Catheter with high density mapping electrodes

Abstract

Catheters having high density mapping electrodes are disclosed, as are high density mapping catheters having arrays of mapping electrodes. These catheters can be used, for example, in the diagnosis and treatment of arrhythmias. The catheters are adapted to contact tissue and include a flexible frame that includes an array of electrodes. The array of electrodes can be formed of a plurality of longitudinally aligned columns and transversely aligned rows.

Description

[0001] This application is a divisional application of patent application No. 201880064795.9 filed on April 3, 2020, entitled "Cavity with High-Density Mapping Electrodes".

[0002] Cross-reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 572,186, filed on October 13, 2017. Technical Field

[0004] This disclosure relates to high-density electrophysiological mapping catheter assemblies and mapping ablation catheter assemblies for the diagnosis and treatment of arrhythmias via, for example, radiofrequency ablation. In particular, this disclosure relates to flexible high-density mapping catheter assemblies, and to flexible ablation catheter assemblies comprising on-plate high-density mapping electrodes. Background Technology

[0005] For many years, endovascular catheters have been used in non-invasive cardiac medical procedures. When placed within a patient's vascular system, the catheter can be used, for example, to diagnose and treat arrhythmias that would otherwise be impossible without more invasive procedures.

[0006] Traditional electrophysiological mapping catheters may include, for example, multiple adjacent loop electrodes that surround the longitudinal axis of the catheter and are constructed of platinum or some other metal. These loop electrodes can be relatively rigid. Similarly, traditional ablation catheters may include relatively rigid tip electrodes for delivering treatment (e.g., delivering RF ablation energy) and may also include multiple adjacent loop electrodes. In many applications, maintaining good electrical contact with cardiac tissue can be difficult when using these traditional catheters and their relatively rigid (or non-compliant) metallic electrodes, especially in the presence of sharp gradients and undulations.

[0007] Whether mapping or creating damage in the heart, the heart's beating (especially if unstable or irregular) complicates matters, making it difficult to maintain adequate contact between the electrode and tissue for a sufficient duration. These problems are exacerbated on contour or trabecular surfaces. Without adequate electrode-tissue contact, high-quality damage or accurate mapping is unlikely.

[0008] The foregoing discussion is intended to illustrate the field only and should not be construed as a denial of the scope of the claims. Summary of the Invention

[0009] This disclosure relates to high-density electrophysiological mapping catheter assemblies, and to mapping ablation catheter assemblies for, for example, diagnosing and treating arrhythmias via radiofrequency ablation. In particular, this disclosure relates to flexible high-density mapping catheter assemblies, and to flexible ablation catheter assemblies including on-plate high-density mapping electrodes.

[0010] This disclosure relates to a basket catheter comprising an elongated catheter shaft having a proximal and distal end, a flexible basket catheter having multiple splines, and multiple electrodes mounted to the splines. The flexible basket catheter is coupled to the distal end of the catheter shaft and conforms to tissue when extended into an unfolded configuration. The multiple electrodes are further organized into triangular clusters along each spline. In a more specific embodiment, when the flexible basket catheter is actuated into a contracted configuration, each spline is nested with an adjacent spline.

[0011] Some embodiments relate to a planar array catheter comprising an elongated catheter shaft having a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis of the catheter extending between the proximal and distal ends. The planar array catheter further comprises a flexible planar array coupled to the distal end of the catheter shaft. The planar array conforms to tissue and includes two or more arms extending substantially parallel to the longitudinal axis. Each arm has a plurality of electrodes mounted thereon. The electrodes on each arm are grouped into clusters of three or more electrodes defining a two-dimensional shape. In some specific embodiments, the plurality of electrodes on each arm are located in at least two columns oriented substantially parallel to the longitudinal axis.

[0012] Various embodiments of this disclosure relate to a linear catheter comprising an elongated catheter shaft having a proximal and a distal end, and a flexible distal tip assembly at the distal end of the catheter shaft. The distal tip assembly conforms to tissue and includes a plurality of electrodes. These electrodes are grouped into clusters of three or more electrodes, each cluster sampling the electrical properties of the contacting tissue in at least two substantially lateral directions. In this embodiment, the center-to-center distance between the electrodes in each cluster can be between 0.5 and 4 mm. In various specific embodiments, the electrical properties sampled by the electrodes in the cluster collectively indicate the true electrical properties of the contacting tissue, independent of the orientation of the linear catheter relative to the tissue.

[0013] The foregoing and other aspects, features, details, utility, and advantages of this disclosure will become apparent from reading the following description and claims, and from referring to the accompanying drawings. Attached Figure Description

[0014] A more complete understanding of various exemplary embodiments can be achieved by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0015] Figure 1AThis is a planar view of the tip portion of a planar array catheter for high-density electrophysiological mapping, consistent with various embodiments of this disclosure.

[0016] Figure 1B The various embodiments shown are consistent with those of this disclosure and are illustrated in a flexural configuration. Figure 1A An isometric side view of the tip portion of a planar array of ducts.

[0017] Figure 1C It is consistent with various embodiments of this disclosure. Figure 1A Close-up isometric view of the arm of the planar array conduit.

[0018] Figure 1D It is consistent with various embodiments of this disclosure. Figure 1A A cross-sectional side view of a planar array of ducts.

[0019] Figure 2A This is a partial isometric view of a high-density mapping catheter consistent with various embodiments of this disclosure.

[0020] Figure 2B It is shown in a flexible configuration (representing the contact between the catheter tip and cardiac tissue) consistent with various embodiments of this disclosure. Figure 2A Partial isometric view of the high-density mapping catheter shown.

[0021] Figure 2C It is consistent with various embodiments of this disclosure. Figure 2A A partial view of the planar pattern design of the electrode carrier strip on the high-density mapping catheter shown.

[0022] Figure 3A This is a partial isometric view of the tip region of an ablation catheter with a distal high-density mapping electrode, consistent with various embodiments of this disclosure.

[0023] Figure 3B It is consistent with various embodiments of this disclosure. Figure 3A A magnified view of the distal tip of the ablation catheter.

[0024] Figure 4A This is a plan view of a basket catheter in an expanded configuration, consistent with various embodiments of this disclosure.

[0025] Figure 4B It is consistent with various embodiments of this disclosure and is in a contracted configuration. Figure 4A A plan view of the basket-type conduit.

[0026] Figure 4C It is consistent with various embodiments of this disclosure. Figure 4A Enlarged plan view of the spline cross-section of the basket-type conduit.

[0027] Figure 5A This is a plan view of a basket catheter in an expanded configuration, consistent with various embodiments of this disclosure.

