Patent Application
20230181242
The present invention relates generally to medical probes, and particularly to multi-electrode ablation catheters.
Cardiac arrythmias are commonly treated by ablation of myocardial tissue in order to block arrhythmogenic electrical pathways. For this purpose, a catheter is inserted through the patient's vascular system into a chamber of the heart, and an electrode or electrodes at the distal end of the catheter are brought into contact with the tissue that is to be ablated with a suitable energy. In some cases, high-power radio-frequency (RF) electrical energy is applied to the electrodes in order to ablate the tissue thermally. Alternatively, high-voltage pulses may be applied to the electrodes in order to ablate the tissue by irreversible electroporation (IRE) also known as pulse field ablation.
Some ablation procedures use basket catheters, in which multiple electrodes are arrayed along the spines of an expandable basket assembly at the distal end of the catheter. The spines bend outward to form a basket-like shape and contact tissue within a body cavity. For example, U.S. Patent Application Publication 2020/0289197 describes devices and methods for electroporation ablation therapy, with the device including a set of spines coupled to a catheter for medical ablation therapy. Each spine of the set of spines may include a set of electrodes formed on that spine. The set of spines may be configured for translation to transition between a first configuration and a second configuration.
An embodiment of the present invention that is described hereinafter provides a medical probe including a shaft and a basket assembly. The shaft is configured for insertion into a cavity of an organ of a patient. The basket assembly, which is connected at a distal end of the shaft, includes (a) multiple electrically-conductive spines that are electrically-connected to one another so as to form a distributed electrode, and (b) a plurality of spine mounted electrodes, which are disposed along the spines and are configured to (i) sense electrical activity in the cavity, and (ii) prevent the distributed electrode from indenting tissue in the cavity.
In some embodiments, the spines are electrically-connected to one another at a distal end of the basket assembly. In other embodiments, the spines are electrically-connected to one another at a proximal end of the basket assembly.
In some embodiments, the distributed electrode is configured to apply an ablation signal.
In an embodiment, the spine mounted electrodes protrude radially outward from the spines so as to prevent the distributed electrode from indenting the tissue. In another embodiment, the spine mounted electrodes are surface-mounted on the spines and have a given thickness protruding externally to the spines.
There is additionally provided, in accordance with another embodiment of the present invention, a method including inserting, into a cavity of an organ of a patient, a medical probe including a shaft and a basket assembly connected at a distal end of the shaft. The basket assembly includes (i) multiple electrically-conductive spines that are electrically-connected to one another so as to form a distributed electrode, and (ii) a plurality of spine mounted electrodes disposed along the spines. Using the plurality of spine mounted electrodes, electrical activity is sensed in the cavity while the distributed electrode is prevented from indenting tissue in the cavity.
There is additionally provided, in accordance with another embodiment of the present invention, a method for producing a medical probe. The method includes producing a basket assembly, including multiple electrically-conductive spines that are electrically-connected to one another so as to form a distributed electrode, and a plurality of spine mounted electrodes, which are disposed along the spines and are configured to (i) sense electrical activity in the cavity, and (ii) prevent the distributed electrode from indenting tissue in the cavity. The basket assembly is connected to a shaft configured for insertion into a cavity of an organ of a patient.
The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings in which:
A multi-electrode cardiac catheter typically comprises a distal-end assembly disposed with multiple electrodes. For example, a basket catheter typically comprises an expandable frame of spines which is coupled to the distal end of a shaft for insertion into a cavity of an organ of a patient.
Basket catheters are useful to perform ablation procedures rapidly and efficiently, since the spines of the basket catheter (and thus the electrodes on the spines) are able to contact and ablate the tissue at multiple locations concurrently. These spine mounted electrodes, however, can indent the tissue during the procedure, which can lead to local overheating, resulting in charring and/or other trauma, in particular with RF ablation. The use of electrodes having smooth, rounded profiles can be helpful in mitigating these effects, but by itself its use does not eliminate the problems of tissue damage.
