Adjustable electrode array geometry

Abstract

A catheter includes a catheter body having a proximal end and an opposite, distal end, and an electrode assembly to be deployed from the distal end of the catheter body. The electrode assembly includes a wire disposed at least partially within the catheter body, first and second electrodes coupled to the wire and disposed within the catheter body, and a sensor that detects whether at least one of the first electrode or the second electrode has been deployed from the distal end of the catheter body. The sensor generates a signal corresponding to whether the at least one of the first electrode or the second electrode has been deployed from the distal end of the catheter body. The catheter also includes a controller coupled to the sensor to receive the signal. The controller activates the at least one of the first electrode or the second electrode based on the signal.

Description

A0012712W001ADJUSTABLE ELECTRODE ARRAY GEOMETRY

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 749,045, filed January 24, 2025, the entire content of which is incorporated herein by reference.FIELD

[0002] The present technology is generally related to catheters and to electrode assemblies for catheters, including electrode assemblies for ablation catheters.BACKGROUND

[0003] Catheters, including ablation catheters, often include an electrode assembly having one or more electrodes that are used for ablation and / or mapping of the human body. The electrode assemblies have a particular geometry and arrangement of the electrodes, depending for example upon the type of treatment. For example, with atrial fibrillation cases (e.g., paroxysmal and persistent cases), different anatomies and diagnoses benefit from using particular electrode geometries to deliver the required treatment. Some patients require ablation to the pulmonary veins, which may require or otherwise benefit from an electrode assembly having a lasso or focal shape. Other patients require ablation to the posterior wall of the heart, which may require or otherwise benefit from an electrode assembly having a linear or focal shape. For patients requiring both types of ablation, a device exchange is required, which may add to the operation time. Additionally, current lasso and linear designs used during surgical operations have only a single size, and only account for a nominal heart anatomy. The current designs do not account for varying heart anatomies. Accordingly, usability and surgical success can be impacted when trying to use these devices on abnormal (e.g., extreme) heart anatomies.SUMMARY

[0004] The techniques of this disclosure generally relate to catheters having adjustable electrode assemblies that deploy from a distal end of a catheter body to expose a portion or all of the electrodes on the electrode assembly. The techniques relate toA0012712W001activating one or more of the electrodes in the electrode assembly based for example on a position of the electrode(s), and / or a position of a deployment mechanism (e.g., a thumb slide on a handle of the catheter), and to forming the electrode assembly into one or more of a plurality of different positions and / or geometric shapes when the electrode assembly is deployed from the distal end of the catheter body. The electrode assemblies may be adjusted to various types of geometric shapes to account for different types of treatment, and / or may be adjusted in size to account for varying heart anatomies.

[0005] In one aspect, the disclosure provides a catheter including a catheter body having a proximal end and an opposite, distal end, and an electrode assembly to be deployed from the distal end of the catheter body. The electrode assembly includes a wire disposed at least partially within the catheter body, first and second electrodes coupled to the wire and disposed within the catheter body, and a sensor that detects whether at least one of the first electrode or the second electrode has been deployed from the distal end of the catheter body. The sensor generates a signal corresponding to whether the at least one of the first electrode or the second electrode has been deployed from the distal end of the catheter body. The catheter also includes a controller coupled to the sensor to receive the signal. The controller activates the at least one of the first electrode or the second electrode based on the signal.

[0006] 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 THE DRAWINGS

[0007] FIG. l is a schematic view of a catheter according to one example, with an adjustable electrode assembly in a first, focal position.

[0008] FIG. 2 is a schematic view of the catheter of FIG. 1, with the electrode assembly in a second, lasso position.

[0009] FIG. 3 is a schematic view of the catheter of FIG. 1, with the electrode assembly in a third, linear position.A0012712W001

[0010] FIG. 4 is a partial, schematic view of the catheter of FIG. 1, showing a deployed portion of the electrode assembly having a first diameter in the second, lasso position.

[0011] FIG. 5 is a partial, schematic view of the catheter of FIG. 1, showing a deployed portion of the electrode assembly having a second, enlarged diameter in the second, lasso position.

[0012] FIG. 6 is a partial, schematic view of a catheter according to another example, having an adjustable electrode assembly.

[0013] FIG. 7 is a partial, schematic view of the catheter of FIG. 6, illustrating the electrode assembly in a first, non-deployed position.

[0014] FIG. 8 is a partial, schematic view of the catheter of FIG. 6, illustrating the electrode assembly in a second, partially-deployed position.

[0015] FIG. 9 is a partial, schematic view of the catheter of FIG. 6, illustrating the electrode assembly in a third, fully deployed position.

[0016] FIG. 10 is a partial, schematic view of a catheter according to another example, having an adjustable electrode assembly.

[0017] FIG. 11 is a partial, schematic view of the catheter of FIG. 10, illustrating the electrode assembly in a first, non-deployed position.

[0018] FIG. 12 is a partial, schematic view of the catheter of FIG. 10, illustrating the electrode assembly in a second, partially deployed position.

[0019] FIG. 13 is a partial, schematic view of the catheter of FIG. 10, illustrating the electrode assembly in a third, fully deployed position.DETAILED DESCRIPTION

[0020] FIGS. 1-5 schematically illustrate a medical device in the form of a catheter 110. The illustrated catheter 110 is an ablation catheter for treating atrial fibrillation. InA0012712W001other examples, the catheter 110 is a different type of ablation catheter, is used to treat other conditions, and / or is a catheter used for purposes other than ablation.

