Steerable multi-function catheter device

Abstract

In a described example, a catheter includes a handle including a manipulator. A catheter shaft extends from the handle to terminate in a distal end portion, and the catheter shaft includes a lumen extending through the shaft. An electrically conductive anchor is at the distal end portion and includes an anchor body configured to provide a sensor signal in response to sensed, electrical signal. A steering wire has proximal and distal ends, in which the proximal end is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor. A conductive wire is electrically coupled, to the anchor and configured to transmi t the sensor signal to a location beyond the proximal end of the steering wire.

Description

STEERABLE MULTI-FUNCTION CATHETER DEVICE

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 555,664, filed Feb. 20, 2024, the disclosure of which is incorporated by reference herein in its entirety.FIELD

[0002] The present technology is generally related to a steerable multi-function catheter device.BACKGROUND

[0003] Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. As an example, a catheter can include a sensor that is used by a navigation system to track the position of the catheter during the procedure. The catheter can also include one or more other sensors, which can be used to track the progress and other aspects of the procedure. Such sensors and other structures tend to increase the overall diameter of the catheter.SUMMARY10004] The techniques of this disclosure generally relate to a steerable multi-function catheter device.

[0005] In one aspect, the present disclosure provides a catheter that includes a handle including a manipulator. A catheter shaft extends from the handle to terminate in a distal end portion, and the catheter shaft includes a lumen extending through the shaft. An electrically conductive anchor is at the distal end portion and includes an anchor body configured to provide a sensor signal in response to sensed electrical signal. A steering wire has proximal and distal ends, in which the proximal end is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor. A conductive wire is electrically coupled to the anchor and configured to transmit the sensor signal to a location beyond the proximal end of the steering wire.

[0006] In another aspect, the disclosure provides a catheter. The catheter includes a handle, a catheter shaft, a coil of electrically conductive wire, and an electrode apparatus.The catheter shaft extends from the handle to terminate in a distal end portion, in which the catheter shaft includes a lumen extending through the catheter shaft. The coil is at the distal end portion of the catheter shaft, and the coil includes a first portion of a first number of windings having a first outer diameter and second portion of a second number of windings having a second outer diameter, the second outer diameter is greater than the first outer diameter, a length of the conductive wire extends from the coil through the lumen and to the handle, and the coil is configured to provide a sensor signal in response to sensed electrical signal. An overmolding encapsulates the first portion of the coil, including a radially outer surface thereof, around the catheter shaft, and at least a radially outer surface of the second portion of the coil is exposed beyond the overmolding. The electrode apparatus includes an electrode and is movable relative to the distal end portion of the catheter shaft.

[0007] In another aspect, the disclosure provides a system that includes a catheter and a tracking system. The catheter includes a handle including a manipulator. A catheter shaft extends from the handle to terminate in a distal end portion, and the catheter shaft includes a lumen extending through the shaft. An electrically conductive anchor has an anchor body at the distal end portion of the shaft, in which the anchor body defines a first sensor configured to provide a first sensor signal in response to a first sensed signal. A steering wire has proximal and distal ends, in which the proximal end of the steering wire is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor. A second sensor extends from the distal end portion of the shaft and has a known fixed spatial position relative to the anchor body, in which the second sensor is configured to provide a second sensor signal in response to the second sensed signal. The tracking system includes first and second tracking modalities. The first tracking modality is configured to determine a position of the anchor based on the first sensor signal. The second tracking modality is configured to determine a position of the second sensor based on the second sensor signal.

[0008] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0009] FIG. 1 is a perspective view illustrating the distal end portion of a catheter that includes an electrode apparatus.

[0010] FIG. 2 is a side view illustrating a first example of internal features of the catheter of FIG. 1.

[0011] FIG. 3 is a side view illustrating a second example of the internal features of the catheter of FIG. 1.

[0012] FIG. 4 is a side view of an example handle, partially in phantom to show internal part of the handle.

[0013] FIG. 5 is a side view illustrating an example of variable diameter coil sensor.

[0014] FIG. 6 is a side view illustrating another example of a variable diameter coil sensor configured as an anchor.

[0015] FIG. 7 is a side view of a distal end portion of an example catheter illustrating the coil of FIG. 5 at the distal end portion without an overmolding layer.

[0016] FIG. 8 is a side view of a distal end portion of an example catheter illustrating the coil of FIG. 5 at the distal end portion with the overmolding layer.

[0017] FIG. 9 is a cross-sectional view of the catheter of FIG. 8 taken along lines 9-9.

[0018] FIG. 10 is an enlarged view of part of the cross-sectional view of FIG. 9 illustrating the catheter with the overmolding layer removed.

[0019] FIG. 11 is an enlarged view of part of the cross-sectional view of FIG. 9 with the oveimolding layer.

[0020] FIG. 12 is a block diagram of a system illustrating an example operating environment for a catheter device.DETAILED DESCRIPTION

[0021] This disclosure relates to a steerable multi-function catheter. The catheter includes an elongated shaft extending from a handle to terminate in a distal end portion of the shaft. The catheter also includes an anchor at a distal end portion of the shaft. One or more steering wires are coupled to the anchor, and a length of the steering wire(s) extends proximally from the anchor through the shaft to couple to a manipulator of the handle. The manipulator can be configured to adjust the length of the steering wire(s) to deflect a distal end portion of the catheter. A conductive wire is electrically coupled to the anchor.For example, the conductive wire can be coupled directly to the anchor (e.g., by welding, soldering or mechanical coupling) or to the steering wire (e.g., by welding, soldering or inter-wire coupling). The anchor can be configured to sense an electrical signal (e.g., a current or voltage), which can be initiated by one or more sources external to the body and / or within the body. The conductive wire can carry an electrical signal to a location beyond the proximal end of the steering wire in response to the electrical signal sensed by the anchor. A first localization system (e.g., configured to perform impedance-based localization) can be configured to determine a spatial position of the anchor based on the electrical signal sensed by the anchor.

