HIGH DENSITY ELECTRODE MAPPING CATHETER
20210153932 · 2021-05-27
Inventors
- Eric J. Voth (Maplewood, MN, US)
- Gregory` K. Olson (Elk River, MN, US)
- Brian Michael Monahan (Elk River, MN, US)
Cpc classification
A61B2018/1497
HUMAN NECESSITIES
A61B2018/1467
HUMAN NECESSITIES
A61B5/287
HUMAN NECESSITIES
A61B2562/028
HUMAN NECESSITIES
A61B5/352
HUMAN NECESSITIES
A61B18/1492
HUMAN NECESSITIES
A61B2562/0209
HUMAN NECESSITIES
A61B2018/0016
HUMAN NECESSITIES
International classification
Abstract
A medical device can comprise a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. A flexible tip portion can be located adjacent to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework. A plurality of curved microelectrodes can be disposed on the flexible framework and can form a flexible array of curved microelectrodes adapted to conform to tissue.
Claims
1. A medical device, comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible tip portion located adjacent to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework; and a plurality of curved microelectrodes disposed on the flexible framework and forming a flexible array of curved microelectrodes adapted to conform to tissue, wherein each one of the curved microelectrodes is segmented.
2. The medical device of claim 1, wherein: the flexible framework includes a first inboard arm, second inboard arm, first outboard arm, and second outboard arm; and each of the first inboard arm, second inboard arm, first outboard arm, and second outboard arm extends along a respective arm longitudinal axis.
3. The medical device of claim 2, wherein a plurality of the curved microelectrodes are disposed on each one of the first inboard arm, second inboard arm, first outboard arm, and second outboard arm and are longitudinally spaced apart from one another.
4. The medical device of claim 3, wherein each one of the curved microelectrodes is partially wrapped about an arm longitudinal axis of a particular one of the arms.
5. The medical device of claim 3, wherein each of the first inboard arm, second inboard arm, first outboard arm, and second outboard arm comprises a top half and a bottom half.
6. The medical device of claim 5, wherein at least one of the plurality of curved microelectrodes is disposed on the top half and at least one of the plurality of curved microelectrodes is disposed on the bottom half.
7. The medical device of claim 6, wherein each of the at least one of the plurality of curved microelectrodes disposed on the top half is disposed opposite of a respective one of the plurality of curved microelectrodes disposed on the bottom half to form a corresponding pair of curved microelectrodes.
8. The medical device of claim 7, wherein each of the corresponding pairs of curved microelectrodes are circumferentially spaced apart from one another.
9. The medical device of claim 2, wherein: a flexible circuit is disposed on each one of the first inboard arm, second inboard arm, first outboard arm, and second outboard arm; and the plurality of curved microelectrodes are disposed on each one of the flexible circuits.
10. The medical device of claim 9, wherein the first inboard arm, second inboard arm, first outboard arm, and second outboard arm include a top half and a bottom half.
11. The medical device of claim 10, wherein a first flexible circuit is disposed on a top half of each one of the arms and a second flexible circuit is disposed on a bottom half of each one of the arms.
12. The medical device of claim 10, wherein the first flexible circuit and the second flexible circuit include corresponding pairs of curved microelectrodes.
13. The medical device of claim 9, wherein the flexible circuit includes electrical traces electrically coupled to each one of the plurality of curved microelectrodes.
14. The medical device of claim 8, wherein: each of the first inboard arm, second inboard arm, first outboard arm, and second outboard arm includes a plurality of corresponding pairs of curved microelectrodes; and the plurality of corresponding pairs of curved microelectrodes are longitudinally spaced apart from one another.
15. The medical device of claim 1, wherein a first portion of the plurality of curved microelectrodes are disposed on a top of the flexible framework and a second portion of the plurality of curved microelectrodes are disposed on a bottom of the flexible framework.
16. A medical device, comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible tip portion located adjacent to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework, the flexible framework including a first inboard arm, second inboard arm, first outboard arm, and second outboard arm, wherein the flexible framework further includes a top portion and a bottom portion; and a first plurality of curved electrodes disposed on the top portion of the flexible framework; and a second plurality of curved electrodes disposed on the bottom portion of the flexible framework.
17. The medical device of claim 16, wherein the first plurality of curved electrodes and the second plurality of curved electrodes are disposed in corresponding pairs of curved electrodes, wherein a corresponding pair of curved electrodes includes a first curved electrode disposed on the top half of the flexible framework and a second curved electrode disposed on the bottom half of the flexible framework, opposite the first curved electrode.
18. The medical device of claim 17, wherein the flexible framework is configured to be disposed against a tissue of a patient.
19. The medical device of claim 18, wherein the corresponding pairs of curved electrodes are longitudinally spaced apart from one another on the flexible framework.
20. The medical device of claim 19, wherein selected ones of the plurality of curved electrodes are configured to be deactivated to form a pattern of a plurality of activated curved electrodes, the activated curved electrodes being configured to measure electrical signals produced by the tissue of the patient.
