or unfolding via an opening 122 located on or near the outer surface of segment 114. Similar to the previously described mechanism 50, mechanism 150 may include one or more segments 152 (e.g., wire or other biocompatible material) forming one or more annular segments 153. It can be seen that one or more segments 152 may be thicker than one or more wires 52, although they may not necessarily be thicker. In some examples, one or more segments 152 may include a catheter configuration with a lumen diameter smaller than that of catheter 110.

[0204] As can be seen, the coiled wire 154 may be attached proximally to the mechanism 50 and any corresponding one or more loop segments 153. The coiled wire 154 may be configured such that twisting or otherwise moving the wire 154 may cause the mechanism 150 to extend and / or unfold through the opening 122. In some examples, twisting or otherwise moving the wire 154 may also cause the mechanism 150 (including any loop of its one or more loops 153) to anchor to the vessel wall in a second configuration, such as Figure 3B As shown, the user can thus adjust and precisely push the abutment mechanism 150 against the vessel wall. The filament 154 may include one or more kinks on or around the catheter 110 and be axially connected to the catheter 110 (e.g., wound around the outer surface of the catheter 110). However, the filament 154 is not limited thereto, and may be attached to the outer and / or inner surfaces of the catheter 110 elsewhere or differently as needed or required. Furthermore, in some examples, the mechanism 150 can be unfolded by adding or removing twists to the coiled filament 154 in the second configuration (e.g., by twisting or otherwise moving the filament 154), which in turn actuates the mechanism 150 to form one or more loops 153 and / or otherwise anchor the vessel wall.

[0205] Figure 4A This is a close-up side view of a portion of the terminal section 214 of another exemplary conduit 210 of this disclosure in the first configuration prior to anchoring. Figure 4B This is another close-up side view of this portion of the distal end section 214 in the second configuration, where the mechanism 250 is configured for anchoring. The mechanism 250, as shown, may include one or more strips capable of extending and / or unfolding through slits 222 in the outer surface of the conduit 210. In some examples, one or more electrodes may include one or more strips of the strips 252. The one or more strips 252 may be configured to converge and extend outward when one or more portions of the distal end section 214 retract toward one or more portions of the conduit located proximal to the distal end section, as... Figures 4A to 4B As seen between, segment 214 has shortened the distance D. The distance D can vary, including by being selected by a predetermined ratio (e.g., a 1:1 ratio, a 1:2 ratio, etc.) to the radial length of one or more strips 252 in the second configuration. It should be understood that any ratio can be used to select the distance D corresponding to the desired outer diameter of the second configuration, as needed or required. One or more strips 252 can be actuated to the second configuration by one or more pulling members that can be actuated by an end user operatively connected to the one or more strips 252. In some examples, one or more wires 252 and / or slits 222 can be radially uniformly spaced strips to center the conduit 210.

[0206] In some examples, one or more strips 252 may extend outwards to at least twice the outer diameter of the catheter 210. One or more strips 252 may be positioned on only one side of the catheter 210 and configured to be pushed into the blood vessel on that only side, as shown. However, it is contemplated that one or more strips 252 may be designed to extend outwards from multiple sides of the catheter 210, similar to a balloon. One or more strips 252 may be positioned between electrodes 19, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, etc. In some examples, one or more sensing electrodes may be included to detect movement of the catheter 210 and / or whether the mechanism 250 is anchored to the vessel wall. Such sensing by the electrodes 19 may be particularly advantageous in communicating to the end user whether the mechanism 250 is adequately anchored or unnecessarily moved.

[0207] The area surrounding one or more strips 252 may comprise a relatively soft and / or flexible plastic including an elastomer. Acceptable materials for the surrounding area may include polyether block amide, polyether ether ketone (PEEK), etc. One or a combination thereof, which may include an elastomer as a block copolymer composed of rigid polyamide blocks and flexible polyether blocks.

[0208] Go to Figure 5A The catheter body 12 is shown in the first configuration, while Figure 5B It is shown in the second configuration. Figure 5B The mechanism 350 is shown more clearly, which has been deployed across the outer surface of the conduit body 12. After one or more portions of the conduit body 12 are retracted a distance D toward one or more portions of the conduit located proximal to the conduit body, one or more strips 352 converge and extend outward. In some examples, the anchoring mechanism 350 may include multiple walls 352, 358. The first wall 358 may be flexible, and the second wall 352 of the multiple walls may be formed as a strip that is more rigid than the first wall 358. For example, the flexible first wall 358 with lower hardness may be made of any low-hardness Pebax, polyurethane, other polymers, etc. In other examples, the first wall 358 may be made of a thin-walled extrusion, which may allow the first wall 358 to collapse and / or wrinkle itself. The rigid material may be made of PEEK, a plastic that incorporates a relatively high-hardness shape metal (such as nitinol, conventional polyurethane, Pebax, etc.).