[0022] In some examples, the catheter includes one or more other sensors, such as an electromagnetic sensor having a distal sensor portion extending from the distal end portion of the catheter shaft and having a known fixed spatial position relative to the anchor. The electromagnetic sensor can be configured to sense an electromagnetic field or generate an electromagnetic field. The sensor signal from the electromagnetic sensor can be processed by a second localization system (e.g., configured to perform electromagnetic-based localization) to determine a spatial position of the electromagnetic sensor.

[0023] As a further example, the anchor can have a cylindrical body, which can include a coil of electrically conductive wire. A length of the conductive wire can extend from an end of the coil through a lumen of the catheter shaft and be coupled to the handle. The coil can include a first portion having a first number of windings and a first outer diameter and a second portion having a second number of windings and a second outer diameter. The second portion can have a greater outer diameter than the first portion. An overmolding layer can encapsulate the first portion of the coil, including a radially outer surface thereof, and at least a radially outer surface of the second portion of the coil be exposed beyond the overmolding.

[0024] FIG. 1 is a perspective view of a catheter device (also referred to as a catheter) 100 illustrating a distal end portion 102 thereof. The device 100 includes an elongated catheter shaft 104 having a distal end 106 spaced apart from a proximal end (not shown). The shaft 104 extends from a handle (not shown - see FIG. 4) to terminate in the distal end 106, which defines a distal edge of the shaft 104. The shaft 104 can be formed of a flexible (e.g., pliant) material and be adapted to enable deflection of the distal end portion 102 relative to a proximal portion thereof. In some examples, the shaft 104 candefine a tubular body that includes one or more layers of a polymeric material, in which an inner polymer layer is surrounded by a wound or braided layer (e.g., braided stainless steel).

[0025] A jacket or jacketing layer (e.g., a tubular sleeve, overmolding, or lamination) 118 can surround the braided layer of the shaft 104 such that the braided layer is sandwiched between the inner and jacket layers. The jacket 118 can extend partially or fully over the length of the shaft 104. In some examples, the jacket 118 is over at least the distal end portion 102 of the shaft 104. The jacket 118 can extend axially a length beyond the distal end 106 of the shaft to terminate in a distal end 120 of the catheter 100 that defines an opening (also referred to as a distal opening of the catheter). For example, one or more apparatuses (e.g., an ablation electrode, sensor, probe, etc.) can move through the opening at the distal end 106 of the catheter.

[0026] The shaft 104 also includes a lumen 108 extending through the shaft 104 between proximal and distal ends thereof. The lumen 108 constitutes a main central lumen that extends axially through the shaft. Various parts and structures can extend through the lumen 108, including being axially movable within such lumen. In some examples there can be more than one lumen extending through the shaft 104, in which various devices or structures can extend. Also, or as an alternative, devices or structures can be axially moveable within respective lumens.(00027] The catheter 100 also includes an anchor 110 at the distal end portion 102, which can circumscribe the shaft 104, wholly or partially, depending on the configuration of the anchor. In some example embodiments the anchor 110 includes a ring-shaped anchor body 112, which is fixed with respect to distal end portion 102 of the shaft 104. In other example embodiments, the anchor body 112 has a generally cylindrical shape with a variable outer diameter along its axial length, such as including one or more portions (e.g., circumferentially extending ribs) having an outer diameter greater than a given amount located at one or more spaced apart axial regions along the length of the anchor body 112. A distal edge of the anchor body 112 can be flush with or spaced axially apart from the distal end 106 of the shaft 104. In other examples, the anchor body can have a C-shaped cross-sectional shape around the shaft 104.

[0028] The anchor body 112 has a sidewall that can extend axially a length along the shaft 104 and has a radial thickness along its axial length, which can be a fixed orvariable thickness. In some examples, the anchor body 112 includes a coil having a number of windings arranged axially to define the length of the anchor body. A radially outer surface portion of the anchor body 112 can remain exposed and contact bodily fluids during use of the catheter 100. As described herein, the anchor body 112 includes or is formed of an electrically conductive material and defines an electrode configured to provide a sensor signal in response to sensed electrical signal. For example, the anchor body 112 can define a reference electrode of an impedance-based navigation system. In other examples, the anchor body 112 can be part of or form another type of sensor or constitute an electrode for other sensing purposes. The anchor body 112 can be formed of stainless steel or an alloy, such as a corrosion-resistant biocompatible alloy platinum iridium and nickel alloys (e.g., a nickel-cobalt-chromium-molybdenum alloy, available commercially as MP35N®, from Standard Pressed Steel Co., Jenkinstown, PA). Other suitable electrically conductive and biocompatible materials can be used to form the anchor in other examples. The exposed surface of the anchor body 112 can also include an electrically conductive coating (e.g., silver or an alloy thereof) to facilitate sensing and / or biocompatibility functions. The exposed surface of the anchor body 112 thus can contact bodily fluid (e.g., blood) and / or tissue when inserted within a patient’s body.