21. A catheter, comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible tip portion located adjacent to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework, the flexible framework including a first inboard arm, second inboard arm, first outboard arm, and second outboard arm, wherein the flexible framework further includes a top face and a bottom face; and a plurality of curved electrodes disposed about a longitudinal axis of each one of the first inboard arm, second inboard arm, first outboard arm, and second outboard arm, wherein each one of the plurality of curved electrodes is wrapped about an arm longitudinal axis of a respective one of the arms, and wherein each one of the plurality of curved electrodes is segmented.
22. The catheter of claim 21, wherein each one of the plurality of curved electrodes circumferentially extends about the arm longitudinal axis of the respective one of the arms in a range from 90 to 270 degrees.
23. The catheter of claim 22, wherein each one of the curved electrodes is centered about the bottom face of the flexible framework.
24. The catheter of claim 21, wherein: the plurality of curved electrodes are disposed on the bottom face and the top face of the flexible framework and form pairs of curved electrodes disposed opposite from one another, and each curved electrode in each one of the pairs of curved electrodes extends about the arm longitudinal axis of the respective one of the arms in a range from 90 to 170 degrees.
25. The catheter of claim 24, wherein: each of the pairs of curved electrodes includes a top curved electrode and a bottom curved electrode, the top curved electrode is centered about the top face of the flexible framework; and the bottom curved electrode is centered about the bottom face of the flexible framework.
26. The medical device of claim 21, wherein each of the at least one of the plurality of curved microelectrodes disposed on the top face is longitudinally staggered from a respective one of the plurality of curved microelectrodes disposed on the bottom face.
27. A medical device, comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible tip portion located adjacent to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework, wherein the flexible framework includes a first inboard arm, second inboard arm, first outboard arm, and second outboard arm, wherein each of the arms is disposed through a tube; and a plurality of microelectrodes disposed on each one of the tubes, the plurality of microelectrodes forming a flexible array of microelectrodes adapted to conform to tissue.
28. The medical device of claim 27, further comprising a plurality of conductive traces electrically coupled to each one of the microelectrodes.
29. The medical device of claim 28, wherein the tube is reflowed to incorporate the plurality of conductive traces and each one of the microelectrodes into the tube.
30. The medical device of claim 29, wherein the plurality of conductive traces extend along an inner wall of the tube.
30. The medical device of claim 27, wherein a plurality of conductive wires extend through a lumen defined by the tube.
31. The medical device of claim 30, wherein the plurality of conductive wires are electrically coupled to the microelectrodes through vias defined in a sidewall of the tube.
32. The medical device of claim 31, wherein the microelectrodes are formed from a conductive epoxy.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0027] The contents of International Application No. PCT/US2014/011940 entitled Flexible High-Density Mapping Catheter Tips and Flexible Ablation Catheter Tips with Onboard High-Density Mapping Electrodes is hereby incorporated by reference as though fully set forth herein. The contents of U.S. application Ser. No. 15/331,562 entitled High Density Electrode Mapping Catheter and U.S. Application No. 62/572,186 entitled Catheter with High-Density Mapping Electrodes are hereby incorporated by reference as though fully set forth herein.
[0028]
[0029] Each of the four arms can carry a plurality of electrodes 102. For example, each of the four arms can carry electrodes 102 spaced along a length of each of the four arms. Although each of the high density electrode mapping catheters 101 depicted in
[0030] In some embodiments, the electrodes 102 can be used in diagnostic, therapeutic, and/or mapping procedures. For example and without limitation, the electrodes 102 can be used for electrophysiological studies, pacing, cardiac mapping, and ablation. In some embodiments, the electrodes 102 can be used to perform unipolar or bipolar ablation. This unipolar or bipolar ablation can create specific lines or patterns of lesions. In some embodiments, the electrodes 102 can receive electrical signals from the heart, which can be used for electrophysiological studies. In some embodiments, the electrodes 102 can perform a location or position sensing function related to cardiac mapping.
[0031] In some embodiments, the high density electrode mapping catheter 101 can include a catheter shaft 107. The catheter shaft 107 can include a proximal end and a distal end. The distal end can include a connector 108, which can couple the distal end of the catheter shaft 107 to a proximal end of the planar array. The catheter shaft 107 can define a catheter shaft longitudinal axis aa, as depicted in
[0032] The flexible tip portion 110 can be adapted to conform to tissue (e.g., cardiac tissue). For example, when the flexible tip portion 110 contacts tissue, the flexible tip portion can deflect, allowing the flexible framework to conform to the tissue. In some embodiments, the arms (or the understructure of the arms) comprising the paddle structure (or multi-arm, electrode-carrying, flexible framework) at the distal end of the catheters depicted in
[0033] Among other things, the disclosed catheters, with their plurality of electrodes, are useful to (1) define regional propagation maps of particularly sized areas (e.g., one centimeter square areas) within the atrial walls of the heart; (2) identify complex fractionated atrial electrograms for ablation; (3) identify localized, focal potentials between the electrodes for higher electrogram resolution; and/or (4) more precisely target areas for ablation. These mapping catheters and ablation catheters are constructed to conform to, and remain in contact with, cardiac tissue despite potentially erratic cardiac motion. Such enhanced stability of the catheter on a heart wall during cardiac motion provides more accurate mapping and ablation due to sustained tissue-electrode contact. Additionally, the catheters described herein may be useful for epicardial and/or endocardial use. For example, the planar array embodiments depicted herein may be used in an epicardial procedure where the planar array of electrodes is positioned between the myocardial surface and the pericardium. Alternatively, the planar array embodiments may be used in an endocardial procedure to quickly sweep and/or analyze the inner surfaces of the myocardium and quickly create high-density maps of the heart tissue's electrical properties.