[0021] With continued reference to FIGS. 1-5, the catheter 110 includes a catheter body 114 (e.g., a main catheter body and / or hollow tube) having a proximal end 118, an opposite distal end 122, and a central axis Al (e.g., extending axially through the catheter body 114). In some examples, the catheter body 114 (or at least a portion thereof) is flexible, and / or is formed from stainless steel or other suitable material. In some examples, the stainless steel is a braid or hypotube, and is encapsulated in plastic.

[0022] With reference to FIGS. 1-3, the catheter 110 also includes a handle 126 (illustrated schematically in an enlarged form in FIGS. 1-3) coupled to the catheter body 114 (e.g., to the proximal end 118 of the catheter body 114, or to another location along the catheter body 114). In other examples, the catheter 110 does not include a handle 126, and / or includes multiple catheter bodies 114 (e.g., arranged coaxially), and / or includes other catheter components than those illustrated.

[0023] With continued reference to FIGS. 1-5, the catheter 110 further includes an electrode assembly 130 having one or more electrodes (e.g., ring electrodes or other electrodes) that may be used for ablation and / or mapping (e.g., during atrial fibrillation treatment). The electrode assembly 130 (or at least a portion thereof) is movable relative to the distal end 122 of the catheter body 114, such that a portion or all of the electrode assembly 130 may be deployed distally from the distal end 122 of the catheter body 114.

[0024] In the illustrated example, the electrode assembly 130 includes a single wire 134 (e.g., spline) disposed at least partially within the catheter body 114. The wire 134 may be formed, at least in part, from nitinol, although other examples include other types of materials or combinations of materials forming the wire 134. Additionally, while only a single wire 134 is illustrated, other examples include other numbers of wires 134 (e.g., two wires, three wires, etc.).

[0025] As illustrated in FIGS. 1-3, the wire 134 includes a proximal end 138, and an opposite distal end 142. In the illustrated example, the distal end 142 of the wire 134 is coupled (e.g., fixed) to the catheter body 114, for example at or near the distal end 122 ofA0012712W001the catheter body 114. In some examples, the distal end 142 of the wire 134 is fixed to the catheter body 114 with an adhesive, a weld, a fastener, or via any other suitable structures or methods of attachment.

[0026] With continued reference to FIGS. 1-3, the proximal end 138 of the wire 134 is coupled to a deployment mechanism 146. In some examples, the proximal end 138 of the wire 134 is fixed to the deployment mechanism 146 with an adhesive, a weld, a fastener, or via any other suitable structures or methods of attachment. In yet other examples, the proximal end 138 is integrally formed as a single piece with the deployment mechanism 146.

[0027] The deployment mechanism 146 may include, for example, a thumb slide, a lever, a switch, a rotatable knob, and / or other movable structure or body that may be moved linearly and / or rotationally relative to the handle 126 and / or to the catheter body 114, such that when the deployment mechanism 146 is activated (e.g., moved) the proximal end 138 of the wire 134 moves relative to the fixed, distal end 142 of the wire 134. In some examples, the deployment mechanism 146 and / or the handle 126 includes bumps and / or detent structures, or other structures, that facilitate and / or guide movement of the deployment mechanism 146 from one position to another position along the handle 126, and / or provide feedback to the user when the deployment mechanism 146 has reached different positions (e.g., a resistance or lack of resistance or snap-action that is felt by the user’s thumb).

[0028] In the illustrated example, the deployment mechanism 146 is located along an exterior of the handle 126, although in other examples the deployment mechanism 146 is located along a different area of the handle 126. In some examples, the deployment mechanism 146 is instead located along the catheter body 114 (e.g., whether a handle 126 is provided or not). In some examples, the catheter 110 includes more than one deployment mechanism 146.

[0029] With continued reference to FIGS. 1-5, in the illustrated example the electrode assembly 130 includes a first electrode 150a coupled to the wire 134, a second electrode 150b coupled to the wire 134, a third electrode 150c coupled to the wire 134, a fourth electrode 150d coupled to the wire 134, a fifth electrode 150e coupled to the wireA0012712W001134, a sixth electrode 150f coupled to the wire 134, and a seventh electrode 150g coupled to the wire 134. Other examples include other numbers of electrodes (e.g., less than seven electrodes or more than seven electrodes).

[0030] In the illustrated example, the first electrode 150a, the second electrode 150b, the third electrode 150c, the fourth electrode 150d, the fifth electrode 150e, the sixth electrode 150f, and the seventh electrode 150g are spaced evenly apart from one another as measured along a longitudinal axis of the wire 134. For example, a distance between the first electrode 150a and the second electrode 150b is identical to a distance between the second electrode 150b and the third electrode 150c. In other examples the electrodes of the electrode assembly 130 are arranged differently, and / or with different spacing than that illustrated.