[0028] Figure 5B It is consistent with various embodiments of this disclosure and is in a contracted configuration. Figure 5A A plan view of the basket-type conduit.

[0029] Figure 5C It is consistent with various embodiments of this disclosure. Figure 5A Enlarged plan view of the spline cross-section of the basket-type conduit.

[0030] Figure 5D It is consistent with various embodiments of this disclosure. Figure 5A An enlarged top view of the basket-type conduit.

[0031] Figure 6A This is a plan view of a basket-type conduit spline consistent with various embodiments of this disclosure.

[0032] Figure 6B It is consistent with various embodiments of this disclosure. Figure 6A A magnified plan view of a portion of the basket-type conduit spline.

[0033] Figure 7A This is a plan view of a basket-type conduit spline consistent with various embodiments of this disclosure.

[0034] Figure 7B It is consistent with various embodiments of this disclosure. Figure 7A A magnified plan view of a portion of the basket-type conduit spline.

[0035] Figure 8A This is a plan view of two interlaced basket-type conduit splines consistent with various embodiments of this disclosure.

[0036] Figure 8B It is consistent with various embodiments of this disclosure. Figure 8A Enlarged plan view of a portion of the spline of two interlaced basket-type conduits.

[0037] While the various embodiments discussed herein are subject to modification and alternative forms, many aspects of them have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that this is not intended to limit the invention to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and substitutions falling within the scope of this disclosure, including the aspects defined in the claims. Furthermore, the term "example" as used throughout this application is exemplary only and not restrictive. Detailed Implementation

[0038] Various embodiments of this disclosure relate to flexible, high-density electrophysiological mapping catheters and mapping ablation catheters. Typically, the distal portion of these various catheters may include a basic support frame adapted to conform to tissue and maintain contact with tissue (e.g., a beating heart wall).

[0039] This disclosure relates to planar array catheters and basket catheters for electrophysiological mapping. More specifically, many embodiments of this disclosure utilize printed circuit boards (e.g., flexible printed circuit boards) to form the planar array arms and / or basket splines. Furthermore, aspects of this disclosure include multiple electrodes positioned along the planar array arms and / or basket splines. In such embodiments, the planar array arms and / or basket splines may have electrodes electrically coupled to a flexible circuit board that at least partially forms the arms and / or splines. The resulting clusters (or groups) of independently addressable electrodes facilitate electrophysiological measurements of tissue in contact with the electrodes, which are orientation-independent. That is, measurements can be taken across bipolar pairs of electrodes within each cluster (with a known distance between them) to capture measurements in at least two orthogonal directions. In more advanced three-dimensional electrogram analysis, electrophysiological measurements can be captured in three orthogonal planes. In some embodiments, it may be desirable to place the electrodes of the cluster equidistant from each other to facilitate enhanced electrogram fidelity.

[0040] Several aspects of this disclosure relate to various high-density electrode array catheters having substantially uniform electrode spacing and / or known and constant spacing between electrodes. The electrode array includes multiple bipolar pairs that facilitate electrophysiological mapping of tissue in contact with the electrodes. More advanced embodiments of this disclosure can mitigate the need for generally square electrode arrays by utilizing orientation-independent sensing / omnipolar technology (“OIS / OT”) and related algorithms. OIS / OT and related algorithms are discussed in more detail in U.S. Provisional Application No. 61 / 944,426, filed February 25, 2014; U.S. Application No. 15 / 118,522, filed February 25, 2015; and International Application No. PCT / US2014 / 011940, filed January 16, 2014, the entire contents of which are incorporated herein by reference as if fully disclosed herein.

[0041] Traditional mapping catheter designs employ bipolar electrode configurations to detect, measure, and visualize electrical signals from the heart. However, this conventional mapping catheter design is prone to errors associated with the orientation of the bipolar electrode pairs relative to the electrical wavefront of the heart, resulting in sensed electrical signals and electrophysiological mapping results that may be orientation-dependent and therefore fail to accurately reflect tissue characteristics. To mitigate this risk, several aspects of this disclosure relate to signal processing techniques that can sample multiple bipolar electrode pair configurations with different orientations to produce orientation-independent electrophysiological mapping results. To facilitate such signal processing techniques, corresponding electrophysiological mapping catheters (e.g., linear, planar array, and basket-type) can utilize electrode clusters with a constant spacing over time.

[0042] Various embodiments of this disclosure relate to electrophysiological mapping catheters, such as linear arrays and basket catheters, wherein each spline and / or arm includes more than one column of electrodes that extend the length of the catheter, thus eliminating the need for measurements across splines / arms. This significantly improves the accuracy of the resulting electrophysiological mapping because the relative distance between electrodes on the same arm / spline is less likely to change over time with electrodes on adjacent arms / splines. Furthermore, during diagnostic procedures, the electrophysiological basket catheter can be operated at any position between a dilated and constricted state because the relative distance between electrodes within a cluster on each arm / spline does not change during movement of the catheter arm / spline or in response to tissue contact.

[0043] Another aspect of this disclosure aims to eliminate the distal cap of the electrophysiology basket catheter, which facilitates sampling of electrogram data from the farthest tip of the basket.

[0044] The details of various embodiments of this disclosure are described below with reference to the accompanying drawings.

[0045] Figure 1A This is a planar view of the tip portion 110 of a planar array catheter 101 for high-density electrophysiological mapping, consistent with various embodiments of this disclosure. The tip portion 110 includes (micro)electrodes 102 distributed along the top surfaces of arms 103, 104, 105, and 106. 1-N The flexible array comprises four longitudinally extending arms comprising a flexible frame of planar array. In various embodiments of this disclosure, arms 103, 104, 105, and 106 are flexible printed circuit boards. In this embodiment, each arm includes two columns of electrodes 102 extending along the length of the arm. 1-NIn some embodiments, the relative spacing between the electrodes can be between 1.5 and 3 mm (center-to-center spacing). While various embodiments of this disclosure relate to point electrodes printed on a flexible circuit board, such embodiments can be readily adapted to facilitate the use of annular electrodes on arms 103, 104, 105, and 106 with the positions and spacing disclosed herein. The four arms 103, 104, 105, and 106 include a first outer arm 103, a second outer arm 106, a first inner arm 104, and a second inner arm 105. These arms can be laterally separated from each other (when unfolded) for example, about 3.3 mm. In some specific embodiments, electrode 102 1-N The relative spacing can be 1 mm or less. Although the planar array described herein includes four arms 103, 104, 105, 106, other embodiments with varying numbers of arms, relative electrode spacing, total number of electrodes on each arm, number of rows and columns of electrodes on each arm, and electrode placement on one or both sides of the planar array are readily adaptable to and contemplated by this disclosure.