[0034]
[0035] In some embodiments, a plurality of curved electrodes 102 can be disposed on the flexible framework 110 and can form a flexible array of curved electrodes 102 adapted to conform to tissue. In embodiments disclosed in
[0036] In some embodiments, the plurality of curved electrodes 102 are disposed on each one of the first inboard arm 104, second inboard arm 105, first outboard arm 103, and second outboard arm 106 and are longitudinally spaced apart from one another, as depicted in
[0037] In some embodiments, at least one of the plurality of curved electrodes can be disposed on the top half and at least one of the plurality of curved electrodes can be disposed on the bottom half. In some embodiments, each one of the curved electrodes can be partially wrapped about an arm longitudinal axis of a particular one of the arms upon which the curved electrode is disposed. For example, as depicted with respect to the top and bottom curved electrodes 102-1′, 102-1″, the curved electrodes can be wrapped and/or revolved about the arm longitudinal axis cc. In some embodiments, the top curved electrode 102-1′ and the bottom curved electrode 102-1″ can form a curved electrode pair.
[0038] As depicted in
[0039] As further depicted in
[0040] In some embodiments, each of the first inboard arm 104, second inboard arm 105, first outboard arm 103, and second outboard arm 106 can include a plurality of corresponding pairs of curved electrodes 102. A first portion of the plurality of curved electrodes 102 can be disposed on a top of the flexible framework 110 and a second portion of the plurality of curved electrodes 102 can be disposed on a bottom of the flexible framework 110. In some embodiments, the placement of the plurality of curved electrodes 102 can be varied, as well as a circumferential width, longitudinal length, and/or thickness of the plurality of curved electrodes 102, as further discussed herein.
[0041]
[0042] The circumferential spacing defined between the top curved electrode 102-13′ and the bottom curved electrode 102-13″ can be larger and/or smaller than that depicted in
[0043]
[0044]
[0045] As further depicted with respect to
[0046]
[0047] In some embodiments, an angle Θ.sup.C can be defined between a central axis ee′″, for example, along which the second outboard arm 136C extends and the top outboard edge 142-1C of the top curved electrode 138-4C′ and the bottom outboard edge 142-2C of the bottom curved electrode 138-4C”, as similarly discussed in relation to
[0048]
[0049] The top curved electrodes 172A and the bottom curved electrodes can be disposed along the longitudinally-extending arms in a manner similarly to that discussed herein, for example in relation to
[0050]
[0051] In some embodiments, one or more of the electrodes can be deactivated, such that a pattern of active electrodes is created on the high density electrode mapping catheter 170B. For instance, a first top electrode 172-1B′ can be turned off, as well as a third top electrode 172-3B′, in addition to their corresponding bottom electrodes, thus leaving the second top electrode 172-1B′ and the fourth top electrode 172-4W as active electrodes. Additionally, a sixth top electrode 172-6B′ and an eighth top electrode 172-6W can be turned off, in addition to their corresponding bottom electrodes, thus leaving the fifth top electrode 172-5B′ and the seventh top electrode 172-7W as active electrodes. In an example, an electrode can be deactivated (i.e., turned off) by electrically disconnecting the electrode from a central processing unit via a physical and/or virtual switch in some embodiments. Thus, measurements can be taken from the active electrodes and not the deactivated electrodes.
[0052]
[0053] In an example, the pattern can include an alternating arrangement, wherein electrodes on each one of the arms are staggered. This can reduce the number of electrodes disposed on the flexible tip portion 220A and also reduce a number of electrical wires needed to electrically couple all of the electrodes. In an example, placement of the electrodes in the alternating arrangement, versus an arrangement such as that depicted in
[0054] With reference to the top curved electrodes 202-3A′, 202-7A′, 202-11A′, 202-15A′, 202-19A′, and 202-23A′ disposed on the first inboard arm 206A, the electrodes 202-3A′, 202-7A′, 202-11N, 202-15A′, 202-19A′, and 202-23A′ can have a same spacing as the top curved electrodes 202-1A′, 202-5A′, 202-9A′, 202-13A′, 202-17A′, and 202-21A′ disposed on the first inboard arm 204A, however, a position of each one of the top curved electrodes 202-3A′, 202-7A′, 202-11A′, 202-15A′, 202-19A′, and 202-23A′ can be shifted proximally to form a checkerboard pattern. For instance, the most distal top curved electrode 202-3A′ on the first inboard arm 206A can be longitudinally disposed at a position on the first inboard arm 206A between the top curved electrodes 202-1A′ and 202-5A′. With reference to
[0055]
[0056] In some embodiments, the arrangement of electrodes can include a checkerboard pattern, wherein a plurality of electrodes are longitudinally disposed along each one of the arms in a spaced apart relationship. In an example, a spacing of the electrodes can be staggered with respect to adjacent arms. For instance, with respect to the first outboard arm 204B, the top curved electrodes 202-1B′, 202-5B′, 202-9B′, etc. can be disposed along the first outboard arm 204B in a spaced apart relationship. In an example, a spacing between each one of the top curved electrodes 202-1B′, 202-5B′, 202-9B′, etc. can be the same. With reference to the top curved electrodes 202-3B′, 202-7B′, etc. disposed on the first inboard arm 206B, the top curved electrodes 202-3B′, 202-7B′, etc. can have a same spacing as the top curved electrodes 202-1B′, 202-5B′, 202-9B′, etc. disposed on the first inboard arm 204B, however, a position of each one of the top curved electrodes 202-3B′, 202-7B′, etc. can be shifted proximally to form a checkerboard pattern. For instance, the most distal top curved electrode 202-3B′ on the first inboard arm 206B can be longitudinally disposed at a position on the first inboard arm 206B between the top curved electrodes 202-1B′ and 202-5B′.