[0209] Wall 352 may comprise a relatively soft and / or flexible plastic including an elastomer. In some examples, wall 352 is designed to have a softer material to allow conduit 310 to contract by a distance D, thereby causing the strip of wall 352 to warp. When the section of wall 352 is retracted by a distance D, the strip of the wall may be capable of expanding outward, thereby causing the first wall 358 itself to wrinkle inward. Acceptable materials for wall 352 may include polyether block amides and One or a combination thereof, which may include an elastomer as a block copolymer composed of rigid polyamide blocks and soft polyether blocks. Wall 358 may be more rigid, including polyether ether ketone (PEEK). Similar to mechanism 250, mechanism 350 may be positioned between electrodes 19, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, etc.

[0210] Go to Figure 6A Mechanism 450 is shown in a first configuration where the catheter body 12 is collapsed. Conversely, Figure 6B Mechanism 450 in a second expansion configuration is shown. Mechanism 450 can be provided through a relatively soft section of region 452, whereby pressure applied thereto causes said softer section 452 to expand and bulge outwards. In some examples, the expandable section of region 452 may be formed from the wall of the conduit body 12, which is softer than the surrounding wall section of the conduit body 12. In some examples, pressure may be applied directly via a lumen 454 in fluid communication with region 452 of mechanism 450. Applying pressure via lumen 454 and into region 452 causes mechanism 450 to expand outwards. Figure 6B The balloon configuration is depicted. In some examples, to achieve expansion on only one side, as shown, reinforcements or other more rigid materials may be added around region 452 to prevent expansion of a certain radial percentage or degree. In some examples, region 452 may expand outward from only one side of the catheter body 12, although it is envisioned that region 452 expands outward from more than one side.

[0211] Go to Figure 7A This shows a close-up side view of the anchoring mechanism 550 in its first configuration before deployment, while Figure 7B A mechanism 550 in a second configuration, extending from the catheter body 12 and capable of anchoring to the vessel wall, is shown. The mechanism 550 may include one or more wires 552 shaped and configured to be withdrawn distally through one or more slits 522 or openings in the catheter body 12. Figure 7BIn the second configuration, after a predetermined distance has been moved distally or translated, one or more wires 552 are visible in the form of hook-shaped anchors, configured to push and anchor into the vessel wall. One or more wires 552 can retract from the second configuration back into the catheter body 12 after deployment. One or more wires 552 can also be repeatedly withdrawn from the corresponding slits 522 or openings of the catheter body 12 and secured at or near the distal segment. In some examples, one or more wires 552 are deployed to the second configuration by advancing a proximal shaft or proximal handle operatively connected to the proximal end of the catheter 10.

[0212] One or more wires 552 may be shaped and connected directly or indirectly to a draw mechanism configured to retract one or more wires 552 into the catheter body 522 when not in use, and to unfold from the slit 522 or opening when in use. While one or more wires 552 may be seen in a fishhook shape, alternative wire shapes are also envisioned for anchoring in less invasive situations. One or more wires 552 may be positioned on only one side of the outer surface of the catheter body 12 for abutment against the vessel wall or for anchoring on multiple sides, such as... Figure 7B As shown.

[0213] Go to Figure 8A This shows a close-up side view of the anchoring mechanism 650 in its first configuration before deployment, while Figure 8B A mechanism 650 is shown in a second configuration, extending from the catheter body 12 and capable of anchoring to the vessel wall. The mechanism 650 may include one or more wires 652 shaped and configured to be withdrawn distally through one or more slits 622 or openings in the catheter body 12. Figure 8B In the second configuration, after moving or translating a predetermined distance to the distal side, one or more wires 652 protrusions can be seen with at least one anchoring protrusion. When in the... Figure 8B In the second configuration, at least one anchoring protrusion of one or more wires 652 may have a total diameter that is at least twice the outer diameter of the conduit body 12.

[0214] At least one anchoring protrusion of one or more wires 652 may include a damage-resistant surface configured to contact the vessel wall during anchoring. One or more wires 652 may retract from the second configuration into the catheter body 12 after deployment. One or more wires 652 may also be repeatedly withdrawn from the corresponding slit 622 or opening of the catheter body 12 and secured at or near the distal segment. In some examples, one or more wires 652 are deployed into the second configuration by advancing a proximal shaft or proximal handle operatively coupled to the proximal end of the catheter 10.