[0029] One or more steering wires (also referred to as pull wires or steering cables) 114 can be coupled to the anchor 110 to provide for deflection (e.g., steering) of the catheter 100 responsive to movement of the steering wire(s) relative to the shaft 104. In some examples, the steering wire(s) 114 are formed of an electrically conductive material, such as stainless steel. In other examples, one or more steering wires can be formed of electrically insulating (non-conductive) material, such a polymer material. In still other examples, the steering wire(s) are formed of a combination of different types of materials, such as including polymer and metal components (e.g., polymer coated stainless steel wires). The steering wire 114 can extend through the central lumen 108 or through another lumen (e.g., a steering lumen), which extends axially through the shaft. The steering wire 114 has a distal end 116 coupled to the anchor body 112, and a proximal end (not shown) coupled to a manipulator in the handle (not shown - but see, e.g., FIG. 4). The distal end of the steering wire 114 is secured to the anchor. In some examples, the anchor includes a slot or recess extending partially or fully through a sidewall of the anchor body 112 arranged and configured to receive the distal end of the steering wire 114therein. Also, or alternatively, the distal end of the steering wire 114 can be secured to a radially outer surface or a radially inner surface of the anchor body 112. For example, the steering wire 114 can be secured to the surface of the anchor body by welding (e.g., laser welding), soldering, brazing or other metallurgical methods of connecting the steering wire and the anchor 110. In other examples, the distal end of the steering wire 114 can be embedded in and / or mechanically coupled with the anchor 110 (e.g., by a mechanical coupling, fitting or connector).

[0030] There can be any number of anchors distributed axially along the length of the shaft 104 to provide for deflection of respective shaft segments. Also, there can be any number of steering wires coupled to each of the anchors to provide for deflection of respective shaft segments in directions transverse to the shaft axis according to movement of the respective steering wires relative to the shaft 104.

[0031] As a further example, the anchor 110 circumscribes a proximal portion of the jacket 118 near (e.g., spaced proximally) the distal end 106 of the shaft. The jacket 118 thus can extend over a portion (e.g., over the distal end portion 102) of the shaft 104 or the entire axial length of the shaft, and at least a portion of the outer surface of the anchor remains exposed. The jacket 118 can be formed by overmolding one or more layers of a polymer or other suitable pliant insulating and biocompatible material to encapsulate the portion of the shaft 104 that resides radially inward from die jacket 118. In examples where the anchor body 112 has a variable outer diameter, the jacket (e.g., overmolding) 118 can be applied to cover portions of the anchor body with an outer diameter less than a given diameter while portion(s) with an outer diameter greater than the given diameter remain exposed through the jacket.

[0032] Also, or as an alternative, the catheter 100 can include one or more other sensors 124 in addition to the anchor 110. The sensor 124 includes a distal sensor portion 126 that extends from the distal end 106 of the catheter shaft. In an example, the distal sensor portion 126 extends axially along or adjacent a radially inner sidewall of the outer layer 118 and the distal end of the sensor 124 is spaced at or proximally located from the distal opening 120. One or more wires (not shown - but see, e.g., FIGS 2 and 3) can extend proximally from the distal sensor portion 126, such as through the central lumen (or another lumen) of the shaft 104, to carry a respective sensor signal based on a detected signal or condition. In an example, the sensor 124 has a known fixed spatial positionrelative to the anchor 110 (also a sensor). The known fixed spatial position can be used, such as for mapping and / or spatial registration, where one or both of the sensor 124 and the anchor 110 are used as sensors for navigation or localization.

[0033] For example, the sensor 124 can be an electromagnetic sensor having a distal sensor portion 126 extending from the distal end portion of the catheter shaft to terminate in a distal end thereof. The electromagnetic sensor 124 can be configured to provide a sensor signal in response to an electromagnetic field provided by a field generator. For example, the distal sensor portion 126 can include a conductive sensor coil around a magnetic core and a conductive link (e.g., a twisted pair of wires) that extends from the coil to carry the sensor signal to processing electronics. The sensor 124 can be a five degree of freedom (5DOF) or six degree of freedom (6DOF) sensor (e.g., commercially available from Northern Digital Inc. of Ontario, Canada). The electromagnetic sensor 124 thus can be configured to provide a sensor signal in response to an electromagnetic field, such as provided by a field generator of a navigational tracking system. Other examples of sensing coils that can be used for determining the location of a catheter or probe inserted into a selected body cavity of a patient response to electromagnetic fields that are consistent with this disclosure would also be known to one of ordinary skill in the art. Other types of electromagnetic sensors and electromagnetic localization methods can also be used to track the catheter 100 in other examples.

[0034] In some examples, the catheter 100 includes an electrode apparatus 130 extending from the distal end portion 102. The electrode apparatus 130 can include one or more electrodes 132 distributed over a surface of a substrate (or body) 134. The one or more of the electrodes 132 can be configured to sense of electrical signals, sense electric fields, transmit electrical signals (e.g., electrical signals generated by a generator coupled to the catheter 100) and / or generate electric fields (e.g., via the transmitted electrical signals). The number and type of electrodes in the apparatus 130 can vary according to desired use of the electrode apparatus. The substrate 134 can have any of a variety of shapes and configurations, such as a basket (e.g., having a spherical, teardrop, or ellipsoidal shape), a ring (e.g., a circular or ellipsoidal loop, a spiral or coil shape, a helical shape), or a probe electrode (e.g., having an elongate tubular body with a flat or semi- spherical tip). In the example of FIGS. 1-3, the electrode apparatus 130 includes aplurality of electrodes 132 distributed along a circular loop body 134 that extends between respective ends thereof, shown at 136 and 138.