[0057]
[0058] Input/output mechanisms 234 may comprise conventional apparatus for interfacing with a computer-based control unit including, for example, one or more of a keyboard, a mouse, a tablet, a foot pedal, a switch and/or the like. Display 236 may also comprise conventional apparatus, such as a computer monitor.
[0059] System 230 may optionally include image database 238 to store image information relating to the patient's body. Image information may include, for example, a region of interest surrounding a destination site for medical device 244 and/or multiple regions of interest along a navigation path contemplated to be traversed by medical device 244. The data in image database 238 may comprise known image types including (1) one or more two-dimensional still images acquired at respective, individual times in the past; (2) a plurality of related two-dimensional images obtained in real-time from an image acquisition device (e.g., fluoroscopic images from an x-ray imaging apparatus), wherein the image database acts as a buffer (live fluoroscopy); and/or (3) a sequence of related two-dimensional images defining a cine-loop wherein each image in the sequence has at least an ECG timing parameter associated therewith, adequate to allow playback of the sequence in accordance with acquired real-time ECG signals obtained from ECG monitor 240. It should be understood that the foregoing embodiments are examples only and not limiting in nature. For example, the image database may also include three-dimensional image data as well. It should be further understood that the images may be acquired through any imaging modality, now known or hereafter developed, for example X-ray, ultra-sound, computerized tomography, nuclear magnetic resonance or the like.
[0060] ECG monitor 240 is configured to continuously detect an electrical timing signal of the heart organ through the use of a plurality of microelectrodes 252. As discussed herein, the microelectrodes 252 can include the electrodes disposed on the flexible tip portions of the devices previously discussed herein, for example, in relation to
[0061] In some embodiments, the main control can execute computer-readable instructions configured to disable particular ones of the electrodes and/or enable particular ones of the electrodes to form a particular pattern of electrodes disposed on a flexible tip portion of a high density electrode mapping catheter, as discussed in relation to
[0062] In some embodiments, the method can include determining a degree of contact between the first electrode and the tissue based on a comparison between the first electrical signal and the second electrical signal. In an example, when the first electrode is disposed against tissue, the second electrode can be disposed on the opposite side of the medical device and in a blood pool. As such, a different electrical signal (e.g., voltage) can be received from the first electrode versus the second electrode. Accordingly, in some embodiments, the comparison between the first electrical signal and the second electrical signal can include comparing a first voltage associated with the first electrical signal and a second voltage associated with the second electrical signal.
[0063] In an example, cardiac tissue can generate a voltage whenever it depolarizes. The voltage can propagate through the heart muscle and also through the blood pool and can be picked up by both the first electrode and the second electrode. If one of the electrodes (e.g., first electrode) is touching the tissue, then that voltage will be different than the voltage picked up by the electrode disposed in the blood pool (e.g., second electrode). The difference between the first electrical signal associated with the first electrode and the second electrical signal associated with the second electrode will be greater when the first electrode is touching the tissue and the second electrode is disposed in the blood pool. The difference between the first electrical signal associated with the first electrode and the second electrical signal associated with the second electrode will be smaller when the first electrode and second electrode are both disposed in the blood pool.
[0064] Based on the differences in electrical signals (e.g., voltages), a determination of contact between the medical device (e.g., first electrode) and the tissue can be made. For example, the method can include determining that the first electrode is not in contact with the tissue when the first voltage associated with the first electrical signal and the second voltage associated with the second electrical signal are the same. For example, when the voltages associated with the first electrode and the second electrode are the same, this can be an indication that the first electrode and the second electrode are disposed in the blood pool and are not in contact with the tissue. In some embodiments, the method can include determining that the first electrode is not in contact with the tissue when a difference between the first voltage associated with the first electrical signal and the second voltage associated with the second electrical signal is less than a threshold voltage (e.g., the voltages are close to being the same). For example, the voltages associated with each of the first and second electrodes may not be exactly the same due to electrical interference in the blood pool.