[0046] and Figure 1A Consistent with the embodiments disclosed herein, some specific embodiments of the planar array catheter may include electrodes of varying sizes. For example, the distal electrode 102 on the first lateral arm 103 and / or the proximal electrode 102 on the second lateral arm 106 may be larger in surface area. These enlarged electrodes can be used for precise positioning of flexible arrays, for example, in impedance-based navigation systems. In some embodiments, the larger electrodes may facilitate tissue ablation. In such embodiments, if desired, the larger electrodes may be driven with ablation current between two or more of the larger electrodes for bipolar ablation, or alternatively, to drive the ablation current in a unipolar mode between one or two of the enlarged electrodes and, for example, a patch electrode located on the patient (e.g., the patient's back). Unipolar or bipolar ablation may also be performed between smaller electrodes and / or combinations of smaller and larger electrodes 102. Alternatively or simultaneously, current may flow between one or more enlarged electrodes and any or all of the smaller electrodes. This unipolar or bipolar ablation may be used to create specific lines or patterns of damage.

[0047] like Figure 1AAs further shown, the catheter shaft 107 is coupled to the tip portion 110 (including a planar array) via a proximal bushing 108, which receives one or more arms 103, 104, 105, 106 of the planar array. The distal portion of the catheter shaft 107 may include a radiopaque marking strip 111 to facilitate fluorescence fluoroscopic visualization of the catheter within the patient's cardiovascular system. In other embodiments, the radiopaque marking strip 111 may be a positioning coil to facilitate navigation using impedance-based, magnetic-based, or hybrid-type navigation systems (e.g., MediGuide, sold by Abbott Laboratories). TM Visualization of a planar array in a system. In a further embodiment, the planar array may include a combination of transmissive marker strips and positioning coils.

[0048] Figure 1B This is consistent with various embodiments of the present disclosure for high-density electrophysiological mapping. Figure 1A An isometric side view of the tip portion 110 of the planar array catheter 101, depicted in a flexural configuration (representing the contact between the catheter tip and cardiac tissue). Figure 1B In the middle, the planar flexible arms 103, 104, 105, and 106 flex to conform to the cardiac tissue (not shown), thereby enabling the physician to maintain multiple electrodes 102. 1-N Contact between the tissue and the organ. This improves the accuracy of the recorded information about cardiac electrical activity and its corresponding diagnostic value.

[0049] While many embodiments of this disclosure relate to electrophysiological mapping, embodiments of this disclosure can also be configured for pacing. For example, one or more electrodes 102 1-N It can send pacing signals to tissues such as the heart.

[0050] While some embodiments relate to a planar array structure that substantially comprises flexible printed circuitry, arms 103, 104, 105, and 106 may alternatively (or, in addition to the following) comprise flexible materials or spring-like materials (such as nitinol) (or be reinforced therewith). The construction of the arms (including, for example, the length and / or diameter of the arms) and the material composition can be tailored to a specific application. For example, desired elasticity, flexibility, foldability, compliance, and stiffness characteristics (including one or more characteristics that may vary from the proximal end to the distal end of a single arm or between or among multiple arms comprising a planar array). The foldability of materials such as nitinol or flexible circuit board materials (e.g., thin polymer films) provides the added advantage of convenient insertion of the planar array into the delivery catheter or introducer, whether during catheter delivery into the body or removal from the body at the end of the procedure.

[0051] The high-density electrode configurations of the various electrophysiological mapping catheters disclosed herein can be found for the following specific applications: (1) defining regional propagation mapping over an area of, for example, 1 square millimeter within the atrial wall of the heart; (2) identifying complex graded atrial electrograms for ablation; (3) identifying localized focusing potentials between electrodes for higher electrogram resolution; and / or (4) more precisely targeting the ablation area. The mapping and ablation catheters disclosed herein are constructed to conform to and maintain contact with cardiac tissue despite cardiac motion (potentially unstable). The contact stability of the catheters disclosed herein during cardiac motion, due to continuous tissue-electrode contact, contributes to improved mapping accuracy and ablation continuity. Although various embodiments of this disclosure have been proposed for endocardial applications, the catheters described herein can also be used for epicardial applications.

[0052] Although not in Figure 1A As shown in section -B, however, various embodiments of the planar array conduit 101 may include one or more flushing ports. For example, one or more proximal flushing ports may be located on / distal to the proximal end of the proximal bushing 108, positioned to deliver flushing fluid to or near the point where the electrode carrier arms 103, 104, 105, 106 exit from or near the distal end of the proximal bushing 108 mounted on the distal end of the conduit shaft 107 in this embodiment. In some more specific embodiments, one or more second distal flushing ports may be located near the distal intersection of the arms 103, 104, 105, 106 and on or near the distal tip 109. In further embodiments, multiple flushing ports may be present at multiple locations along the arms 103-106 if desired. Having more than one flushing port located at the proximal and / or distal end of the planar array 110 can promote a more uniform flushing fluid distribution at or near the proximal / distal apex of the arms 103-106.

[0053] Figure 1C It is consistent with various embodiments of this disclosure. Figure 1A A close-up isometric view of a portion of the arm 106 of the high-density mapping catheter 101. The arm 106 includes two rows of electrodes 102 extending along the length of the arm. 1-N Each group of three adjacent electrodes forms an electrode cluster 112. 1-3Each cluster is capable of mapping the electrophysiology of the tissue it contacts in a manner independent of the orientation of a single bipolar electrode pair within the cluster used to sense the electrical properties of the tissue. Specifically, the cluster is capable of sampling electrical signals across the contacting tissue in at least two orientations. For example, the first bipolar electrode pair in example cluster 1121 samples electrical signals across the contacting tissue in the x-orientation, while the second bipolar electrode pair in cluster 1121 samples a second electrical signal across the contacting tissue in the y-orientation. The true electrical signal at that location can then be determined using a signal processing circuitry system. Although the two bipolar pairs are substantially in the same location and contact the same tissue volume, different electrical properties of the tissue can be sampled due to the directionality of the electrical activation wavefront propagating through the heart. The electrical activation wavefront typically originates from the sinoatrial node and atrioventricular node, however, interfering electrical signals may also originate from one or more pulmonary veins.

[0054] Importantly, in order to help determine the important electrical properties of the tissue (e.g., impedance), the first bipolar pair (D A The distance between the second bipolar pair (D) and the second bipolar pair (D) B The distance between them must be known and / or constant. Figure 1A In -D, electrode 102 on arms 103-106 1-N The spacing is constant. Furthermore, in various embodiments, it is expected that the distance between the two sets of bipolar pairs of a single cluster 112 is the same (D...). A =D B ).