[0035] The ends 136 and 138 of the body 134 can be coupled to elongated rods 140 and 142, respectively, which can be moveable axially within the lumen 108, independently or collectively, such as to adjust the position, size, and / or shape of the apparatus 130. The body 134 can have a solid or hollow core structure, which can carry wires or traces coupled to each of the electrodes 132. The rod 140 can include a lumen through which a guidewire (not shown) can traverse, and the guidewire can have a distal end portion that is independently steerable from the catheter body. As one example, the electrode apparatus 130 can be configured according to the electrode in the PULSESELECT® medical device system from Medtronic Inc. of Minnesota, USA. Other types and configurations of electrode apparatuses can be used as the electrode apparatus 130 in other examples.

[0036] In some examples, the electrode apparatus 130 can be transitioned between compressed and uncompressed states, and is shown in the uncompressed (e.g., expanded) state in FIGS. 1-3. The expansion can be automatic, such as in response to removal of an external force when the electrode apparatus 130 is moved distally through the lumen and beyond the distal end of the catheter 100. Alternatively, or additionally, the electrode apparatus 130 can be expandable in response to application of a radially outward force, such as by a balloon or other expansion mechanism. Alternatively, the electrode apparatus 130 can have a generally fixed shape and size in the absence of application of an external force. The materials of the electrode apparatus 130 can be selected according to mechanical properties of the apparatus.

[0037] Additionally, the catheter 100 includes conductive wire electrically coupled to the anchor 110 and configured to transmit the sensor signal to a location beyond the proximal end of the steering wire 114, such as by signal processing and / or other circuitry. For example, the external location includes an electrical connector that may be on or external to the catheter 100 and the handle thereof. The electrical connection between the conductive wire, which carries the sensor signal, and the anchor 110 can be implemented according to various example embodiments described herein. For example, the conductive wire can have a distal end that is fixed to and / or extends from the anchor body 112 or it can be coupled to a steering wire that is fixed to and / or extends from the anchor body.

[0038] FIGS. 2 and 3 are side views of different example embodiments of the distal end portion 102 of the catheter 100 of FIG. 1. FIG. 4 shows an example of the handle that can be used with die catheter of FIG. 3. Accordingly, the description of FIGS. 2, 3, and 4 also refers to die catheter 100 of FIG. 1.

[0039] As shown in the example of FIG. 2, the catheter 100 includes a conductive wire 150 having a distal end 152 fixed to the anchor body 112. The conductive wire 150 can extend through the central lumen 108 or through another lumen that extends axially through the shaft 104. In another example, the conductive wire 150 can include a conductive wire that forms part of a braided tubular wall of the shaft 104. The conductive wire 150 thus can communicate electrical signals (e.g., representative of sensed electrical signals) fiom the anchor body 112 to a location that is external to the catheter 100, such as to associated sensing and / or processing circuitry. For example, the conductive wire 150 has a proximal termination at a connector or junction, which can be coupled to the associated sensing and / or processing circuitry.

[0040] FIGS. 3 and 4 illustrate another example of the catheter 100, in which the anchor 110 is configured to enable steering of the distal aid portion 102 by one or more steering wires 114 and to operate as a sensor. Each of the steering wires 114 has a distal end 116 that is coupled to the anchor body 112. For example, a pair of steering wire 114 can be coupled to diametrically opposed sides of the anchor body to provide steering of the distal end portion along a plane. Other numbers of steering wires can be used to provide for steering in less or more directions. The steering wires 114 can extend through the central lumen or other lumen (e.g., steering channels) that extend axially through the shaft 104.

[0041] As shown in FIG. 4, a proximal end 154 of die shaft 104 terminates within a handle 160 of the catheter 100. For example, die proximal end 154 of the shaft 104 can be mounted to an internal wall that forms part of a housing of handle 160 to fix die shaft 104 with respect to the handle. The steering wires 114 extend fiom the proximal end 154 of the shaft and are coupled to a manipulator 162. The manipulator 162 can be actuated (e.g., by rotation or translation thereof) in one or more directions to effect steering of the distal aid portion 102 of the catheter. The actuation of the manipulator 162 can be manual or automated (e.g., robotically controlled) or a combination thereof, The type of manipulator and handle design can vary according to user preferences. As shown in FIG.4, the conductive wire 150 is coupled to a proximal portion of a given steering wire 114, such as at a location between the manipulator 162 and the proximal end 154 of die shaft. Thus, a signal received at the anchor 110 is communicated through the steering wire 114, to die conductive wire 150 and to a location external to the catheter, such as to associated sensing and / or processing circuitry. For example, the conductive wire 150 can have a proximal termination at a connector or electrical junction, which can be coupled to associated sensing and / or processing circuitry (see, e.g., FIG. 12).

[0042] FIG. 5 is a side view illustrating an example of a variable diameter coil 200. The coil 200 can be formed of a length of a conductive wire 202 that can be wound with respective windings turned on one or more mandrels or other substrates having respective diameters to produce the variable diameter coil 200 having a circular cross- sectional shape. The conductive wire 202 has a thickness, shown as T1.