[0065] Alternatively, in some embodiments, the method can include determining that the first electrode is in contact with the tissue when the first voltage associated with the first electrical signal is different than the second voltage associated with the with the second electrical signal. In an example, the method can include determining that the first electrode is in contact with the tissue when a difference between the first voltage associated with the first electrical signal and the second voltage associated with the second electrical signal is greater than a threshold value. For instance, the method can include determining that the first electrode is in contact with the tissue when the first voltage associated with the first electrical signal is greater than the second voltage associated with the second electrical signal (e.g., is greater than a defined threshold value). As discussed, when the first electrode is disposed against the tissue and the second electrode is disposed in the blood pool, the first electrical signal associated with the first electrode can have a greater voltage than the second electrical signal.
[0066] In some embodiments, the method can include determining that a degree of contact between the first electrode and the tissue is increasing based on the first voltage associated with the first electrical signal being increased with respect to the second voltage associated with the second electrical signal. For example, if the first voltage associated with the first electrical signal increases at a greater rate than the second voltage associated with the second electrical signal and/or increases while the second voltage stays the same, a determination can be made that a degree of contact between the first electrode and the tissue is increasing. In some embodiments, ensuring that sufficient contact exists between the medical device and the tissue can be beneficial where diagnostic information is being collected by the medical device (e.g., electrodes) and/or therapeutic energy is being delivered to the tissue from the medical device (e.g., electrodes). Alternatively, the method can include determining that a degree of contact between the first electrode and the tissue is decreasing based on the first voltage associated with the first electrical signal being decreased with respect to the second voltage associated with the second electrical signal.
[0067] In some embodiments, the first and/or second electrode can be configured to be driven by an electrical current (e.g., high frequency electrical current). In an example, the first and/or second electrode can be driven with the electrical current and a voltage (e.g., high frequency voltage) can be induced by the electrical current. For instance, a voltage can be induced in the cardiac tissue and/or in the blood pool. Accordingly, an induced voltage, which is generated by one or more of the electrodes, rather than the heart, can be received by one or more of the electrodes on the medical device. The induced voltage (e.g., impedance) associated with an electrical signal received from one of the electrodes can be measured. Depending on whether an electrode from which the electrical signal is received is disposed in the blood pool or is in contact with the tissue, the electrical signal can vary. In an example, the induced voltages that are measured from an electrical signal received from the first electrode and the second electrode can be different if one of the electrodes is disposed against tissue and one of the electrodes is disposed in the blood pool and can be similar if both electrodes are disposed in the blood pool.
[0068] In some embodiments, one or both of the first electrode and the second electrode can be driven with the current and one or more other electrodes disposed on the medical device or an electrode disposed on a skin patch can receive an induced voltage. In some embodiments, the current can be induced in the first electrode and an induced voltage can be received by the second electrode. Whether the second electrode is disposed in the blood pool or in contact with cardiac tissue can affect a magnitude of the induced voltage. Likewise, the current can be induced in the second electrode and an induced voltage can be received by the first electrode. Whether the first electrode is disposed in the blood pool or in contact with cardiac tissue can affect a magnitude of the induced voltage. In some embodiments, a current can be induced in another electrode disposed on the medical device and an induced voltage can be received by one or both of the first and second electrodes. Induced voltages associated with electrical signals received from the first and second electrodes can vary depending on whether one or more of the first and second electrodes are disposed in the blood pool or disposed against cardiac tissue, as discussed herein.
[0069] Some embodiments of the present disclosure can include a method for determining a cardiac activation associated with endocardial tissue, according to various embodiments of the present disclosure. As discussed, the method can include receiving a first electrical signal from a first electrode disposed on a first side of a tip portion of a medical device. In some embodiments, the method can include receiving a second electrical signal from a second electrode disposed on a second side of the tip portion of the medical device. As previously discussed, the first electrode and the second electrode can be disposed vertically adjacent with respect to one another in a manner analogous to that depicted and discussed herein.
[0070] In some embodiments, the method can include determining a characteristic associated with the cardiac activation, wherein the cardiac activation is in a direction that is normal to a surface of the endocardial tissue. In an example, because the first electrode and the second electrode are vertically adjacent to one another, as a cardiac activation travels through endocardial tissue, an electrical activation signal can be received by the first electrode disposed against the tissue and can then be received by the second electrode that is vertically adjacent to the first electrode. For instance, as the electrical activation signal travels toward a surface of the endocardial tissue on which the first electrode is disposed, the electrical activation signal can travel in a direction that is normal to the surface of the endocardial tissue, toward the first electrode. As the electrical activation signal reaches the surface of the endocardial tissue on which the first electrode is disposed, a first electrical signal can be received from the first electrode. The electrical activation signal can then travel through a portion of the blood pool and can be received by the second electrode disposed vertically adjacent to the first electrode. This can allow for a better measurement of the electrical activation signal since the two electrodes are disposed vertically adjacent to one another.
[0071] In some embodiments, the characteristic associated with the cardiac activation can include a direction of the cardiac activation. For example, a determination that a component of a directional vector of the cardiac activation is normal to a surface of the endocardial tissue can be made. In some embodiments, it can be common for cardiac activation to be in a direction that is normal to the surface of the endocardial tissue. For example, in thick ventricular tissue, cardiac activation can be in a direction that is normal to the surface of the endocardial tissue.