[0055] Figure 1D It is consistent with various embodiments of this disclosure. Figure 1A A cross-sectional side view of the arm 106 of the planar array conduit 101. (See attached image.) Figure 1D As shown, some embodiments of the planar array conduit 101 may include two rows of electrodes 102 mounted on the top surface 198 of the arm 106. 1-N A complementary set of electrodes. The second set of electrodes is 102'. 1-N This facilitates electrophysiological mapping on either side of a planar array and the ability to detect electrical signal flow through the myocardium in a z-direction. (See reference...) Figure 1C The discussed group of electrode clusters 112 on the top surface 198 of the planar array 1-3 Electrical signal flow through heart tissue can be detected in the x and y orientations, while another electrode 102' on the bottom surface 199 of the planar array (when used in conjunction with one of the electrodes 102 of the same cluster on the top surface 198) helps to determine electrical properties in the z orientation. Figure 1D Multiple clusters 112 are shown in a cross-sectional side view of the planar array conduit 101. 4-6 Similar to the positioning of electrode 102 on top surface 198, it is expected that bottom electrode 102' (D B) and the depth of the circuit board (D) C The distance between them is known. Furthermore, in various embodiments, it is expected that the distance between the two sets of bipolar pairs of a single cluster 112' is the same (D). B =D C ).

[0056] Figure 2A This is a partial isometric view of the linear high-density mapping catheter assembly portion 210, consistent with various embodiments of this disclosure. (See also...) Figure 2A As shown, the tip portion 210 includes an interlocking ring or band 212 of a non-conductive material (e.g., polyether-etherketone, also known as PEEK), forming a basic support framework for a plurality of electrodes 218. In this embodiment, a circumferential or helical through-cut pattern 214 defines a plurality of dovetail surfaces 216. Each dovetail surface 216 has an electrode 218 attached thereto, thereby defining a flexible electrode array arranged in a circumferential ring or band around the tip portion 210 of the linear mapping catheter. The electrodes 218 are also aligned in rows of longitudinal extensions of the electrodes (e.g., parallel to the longitudinal axis 220 of the catheter), which are capable of flexing or slightly moving relative to each other during use of the catheter (e.g., contact with tissue). The non-conductive material of the band 212 insulates each electrode 218 from each other. The non-conductive substrate on which the electrodes 218 are mounted may include PEEK. In some embodiments, the tip 210 may include a transmissive tip cap 222 that facilitates fluorescence visualization. The pointed cap can be dome-shaped, hemispherical, flat-topped, conical, or any other desired overall shape.

[0057] exist Figure 2A In the embodiment of the tip portion 210 shown in -C, there are approximately 64 discrete electrodes 218, either separate wires extending from the proximal end of the catheter to each electrode in the electrode 218, or one or more flexible circuit boards electrically / communically coupled to each of the electrodes 218 and the signal processing circuitry system (located near the proximal end of the catheter) within the tip portion 210. In some embodiments, the catheter may be 7 French or 7.5 French in diameter. The flexible tip 210 helps to facilitate continuous contact between the electrodes and cardiac tissue, for example, during cardiac exercise, which in turn improves the accuracy of the resulting cardiac electrical activity mapping. Multiple serpentine gaps can be created by circumferential or helical incisions 214 formed by a laser, which allow the tip to flex as the cardiac wall moves within the beating heart. When multiple circumferential through incisions are used, multiple dovetail (or “serrated”) bands 212 are formed.

[0058] As in the previous embodiments, each electrode in electrode 218 is positioned equidistant from each other, or positioned at least at a known or constant distance from each other.

[0059] Figure 2B It is shown in terms of flexural structure. Figure 2A The diagram shows a partial isometric view of portion 210 of the high-density mapping catheter assembly. The flexural configuration represents the contact between the catheter tip 210 and the cardiac tissue. Upon contact with the tissue, the resulting flexure of the flexible tip 210 along the spiral cuts 214 between each of the dovetail bands 212 creates minute variations in the relative positions of the electrodes 218. Because the total flexure of the tip 210 is divided across multiple electrode bipolar pairs, the overall impact on the resulting cardiac electrical activity mapping is significantly reduced.

[0060] Figure 2A The linear high-density mapping catheter of type -B may include a flushing configuration. In the flushing configuration, the catheter may include a flushing port extending through a dovetail band 212 and / or flushing fluid may be discharged through a spiral cut 214 (serpentine gap) between pairs of staggered dovetail bands 212.

[0061] Figure 2C It is consistent with various embodiments of this disclosure. Figure 2A A partial view of the planar pattern design of the electrode carrier strip (also known as the dovetail strip) 212 on the high-density mapping catheter shown.

[0062] like Figure 2C As shown, the pattern includes a circumferential waistline or ring 224 defined between a circumferentially extending proximal edge 226 and a circumferentially extending distal edge 228. Each of these edges is interrupted by a plurality of proximally extending pads 230 or distally extending pads 232. In this embodiment, each pad has the shape of a truncated isosceles triangle with sides S and a base B. Two adjacent proximally extending pads define a groove 234 that opens proximally between them. Similarly, on opposite sides of the circumferential waistline 224, two adjacent distally extending pads 232 define a groove 236 that opens distally.

[0063] When two dovetail strips 212 are connected, each distally extending pad 232 is flexibly interlocked in a proximal opening dovetail groove 234 (of the adjacent dovetail strip 212), and each proximal extending pad 230 is flexibly interlocked in a distally opening dovetail groove 236 (of the other adjacent dovetail strip 212). The interlocking pads 230 and 232 and grooves 234 and 236 of each strip 212 define a plurality of serpentine gaps between the alternating electrode carrier strips 212, which facilitate deformation of the catheter tip 210 in response to forces applied to the tip. In this embodiment, each of the pads 230, 232 includes a hole 238 in which the electrode will be mounted. Each hole 238 can extend from the outer surface of the pad through the corresponding pad to the inner surface of the pad.

[0064] In other embodiments, instead of defining a plurality of individual electrode carrier strips 212, a circumferential through-cut 214 is used (see, for example, ...). Figure 2A -B) can form a flexible tip through continuous spiral cuts.

[0065] Although Figure 2A The embodiment of -C illustrates a strip 212 with longitudinally offset pads 230 and 232 on either side of the waistline 224; however, other embodiments may include a carrier strip (instead of offset pads 230 and 232) having multiple bow-tie or hourglass-shaped structures extending across the waistline 224. Each of the bow-tie or hourglass-shaped structures has an electrode mounting hole 238 on one or more sides of the waistline 224. This embodiment is substantially symmetrical about the waistline 224, with the exception of cases where the electrode mounting hole is placed only on one side of the bow-tie or hourglass-shaped structure.