[0031] With reference to FIGS. 1-3, each of the first electrode 150a, the second electrode 150b, the third electrode 150c, the fourth electrode 150d, the fifth electrode 150e, the sixth electrode 150f, and the seventh electrode 150g is positioned closer to the distal end 142 of the wire 134 than to the proximal end 138 of the wire 134. In other examples, however, at least one of the electrodes (e.g., the seventh electrode 150g, or a different electrode or electrodes if the catheter 110 includes more than seven electrodes) may be positioned closer to the proximal end 138 of the wire 134 than to the distal end 142 of the wire 134.

[0032] As described above, one or more of the electrodes of the electrode assembly 130 may be an ablation electrode, to deliver sufficient energy to a tissue (e.g., pulmonary vein) to ablate the tissue. Similarly, one or more of the electrodes of the electrode assembly 130 may be a mapping electrode, to map a location within the body. In the illustrated example, each of the electrodes in the electrode assembly 130 is both an ablation electrode and a mapping electrode. In other examples, only a portion of the electrodes of the electrode assembly 130 are ablation electrodes, and / or only a portion of the electrodes of the electrode assembly 130 are mapping electrodes. In some examples, all of the electrodes of the electrode assembly 130 are ablation electrodes and none of the electrodes are mapping electrodes, or all of the electrodes of the electrode assembly 130 are mapping electrodes, and none of the electrodes are ablation electrodes.A0012712W001

[0033] With reference to FIGS. 1-5, the deployment mechanism 146 is operable to adjust a location and / or positioning of each of the electrodes of the electrode assembly 130. For example, the deployment mechanism 146 allows the user to selectively deploy one or more of the electrodes of the electrode assembly 130 from the distal end 122 of the catheter body 114, and / or to activate one or more of the electrodes of the electrode assembly 130. Activation of an electrode may include, for example, receiving and / or emitting energy such as ablation energy to ablate tissue, and / or receiving a signal or signals for purposes of mapping. Additionally, the deployment mechanism 146 is operable to adjust the electrode assembly 130 to various types of geometric shapes, to account for different types of treatment.

[0034] For example, and with reference to FIG. 1, when the deployment mechanism 146 is moved (e.g., slid, rotated, etc.) into a first deployment mechanism position (e.g., a lower thumb slide position along the handle 126), the electrode assembly 130 is placed into a first, focal position in which only a single one of the electrodes (e.g., the first electrode 150a in the illustrated example) is both deployed from the distal end 122 of the catheter body 114 and is activated. In this first, focal position, the first electrode 150a is both deployed from the distal end 122 of the catheter body 114 and is also activated. The remaining electrodes remain partially or entirely positioned within the catheter body 114, and are not activated.

[0035] In other examples, the second electrode 150b (and for example one or more other electrodes of the electrode assembly 130) is also deployed from the distal end of the catheter body 114 in this focal position, but is not activated. As seen in FIG. 1, the first electrode 150a may be orientated and positioned generally along the central axis Al in the focal position, although in other examples the first electrode 150a is positioned or oriented differently than that illustrated in FIG. 1.

[0036] With continued reference to FIG. 1, activation of the first electrode 150a includes, for example, delivering ablation energy (e.g., radio frequency or pulsed field ablation energy) to the first electrode 150a, and / or receiving mapping signals from the first electrode 150a. In some examples, the catheter 110 includes an energy source 154 (FIG.1) coupled (e.g., with one or more wires) to the electrode assembly 130 and to one or moreA0012712W001of the first electrode 150a, the second electrode 150b, the third electrode 150c, the fourth electrode 150d, the fifth electrode 150e, the sixth electrode 150f, or the seventh electrode 150g. For example, separates wires (not shown) may extend from each of the electrodes within the electrode assembly 130 through (or alongside or separate from) the wire 134, and to the energy source 154. In yet other examples, the wire 134 itself, or a portion thereof, may provide a pathway for delivery of the energy from the energy source 154 to one or more of the electrodes of the electrode assembly 130.

[0037] In the illustrated example, the catheter 110 also includes a controller 158 (FIG. 1). The controller 158 may control an amount of energy delivered from the energy source 154 to one or more of the electrodes of the electrode assembly 130 (e.g., through the wire 134 and / or other separate wires), and / or receive signals from one or more of the electrodes of the electrode assembly 130 (e.g., through the wire 134 and / or other separate wires).

[0038] With continued reference to FIG. 1, in some examples the catheter 110 includes a first sensor 162 that detects (e.g., directly) whether the first electrode 150a, the second electrode 150b, or any of the other electrodes of the electrode assembly 130, has been deployed from the distal end 122 of the catheter body 114. The first sensor 162 may be located, for example, on or near the distal end 122 of the catheter body 114, or elsewhere (e.g., remotely from the distal end 122 and / or from the catheter body 114 itself). The first sensor 162 may be any type of sensor (e.g., proximity sensor or other type of sensor) that detects the electrodes as they deploy from the distal end 122 of the catheter body 114.

[0039] The first sensor 162 may generate a signal corresponding to whether the first electrode 150a, the second electrode 150b, and / or other electrodes have been deployed from the distal end 122 end of the catheter body 114, and the controller 158 may receive the signal or signals. The signal may be sent to the controller 158. The controller 158 may then activate one or more of the electrodes of the electrode assembly 130 based on the signal. For example, if the first sensor 162 detects that the first electrode 150a has been deployed, the first electrode 150a may then be activated. If the first sensor 162 detects that both the first electrode 150a and the second electrode 150b have beenA0012712W001deployed, but the remaining electrodes have not, the controller 158 may activate only the first and second electrodes 150a, 150b, or may activate only the first electrode 150a.Accordingly, the controller 158 may determine how many of the electrodes of the electrode assembly 130 have been deployed. Based on that determination, the controller 158 may then determine whether the electrode assembly 130 has been placed into a certain position (e.g., the focal position or other position), and deliver energy to one or more of the electrodes.