[0215] Go to Figure 9AThis shows a close-up side view of the anchoring mechanism 650'. Specifically, Figure 9A The mechanism 650' is shown in a second configuration that has been deployed and expanded. One or more electrodes 19 are positioned between slits or openings 622, thus 650' is shown to be deployed asymmetrically on only one side of the catheter body 12. In the depicted configuration, the filament 652' is shown to be pushed outward by moving its proximal (not shown) toward the distal side, thereby warping the outward filament 652' into the second configuration. The filament 652' may be secured at one or more points (e.g., at the distal slit or opening 622). During movement between the first and second configurations, some or all of the filaments 652' may be configured to contact and anchor into the corresponding vessel wall. The expansion diameter of the filament 652' may also be manipulated as needed or required by translating the filament 652' distally or proximally.

[0216] Advantageously, by providing the pull-out point of suture 652' and the distal fixation point oriented at an angle α of approximately 90 degrees to each other in the second configuration, the amount of force required to deploy the suture is significantly reduced, which is desirable because less force is required to actuate between configurations, and thus deployment control is increased with reduced force transmitted to the patient. It should be understood that a mechanism 650 in an orthogonal configuration, as defined by angle α, may not necessarily be preferred or even optimal, but having a pull-out point and endpoint aligned as depicted generates a force transmitted closer to the axial direction along suture 652', thus requiring a greater force to warp, while off-axis warping is easier. Additionally, making the plane conforming to the parabolic shape formed by the expanded suture 652' more parallel to the catheter axis allows for more effective anchoring. Figure 9B The cross-sectional view is taken at or near the distal fixed end of the distal slit 622, showing an exemplary right angle α defined between the expanded wire 652' and the fixed distal end of the distal slit 622.

[0217] Go to Figure 10A This is a close-range side view of a portion of the distal end segment 714 of another exemplary catheter. Figure 10B It is in the second configuration Figure 10AAnother close-up side view of this portion of the distal segment 714. In this example, similar to existing mechanisms 50 and 150, mechanism 750 can be deployed and retracted by expanding and contracting one or more variable lasso loops around the body 12, similar to pythons and king cobras. The distal end 756 of mechanism 750 may be a free end, not attached to the catheter body 12, while the proximal end 757 may be attached to the body 12 and sealed. Mechanism 750 may still use a side outlet, but may not necessarily include an open passage. Similar to previously described mechanisms 50 and 150, mechanism 750 may include one or more segments 752 (e.g., filament or other biocompatible material) forming one or more loop segments 753. Outside the patient, an operator (e.g., a physician) may use an actuation mechanism such as a pull cord, configured to tighten the coil or loop (in) when moved against the adjustable anchoring mechanism 750 against the corresponding vessel wall. Figures 10A to 10B (It's clearer between them). Once released from the corresponding delivery facility at the treatment site. Figure 10A The configuration can be expanded from this delivery mechanism.

[0218] Go to Figures 11A to 11B Another exemplary anchoring mechanism 750 is shown. Figure 11A This is a close-up side view of a portion of the distal section 14 of another exemplary conduit body 12 and the corresponding mechanism 750 in the first configuration prior to anchoring. Figure 11B This is another close-up side view of this portion of the terminal section 14 in the second configuration, whereby the mechanism 750 is now radially expanded and configured to anchor to the vessel wall, similar to Figure 9. The mechanism 750 shown may include one or more wires 752 that are capable of expanding and / or unfolding through slits or openings 722 in the outer surface of the catheter body 12.

[0219] One or more filament components 752 may be configured to converge and extend outward through one or more portions of the catheter body 12, such as one or more orifices, elongated strips or slits, or flexible valves formed in the outer surface of the catheter body 12, through which the one or more filament components 752 may be deployed. In some examples, the one or more filament components 752 may apply an outward force to the blood vessel. In one example, the force applied to the blood vessel by the one or more filament components 752, along with the corresponding frictional force between the catheter 10 and the tissue, typically anchors the catheter 10 in place and prevents movement within the blood vessel.

[0220] One or more wire members 752 may be configured to deliver a specific force and / or include sensors to detect contact forces with the vessel wall during the anchoring process, thereby ensuring that a predetermined force is achieved for anchoring. Optionally, the sensors may be used to ensure that the predetermined force is not exceeded to avoid rupture of the corresponding vessel wall. A contact force sensor particularly suitable for mechanism 750 is described in U.S. Patent Application No. 16 / 036710, filed July 16, 2018, the entire contents of which are incorporated herein by reference.