[0043] In an example, the coil 200 includes a number of windings, shown as proximal and distal winding portions 204 and 206 having a first outer diameter DI , and another number of windings, shown as intermediate winding portion 208, having a second outer diameter D2. In the example of FIG. 5, D2>D1. While three winding portions 204, 206, and 208 are shown in FIG. 5, in other examples, the coil can have any number of two or more winding portions having different outer diameters. Also, each of the winding portions 204, 206 and 208 can have a desired number of windings according to application requirements, and the number of windings in each portion 204, 206 and 208 can be the same or different. One or more lengths 210 of the conductive wire 202 can extend axially from the proximal winding portion 206. Also, or as an alternative, a length of the conductive wire 202 can extend axially from one or more other of the winding portions 204 and / or 208 (not shown, but see, e.g., FIG. 6). In some examples, winding portions with the smaller first outer DI (e.g., proximal winding portion 204 and distal winding portion 206) as well as the length 210 of the wire can be encapsulated by an electrically insulating material, such as a polymer. The winding portion with the larger second outer diameter D2 (e.g., intermediate winding portion 208) can remain unencapsulated to expose a radially outer surface of the conductive wire in such winding portion 208. For example, the proximal and distal winding portions 204 and 206 can be embedded within a sidewall of a tubular sleeve (e.g., outer layer 118) and the intermediate winding portion 208 (or atleast a radially outer surface extends outwardly from the jacket to remain exposed, such as to enable direct contact with bodily fluid and / or tissue (see, e.g., FIG. 6).

[0044] The coil 200 can be implemented as a sensor, such as an electromagnetic sensor for detecting an electric field and / or as an electrode sensor for detecting an electrical signal (e.g., an electrophysiological signal or a signal provided by another electrode. Also, or as an alternative, the coil 200 can be implemented as an anchor ring of a steerable catheter (e.g., as anchor 110 or the catheter 100), as described herein. As described herein, the length of conductive wire 210 extending from the coil 200 thus can implement one or more functions, including as a wire to communicate sensor signals from the coil to external circuitry and / or as a steering wire to deflect a portion of a catheter shaft to which the coil is coupled. That is, the coil 200 can be an anchor ring of a catheter that is also used as a reference electrode sensor.

[0045] FIG. 6 is a side sectional view illustrating an example of part a catheter 250 that includes variable diameter coil 200 of FIG. 5. Accordingly, aspects of the description of FIG. 6 also refer to aspects of the coil 200 described with respect to FIG. 5. In the example of FIG. 6, two lengths 210 of the conductive wire 202 extend from the coil 200, in which one length of wire extends from the proximal winding portion 206 and the other length of wire extends from the distal winding portion 204. In some examples, the coil 200 and the two lengths extending therefrom are formed of a single length of the conductive wire 202. As shown in the example of FIG. 6, the respective lengths 210 extend from opposite ends of the coil 200, which ends can be angularly positioned at diametrically opposed sides of the coil to facilitate passage of the wires axially through the catheter (e.g., within respective lumens).

[0046] As shown, the coil 200, including winding portions 204, 206 and 208, circumscribes an elongated catheter shaft 252 (e.g., the shaft 104). The shaft 252 can extend longitudinally between a distal end 254 and a proximal end (not shown, but see, e.g., end 154 in FIG. 4). In an example, the shaft 252 includes a central lumen 256 defined by an inner sidewall of the shaft. The shaft 252 can also include one or more other lumens (e.g., channels) through which the lengths of wire 210 can extend. Alternatively, the lengths of wire 210 can extend through the central lumen.

[0047] In the example of FIG. 6, the lengths 210 of conductive wire 202 can be adapted both to carry electric signals responsive to signals sensed by the coil 200 and steerthe distal end portion of the catheter shaft 252 based on movement of the lengths of wire relative to the shaft. To facilitate the steering function a number of windings in coil 200 can be mechanically coupled together by support structures 260, such as rods, pins or other couplings affixed to adjacent windings in the axial direction. As shown in FIG. 6, for example, the support structures 260 can increase the rigidity or stiffness of the proximal and distal winding portions 206 and 204 from which the lengths of wire 210 extend. For example, the support structures 260 can be formed by laser welding two more windings together at locations across the coil 200 to increase the stiffness along the coil. Other support structures can be used to increase the stiffness and resist deflection of the winding portions responsive to axial steering forces being applied to the lengths of wire 210 (e.g., by a manipulator).

[0048] Additionally, in some examples, a jacket or jacketing layer 262 (e.g., a tubular outer sleeve or overmolding) can encapsulate the proximal and distal winding portions 204 and 206 while leaving at least a radially outer surface of the intermediate winding portion 208 exposed. In some examples, approximately one-half of the larger second outer diameter D2 of the intermediate winding portion 208 can remain exposed outside of the jacket 262. Less or more of the larger diameter intermediate winding portion 208 can remain exposed in other examples. The jacket 262 can be implemented according to the example jacket 118 described herein with respect to FIGS. 1-3. For example, the jacket 262 can be applied as one or more layers of an electrically insulating material (e.g., through an overmolding, injection molding, or other fabrication technique) to define an ovennolding layer around part of the distal end portion of the catheter shaft 252. In an example, the distal end 254 of the catheter shaft 252 can extend a distance axially beyond a distal end 266 of the jacket 262. Thus, the ovennolding provided by the jacket 262 can provide a mechanical interlock (or interference fit) between outer surface of the catheter 250 and the coil 200. The jacket 262 can also increase the stiffness of the distal end portion of the shaft as well as provide a seal (e.g., a hermetic seal) between the exterior of the catheter and an interior of the catheter through which the lengths of wire 210 can extend to communicate signals to and / or from the coil 200.