[0040] Additionally, or alternatively, a second sensor 166 (FIG. 1) may detect movement of the deployment mechanism 146 itself to thereby detect (e.g., indirectly) whether one or more of the electrodes of the electrode assembly 130 has been deployed from the distal end 122 of the catheter body 114. In the illustrated example, second sensor 166 is positioned to detect whether the deployment mechanism 146 has moved to the first deployment mechanism position (corresponding to the first, focal position). In some examples, the second sensor 166 is located, for example, on the deployment mechanism 146 itself, on or within the handle 126, on or within the catheter body 114, or elsewhere (e.g., remotely from the handle 126 and the deployment mechanism 146), and is positioned to detect the movement of the deployment mechanism 146. The second sensor 166 may be any type of sensor (e.g., proximity sensor or other type of sensor) that detects movement of the deployment mechanism 146. The second sensor 166 may send a signal, for example, to the controller 158. Based on that signal, the controller 158 may recognize that the deployment mechanism 146 is in a certain position (e.g., the focal position or other position), and deliver energy to one or more of the electrodes.

[0041] In some examples, the catheter 110 includes the first sensor 162, but does not include the second sensor 166. In yet other examples, the catheter 110 includes the second sensor 166, but does not include the first sensor 162. In yet other examples, the catheter 110 includes both the first sensor 162 and the second sensor 166, or does not include any of the first sensor 162 or the second sensor 166.

[0042] With reference to FIG. 2, when the deployment mechanism 146 is moved (e.g., slides, rotates, etc.) into a second deployment mechanism position (e.g., a middle thumb slide position along the handle 126), the electrode assembly 130 is placed into aA0012712W001second, lasso position in which two or more of the electrodes of the electrode assembly 130 are deployed from the distal end 122 of the catheter body 114, and are arranged in a lasso shape distally of the distal end 122. In some examples, each of the deployed electrodes in the lasso shape is activated in the second deployment mechanism position. In the illustrated example, each of the first electrode 150a, the second electrode 150b, the third electrode 150c, the fourth electrode 150d, the fifth electrode 150e, the sixth electrode 150f, and the seventh electrode 150g is within the lasso shape, and is both deployed and activated in the second, lasso position.

[0043] As described above, the catheter 110 may include one or more sensors (e.g., the first sensor 162 and / or the second sensor 166) that detect whether one or more of electrodes of the electrode assembly 130 have been deployed from the distal end 122 of the catheter body 114, and / or detect movement itself of the deployment mechanism 146. Accordingly, in some examples, one or more of the sensors may be used to determine that the deployment mechanism 146 is in the second deployment mechanism position, and the controller 158 may then active one or more of the electrodes based on that detection.

[0044] With reference to FIG. 3, when the deployment mechanism 146 is moved (e.g., slides, rotates, etc.) into a third deployment mechanism position (e.g., an upper thumb slide position along the handle 126), the electrode assembly 130 is placed into a third, linear position in which the electrodes of the electrode assembly 130 (e.g., all of the electrodes of the electrode assembly 130) are deployed from the distal end 122 of the catheter body 114, and are aligned linearly. In some examples, in this third, linear position, each of the aligned electrodes is also activated.

[0045] As described above, the catheter 110 may include one or more sensors (e.g., the first sensor 162 and / or the second sensor 166) that detect whether one or more of electrodes of the electrode assembly 130 have been deployed from the distal end 122 of the catheter body 114, and / or detect movement itself of the deployment mechanism 146. Accordingly, in some examples, one or more of the sensors may be used to determine that the deployment mechanism 146 is in the third deployment mechanism position, and the controller 158 may then active one or more of the electrodes based on that detection.A0012712W001

[0046] With continued reference to FIG. 3, in the illustrated example the wire 134 (or the catheter 110 in general) includes a rigid portion 170 that is located near (e.g., below) the lowermost of the electrodes in the electrode assembly 130, and is deployed from the distal end 122 of the catheter body 114 when the electrode assembly 130 is in the third, linear position. This rigid portion 170 facilitates the orientation of the electrodes in the third, linear position seen in FIG. 3, and helps to hold the electrodes in this orientation. In some examples, the rigid portion 170 is formed from a material different from that of the rest of the wire 134, or has a thickness different from that of the rest of the wire 134. In some examples, the rigid portion 170 is formed via a hypo tube placed over (e.g., telescoped over) a portion of the wire 134. The rigid portion 170 may or may not be attached to the deployment mechanism 146. In some examples, the rigid portion 170 is not attached to the deployment mechanism 146, and instead includes its own sliding mechanism (e.g., deployment mechanism) to extend the rigid portion 170 (e.g., over one or more of the electrodes of the electrode assembly 130 and / or a portion of the wire 134). In some examples, the rigid portion 170 (or a portion thereof) may initially be positioned within the catheter body 114, until the deployment mechanism 146 is moved to the third deployment mechanism position, at which point the rigid portion 170 is then deployed and moved out of the distal end 122 of the catheter body 114 to take the position seen for example in FIG. 3.