[0066] like Figure 2C As shown, each strip 212 includes two rows of electrodes, each electrode coupled to a corresponding electrode mounting hole 238. The two rows of electrodes extend along the waistline 224 of the strip 212, and the relative positions of the electrodes in each row are longitudinally offset relative to each other. The resulting configuration creates multiple triangular electrode clusters 213 formed by three adjacent electrodes. 1-3 Each cluster 213 is capable of mapping the electrophysiology of the tissue it contacts in a manner independent of the orientation of a single bipolar electrode pair. Specifically, the triangular cluster 213 of this embodiment is capable of sampling electrical signals across the contacting tissue in three directions (offset from each other by approximately 60°). Then, regardless of the bipolar pair sampling orientation, signal processing circuitry can be used to determine the true electrical signal characteristics at that location. Importantly, to aid in determining important electrical properties of the tissue (e.g., impedance), the first bipolar pair (D... E ), second bipolar pair (D F ) and the third bipolar pair (D G The distance between them must be known and constant. Figure 2C In this context, the spacing between the electrodes on band 212 is not only known and constant, but the spacing between each electrode in band 213 is also equal. Therefore, for band 2131, the distance between each of the three sets of bipolar pairs is equal (D...). E =D F =D G ).

[0067] In some embodiments, Figure 2C The relative spacing of the electrode mounting holes 238 (and therefore the electrodes) can be between 1.5 and 3 mm (center-to-center spacing). In some specific embodiments, the relative spacing of the electrode mounting holes 238 can be 1 mm or less.

[0068] Figure 3A This is a partial isometric view of the tip portion 310 of an ablation catheter with a distal high-density mapping electrode, consistent with various embodiments of this disclosure. Figure 3B yes Figure 3A A magnified view of the distal tip of the ablation catheter.

[0069] like Figure 3A As shown in Figure -B, an ablation catheter tip portion 310 with interlocking dovetail patterns 356 formed of a conductive material is illustrated to facilitate tissue ablation of contact tissue via heat / electrical energy transfer. Each dovetail pattern in the dovetail patterns 356 extending circumferentially around the tip portion 310 is separated by a serpentine incision 354. The distal end 344 of this flexible ablation tip 310 includes a pair of symmetrically placed high-density microelectrodes 346 for electrophysiological mapping. The distal end further includes two forward-facing flushing ports 348 and thermocouples or temperature sensors 350. The mapping electrodes 346 can be mounted on a non-conductive insert 352 (e.g., Figure 3B As shown in the diagram, the mapping electrode is electrically insulated from the rest of the ablation tip. In this configuration, the flexible ablation tip 310 can be approximately 4-8 mm long. Figure 3A In embodiment -B, the pads and grooves of the interlocking dovetail pattern 356 defined by the serpentine cutout 354 can be smaller than, for example, in... Figure 2A As shown in -C, the corresponding pads and grooves, the individual pads of the tip portion 310 do not accommodate electrodes. However, in other embodiments, they can be... Figure 2A -C pads and grooves with Figure 3A The distal 344 combination helps to form two high-density electrode arrays on a single catheter.

[0070] exist Figure 3A In some embodiments of the ablation catheter tip portion 310 of -B, the flushing port 348 can be replaced with an additional mapping electrode 346. The resulting square pattern of the mapping electrode 346 facilitates the use of electrodes in a bipolar pair arrangement. Utilizing three or more mapping electrodes forming a cluster on the distal end 344 of the tip portion 310, the resulting bipolar pair arrangement can be independently addressable to aid in determining electrical characteristics in the x and y directions. To further facilitate the measurement of electrical characteristics in the z direction, one or more mapping electrodes can be placed on the shaft of the ablation catheter (with a center-to-center spacing approximately the same as other mapping electrodes in the cluster). The actual electrical signal at that location can then be determined using signal processing circuitry that receives electrical signals from the electrodes, regardless of the orientation of the bipolar pair. In this embodiment, the distal end 344 may still include a flushing port.

[0071] In some embodiments where z-direction measurement is desired, four or more electrodes can be used to form a “pyramid-shaped” electrode cluster.

[0072] According to this disclosure, some specific embodiments can Figure 2A The embodiments of -C and 3A-B are combined with mapping electrodes on the distal end 344 extending circumferentially and longitudinally along the tip portion 210 / 310 of the catheter shaft. The resulting embodiments facilitate combination with the distal end 344 of the catheter tip portion 310 (e.g., Figure 3A Electrophysiological mapping of tissues in contact with the distal tip of the catheter shaft (B in the middle) and / or the distal tip portion of the catheter shaft. This allows clinicians to contact the target tissue in various relative orientations (e.g., vertical, parallel, etc.) during electrophysiological diagnostic procedures.

[0073] Figure 4A This is a plan view of the distal portion of a basket catheter 400 in an expanded configuration, consistent with various embodiments of the present disclosure. The basket includes a plurality of splines 403, 404, 405, 406, which are coupled proximally to the catheter shaft 407 and distally to a distal cap or to each other at a distal end 444. Although this embodiment presents a basket consisting of four splines 403, 404, 405, 406, basket catheters with three or more splines are readily conceivable in design, depending on the intended clinical application and desired electrophysiological mapping granularity. To facilitate basket expansion / contraction, a deployment member 460 extends along the longitudinal axis of the basket. In some embodiments, the deployment member may be a drawstring extending proximally to the catheter handle at the proximal end of the catheter shaft 407. Actuation of the drawstring causes expansion / contraction of the basket. In other embodiments, the deployment member 460 may be a lumen that can be actuated by a manipulator on the catheter handle to expand / contract the basket.

[0074] In this embodiment, each of splines 403, 404, 405, and 406 includes electrode islands 461 distributed along the length of each spline. 1-N Despite Figure 4A The embodiment proposed in -C depicts electrode islands 461 regularly distributed along the length of each spline. 1-N However, other embodiments may include electrode islands 461 that are not uniformly distributed along the spline. 1-N For example, in pulmonary vein electrophysiological mapping applications, only the distal portion of the basket can contact the tissue proximal to the pulmonary vein. Therefore, electrode island 461 can be used... 1-N The distribution is weighted 444 towards the distal end of the basket to promote enhanced electrophysiological mapping particle size near the pulmonary vein.

[0075] Various embodiments of this disclosure relate to electrode islands 461 on each of the corresponding splines 403, 404, 405, 406. 1-N Electrode islands 461 on adjacent splines 1-N It is longitudinally offset to facilitate staggering as the basket is conveyed in a contracted configuration via the inlet sheath.