[0072] In some embodiments, the method can include filtering out noise from the first electrical signal based on the second electrical signal. For example, where the first electrode is disposed against the surface of the endocardial tissue, surrounding noise can have negative effects on the first electrical signal associated with the first electrode. The surrounding noise can be caused by stray electrical signals that are flowing through the blood pool in some embodiments. Accordingly, the second electrode, which is disposed in the blood pool can receive any stray electrical signals that are flowing through the blood pool, which can be represented in the second electrical signal associated with the second electrode. In some embodiments, the second electrical signal can be used to filter out the stray electrical signals from the first electrical signal. In some embodiments, the methods discussed herein can be executed by a computer such as that discussed in relation to
[0073]
[0074] In some embodiments, outer curved electrodes 262-1′, 262-2′, 262-3′ can be disposed on an outer face of one or more of the splines 264 and inner curved electrodes 262-7″, 262-8″, 262-9″ can be disposed on an inner face of one or more of the splines 264. For example, a cross-section of each one of the splines 264 can be similar to or the same as the cross-sections of the arms depicted and discussed in relation to
[0075]
[0076] In some embodiments, the high density electrode mapping catheter 270 can include one or more flexible circuits disposed on each one of the first outboard arm 276-1, second outboard arm 276-2, first inboard arm 276-3, and second inboard arm 276-4. In some embodiments, a first flexible circuit 274-1 can be disposed on the first outboard arm 276-1, a second flexible circuit 274-2 can be disposed on the first inboard arm 276-3, a third flexible circuit 274-3 can be disposed on the second inboard arm 276-4, and a fourth flexible circuit 274-4 can be disposed on the second outboard arm 276-2. The flexible circuits 274-1, 274-2, 274-3, 274-4 can be disposed directly on each one of the arms 276-1, 276-2, 276-3, 276-4. In some embodiments, the flexible circuits 274-1, 274-2, 274-3, 274-4 can be attached directly to each one of the arms 276-1, 276-2, 276-3, 276-4 via an adhesive bonding agent. The flexible circuits 274-1, 274-2, 274-3, 274-4 can extend proximally along a flexible tip portion of the high density electrode mapping catheter 270 and can terminate at or near a junction of the flexible tip portion. In some embodiments, individual leads can be connected to conductive traces included in the flexible circuits 274-1, 274-2, 274-3, 274-4, as further discussed herein.
[0077] In some embodiments, each one of the flexible circuits 274-1, 274-2, 274-3, 274-4 can be constructed through deposition of various materials directly on each one of the arms 276-1, 276-2, 276-3, 276-4, as further discussed in U.S. patent application Ser. No. 15/331,562, which is hereby incorporated by reference as though fully set forth herein. For example, in some embodiments, a dielectric layer can be formed directly on each one of the arms 276-1, 276-2, 276-3, 276-4. One or more curved electrodes 272 can be formed on top of the dielectric layer, along with leads to each respective curved electrode 272.
[0078] The curved electrodes 272-1, 272-2, 272-3, 272-4 can include features such as those previously disclosed herein. In some embodiments, the flexible circuit 274-1 can include a conductive trace (e.g., lead) that is electrically coupled with each one of the curved electrodes 272-1, 272-2, 272-3, 272-4. For example, a first electrical trace 278-1 can be electrically coupled with the first curved electrode 272-1, a second electrical trace 278-2 can be electrically coupled with the second curved electrode 272-2, a third electrical trace 278-3 can be electrically coupled with the third curved electrode 272-3, and a fourth electrical trace 278-4 can be electrically coupled with the fourth curved electrode 272-4. Each one of the electrical traces 278-1, 278-2, 278-3, 278-4 can extend proximally along the flexible circuit 274-1 and can terminate at a junction. In some embodiments, the junction can be located on the high density electrode mapping catheter 270, along a shaft (not depicted) of the high density electrode mapping catheter 270, or some other area located proximally with respect to the shaft of the high density electrode mapping catheter, such as at a main control 232, as depicted in
[0079] As further depicted in
[0080] In some embodiments, the flexible circuit 274-1 on which the curved electrodes are disposed can be formed from a flexible material, as previously mentioned. Accordingly, the flexible circuit 274-1 can be applied to a respective one of the arms (e.g., first outboard arm 276-1). In some embodiments, the flexible circuit 274-1 can envelop a portion of the respective one of the arms. For example, the flexible circuit 274-1 can envelop a top portion of the first outboard arm 276-1. In some embodiments, an additional flexible circuit 274-5 can envelop a bottom portion of the first outboard arm 276-1, leaving a gap 280 between the two flexible circuits that run longitudinally along the first outboard arm 276-1. However, in some embodiments, the pair of flexible circuits 274-1, 274-5 can overlap one another and/or a single flexible circuit can be wrapped about a respective one of the arms. For example, a single flexible circuit that includes two rows of curved electrodes can be wrapped about a respective one of the arms such that a first row of curved electrodes is disposed on a top of the respective one of the arms and the second row of curved electrodes is disposed on a bottom of the respective one of the electrodes.
[0081] In some embodiments, the curved electrodes 272 can be flexible, such that the curved electrodes 272 can flex along with the flex circuit. However, in some embodiments, the curved electrodes 272 can be preformed to a curvature of the arms 276-1, 276-2, 276-3, 276-4 of the high density electrode mapping catheter 270.