[0047] With reference to FIGS. 4 and 5, in some examples the electrode assembly 130 is adjustable to accommodate for different sizes and / or shapes of anatomy (e.g., extreme heart anatomies). For example, the lasso of electrodes formed in the second, lasso position of the electrode assembly 130 may take any of a variety of shapes and sizes. FIG.4 illustrates a lasso having a first diameter or overall size, and FIG. 5 illustrates a lasso having a second, larger diameter or overall size. In some examples, the deployment mechanism 146 is movable to change the overall size (e.g., diameter) of the lasso.

[0048] With reference to FIGS. 1-5, the deployment mechanism 146 may include the first deployment mechanism position corresponding to the first, focal position of the electrode assembly 130 (FIG. 1), and also include the third deployment mechanism position corresponding to the third, linear position of the electrode assembly 130 (FIG. 3). The deployment mechanism 146 may further include two, three, or more, additionalA0012712W001intermediate positions, corresponding to different lasso positions of the electrode assembly 130 having different lasso shapes, diameters, and / or sizes. As illustrated in FIGS. 4 and 5, for example, when the deployment mechanism 146 is moved in a first direction, more electrodes may be deployed from the distal end 122 of the catheter body 114. Conversely, when the deployment mechanism 146 is moved in a second (e.g., opposite) direction, fewer electrodes may be deployed from the distal end 122 of the catheter body 114.

[0049] Overall, the catheter 110 may combine one, two, or more (e.g., all) of the standard electrode geometries (e.g., focal, lasso and linear) into a single device, and / or allow for adjustment of the size of the lasso of the electrode assembly 130, for better usability in extreme anatomies. The distal geometry of the electrode assembly 130 may correspond to particular equipment settings, so that certain electrodes activate and inactivate to optimize performance and safety, based on the geometry being used.Sensors, such as the first sensor 162 and / or the second sensor 166, may be used to detect positions of the electrodes and / or positions of the deployment mechanism 146, and may be used to therefore control which electrodes (deployed or otherwise) are activated and which are not. The catheter 110 may deliver one or both of radio frequency or pulsed frequency ablation energy (or other energy) to the activated electrodes. While the catheter 110 described above has at least each of a first, second, and third deployment mechanism position (and corresponding first, second, and third electrode assembly positions), in other examples the catheter 110 has just two deployment mechanism positions (e.g., the first and third positions, or the first and second positions, or the second and third positions described above, and their corresponding electrode assembly positions). In some examples, the catheter 110 is used only to generate lasso positions having different lasso shapes, and does not include the first, focal position of the electrode assembly 130 or the third, linear position of the electrode assembly 130. Other catheters 110 may include various other deployment mechanism positions and / or electrode assembly positions than those illustrated.

[0050] FIGS. 6-9 illustrate another catheter 210. As illustrated in FIG. 6, the catheter 210 has an outer catheter body (e.g., a sheath) 214 and an inner catheter body 218 that slides relative to the outer catheter body 214. In some examples, one or both of the outer catheter body 214 and the inner catheter body 218 are flexible. In some examples,A0012712W001one or both of the outer catheter body 214 and the inner catheter body 218 are formed at least in part from stainless steel, although other examples include other materials or combinations of materials.

[0051] With continued reference to FIGS. 6-9, the outer catheter body 214 includes an outer catheter body distal end 222, and the inner catheter body 218 includes an inner catheter body distal end 226. The catheter 210 includes an electrode assembly 230 having a wire (e.g., spline) 234 that extends from the inner catheter body 218, and in some examples forms a closed (e.g., fixed) loop. In the illustrated example, the wire 234 extends distally from the inner catheter body distal end 226. In some examples, the wire 234 is integrally formed as a single piece with the inner catheter body 218, and / or is formed from the same material as the inner catheter body 218. In other examples, the wire 234 is formed from a different material than the inner catheter body 218.

[0052] The wire 234 may be formed, at least in part, from nitinol, although other examples include other types of materials or combinations of materials forming the wire. At least a portion of the wire 234 may be flexible, such that the wire 234 may flex and / or bend (e.g., relative to the inner catheter body 218). In some examples, wire 234 has a perimeter length (e.g., extending along the wire from one end of the wire to an opposite end of the wire, and / or around the entire closed loop) of 60mm, or between 50mm and 70mm. Other examples include other values and ranges of values for the perimeter length.

[0053] With continued reference to FIG. 6, the catheter 210 includes one or more electrodes coupled to the wire 234. In the illustrated example, the catheter 210 includes a first electrode 238a, a second electrode 238b, a third electrode 238c, a fourth electrode 238d, a fifth electrode 238e, a sixth electrode 238f, a seventh electrode 238g, an eight electrode 238h, a ninth electrode 238i, a tenth electrode 238j, an eleventh electrode 238k, a twelfth electrode 2381, a thirteenth electrode 238m, and a fourteenth electrode 238n. Other examples include other numbers of electrodes than that illustrated (e.g., fewer than fourteen electrodes, or more than fourteen electrodes).