[0076] Figure 4B It is consistent with various embodiments of this disclosure and is in a contracted configuration. Figure 4A A plan view of the distal portion of the basket conduit 400. Small serpentine gaps 454 are located between each of the adjacent splines 403, 404, 405, and 406. In the contraction configuration of the basket conduit, the unfolding member 460 (as shown) Figure 4A (As shown) can extend distally to allow each spline in the spline to stretch radially to the longitudinal axis of the guide shaft 407. In various embodiments of this disclosure, splines 403, 404, 405, 406 can have a natural setting in an expanded / contracted state and overcome the natural setting by means of the unfolding member 460.

[0077] like Figure 4B As shown, electrode islands 461 on adjacent splines 403, 404, 405, and 406 1-N The longitudinal offset facilitates the interlacing (also known as interlocking or nesting) of the electrode islands, thereby minimizing the size of the collapsed basket-type conduit package. To promote the collapsed state of splines 403, 404, 405, 406, the relative distance between the conduit shaft 407 and the distal end 444 is increased via the unfolding member 460.

[0078] Figure 4C yes Figure 4A A magnified plan view of a portion of spline 405. The magnified plan view further shows multiple electrode islands 461 distributed along the length of spline 405. 1-N One of the electrode islands. Electrode island 461 1-N The electrode cluster may include three or more electrodes 402 configured within the cluster 4121. The electrode cluster can be used in various bipolar configurations to facilitate the measurement of the electrical properties of tissue in contact with the electrodes. Each cluster is capable of measuring signals indicative of unique orientation-specific electrical properties of the tissue in at least two or more orientations. For example, the cluster 4121 in this embodiment includes four electrodes 402. 1-4 The first bipolar pair includes electrode 402. 1,3 This electrode facilitates the collection of tissue electrical property data in an orientation substantially parallel to the longitudinal axis of the catheter. The second bipolar pair includes electrode 402. 2,4 These electrodes facilitate the collection of tissue electrical property data in an orientation substantially transverse to the longitudinal axis of the duct. To aid in the collection of this electrical data, these bipolar electrode pairs can be independently addressed by signal processing circuitry. The signal processing circuitry analyzes the signals received from the electrodes in the cluster to determine orientation-independent electrophysiological information of the tissue in contact with the cluster electrodes.

[0079] Although this embodiment shows an electrode 402 located in a cluster 4121 on the outer surface of spline 405. 1-4Each electrode in the spline 405 is present, but for further detection of contact tissue electrical properties in a third or z-direction (e.g., perpendicular to the tissue), a fifth electrode in the spline 405 can be mounted to the inner surface of the spline 405. The fifth electrode can be a non-contact electrode and can be coupled to electrode 402 on the outer surface of the spline 405. 1-4 At least one electrode is paired to determine the electrical properties of the tissue in the z-direction.

[0080] In various embodiments consistent with this disclosure, the splines and electrode islands can be formed from a flexible electronic circuit board, wherein each electrode is coupled thereto and communicatively coupled to signal processing circuitry via traces extending along the inner or outer surface of the flexible printed circuit board. In some specific embodiments, each spline can consist of a nitinol pillar. The flexible circuitry can be directly coupled to the nitinol, or alternatively, the flexible circuitry can be directly coupled to a Pebax tube that internally houses the nitinol pillars.

[0081] In some specific embodiments, the electrode may have a diameter of 0.8 mm and a total surface area of ​​0.5 mm². 2 The electrodes within each cluster can have a variety of sizes and shapes. For example, smaller electrodes (e.g., 0.8 mm in diameter) are used for electrophysiological mapping, while larger electrodes are capable of electrophysiological mapping and have sufficiently high impedance to facilitate use in impedance-based or hybrid catheter navigation systems (e.g., MediGuide). TM Positioning within the system and / or the EnSite NavX system. In one specific embodiment, a smaller electrophysiological mapping catheter may be coupled to the outward-facing surface of the spline for direct tissue contact, while a larger non-contact navigation electrode is coupled to the inward-facing surface of the spline.

[0082] While equal spacing between all electrodes within a cluster may be desirable in some embodiments, knowledge of the relative spacing between each electrode in a bipolar pair is sufficient to accurately capture orientation-specific electrical property data of the tissue in contact with the electrodes. In some specific embodiments, the edge-to-edge spacing of one or more bipolar pair electrodes may be between 2 and 2.5 mm. To simplify signal processing, it may be desirable to maintain consistent spacing between all electrodes within the cluster or across the entire basket catheter. In other specific embodiments, the center-to-center spacing of the electrodes within the cluster may be between 0.5 and 4 mm.

[0083] Various embodiments of this disclosure relate to electrode clusters forming a 2x2 array and triangular clusters having electrodes located at each corner. Any of these cluster configurations is sufficient to determine the electrical properties of contact tissue in two or more orientations. Some embodiments of the triangular cluster may form right-angled or isosceles triangles. Some embodiments of the isosceles triangle include vertex angles between 30 and 140°. More complex clusters may include five or more electrodes to facilitate sampling the electrical properties of tissue at relative orientations of less than 90°. This embodiment further reduces electrophysiological mapping errors associated with the directionality of the electrical wavefront propagating through the heart.

[0084] Figure 5A This is a plan view of a basket catheter 500 in an expanded configuration, consistent with various embodiments of this disclosure. The basket is composed of a plurality of splines 503, 504, 505, 506, which are coupled proximally to the catheter shaft 507 and distally to a distal cap or to each other at a distal end 544. While this embodiment presents a basket composed of four splines 503, 504, 505, 506, basket catheters with three or more splines can readily be conceived in design, depending on the intended clinical application and desired electrophysiological mapping granularity. To facilitate the expansion / contraction of the basket, a deploying member 560 extends along the longitudinal axis of the basket. In some embodiments, the deploying member may be a drawstring that extends proximally from the proximal end of the catheter shaft 507 to the catheter handle. Actuation of the drawstring causes the basket to expand / contract.

[0085] In this embodiment, each of splines 503, 504, 505, and 506 includes ribs 561 distributed along the length of each spline. 1-N Each rib extends transversely to the direction of the mating spline. The spline and ribs facilitate the distribution of electrodes across their inner and / or outer surfaces. In various embodiments, the spline and ribs are formed of a flexible electronic circuit board, and / or a flexible electronic circuit board having one or more surfaces adhered to the spline and ribs. Each electrode in the circuit board can be communicatively and mechanically coupled to the flexible circuit board via a pad, and traces can communicatively couple the electrodes to signal processing circuitry.