[0221] In some examples, one or more electrodes 19 may be included in one or more wire members 752. In this example, one or more electrodes positioned on one or more wire members 752 may allow acquisition of multiple signals around the inner circumference of the blood vessel at the same or similar depth within the vessel. In one example, deployment can be achieved by retracting one or more portions of the catheter 10 proximal to segment 14, as... Figures 11A to 11B As shown in the diagram, section 14 has been retracted, causing section 14 to bend or otherwise fold.

[0222] In one example, one or more wire members 752 are deployed by activating a pull cord, 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 rather than the length of the wire member). In some examples, the pull cord may be attached to the distal end of one or more wire members 752. Furthermore, when pulled or otherwise activated, one or more wire members 752 expand outward and deploy. In some examples, the proximal portion of one or more wire members 752 may be secured to the catheter body 12. In this respect, when the pull cord is in a neutral position, one or more wire members 752 may include a profile similar to the catheter body 12 (e.g., aligned axially with it). In some examples, one or more wire members 752 may extend outward to at least four times the outer diameter of the catheter body 12.

[0223] In one example, one or more wire members 752 may be deployed by a pusher wire passing through the conduit body 12 and coupled to one or more wire members 752. The distal end of the pusher wire may be secured at the distal end of one or more wire members 752, and the proximal end may control the axial translation of the mechanism 750 at the corresponding handle. In this example, the anchoring of the mechanism 750 may be achieved by pushing the proximal end of the pusher wire in the distal direction, which may cause a section of the pusher wire and one or more wire members 752 inside the conduit body 12 to expand radially outward.

[0224] As shown, one or more wire members 752 may be positioned on only one side of the catheter body 12 and configured to be inserted into the blood vessel on that only side. However, it is contemplated that one or more wire members 752 may extend outward from multiple sides of the catheter body 12, similar to a balloon. One or more wire members 752 may be positioned between and / or around electrodes 19, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, etc. 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 determine whether the mechanism 750 is anchored to the vessel wall. Such sensing by the electrodes 19 may be particularly advantageous in communicating to the end user whether the mechanism 750 is adequately anchored or has moved unnecessarily.

[0225] Go to Figure 12A The catheter body 12, which has mechanism 850, is shown in a first configuration, while Figure 12B A catheter body 12 with mechanism 850 in a second configuration is shown. In some examples, mechanism 850 may include an extendable member 852B that can retract into and extend from sheath member 852A between the first and second configurations. In this respect, member 852A may have a lumen with an inner diameter greater than the outer diameter of member 852B. Each of members 852A and 852B may contain the same or different materials, and each member may be individually actuable.

[0226] Specifically, agency 850 in Figure 12B As shown, it has been deployed through an opening 822 located in the outer surface of the catheter body 12. The opening 822 may be a slit forming a one-way valve in the outer surface of the catheter 12. In other embodiments, the opening 822 may be generally elliptical, rectangular, or any other shape to accommodate a first configuration and a second configuration of the mechanism 850.

[0227] In some examples, member 852A may be moved proximally (e.g., pulled), while the distal end of member 852B may be fixedly attached to the distal end of opening 822. By moving member 852A proximally and / or moving member 852B distally a first distance, member 852B may be radially expanded outward between one or more expansion states with a diameter greater than the outer diameter of catheter 12. In some examples, a segment of member 852B previously included in member 852A and / or catheter 12 may be released through opening 822 and radially outward to the corresponding vessel wall.

[0228] In some examples, the diameter of the second configuration of mechanism 850 may be the same as or larger than the diameter of the corresponding blood vessel. One or both of components 852A and 852B may be formed with a predetermined bias (e.g., by heat setting, constructed with a spring-like element, etc.) so that the mechanism expands radially outward when component 852A is retracted and moved proximally.

[0229] Acceptable materials for use on or near opening 822 may include polyether block amides and One or a combination thereof, which may include an elastomer as a block copolymer composed of rigid polyamide blocks and soft polyether blocks. Similar to the prior anchoring mechanisms of this disclosure, mechanism 850 may be positioned between electrodes 19, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, etc. Although not shown, components 852A, 822B may also include electrodes 19 selectively positioned and / or spaced along them. Similarly, portions of conduit 12 adjacent to opening 822 may also include one or more electrodes 19 selectively positioned and / or spaced along them.