[0049] FIGS. 7, 8, 9, 10, and 11 depict various views of part of a catheter 300 that includes the variable diameter coil 200 of FIG. 5 or 6. Accordingly, aspects of the description of FIGS. 7, 8, 9, 10, and 11 may also refer to aspects of the coil described withrespect to FIGS. 5 and 6. The catheter 300 includes an elongated catheter shaft 302 of a pliant material to enable deflection of at least the distal end portion of the catheter 300. The shaft 302 includes a central lumen 304 extending through the shaft. The shaft 302 can include a number of other lumens (e.g., channels) 306 through which respective wires or devices can traverse. The coil 200 is disposed around the shaft 302. For example, smaller diameter winding portions 204 and 206 have an inner diameter that approximates an outer diameter of the shaft 302 (or a liner or other outer layer thereof) to create an interference fit between the coil and the shaft. As described herein, the coil 200 is configured as an electrode or sensor that includes one or more integrated wires that extend from respective ends of the coils and through a lumen (e.g., lumen 304 or 306) to a proximal end of the shaft. In some types of catheters, a distal ring 308 can be positioned around the shaft 302 distally of the coil 200. For example, the distal ring 308 has a proximal end that abuts a distal end of the coil 200. A distal end of the ring 308 can be spaced apart from an open distal end of the shaft 302.

[0050] As shown in FIGS. 8, 9, and 11, a jacket (e.g., a jacketing layer, tubular sleeve or overmolding) 310 can encapsulate the smaller diameter proximal and distal winding portions 204 and 206. At least a radially outer surface of the larger diameter winding portion 208 remains exposed (unencapsulated), such as to contact bodily fluid and / or tissue. FIG. 9 is a cross-sectional view of the catheter shown in FIG. 8 showing the mechanical interlock between the jacket 310 and the coil 200. FIGS. 10 and 11 are enlarged sectional views depicting the catheter before and after the jacket 310 is formed on the catheter 300.

[0051] The jacket 310 can be an electrically insulating (non-conductive) plastic material or resin that is injection molded as an overmolding to secure the coil 200 at a fixed position on the shaft 302. The fixed position of the coil 200 can be known relative to one or more other sensors (e.g., navigation or localization sensors 124) that can also be mounted on the catheter 300. In some examples, the coil 200 can also be adapted to operate as a steering anchor. In examples when the coil 200 is used as a steering anchor and sensor, each wire 202 that extends from the coil is adapted to function both as a steering wire and as a conductor to communicate electrical signals sensed by the exposed winding portion 208 of the coil. In other examples, a separate steering anchor 314 can be used to implement steering functions for the catheter 300.

[0052] FIG. 12 is a block diagram of a system 350 illustrating an example operating environment for a catheter 352, which can be positioned within a patient’s body. The catheter 352 can be implemented according to any of the example catheters described herein (e.g., the catheter 100, 250, 300). In the system 350 of FIG. 12, the catheter 352 includes an arrangement of two or more sensors 354 and 356 that provide respective sensor signals for localization thereof by a tracking system 358, which includes two or more respective tracking modalities 360 and 362. For example, the sensor 354 is implemented as one or more sensor coils (e.g., sensor 124) configured to provide a current signal responsive to an electromagnetic field that is generated by one or more field generators implemented by the tracking modality 360. The other sensor 356 can be implemented by a steering anchor (e.g., anchor 110, coil 200), as described herein. For example, the sensor 356 is configured to provide a sensor signal responsive to a voltage or current provided at one or more electrodes (e.g., orthogonal patch electrodes) on the surface of the body 353. The sensor signal provided by the sensor 356 thus can be representative of an impedance measurement (e.g., bioimpedance) between the body 353 and the respective electrodes.

[0053] In an example, the tracking modality 360 is an electromagnetic tracking system and the tracking modality 362 is an impedance-based tracking system. Examples of a tracking system that can implement multiple tracking modalities to localize a catheter are known to those of ordinary skill in the art. Other tracking modalities can be used in other examples. The tracking system 358 is configured to spatially correlate the respective positions of the sensors 354 and 356, which have a fixed known position relative to each other on the catheter 352. The tracking system 358 can further register the positions of the respective sensors 354 and 356 in a respective spatial domain based on the sensors’ known relative positions and tracking sensor signals provided by the respective sensors. For example, the catheter 352 can be moved throughout an anatomical structure (e.g., cavity or vessel) while each tracking modality 360, 362 compute positions of the sensors 354 and 356. The tracking system 358 can use the position information determined by tracking modalities 360 and 362 during movement of the catheter 352 to construct a spatial map (e.g., a table). The tracking system 358 can also compute a spatial transform between the electromagnetic and impedance spatial tracking domains, which can be used to track thespatial position of the catheter 352, including one or more other electrodes (e.g., ablation or mapping electrodes) earned by the catheter.

[0054] The system 350 also includes a controller 370 and a catheter interface unit 372.The catheter interface unit 372 is coupled (e.g., in electrical communication) with the catheter 352 through one or more electrically conductive wires. The interface unit 372 can include connectors or couplings adapted to electrically couple the controller 370 with the sensors 354 and 356 and electrodes of the catheter 352. The controller 370 includes a signal generator 374 which can be configured to provide ablation energy to the catheter 504 through the catheter interface unit 372. The catheter interface unit 372 can also route sensor signals provided by sensors 354 and 356 to the tracking system to enable localization thereof.