[0082] In some embodiments, the flex circuits 274-1, 274-2, 274-3, 274-4 can be disposed directly on an understructure that forms each one of the arms 276-1, 276-2, 276-3, 276-4, which can consist of a flexible metal, such as Nitinol. However, in some embodiments, the understructure can be inserted in a tubing. The tubing can be a heat shrink tubing, in some embodiments, which can be heated, thus shrinking the tubing around each one of the arms 276-1, 276-2, 276-3, 276-4. The flex circuits 274 can then be applied to an exterior of the heat shrink tubing. In some embodiments, the arms 276-1, 276-2, 276-3, 276-4 can be coated with a material (e.g., polymer), which can be flexible, and the flex circuits 274 can be applied to the exterior of the coating material. In some embodiments, the tubing through which the understructure is inserted and/or the material that coats the understructure can include a polymer, such as PEBAX®. In some embodiments, the understructure of the high density electrode mapping catheter 270 can be inserted through a tube that does not include a flexible circuit, as further depicted and described in relation to
[0083]
[0084] The conductive traces 294-1, 294-2, 294-3 can extend distally from a proximal end of the reflowed electrode tube 290 and can terminate at respective ones of the electrodes 292-1, 292-2, 292-3. For example, the conductive traces 294-1, 294-2, 294-3 can extend distally from a proximal end of the reflowed electrode tube 290 and can extend through each one of the respective vias 298-1, 298-2, 298-3 and can be coupled to each one of the respective electrodes 292-1, 292-2, 292-3. The one or more conductive traces 294-1, 294-2, 294-3 can transmit one or more signals from each one of the electrodes 292-1, 292-2, 292-3. In some embodiments, one or more signals can be transmitted to one or more of the electrodes 292-1, 292-2, 292-3 to perform a therapeutic action (e.g., ablation) and/or diagnostic action. In some embodiments, the electrodes 292-1, 292-2, 292-3 can be curved electrodes, as previously discussed herein. However, in some embodiments, the electrodes 292-1, 292-2, 292-3 can be flat electrodes.
[0085] In some embodiments, the reflowed electrode tube 290 can be reflowed around the electrodes 292-1, 292-2, 292-3 and conductive traces 294-1, 294-2, 294-3. For example, the electrodes 292-1, 292-2, 292-3 can be placed on the outer surface of the sidewall 296 and the conductive traces 294-1, 294-2, 294-3 can be placed on an inner surface of the sidewall 296 and threaded through each respective via 298-1, 298-2, 298-3. The tube can then be heated to reflow the tube and adhere the electrodes 292-1, 292-2, 292-3 to the outer surface of the sidewall 296 and adhere their respective conductive traces 294-1, 294-2, 294-3 to the inner surface of the sidewall 296.
[0086] In some embodiments, the electrodes 292-1, 292-2, 292-3 can be formed and/or disposed on a first surface of a flat polymer material and the conductive traces 294-1, 294-2, 294-3 can be formed and/or disposed on a second surface of the flat polymer that is opposite of the first surface. Interconnects can be formed between the first surface and the second surface of the flat polymer before or after placement of the electrodes 292-1, 292-2, 292-3 and the conductive traces 294-1, 294-2, 294-3, which can electrically couple the electrodes 292-1, 292-2, 292-3 and the conductive traces 294-1, 294-2, 294-3.
[0087] In some embodiments, the electrode tube 290 can be formed through printing the electrodes 292-1, 292-2, 292-3 and the conductive traces 294-1, 294-2, 294-3, as well as the sidewall 296 of the tube on a form to create the electrode tube 290. For example, through use of a printer (e.g., aerosol/ink jet technologies), the electrodes 292-1, 292-2, 292-3 and the conductive traces 294-1, 294-2, 294-3, as well as the sidewall 296 can be printed onto a circular form to create a tubular component (e.g., the electrode tube).
[0088] In some embodiments, a protective layer can be formed over the inner surface of the sidewall 296 and the conductive traces 294-1, 294-2, 294-3. The protective layer can be an insulative layer that prevents the conductive traces 294-1, 294-2, 294-3 from contacting other conductive material, such as an understructure of a flexible tip portion of a high density electrode mapping catheter 270, such as that depicted in relation to
[0089] In some embodiments, the reflowed electrode tube 290 with the electrodes 292-1, 292-2, 292-3 and conductive traces 294-1, 294-2, 294-3 can be disposed over the understructure of the flexible tip portion of a high density electrode mapping catheter 270. In an example, the reflowed electrode tube 290 can be disposed over a flexible understructure (e.g., formed from nitinol) of the flexible tip portion of the high density electrode mapping catheter 270. For instance, the reflowed electrode tube 290 can be coaxial with a respective arm of the understructure forming the flexible tip portion of the high density electrode mapping catheter 270.