[0230] Go to Figure 13A The catheter body 12, which has mechanism 950, is shown in the first configuration, while Figure 13B A catheter body 12 with mechanism 950 in a second configuration is shown. In some examples, mechanism 950 may include flexible and / or expandable members 952A, 952B, 952C, 952D. Although four (4) expandable members are shown herein, mechanism 950 may include fewer or more expandable members as needed or required. Members 952A, 952B, 952C, 952D may be formed integrally with or separately from catheter body 12. Gaps, voids, or spaces may be positioned between the respective members 952A, 952B, 952C, 952D. Each of members 952A, 952B, 952C, 952D may be arranged radially in series about the longitudinal axis of body 12. In some examples, portions of body 12 proximal to members 952A, 952B, 952C, 952D may be moved distally (e.g., pushed), while the distal end 14 may be relatively stationary. By pushing the main body 12 to the distal side, components 952A, 952B, 952C, and 952D are radially outwardly extended between one or more expansion states where the corresponding diameter is greater than the outer diameter of the conduit 12.

[0231] In some examples, each of components 952A, 952B, 952C, and 952D may include an internal actuation wire (not shown) that can be individually actuated by the end user. The distal end components 952A, 952B, 952C, and 952D may be held fixed or include internal stops that prevent the corresponding actuation wire from translating distally, such that further distal actuation causes the corresponding component 952A, 952B, 952C, and 952D to expand outward. In this case, instead of pushing the entire body 12, each of components 952A, 952B, 952C, and 952D can be individually actuated by moving the actuation wire associated with the corresponding component 952A, 952B, 952C, and 952D distally. This can facilitate the accommodation of blood vessels of different sizes and shapes to increase the amount of surface area in contact with the vessel wall.

[0232] Components 952A, 952B, 952C, and 952D may be arranged radially around the longitudinal axis of the catheter body 12. In the second configuration, each of components 952A, 952B, 952C, and 952D may have a different diameter. In another example, due to the gaps or voids formed between each of components 952A, 952B, 952C, and 952D, each component may have the same or substantially similar diameter and expand in a sac-like manner to form a porous anchoring sac. In another example, components 952A, 952B, 952C, and 952D may be spaced apart, but not necessarily radially separated. For example, the mechanism 950 formed by components 952A, 952B, 952C, and 952D may be substantially planar or otherwise non-circular, or have a shape different from that of the catheter body 12. Components 952A, 952B, 952C, and 952D may also include one or more electrodes, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, etc. Similar to the prior anchoring mechanisms of this disclosure, mechanism 950 may be positioned between electrodes 19, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, etc.

[0233] Figure 14 A mechanism 950 is shown unfolded asymmetrically in a second configuration, whereby member 952A contacts the blood vessel BV. It can be seen that member 952A in the depicted configuration can contact the blood vessel BV along a relatively increased surface area. Furthermore, the electrodes of member 952A (and other expandable members not shown) allow for the simultaneous reading of multiple radial positions of each electrode of each respective expandable member, thereby improving the accuracy and precision of the sensed information, as opposed to existing catheters that record only one radial position at a given vessel depth. For ease of reference and not limitation, Figure 14An exemplary definition of what "vascular depth" may mean for the purposes of this disclosure.

[0234] Go to Figure 15A This is a close-up side view of a portion of the anchoring mechanism 1050 of another exemplary catheter body 12. In this example, the mechanism 1050 can be actuated by the distal translation mechanism 1050 via the actuator wire 1056 when one or more loops 1053 of the mechanism 1050 are relatively stationary or fixedly wound around or near the distal end segment 14. In another example, the mechanism 1050 can be actuated between a first configuration and a second configuration by expanding and contracting one or more of its variable lasso loops 1053 around the body 12, similar to a python or king cobra. The wire 1056 of the mechanism 1050 can be positioned within the lumen of the catheter body 12 and withdrawn distally through the side outlet 1022 of the catheter body 12 until it extends to the convergence point 1057. Distally to the convergence point 1057, a pair of expandable members 1052A, 1052B can extend distally toward the end 14, generally parallel to each other. Components 1052A and 1052B may include one or more wires or other biocompatible materials, which together with other corresponding components form one or more loop segments 1053, similar to the previously described mechanisms 50 and 150. In another example, mechanism 1050 may not necessarily be positioned within the lumen of body 12 or withdrawn through the outlet of body 12, but may typically extend along the outer surface of catheter body 12.

[0235] Outside the patient's body, the operator can actuate mechanism 1050, such as by pushing or pulling mechanism 1050, to tighten the coil or ring (in) when moved against the adjustable anchoring mechanism 1050 against the corresponding blood vessel wall. Figures 15A to 15B (It's clearer between them). Specifically, Figure 15B It is shown that when the ring 1053 is fixed against the end 14, the components 1052A and 1052B expand radially outward, and the portion of the mechanism 1050 located proximal to the components 1052A and 1052B is pushed distally, thereby causing this radial outward expansion for vascular anchoring. Figure 15C and Figure 15D Only shown Figure 15B In the exemplary front view section view, components 1052A and 1052B are taken between the convergence point 1057 and the ring 1053, thereby expanding radially outward. It can be seen that... Figure 15C In the middle, components 1052A and 1052B are usually orthogonal to each other, while... Figure 15DIn the middle, an angle of approximately 120 degrees is formed between components 1052A and 1052B. Such orientation between components 1052A and 1052B can be adjusted as needed or required based on proximal movement of components 1052A and 1052B and any corresponding actuation on the ring 1053 that causes twisting.