[0054] In some examples, each of the electrodes coupled to the wire 234 is a 1mm diameter ring electrode. Other examples include different sizes and / or shapes of electrodes than that illustrated, and / or different types of electrodes than that illustrated.A0012712W001For example, one of the electrodes may have a shape and / or size that differs from a shape and / or size of another one of the electrodes. In some examples, one or more of the electrodes is smaller than a 1mm diameter ring electrode, or is larger than a 1mm ring electrode.

[0055] With continued reference to FIG. 6, the electrodes are spaced at increments from one another along the wire 234, and are generally arranged in pairs. For example, the first electrode 238a is positioned 4mm away from the inner catheter body distal end 226 along the wire 234, and the second electrode 238b is positioned 2mm away from the first electrode 238a along the wire 234. The third electrode 238c is positioned 4mm away from the second electrode 238b along the wire 234, and the fourth electrode 238d is positioned 2mm away from the third electrode 238c along the wire 234. This pattern continues repeating moving along the wire 234.

[0056] Other examples include different patterns and / or spacing of electrodes. In some examples, the first electrode 238a is positioned 7mm away from the inner catheter body distal end 226 along the wire 234, and the second electrode 238b is positioned 2mm away from the first electrode 238a along the wire 234. The third electrode 238c is positioned 7mm away from the second electrode 238b along the wire 234, and the fourth electrode 238d is positioned 2mm away from the third electrode 238c along the wire. This pattern continues repeating moving along the wire 234.

[0057] In yet other examples, each of the electrodes is spaced equally apart from one another along the wire 234 (and not arranged in pairs), or is arranged in other manners (e.g., in groups of three). Other examples include other arrangements and numbers of electrodes.

[0058] With reference to FIGS. 7-9, the inner catheter body 218 is movable (e.g., linearly) relative to the outer catheter body 214 to deploy (and thereby expose) some or all of the electrodes on the wire 234, and / or to active one or more of the electrodes on the wire 234. For example, the catheter 210 may include a deployment mechanism (similar to the deployment mechanism 146 described above) that is located on a handle of the catheter 210 (or other portion of the catheter) that moves between two, three, or more positions to change a relative position of the inner catheter body 218 to the outer catheterA0012712W001body 214. Additionally, while not illustrated, in some examples the catheter 210 may include an energy source and / or controller, similar to the energy source 154 and the controller 158 described above, which delivers and controls energy (e.g., radio frequency or pulsed field ablation energy) to one or more of the electrodes, depending upon a position of the electrodes or a position of the deployment mechanism. In some examples, the catheter 210 may also, or alternatively, include one or more sensors, similar to the first sensor 162 and the second sensor 166 described above, that senses a position of one or more of the electrodes on the wire 234, and / or senses a position of the deployment mechanism. The controller may determine whether to activate any of a given electrode, depending upon the sensed positions.

[0059] With reference to FIG. 7, in some examples the catheter 210 has a first position in which the wire 234 and all of the electrodes on the wire 234 are disposed within the outer catheter body 214. In this first position, none of the electrodes are activated.

[0060] With reference to FIG. 8, the catheter 210 also has a second position in which a portion of the wire 234, and a portion of the electrodes of the electrode assembly 230, are deployed and / or activated. In the illustrated example, six of the electrodes are deployed (and also activated) in this second position. In other examples, only one (or only two, or three, or four) of the six deployed electrodes may be activated. In yet other examples, other numbers of electrodes are deployed and / or activated in the second position.

[0061] With reference to FIG. 9, the catheter 210 also has a third position in which all of the wire 234, and / or all of the electrodes on the wire 234, are deployed and / or activated. In the illustrated example, all fourteen of the electrodes on the wire 234 are deployed from the outer catheter body distal end 222, and are also activated. In other examples, all of the electrodes are deployed, but only a portion of the electrodes are activated.

[0062] FIGS. 10-13 illustrate another catheter 310. Similar to the catheter 210, the catheter 310 has an outer catheter body 314 (e.g., sheath) and an inner catheter body 318 that slides (e.g., linearly) relative to the outer catheter body 314. The outer catheter bodyA0012712W001314 includes an outer catheter body distal end 322, and the inner catheter body 318 includes an inner catheter body distal end 326.

[0063] In contrast to the catheter 210, the catheter 310 includes an electrode assembly 330 having multiple (e.g., fixed) loops of electrodes. In the illustrated example, the catheter 310 includes a first fixed loop 334a defined by a first wire (e.g., spline) 338a, and a second fixed loop 334b defined by a second wire (e.g., spline) 338b. The first wire 338a and / or the second wire 338b may be formed, at least in part, from nitinol, although other examples include other types of materials or combinations of materials.

[0064] With continued reference to FIGS. 10-13, the second fixed loop 334b is positioned entirely within the first fixed loop 334a, although in other examples the two loops may be side-by-side, may overlap one another, or may be arranged in a different manner.

[0065] As illustrated in FIGS. 10-13, each of the first fixed loop 334a and the second fixed loop 334b has at least one electrode 342 (e.g., ring electrode or other type of electrode) positioned on the wire 338a, 338b. Additionally, each of the first fixed loop 334a and the second fixed loop 334b extends from the inner catheter body 318 (e.g., from the inner catheter body distal end 326). In some examples, the first and / or second fixed loops 334a, 334b are integrally formed in a single piece with the inner catheter body 318.