[0086] Although Figure 5A The embodiment presented in -D shows ribs 561 regularly distributed along the length of each spline 503, 504, 505, 506. 1-N However, other embodiments may include ribs 561 that are not uniformly distributed along the spline. 1-N For example, in pulmonary vein electrophysiological mapping applications, only the distal portion of the basket can contact the tissue proximal to the pulmonary vein. Therefore, rib 561 1-N The distribution can be weighted 544 towards the distal end of the basket to contribute to enhanced electrophysiological mapping granularity near the pulmonary veins.

[0087] Various embodiments of this disclosure relate to rib 561 on each of the corresponding splines 503, 504, 505, 506. 1-N Ribs 561 on adjacent splines 1-N The longitudinal offset helps to stagger the basket as it is conveyed in a contracted configuration via the inlet sheath.

[0088] Figure 5B It is consistent with various embodiments of this disclosure and is in a contracted configuration. Figure 5A A plan view of the basket conduit 500. Small serpentine gaps 554 are located between each adjacent spline in adjacent splines 503-506. In the contraction configuration of the basket conduit, the unfolding member 560 (as shown) Figure 5A (As shown) can extend distally to allow each spline in the spline to stretch radially toward the longitudinal axis of the guide shaft 507.

[0089] like Figure 5B As shown, rib 561 on adjacent splines 503-506 1-N The longitudinal offset helps to interlock the ribs to minimize the size of the collapsed basket conduit package. To facilitate the collapsed state of splines 503-506, the relative distance between the conduit shaft 507 and the distal end 544 is increased via the unfolding member 560.

[0090] Figure 5C It is consistent with various embodiments of this disclosure. Figure 5A A magnified plan view of a portion of spline 505. The magnified plan view further shows the three ribs 561 distributed along the length of spline 505. 1-3 Spline 505 and rib 561 1-3 It can accommodate multiple electrodes, for example, for electrophysiological mapping of cardiovascular tissue. Figure 5C As shown, the plurality of electrodes 502 are configured into three overlapping clusters 512 1-3 Each electrode cluster can be used in multiple bipolar configurations to facilitate the measurement of electrical properties of the tissue in contact with the electrodes. Each cluster is capable of measuring electrical properties of the tissue in contact with different orientations in two or more orientations. For example, cluster 5121 in this embodiment includes five electrodes 502. 1-5 The first bipolar pair may include, for example, electrode 502. 1,3 This facilitates the collection of tissue electrical property data in an orientation substantially parallel to the longitudinal axis of the catheter. The second bipolar pair includes electrode 502. 2,4 This helps to collect tissue electrical property data in an orientation that is substantially transverse to the longitudinal axis of the catheter.

[0091] In some specific embodiments, some electrodes among the electrodes 502 within group 512 may be multi-purpose, while others are single-purpose. For example, electrode 502 1,3 Electrode 502 can be used simultaneously as a navigation and electrophysiological mapping electrode. 2,4 It can be used solely as an electrophysiological mapping electrode, and electrode 5025 can be used solely as a navigation electrode. In various embodiments of this disclosure, the cluster is formed into a two-dimensional shape (e.g., a triangle, a square, a hexagon, etc.).

[0092] Although this embodiment shows an electrode 502 located in a cluster 5121 on the outer surface of spline 505. 1-5 Each electrode in the spline 505 may be mounted on the inner surface of the spline 505, but for further detection of tissue electrical properties in a third orientation (i.e., perpendicular to the tissue). The fifth electrode may be a non-contact electrode and may be mounted on the outer surface of the spline 505 along with electrode 502. 1-5 At least one electrode is paired to determine the electrical properties of the contacting tissue in the normal direction relative to the tissue surface. Furthermore, since the navigation electrode does not necessarily need to be in contact with the tissue, only the navigation electrode can be placed on the inner surface of spline 505.

[0093] Figure 5D It is consistent with various embodiments of this disclosure. Figure 5A A magnified top view of the distal end 544 of the basket catheter. Figure 5D Electrode cluster 512 is further shown 4-6 Placement of the electrode at the distal end 544 of the basket catheter. This distal placement of the electrode may be particularly advantageous in a variety of applications (e.g., electrophysiological mapping of the left atrium, with particular attention to electrical signals emanating from and around the pulmonary veins).

[0094] Figure 6A This is a plan view of a basket-type conduit spline 600 consistent with various embodiments of this disclosure, and Figure 6B yes Figure 6A An enlarged plan view of a portion of a basket conduit spline 600. The basket conduit spline 600 includes a plurality of electrodes 602 that can be associated with one or more clusters 612. 1-N .like Figure 6B As shown, electrode 602 1,3-4 The electrode cluster is constructed as 6121. For example, the electrodes in cluster 6121 can be independently addressed by signal processing circuitry to detect the electrical properties of tissue in contact with the electrodes via one or more electrode bipolar pairs in the cluster. This allows for the detection of electrical signal changes associated with the directional flow of electrical signals through the myocardium. In this embodiment, the electrode cluster forms an isosceles triangle with an apex angle of approximately 30°.

[0095] like Figure 6BAs shown, multiple electrodes (e.g., electrode 602) 1,3 It is not positioned along the centerline of spline 600. Instead, electrode 602... 1,3 Positioned off-center from the spline 600 on the pads to form the desired triangular cluster 6121 arrangement. In this embodiment, adjacent splines may have their electrodes longitudinally offset to facilitate the staggering of the corresponding pads extending from each spline when the basket conduit is contracted.

[0096] Figure 7A This is a plan view of a basket-type conduit spline 700 consistent with various embodiments of this disclosure, and Figure 7B yes Figure 7A A magnified plan view of a portion of the basket conduit spline 700. The basket conduit spline 700 includes multiple electrodes 702. 1-N The electrode 702 1-N It can be associated with one or more regiments 712. For example... Figure 7B As shown, electrode 702 1-3 The electrode cluster 7121 is constructed. In this embodiment, the electrode cluster forms an isosceles triangle with a vertex angle of approximately 110°.

[0097] like Figure 7B As shown, each electrode in electrode 702 is positioned off-center from the centerline of spline 700 on the pad to form a triangular cluster 712 arrangement. In this embodiment, adjacent splines on the basket conduit can longitudinally offset their electrodes to facilitate the staggering of the corresponding pads extending from each spline when the basket conduit is contracted.

[0098] Figure 8A This is a plan view of two interlaced basket-type conduit splines 800, consistent with various embodiments of this disclosure. Figure 8B yes Figure 8A A magnified plan view of a portion of two interlaced basket-type conduit splines 800. The two splines 803 and 804 include multiple electrodes 802 distributed along the length of the splines. 1-N In this embodiment, each of splines 803 and 804 has a "serrated" shape, which helps to house adjacent splines within their complementary features when the basket conduit contracts. The serrated shape further facilitates the electrode 802. 1-3 The triangular cluster 8121, in some embodiments, forms an isosceles triangle with a vertex angle of approximately 110°.