Embodiments of the present invention that are described herein provide a basket catheter with a distributed electrode configured to apply ablative signal safely. The distributed electrode is made of the basket spines wired to deliver RF and/or IRE in unipolar mode against an indifferent electrode (e.g., a back patch). In addition, multiple spine mounted electrodes are disposed on the spines, for performing electrophysiological (EP) sensing or ablating. The spines are electrically-conductive and are typically electrically uninsulated (exposed) except for small regions around each of the spine mounted electrodes. The spines are electrically-connected to one another (e.g., by contacting each other at the distal end of the basket and/or shorting connecting wires together), so the spines together form the distributed electrode (e.g., for use in RF ablation in a unipolar mode, but other possible usages are described below). The insulation typically covers short sections of the spines, just enough to prevent sparking between a spine mounted electrode and a spine, or between electrodes on adjacent spines. In some configurations, where the spines are configured as a single electrode, the mounted electrode (or electrodes) can be the indifferent electrode(s).
The distributed electrode spreads the ablation (RF or IRE) energy in a way that can reduce thermal hazard to tissue, such as charring. Typically, the spine mounted electrodes are made thicker than the spines, causing the basket assembly to act as a mechanical barrier that prevents the distributed electrode from burying into the tissue (e.g., indenting the tissue). In other words, the thick spine mounted electrodes act as “bumpers” to prevent the spines (the distributed electrode) from pressing too strongly against the tissue during the RF ablation. At the same time, the spine mounted electrodes can be used to acquire electrograms to verify an efficacy of the ablation, such as in an arrhythmia-treatment procedure of pulmonary vein isolation.
In one embodiment, distributed electrode 60 is used for RF ablation. In another embodiment, distributed electrode 60 may be used as a reference electrode for electrophysiological mapping done using the mounted electrodes 50. In yet another embodiment, distributed electrode 60 may serve as a shared reference electrode during IRE ablation by spine mounted electrodes 50. For all the above purposes, the spines are electrically short-circuited and connected to a single wire (not shown) running in shaft 25 to a console 24. Alternatively, each spine may be individually wired and all wires are electrically shorted together within ablation system 20. Spine mounted electrodes 50 are individually wired and can each be used separately.
A physician 30 navigates a catheter 22 through the vascular system of a patient 28 into a chamber of a heart 26 of the patient, and then deploys basket catheter assembly 40. The proximal end of basket catheter assembly 40 is connected to the distal end of a shaft 25, which physician 30 steers using a manipulator 32 near the proximal end of catheter 22. Basket catheter assembly 40 is inserted in a collapsed configuration through a tubular sheath 23, which passes through the vascular system of patient 28 into the heart chamber where the ablation procedure is to be performed.
Once inserted into the heart chamber, basket catheter assembly 40 is deployed from the tubular sheath and allowed to expand within the chamber. Catheter 22 is connected at its proximal end to a control console 24. A display 27 on console 24 may present a map 31 or other image of the heart chamber with an icon showing the location of basket catheter assembly 40 in order to assist physician 30 to position the basket assembly at the target location for the ablation procedure.
In one embodiment, once basket catheter assembly 40 is properly deployed and positioned in heart 26, physician 30 actuates an electrical signal generator 38 in console 24 to apply electrical energy (such as RF waveforms or high voltage IRE pulses) to distributed electrode 60 in a unipolar mode, i.e., between the spine mounted electrodes on basket catheter assembly 40 and a separate external common electrode, for example a conductive back patch 41 which is applied to the patient's skin. During the ablation procedure, an irrigation pump 34 delivers an irrigation fluid, such as saline solution, through shaft 25 to basket catheter assembly 40. In this embodiment, spine mounted electrodes 50 can be used as electro-physiologically sensing electrodes to acquire electrograms, as discussed in
Typically, catheter 22 comprises one or more position sensors (not shown in the figures), which output position signals that are indicative of the position (location and orientation) of basket catheter assembly 40. For example, basket assembly 40 may incorporate one or more magnetic sensors which output electrical signals in response to an applied magnetic field. Processor 36 receives and processes the signals in order to find the location and orientation coordinates of basket catheter assembly 40, using techniques that are known in the art and are implemented, for example, in the above-mentioned Carto system. Alternatively or additionally, system 20 may apply other position-sensing technologies in order to find the coordinates of basket catheter assembly 40. For example, processor 36 may sense the impedances between the electrodes on basket catheter assembly 40 and body surface electrodes 39, which are applied to the chest of patient 28, and may convert the impedances into location coordinates using techniques that are likewise known in the art. In any case, processor 36 uses the coordinates to display the location of basket catheter assembly 40 on map 31.