[0066] Overall, the catheter 310 may operate in a similar manner to the catheter 210 described above. For example, and with reference to FIG. 11, the catheter 310 may have a first position in which the first and second wires 338a, 338b and all of the electrodes on the first and second wires 338a, 338b are disposed within the outer catheter body 314. In this first position, none of the electrodes are activated.

[0067] With reference to FIG. 12, the catheter 310 may have a second position in which a portion of the first and / or second wires 338a, 338b, and a portion of the electrodes, are deployed and / or activated.

[0068] With reference to FIG. 13, the catheter 310 may also have a third position in which all of the first and second wires 338a, 33b, and / or all of the electrodes, are deployed and / or activated.A0012712W001

[0069] Overall, the inner catheter body 318 may be movable (e.g., linearly) relative to the outer catheter body 314 to deploy (and thereby expose) some or all of the electrodes, and / or to active one or more of the electrodes. For example, the catheter 310 may include a deployment mechanism (similar to the deployment mechanism 146 described above) that is located on a handle of the catheter 310 (or other portion of the catheter) that moves between two, three, or more positions to change a relative position of the inner catheter body 318 to the outer catheter body 314. Additionally, while not illustrated, in some examples the catheter 310 may include an energy source and / or controller, similar to the energy source 154 and the controller 158 described above, which delivers and controls energy (e.g., radio frequency or pulsed field ablation energy) to one or more of the electrodes, depending upon a position of the electrodes or a position of the deployment mechanism. In some examples, the catheter 310 may also, or alternatively, include one or more sensors, similar to the first sensor 162 and the second sensor 166 described above, that senses a position of one or more of the electrodes, and / or senses a position of the deployment mechanism. The controller may determine whether to activate any of a given electrode, depending upon the sensed positions.

[0070] As described above, the catheters and electrodes described herein may be used for mapping (along with or separately from being used for ablation). In some examples, each of the plurality of electrodes is a mapping electrode, and the wire (e.g., wire 134, 234, 338a, 338b) is movable to retract electrodes (e.g., into a catheter body) to provide higher resolution mapping. In some examples, each of the plurality of electrodes is a mapping electrode, and the wire (e.g., wire 134, 234, 338a, 338b) is movable to deploy more electrodes from the distal end of the catheter body, to generate faster mapping. Other examples include different numbers and arrangements of electrodes and catheter bodies, to vary and / or adjust the resolution and / or speed of mapping the body.

[0071] 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). InA0012712W001addition, 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.

[0072] The invention may be further described by reference to the following numbered paragraphs:1. A catheter comprising:a catheter body having a proximal end and an opposite, distal end; andan electrode assembly configured to be deployed from the distal end of the catheter body, wherein the electrode assembly comprises:a wire disposed at least partially within the catheter body;a first electrode coupled to the wire and disposed within the catheter body; a second electrode coupled to the wire and disposed within the catheter body;a sensor configured to detect whether at least one of the first electrode or thesecond electrode has been deployed from the distal end of the catheter body, wherein the sensor is configured to generate a signal corresponding to whether the at least one of the first electrode or the second electrode has been deployed from the distal end of the catheter body; anda controller coupled to the sensor and configured to receive the signal, whereinthe controller is configured to activate the at least one of the first electrode or the second electrode based on the signal.2. The catheter of paragraph 1, wherein the controller is configured to activate the first electrode when the first electrode has been deployed from the distal end of the catheter body.3. The catheter of paragraph 2, wherein activating the first electrode includes sending ablation energy to the first electrode when the first electrode has been deployed from the distal end of the catheter body.A0012712W0014. The catheter of paragraph 2 or paragraph 3, wherein the second electrode is configured to remain deactivated when the when the first electrode is activated.5. The catheter of any of paragraphs 2-4, wherein the second electrode is configured to remain disposed within the catheter body when the first electrode has been deployed from the distal end of the catheter body.6. The catheter of paragraph 1, wherein the controller is configured to activate both the first electrode and the second electrode and send ablation energy to both the first electrode and the second electrode when both the first electrode and the second electrode have been deployed from the distal end of the catheter body.7. The catheter of paragraph 1, wherein the controller is configured to activate only the first electrode and send ablation energy to only the first electrode when both the first electrode and the second electrode have been deployed from the distal end of the catheter body.8. The catheter of any of the preceding paragraphs, wherein the wire defines a lasso shape, and wherein the lasso shape is configured to be moved relative to the distal end of the catheter body and deployed from the distal end of the catheter body.9. The catheter of any of the preceding paragraphs, wherein the wire is a flexible nitinol wire.10. The catheter of any of the preceding paragraphs, wherein a distal end of the wire is fixed to the distal end of the catheter body.11. The catheter of paragraph 10, wherein the electrode assembly comprises a plurality of electrodes that include the first electrode and the second electrode, wherein the electrode assembly is configured to be deployed into a first, focal position in which only one of the plurality of electrodes is activated, a second, lasso position in which theA0012712W001plurality of electrodes are arranged in a lasso shape and each of the plurality of electrodes is activated, and a third, linear position in which the plurality of electrodes are aligned linearly and each of the plurality of electrodes is activated.12. The catheter of paragraph 11, further comprising a hypo tube extending over a portion of the wire to facilitate the third, linear position.13. The catheter of paragraph 1, further comprising a handle coupled to the catheter body, wherein the handle includes a deployment mechanism for deploying at least one of the first electrode or the second electrode from the distal end of the catheter body.14. The catheter of paragraph 13, wherein the sensor is coupled to the deployment mechanism.15. The catheter of paragraph 14, wherein the deployment mechanism is a thumb slide, and wherein the sensor is configured to detect how far the thumb slide has moved.16. The catheter of paragraph 15, wherein the electrode assembly comprises a plurality of electrodes that include the first electrode and the second electrode, wherein the electrode assembly is configured to be deployed via the thumb slide into a first, focal position in which only one of the plurality of electrodes is activated, a second, lasso position in which the plurality of electrodes are arranged in a lasso shape and each of the plurality of electrodes is activated, and a third, linear position in which the plurality of electrodes are aligned linearly and each of the plurality of electrodes is activated.17. The catheter of paragraph 13, wherein the electrode assembly comprises a plurality of electrodes that include the first electrode and the second electrode, wherein the deployment mechanism includes body configured to move relative to the handle between a first deployment mechanism position, a second deployment mechanism position, and a third deployment mechanism position, wherein the first deployment mechanism position corresponds to a first arrangement of the plurality of electrodes, the second deployment mechanism position corresponds to a second, different arrangement of the plurality ofA0012712W001electrodes, and the third deployment mechanism position corresponds to a third, different arrangement of the plurality of electrodes.18. The catheter of paragraph 1, wherein the electrode assembly comprises a plurality of electrodes that include the first electrode and the second electrode, wherein the wire is movable relative to the catheter body to change how many of the plurality of electrodes are deployed from the distal end of the catheter body.19. The catheter of paragraph 18, wherein each of the plurality of electrodes is a mapping electrode, and wherein the wire is movable to retract electrodes into the catheter body to provide higher resolution mapping.