[0099] In some embodiments consistent with this disclosure, the electrode cluster remains triangular even when the basket conduit is in a collapsed configuration. In various embodiments, the triangular cluster of electrodes is formed by adjacent electrodes.

[0100] Although this document discloses various embodiments of high-density electrode catheters, the teachings of this disclosure can be readily applied to various other catheter embodiments disclosed, for example, in the following patents and patent applications incorporated herein by reference: U.S. Provisional Application No. 61 / 753,429, filed January 16, 2013; U.S. Provisional Application No. 60 / 939,799, filed May 23, 2007; U.S. Application No. 11 / 853,759, filed September 11, 2007, now U.S. Patent No. 8,187,267, published May 29, 2012; 2007 U.S. Provisional Application No. 60 / 947,791, filed July 3, 2008; U.S. Application No. 12 / 167,736, filed July 3, 2008, now U.S. Patent No. 8,206,404, published June 26, 2012; U.S. Application No. 12 / 667,338, filed January 20, 2011 (Date 371), published as U.S. Patent Application Publication No. US2011 / 0118582A1; U.S. Application No. 12 / 651,074, filed December 31, 2009, published as U.S. Patent Application Publication No. US2011 / 0118582A1. U.S. Patent Application No. 12 / 436,977, filed May 7, 2009, was published as U.S. Patent Application Publication No. 2010 / 0286684A1; U.S. Patent Application No. 12 / 723,110, filed March 12, 2010, was published as U.S. Patent Application Publication No. 2010 / 0174177A1; U.S. Provisional Application No. 61 / 355,242, filed June 16, 2010; U.S. Patent Application No. 12 / 982,715, filed December 30, 2010, was published as U.S. Patent Application Publication No. 2011 / 0288392A1; U.S. Patent Application No. 13 / 159,446, filed June 14, 2011, was published as U.S. Patent Application Publication No. 2011 / 0313417. Published A1; International Application No. PCT / US2011 / 040629, filed June 16, 2011, published as International Publication No. WO 2011 / 159861 A2; U.S. Application No. 13 / 162,392, filed June 16, 2011, published as U.S. Patent Application Publication No. US 2012 / 0010490A1; U.S. Application No. 13 / 704,619, filed December 16, 2012, which is the national phase of International Patent Application No. PCT / US2011 / 040781, filed June 16, 2011, published as International Publication No. WO 2011 / 159955 A1.

[0101] While the various embodiments presented in Figures 1-8 are suitable for applications involving point electrodes coupled to flexible electronic circuits, where the flexible electronic circuits may (in part) include splines, arms, and shafts of various conduits, other embodiments may involve the use of annular electrodes crimped or stretched onto splines, arms, and shafts comprising materials well known in the art. The annular electrodes are electrically coupled to signal processing circuitry using wires. The annular electrodes are positioned along the splines, arms, and shafts of the conduits to form an electrode cluster having equal and known spacing therebetween. In other embodiments, the annular electrodes may be stretched or crimped onto a flexible circuit board comprising at least a portion of the splines, arms, and / or shafts of the various conduits disclosed herein.

[0102] While several embodiments have been described above with a degree of specificity, those skilled in the art can make various modifications to the disclosed embodiments without departing from the spirit of this disclosure. All content contained in the above description or shown in the accompanying drawings is intended to be exemplary only and not restrictive. Changes in detail or structure may be made without departing from the teachings. The foregoing description and the appended claims are intended to cover all such modifications and variations.

[0103] This document describes various embodiments of a variety of devices, systems, and methods. Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments described in the specification and illustrated in the accompanying drawings. However, those skilled in the art will understand that the embodiments can be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those skilled in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and therefore it will be understood that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments, which is defined only by the appended claims.

[0104] Throughout this specification, references to "multiple embodiments," "some embodiments," "one embodiment," "embodiment," etc., mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Therefore, phrases such as "in multiple embodiments," "in some embodiments," "in one embodiment," "in an embodiment," etc., appearing throughout the specification do not necessarily refer to the same embodiment. Furthermore, particular features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Thus, a particular feature, structure, or characteristic shown or described in connection with one embodiment can be combined, in whole or in part, with features, structures, or characteristics of one or more other embodiments without limitation.

[0105] It should be understood that the terms "proximal" and "distal" may be used throughout the instruction manual as a reference for a clinician manipulating one end of the instrument used to treat a patient. The term "proximal" refers to the portion of the instrument closest to the clinician, and the term "distal" refers to the portion furthest from the clinician. It will be further understood that, for the sake of brevity and clarity, spatial terms such as "vertical," "horizontal," "upward," and "downward" may be used with respect to the illustrated embodiments. However, surgical instruments can be used in many orientations and positions, and these terms are not limiting or absolute.

[0106] Any patent, publication, or other disclosure incorporated herein by reference, in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosures set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly set forth herein supersede any conflicting material incorporated herein by reference. Any material, or part thereof, incorporated herein by reference that conflicts with existing definitions, statements, or other disclosures set forth herein is incorporated only if there is no conflict between the incorporated material and existing disclosures.

Claims

1. A planar array catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end and defining a catheter longitudinal axis extending between the proximal end and the distal end; and a flexible planar array at the distal end of the catheter shaft, the planar array configured to conform to tissue and comprising two or more arms extending substantially parallel to the longitudinal axis, each of the arms having a plurality of electrodes mounted thereon; and wherein the electrodes on the same side of each arm are grouped into clusters of three or more electrodes defining a two-dimensional shape, wherein the electrodes on each arm are in fixed relative positions in at least two columns oriented substantially parallel to the longitudinal axis on one or both sides along the same arm, wherein the three or more electrodes in each cluster are in fixed relative positions along the same arm, and wherein the clusters of three or more electrodes are configured as triangles, wherein the three or more electrodes in each cluster form a right triangle. The electrode clusters are configured to sample electrical properties of contacted tissue in at least two substantially transverse directions.

2. The planar array catheter of claim 1, wherein, Each arm of the planar array comprises electrodes on both an inner surface and an outer surface, each of the clusters comprising at least one electrode on the inner surface of the arm, the at least one electrode on the inner surface of the arm configured to facilitate sampling of electrical properties in a direction perpendicular to contacted tissue.

3. The planar array catheter of claim 1, wherein, The distance between at least two pairs of electrodes within each cluster is equal.

4. The planar array conduit of claim 1, wherein, The distance between electrodes in each cluster is constant in both the collapsed and deployed configurations of the planar array.

5. The planar array conduit of claim 1, wherein, ​

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