[0236] Figure 16 A close-up side view of a portion of an anchoring mechanism 1150, similar to mechanism 1050, is depicted. In this example, similar to mechanism 1050, the mechanism 1150 can be deployed and deployed to push or pull the device when one or more variable lasso loops 1153 are securely wound around the body 12. Mechanism 1150 can be positioned within the lumen of the catheter body 12 and withdrawn distally through an opening 1122 in the catheter body 12. Distally to the opening 1122, one or more expandable members 1152 can extend substantially parallel distally toward the end 14. One or more members 1152 may comprise one or more wires or other biocompatible materials that, together with other corresponding members, form one or more loop segments 1153, similar to the previously described loop segments 1053. Furthermore, the segments 1153 secure the distal end of mechanism 1150 to the outer surface of the end 14. Outside the patient's body, the operator can actuate mechanism 1150, such as by pushing mechanism 1150, to cause mechanism 1150 to expand radially outward, as in the expansion member 1152' indicated by the dashed line in the second configuration.

[0237] Specifically, Figure 16 The diagram shows the components after the radially outward expansion of components 1152 (first configuration) and 1152' (second configuration) when the ring 1153 is fixedly wound around the end 14, causing the mechanism 1150 to expand radially outward. Components 1152, 1152' may also include electrodes selectively positioned and / or spaced along them. Similarly, portions of the catheter body 12 adjacent to the opening 1122 and / or the ring 1153 may also include one or more electrodes 19 selectively positioned and / or spaced along them, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, etc.

[0238] Go to Figure 17A This is a close-up top view of a portion of the anchoring mechanism 1250 of another exemplary conduit body 12, whereby the solid line of the expandable member 1252 corresponds to the first configuration, while the dashed line of the expandable member 1252' corresponds to the second expansion configuration. The up and down arrows between members 1252 and 1252' are intended to indicate the outward radial expansion described herein as exhibited when the mechanism moves from the first configuration to the second configuration. Figure 17B It shows along Figure 17A A close-up side view of mechanism 1250 in the first collapsed configuration, taken from section AA. Figure 17C A perspective view of mechanism 1250 is shown, in which components 1252, 1252' are in their respective configurations.

[0239] Specifically, Figure 17A and Figure 17C The diagram shows that mechanism 1250 can pass through an opening 1222A located in the outer surface of catheter body 12 from the lumen of catheter body 12. Opening 1222A may be a hole forming a one-way valve in the outer surface of catheter body 12. In other embodiments, opening 1222A may be generally elliptical, rectangular, or any other shape to accommodate members 1252, 1252' passing through it. The distal ends of members 1252, 1252' may be securely attached to end 1222B of catheter body 12.

[0240] In some examples, member 1252 can be pushed distally while its distal end is fixedly attached to end 1222B, thereby actuating member 1252 to cause it to expand radially outward to a second configuration as depicted with member 1252'. Figure 17D An exemplary side view, taken along section AA, shows the distal end 1255 of components 1252, 1252' being secured to end 1222B. As shown, end 1255 may be oriented or otherwise extended from the outer surface of catheter body 12 and ultimately attached to and / or located within lumen 1243 of catheter body 12. Catheter body 12 may include multiple lumens, whereby lumen 1243 is configured to be securely attached to end 1255. End 1255 may be welded, fused, bonded, adhered, and / or mechanically etched into lumen 1243, but other attachment methods are contemplated as desired or required, including the use of connectors. In some examples, components 1252, 1252' may be thermoformed or otherwise configured to have predetermined biasing features such that the depicted shape bends radially outward toward the corresponding vessel wall.

[0241] In some examples, the diameter of the second configuration of mechanism 1250, as indicated by component 1252', may be the same as or larger than the diameter of the corresponding blood vessel. Components 1252, 1252' may also include electrodes 1219 selectively positioned and / or spaced along them. Similarly, portions of the catheter body 12 adjacent to the opening 1222A and / or the end 1222B may also include one or more electrodes 19 selectively positioned and / or spaced along them, which may be one or a combination of ablation electrodes, recording electrodes, sensing electrodes, etc. Acceptable materials for or near the opening 1222A may include polyether block amides and One or a combination thereof, which may include an elastomer as a block copolymer composed of rigid polyamide blocks and soft polyether blocks. Figure 17EA view of mechanism 1250 in a second configuration is shown, and similarly cut along section AA, whereby member 1252' has been radially expanded outward into an exemplary shape.