[0055] In some examples, the catheter interface unit 372 can include a graphical user interface to display information (e.g., positional and / or operating information) about the ablation electrode during treatment. Further, or instead, the catheter interface unit 372 can display information about the energy provided by the ablation electrode 512 signal generator 374 and / or information about the state or condition of tissue being ablated. For example, the catheter 352 can include one or more ablation delivery mechanism configured to perform any one or more types of ablation including pulsed field ablation (e.g., reversible or irreversible electroporation), radio frequency ablation, cryoablation, laser ablation, etc., and the interface unit 372 can provide information about the ablation procedure, including position information derived from one or more of the sensor signals.EXAMPLE EMBODIMENTS:(00056] Several aspects of the present technology are set forth in the following examples.1. A catheter, comprising: a handle including a manipulator; a catheter shaft extending from the handle to terminate in a distal end portion, the catheter shaft including a lumen extending through the shaft;an electrically conductive anchor at the distal end portion and including an anchor body configured to provide a sensor signal in response to sensed electrical signal; a steering wire having proximal and distal ends, in which the proximal end is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor; and a conductive wire electrically couples! to the anchor and configured to transmit the sensor signal to a location beyond the proximal end of the steering wire.2. The catheter of example 1, wherein the location comprises an electrical connector on or external to the catheter and the handle.3. The catheter according to example 1 or 2, wherein a distal end of the conductive wire is coupled to the anchor.4. The catheter according to example 1 or 2, wherein the steering wire is an electrically conductive material and a distal end of the conductive wire is coupled to the steering wire within the handle.5. The catheter according to any preceding example, wherein the sensor signal is a first sensor signal and the catheter further comprises an electromagnetic sensor having a distal sensor portion extending from the distal end portion of the catheter shaft and having a known fixed spatial position relative to the anchor, the electromagnetic sensor configured to provide a second sensor signal in response to an electromagnetic field.6. The catheter according to any preceding example, wherein the anchor comprises a ring having a cylindrical body.7. The catheter of example 6, wherein the cylindrical body of the anchor comprises a coil of the electrically conductive wire, in which a length of the conductive wire extends from the coil through the lumen and into the handle.8. The catheter of example 7, wherein the coil includes a first portion of a first number of windings having a first outer diameter and second portion of a second number of windings having a second outer diameter, in which the second outer diameter is greater than the first outer diameter.9. The catheter of example 8, further comprising an overmolding encapsulating the first portion of the coil, including a radially outer surface thereof, and at least a radially outer surface of the second portion of the coil being exposed beyond the overmolding.10. The catheter according to any preceding example, further comprising an electrode apparatus extending from the distal end portion of the catheter shaft.11. The catheter of example 10, wherein the electrode apparatus is axially movable within the lumen and movable between a compressed condition and an expanded condition and includes a plurality of electrodes, each having a known a fixed position relative to each other electrode when in the ablation electrode apparatus is in the expanded condition.12. A catheter, comprising: a handle; a catheter shaft extending from the handle to terminate in a distal end portion, in which the catheter shaft includes a lumen extending through the catheter shaft; a coil of electrically conductive wire at the distal end portion of the catheter shaft, in which the coil includes a first portion of a first number of windings having a first outer diameter and second portion of a second number of windings having a second outer diameter, the second outer diameter is greater than the first outerdiameter, a length of the conductive wire extends from the coil through the lumen and to the handle, and the coil is configured to provide a sensor signal in response to sensed electrical signal; an overmolding encapsulating the first portion of the coil, including a radially outer surface thereof, in which at least a radially outer surface of the second portion of the coil is exposed beyond the overmolding; and an electrode apparatus including an electrode and extending from the distal end portion of the catheter shaft.13. The catheter of example 12, wherein the handle includes a manipulator, the coil defines an anchor and the length of the conductive wire defines a steering wire that extends into the handle and a distal end of the steering wire is coupled to the manipulator.14. The catheter of example 13, wherein the length of the conductive wire is a first length of the conductive wire, the catheter further comprising a second length of the conductive wire extending from the coil through the lumen into the handle and is coupled the manipulator.15. The catheter according to example 13 or 14, wherein the first portion of the coil is a proximal portion in which at least some of the winding of the proximal portion are in a fixed position relative to each other.16. The catheter according to any of examples 13, 14, or 15, wherein the coil further comprises a third portion that extends distally from the second portion and has a third outer diameter commensurate with the first outer diameter, the overmolding encapsulating the third portion of the coil.17. The catheter according to any of examples 14, 15, or 16, further comprising an electromagnetic sensor having a distal end portion extending from the distal end portion of the catheter shaft and having a known fixed spatial position relative to the anchor.18. The catheter according to any of examples 12, 13, 14, 15, 16, or 17, further comprising an electrode apparatus extending from the distal end portion of the catheter shaft.19. The catheter of example 18, wherein the electrode apparatus is axially movable within the lumen and movable between a compressed condition and an expanded condition and includes a plurality of electrodes, each having a known position relative to each other electrode when the ablation electrode apparatus is in the expanded condition.20. A system, comprising: a catheter comprising: a handle including a manipulator; a catheter shaft extending from the handle to terminate in a distal end portion, the catheter shaft including a lumen extending through the shaft; an electrically conductive anchor having an anchor body at the distal end portion of the shaft, wherein the anchor body defines a first sensor configured to provide a first sensor signal in response to a first sensed signal; a steering wire having proximal and distal ends, in which the proximal end of the steering wire is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor; and a second sensor extending from the distal end portion of the shaft and having a known fixed spatial position relative to the anchor body, in which the second sensor is configured to provide a second sensor signal in response to a second sensed signal; a first tracking modality configured to determine a position of the anchor based on the first sensor signal; and a second tracking modality configured to determine a position of the second sensor based on the second sensor signal.21. The system of example 20, further comprising a conductive wire electrically coupled to the anchor and configured to propagate the first sensor signal.22. The system of example 21, wherein a distal end of the conductive wire is coupled to the anchor.23. The system of example 21, wherein the steering wire is an electrically conductive material and a distal end of the conductive wire is coupled to the steering wire within the handle.24. The system according to any of examples 20, 21, 22, or 23, wherein the catheter further comprises an electrode apparatus extending from the distal end portion of the catheter shaft.25. The system of example 24, wherein the electrode apparatus is axially movable within the lumen and movable between a compressed condition and an expanded condition and includes a plurality of electrodes, each having a known position relative to each other electrode when the ablation electrode apparatus is in the expanded condition.26. The system according to any of examples 20, 21 , 22, 23, 24, or 25, wherein: the electrical signal includes a plurality of signals supplied by an arrangement of electrodes spaced apart from first sensor, and the second sensor is an electromagnetic sensor configured to provide the second sensor signal in response to an electromagnetic field.27. The system according to any of examples 20, 21, 22, 23, 24, 25, or 26, wherein the anchor comprises a ring having a cylindrical body.28. The system of example 27, wherein the cylindrical body of the anchor comprises a coil of the electrically conductive wire, in which a length of the conductive wire extends from the coil through the lumen and into the handle.29. The system of example 28, wherein the coil includes a first portion of a first number of windings having a first outer diameter and second portion of a second number of windings having a second outer diameter, in which the second outer diameter is greater than the first outer diameter.30. The system of example 29, wherein the catheter further comprises an overmolding encapsulating the first portion of the coil, including a radially outer surface thereof, and at least a radially outer surface of the second portion of the coil being exposed beyond the overmolding.