[0073] Although various aspects and examples have been described in detail with reference to certain examples illustrated in the drawings, variations and modifications exist within the scope and spirit of one or more independent aspects described and illustrated.

Claims

1. A0012712W001CLAIMSWhat is claimed is:

1. A catheter comprising:a catheter body having a proximal end and an opposite, distal end; andan electrode assembly configured to be deployed from the distal end of the catheter body, wherein the electrode assembly comprises:a wire disposed at least partially within the catheter body;a first electrode coupled to the wire and disposed within the catheter body; a second electrode coupled to the wire and disposed within the catheter body;a sensor configured to detect whether at least one of the first electrode or the second electrode has been deployed from the distal end of the catheter body,wherein the sensor is configured to generate a signal corresponding to whether the at least one of the first electrode or the second electrode has been deployed from the distal end of the catheter body; anda controller coupled to the sensor and configured to receive the signal, wherein the controller is configured to activate the at least one of the first electrode or the second electrode based on the signal.

2. The catheter of claim 1, wherein the controller is configured to activate the first electrode when the first electrode has been deployed from the distal end of the catheter body.

3. The catheter of claim 2, wherein activating the first electrode includes sending ablation energy to the first electrode when the first electrode has been deployed from the distal end of the catheter body.

4. The catheter of claim 2 or claim 3, wherein the second electrode is configured to remain deactivated when the when the first electrode is activated.A0012712W0015. The catheter of any of claims 2-4, wherein the second electrode is configured to remain disposed within the catheter body when the first electrode has been deployed from the distal end of the catheter body.

6. The catheter of claim 1, wherein the controller is configured to activate both the first electrode and the second electrode and send ablation energy to both the first electrode and the second electrode when both the first electrode and the second electrode have been deployed from the distal end of the catheter body.

7. The catheter of claim 1, wherein the controller is configured to activate only the first electrode and send ablation energy to only the first electrode when both the first electrode and the second electrode have been deployed from the distal end of the catheter body.

8. The catheter of any of the preceding claims, wherein the wire defines a lasso shape, and wherein the lasso shape is configured to be moved relative to the distal end of the catheter body and deployed from the distal end of the catheter body.

9. The catheter of any of the preceding claims, wherein the wire is a flexible nitinol wire.

10. The catheter of any of the preceding claims, wherein a distal end of the wire is fixed to the distal end of the catheter body.

11. The catheter of any preceding claim, wherein the electrode assembly comprises a plurality of electrodes that include the first electrode and the second electrode, wherein the electrode assembly is configured to be deployed into a first, focal position in which only one of the plurality of electrodes is activated, a second, lasso position in which the plurality of electrodes are arranged in a lasso shape and each of the plurality of electrodes is activated, and a third, linear position in which the plurality of electrodes are aligned linearly and each of the plurality of electrodes is activated.A0012712W00112. The catheter of claim 11, further comprising a hypo tube extending over a portion of the wire to facilitate the third, linear position.

13. The catheter of any preceding claim, further comprising a handle coupled to the catheter body, wherein the handle includes a deployment mechanism for deploying at least one of the first electrode or the second electrode from the distal end of the catheter body.

14. The catheter of claim 13, wherein the sensor is coupled to the deployment mechanism.

15. The catheter of claim 13 or 14, wherein the deployment mechanism is a thumb slide, and wherein the sensor is configured to detect how far the thumb slide has moved.

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