[0090] The reflowed electrode tube 290 can be formed from a flexible material, such as a polymer (e.g., PEBAX®), which can allow the reflowed electrode tube 290 to flex with the flexible understructure. In some embodiments, the reflowed electrode tube 290 can be adhered to the flexible understructure. For example, the reflowed electrode tube 290 can be adhered to the flexible understructure via an adhesive in some embodiments. In some embodiments, the reflowed electrode tube 290 can be frictionally fit to the flexible understructure. In some embodiments, the reflowed electrode tube 290 can be a heat shrink tube and can be adhered to the flexible understructure through application of heat to the reflowed electrode tube 290, causing the reflowed electrode tube 290 to shrink.
[0091]
[0092] The conductive wires 314-1, 314-2, 314-3 can extend distally from a proximal end of the electrode tube 310 and can terminate at respective ones of the electrodes 312-1, 312-2, 312-3. For example, the conductive wires 314-1, 314-2, 314-3 can extend distally from a proximal end of the electrode tube 310 and can extend through each one of the respective vias 320-1, 320-2, 320-3 and can be coupled to each one of the respective electrodes 312-1, 312-2, 312-3. In some embodiments. The one or more conductive wires 314-1, 314-2, 314-3 can transmit one or more signals from each one of the electrodes 312-1, 312-2, 312-3. In some embodiments, one or more signals can be transmitted to one or more of the electrodes 312-1, 312-2, 312-3 to perform a therapeutic action (e.g., ablation) and/or diagnostic action. In some embodiments, the electrodes 312-1, 312-2, 312-3 can be curved electrodes, as previously discussed herein. However, in some embodiments, the electrodes 312-1, 312-2, 312-3 can be flat electrodes. In some embodiments, the electrodes can be spot electrodes.
[0093] In some embodiments, the electrodes 312-1, 312-2, 312-3 can be formed from a conductive epoxy. In an example, the conductive epoxy can include a silver filled one or two part epoxy. However, the epoxy could also be filled with another conductive materials, such as nickel and/or graphite, among other conductive material options. In an example, the conductive wires 314-1, 314-2, 314-3 can be threaded through the vias 320-1, 320-2, 320-3 and/or connected to a conductive plug disposed in each one of the vias 320-1, 320-2, 320-3. The conductive epoxy can then be deposited over the vias 320-1, 320-2, 320-3, such that the conductive epoxy is electrically coupled with the conductive wires 314-1, 314-2, 314-3 disposed in the vias and/or the conductive epoxy is electrically coupled with the conductive wires 314-1, 314-2, 314-3 via the conductive plugs disposed in the vias 320-1, 320-2, 320-3. In some embodiments, the conductive epoxy in its uncured state can be formed in particular shapes (e.g., circle, square, rectangle, triangle, etc.). Upon cure of the conductive epoxy, the conductive electrodes 312-1, 312-2, 312-3 can be formed.
[0094] In some embodiments, a protective sleeve can be formed over the inner surface of the sidewall 316 and can sandwich the conductive wires 314-1, 314-2, 314-3 between the protective sleeve and an inner wall of the sidewall 316. The protective sleeve can be an insulative layer that prevents the conductive wires 314-1, 314-2, 314-3 from contacting other conductive material and/or prevents an insulative coating (e.g., insulation) disposed around each one of the conductive wires from being worn.
[0095] In some embodiments, the electrode tube 310 with the electrodes 312-1, 312-2, 312-3 and conductive wires 314-1, 314-2, 314-3 can be disposed over the understructure of the flexible tip portion of a high density electrode mapping catheter 270, such as that depicted and disclosed in
[0096] The electrode tube 310 can be formed from a flexible material, such as a polymer (e.g., PEBAX®), which can allow the electrode tube 310 to flex with the flexible understructure. In some embodiments, the electrode tube 310 can be adhered to the flexible understructure. For example, the electrode tube 310 can be adhered to the flexible understructure via an adhesive in some embodiments. In some embodiments, the electrode tube 310 can be frictionally fit to the flexible understructure. In some embodiments, the electrode tube 310 can be a heat shrink tube and can adhered to the flexible understructure through application of heat to the electrode tube 310, causing the electrode tube 310 to shrink.
[0097] Although embodiments of the present disclosure are generally depicted in relation to a catheter with an inboard and outboard understructure and/or in relation to a basket catheter, embodiments of the present disclosure can be applied to any type of catheter. For example, embodiments of the present disclosure can be applied to any type of therapeutic and/or diagnostic catheter.
[0098] The embodiments of
[0099] Embodiments are described herein of various apparatuses, systems, and/or methods. Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and illustrated in the accompanying drawings. It will be understood by those skilled in the art, however, that the embodiments may 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 of ordinary skill in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and thus it may be appreciated that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments, the scope of which is defined solely by the appended claims.
[0100] Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment”, or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment(s) is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment,” or the like, in places throughout the specification, are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features, structures, or characteristics of one or more other embodiments without limitation given that such combination is not illogical or non-functional.
[0101] It will be appreciated that the terms “proximal” and “distal” may be used throughout the specification with reference to a clinician manipulating one end of an 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 located furthest from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the illustrated embodiments. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
[0102] Although at least one embodiment for a high density electrode mapping catheter has been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this disclosure. All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the devices. Joinder references (e.g., affixed, attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relationship to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the disclosure as defined in the appended claims.
[0103] Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.