[0242] Go to Figure 18 The diagram shows a front plan view of mechanism 1250 in a second configuration within an exemplary blood vessel BV having a diameter D. In some examples, the blood vessel BV may be a coronary sinus (CS), the shape of which may vary, for example, passing through or through member 1252', sometimes tubular and sometimes funnel-shaped, depending on the patient. The size of the blood vessel BV may also vary and is relatively flexible, so any anchoring device should be expanded to be larger than the natural blood vessel diameter for adequate anchoring. Preferably, mechanism 1250 may include a diameter D ranging from approximately 2 mm to 15 mm, but other diameters larger (e.g., up to 25 mm) or smaller are contemplated as needed or required.

[0243] As can be seen, the mechanism 1250 in the second configuration has two dilatation sections formed by member 1252' and anchored to the wall of the blood vessel BV. However, fewer or more dilatation sections are envisioned as needed or required. In some examples, due to the dilatation of mechanism 1250 and the movement of member 1252' in opposite directions, the portion of catheter body 12 opposite to member 1252' (e.g., with) Figure 18 The "upper" end of component 1252' relative to the lower end moves toward the wall of the blood vessel BV and anchors to the wall of the blood vessel BV.

[0244] Go to Figure 19 A flowchart illustrating an exemplary method 1900 for anchoring a catheter to a blood vessel at a treatment site is provided. Method 1900 may include step 1910, delivering any catheter of this disclosure to the treatment site. Step 1920 may include deploying an anchoring mechanism. Step 1930 may include anchoring the anchoring mechanism to the vessel wall. As discussed throughout this disclosure, the method may include other steps.

[0245] Figure 20A A perspective view of a portion of the distal segment of another exemplary catheter of this disclosure, having an exemplary mechanism 1350, is shown. Mechanism 1350 may include printed electrodes 1319A, 1319B printed on a cap 1340, whereby a cap 1340 having corresponding printed electrodes can be positioned on mechanism 1350. One or more traces 1370 communicating with the corresponding electrodes 1319A, 1319B may be provided. Figure 20B The radially expanded mechanism 1350 in a second configuration is shown. The mechanism 1350 shown is particularly advantageous for printing flexible circuits on the rotating cover 1340 used in conjunction with the mechanism 1350.

[0246] Figure 21 A perspective view of a portion of the distal segment of another exemplary conduit of this disclosure, having an exemplary mechanism 1450, is shown. As shown, mechanism 1450 may include multiple insulated wires 1412 (e.g., shape memory alloys such as nitinol) bundled together in the same shape. One or more conductor loops 1419 may also be included to bundle the wires 1412 together and function as electrodes similar to those of other exemplary mechanisms previously described.

[0247] In some examples, the method includes: determining the position and orientation of the anchoring mechanism by generating multiple AC magnetic fields, each AC magnetic field at a different frequency; sensing the AC magnetic fields at multiple sensors near the distal end segment; and calculating the size and orientation of a portion of the distal end segment in response to signals representing the generated and sensed magnetic fields.

[0248] In some examples, the method includes generating an externally applied magnetic field via at least one field generator to establish a reference frame, positioning multiple sensors, including single-axis coils, around a distal end segment, each single-axis coil fixed at a different corresponding point around the distal end segment, and determining the dimensional translation and orientation 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 end segment at known fixed locations relative to at least one of the single-axis coils, the positions of the respective electrodes derived from the dimensional translation and orientation coordinates of the single-axis coils. Specific tools for these embodiments can be understood to include features more clearly described in Appendix 1 appended herein, including U.S. Patent Nos. 6,690,963 and 8,926,528.

[0249] In some examples, the method includes deflecting an end segment in response to movement of one or more draw cables. In some examples, the method includes moving one or more draw cables via a steering assembly. In some examples, the method includes deflecting the end segment in a direction of the off-axis lumen of the respective draw cable extension. In some examples, the method includes assembling the catheter with a control handle including a deflection knob and adjusting the end deflection orientation of the end segment by rotating the deflection knob. In some examples, the method includes extending a segment of one or more draw cables pulled by a pulley to deflect at an angle of less than about 7 degrees relative to the longitudinal axis. Specific tools for these embodiments are to be understood as including features more clearly described in Appendix 1 appended herein, including U.S. Patent No. 8,348,888.