[0057] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0058] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or anyother medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0059] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fidly implemented in one or more circuits or logic elements.

[0060] It will be understood that, although the terms “first,” “second,” etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0061] In this description, the term “couple” may cover connections, communications, or signal paths that enable a functional relationship consistent with this description. For example, if device A generates a signal to control device B to perform an action: (a) in a first example, device A is coupled to device B by direct connection; or (b) in a second example, device A is coupled to device B through intervening component C if intervening component C does not alter the functional relationship between device A and device B, such that device B is controlled by device A via the control signal generated by device A.

[0062] Additionally, in an effort to maintain clarity in the Figures, certain ones of duplicative components shown have not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate subcomponents, with either of these formations involving any suitable stock or bespokecomponents and / or any suitable material or combinations of materials; however, the chosen material(s) should be biocompatible for many applications. Any of the described structures and components could be disposable or reusable as desired for a particular use environment.

[0063] Modifications are possible in the described embodiments, and other embodiments are possible, within the scope of the claims.

Claims

WHAT IS CLAIMED IS:

1. A catheter, comprising: a handle including a manipulator; a catheter shaft extending from the handle to terminate in a distal end portion, the catheter shaft including a lumen extending through the shaft; an electrically conductive anchor at the distal end portion and including an anchor body configured to provide a sensor signal in response to a sensed electrical signal; a steering wire having proximal and distal ends, in which the proximal end is coupled to the manipulator, and the distal end of the steering wire is coupled to the anchor; and a conductive wire electrically coupled to the anchor and configured to transmit the sensor signal to a location beyond the proximal end of the steering wire.

2. The catheter of claim 1, wherein the location comprises an electrical connector on or external to the catheter and the handle.

3. The catheter according to claim 1 , wherein a distal end of the conductive wire is coupled to the anchor.

4. The catheter according to claim 1 , wherein the steering wire is an electrically conductive material and a distal end of the conductive wire is coupled to the steering wire within the handle.

5. The catheter according to claim 1, wherein the sensor signal is a first sensor signal and the catheter further comprises an electromagnetic sensor having a distal sensor portion extending from the distal end portion of the catheter shaft and having a known fixed spatial position relative to the anchor, the electromagnetic sensor configured to provide a second sensor signal in response to an electromagnetic field.

6. The catheter according to claim 1 , wherein the anchor comprises a ring having a cylindrical body.

7. The catheter of claim 6, wherein the cylindrical body of the anchor comprises a coil of the electrically conductive wire, in which a length of the conductive wire extends from the coil through the lumen and into the handle.

8. The catheter of claim 7, wherein the coil includes a first portion of a first number of windings having a first outer diameter and second portion of a second number of windings having a second outer diameter, in which the second outer diameter is greater than the first outer diameter.

9. The catheter of claim 8, further comprising an overmolding encapsulating the first portion of the coil, including a radially outer surface thereof, and at least a radially outer surface of the second portion of the coil being exposed beyond the overmolding.

10. The catheter according to claim 1, further comprising an electrode apparatus extending from the distal end portion of the catheter shaft.

11. The catheter of claim 10, wherein the electrode apparatus is axially movable within the lumen and movable between a compressed condition and an expanded condition and includes a plurality of electrodes, each having a known a fixed position relative to each other electrode when in the ablation electrode apparatus is in the expanded condition.

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