[0250] Furthermore, ECG signals can be individually assessed via the electrodes of the electrode catheter, allowing the user or system to determine that the distal segment has made contact with tissue. In embodiments with electrodes, a stable catheter effectively anchored to the corresponding vessel wall may be required to determine which electrodes to activate for ablation treatment. Force contact sensors can also be used to determine contact with tissue, for example, as described in U.S. Patent Publication No. 2018 / 0256247, filed March 8, 2017, the entire contents of which are incorporated herein by reference. A contact force sensor particularly suitable for catheters with split ends is now described, and this contact force sensor is also described in U.S. Patent Publication No. 2020 / 0015693, filed July 16, 2018, the entire contents of which are incorporated herein by reference.

[0251] In some examples, the systems and methods of use described herein can be used with pacemaker lead technology, such as with one or more fixation mechanisms, to secure one or more corresponding electrodes to the vessel wall.

[0252] In any of the above embodiments, an anchoring mechanism may be included on the distal end segment of the catheter. The catheter may also include an elongated body having one or more lumens disposed longitudinally therethrough. The catheter can be used according to the following methods and variations. First, the catheter may be inserted into the subject (e.g., a human subject) close to the heart, manipulating one or more of its electrodes to contact tissue. The catheter may be an aspect of an ablation system that also includes a processor. The sector at the distal end of the catheter and the corresponding electrodes may measure temperature and provide temperature data to the processor. Ablation energy may also be provided to it, for example, as controlled by the processor. One or more electrodes may be included in any of the catheters discussed herein, as shown and previously described.

Claims

1. A catheter, comprising: Catheter body; The distal end section includes an elongated member extending along a longitudinal axis; as well as In a first configuration, the anchoring mechanism is disposed along the outer surface of the elongated member and / or disposed within the elongated member; and in a second configuration, the anchoring mechanism is configured to extend radially outward relative to the longitudinal axis to surround at least a portion of the distal end segment. The anchoring mechanism includes one or more wires, which are drawn out of the distal end of the conduit on or near the distal end section to form one or more wire anchors, wherein the distal end of the one or more wires is fixedly attached to the distal end section. as well as The point where the wire is pulled out forms a 90-degree angle with the far-side fixing point.

2. The conduit according to claim 1, wherein the anchoring mechanism comprises: A pull wire, configured to pull one or more wires and / or the distal end section, thereby causing the anchoring mechanism to change from the first configuration to the second configuration.

3. The catheter according to claim 2, wherein the anchoring mechanism changes from the first configuration to the second configuration such that the catheter bends or folds outward when in the second configuration and delivers a predetermined force to the vessel wall.

4. The catheter according to claim 2, wherein the one or more wires are asymmetrically positioned on only one side of the outer surface of the catheter to anchor against the vessel wall.

5. The conduit according to claim 2, wherein when the one or more wires are in the second configuration, the diameter of the second configuration is at least four times the outer diameter of the conduit.

6. The conduit according to claim 1, wherein the anchoring mechanism comprises: Multiple wires extend axially distally along the conduit body and terminate when fixedly attached to or near the distal end section, wherein the multiple wires are pushed outwards away from the distal end section to expand into the second configuration.

7. The catheter according to claim 6, wherein the plurality of wires extend from within the catheter body through an opening in the lumen of the catheter body.

8. The catheter of claim 6, wherein the catheter body includes at least two internal lumens, wherein at least one of the two internal lumens is configured to permanently receive the distal ends of the plurality of wires.

9. The conduit of claim 1, wherein the elongated member includes a circumferential opening disposed on the outer surface of the elongated member, and the anchoring mechanism is configured to extend radially outward from the circumferential opening of the elongated member.

10. The conduit of claim 1, wherein the one or more wires are in a circular, coiled or spiral form and extend from an opening in the distal end of the conduit when in the second configuration, whereby the anchoring mechanism is axially aligned with the longitudinal axis of the conduit.

11. The catheter of claim 1, wherein the one or more wires comprise circular, coiled, or spiral shapes and extend from an opening in the distal end of the catheter when in the second configuration, whereby the anchoring mechanism is attached to only one side of the outer surface of the catheter to be pushed against the vessel wall.

12. The catheter of claim 1, wherein the one or more wires are configured to converge and extend outward when one or more portions of the distal terminal section are retracted toward one or more portions of the catheter located proximal to the distal terminal section.

13. The conduit according to claim 12, wherein the one or more wires are capable of extending outward through a plurality of slits on the outer surface of the conduit.

14. The conduit of claim 12, wherein the one or more wires are actuated to the second configuration by one or more pulling members, the one or more pulling members being actuated by an end user operatively connected to the one or more wires.

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