Alternatively, catheter 22 and the ablation techniques that are described herein may be used without the benefit of position sensing. In such embodiments, for example, fluoroscopy and/or other imaging techniques may be used to ascertain the location of basket catheter assembly 40 in heart 26.
The system configuration that is shown in
As seen, basket catheter assembly 40 has a distal end 52 and a proximal end 53, which is connected to a distal end of shaft 25. The basket catheter assembly comprises multiple spines 46, whose proximal ends are conjoined at proximal end 53, and whose distal ends are conjoined at distal end 52. Multiple thick rounded and spine mounted electrodes 50 are disposed externally on each of spines 46.
Spines 46 are electrically conducting and are uninsulated so that these portions of spines 46 (as indicated by lead lines in
In the shown expanded state, spines 46 bow radially outward. In the collapsed state (not shown), spines 46 are straight and aligned parallel to a longitudinal axis of shaft 25 to facilitate insertion of basket catheter assembly 40 into heart 26.
In one embodiment, spines 46 are produced such that the stable state of basket catheter assembly 40 is the collapsed state. In this case, when basket catheter assembly 40 is pushed out of the sheath, it is expanded by drawing an actuator wire or rod (48 in
In another embodiment, spines 46 are produced such that the stable state of basket catheter assembly 40 is the expanded state of
In the embodiment shown in
In this embodiment, when basket catheter assembly is pressed against tissue, the spine mounted electrodes prevent indentation of tissue by the distributed electrode by being surface mounted on the spines and having a minimal given thickness in the radial direction (e.g., mounted in a spatially biased way to be mostly external to the spines).
Bulky electrodes on a basket catheter, which are asymmetrically mounted on spines with most of the electrode thickness protruding radially outwards the spines, are described in U.S. patent application Ser. No. 17/371,008, titled, “BIASED ELECTRODES FOR IMPROVED TISSUE CONTACT AND CURRENT DELIVERY,” filed Jul. 8, 2021, which is assigned to the assignee of the current application, and which is incorporated herein by reference.
When pressed against ostium 47 tissue, spine mounted electrodes 50 acquire electrophysiological signals (e.g., electrograms), and processor 36 analyzes these signals to verify that arrhythmogenic electrical pathways are ablated over an entire circumference of ostium 47, so an arrhythmia caused there is fully treated by the ablation.
As shown in the drawings herein, distributed electrode 60 (formed by spines 46 electrically shorted together) can be practiced in a method to deliver ablative energy in various modes. The ablation modes allow for delivering of ablative energy (RF or IRE) to either one or both of the distributed electrode 60 and at least one of the spine mounted electrodes 50. In one mode, ablation energy (RF or IRE) can be provided to at least one of the spine mounted electrodes 50 and configuring the distributed electrode 60 to act as a return electrode for the ablative energy provided to the spine electrode(s) 50. In another mode, the system can be configured for delivering ablative energy to distributed electrode 60 and configuring at least one of the spine mounted electrodes 50 as return electrodes. In yet a third mode, ablative energy can be provided in a unipolar mode to the distributed electrode 60 or at least one of the spine mounted electrodes 50 with the external body electrodes 41 acting as the return electrode.
To summarize, the single distributed electrode 60 can operate in the following modes: (1) bipolar ablation mode with one or more of the spine mounted electrodes 50 being the return or indifferent electrodes; (2) bipolar ablation mode with the central electrode (56 or 102) as the return or indifferent electrode; or (3) unipolar ablation mode with the indifferent electrode being the known electrode patches 41.
On the other hand, spine mounted electrodes 50 can be used to: (1) map or collect electrical signal emanating from biological tissues; (2) deliver ablative energy in bipolar mode with the distributed electrode 60 acting as the return electrode; (3) deliver ablative energy in bipolar mode with the central electrode 56 or 102 as the return electrode; or (4) deliver ablative energy in unipolar mode with the body patch 41 as the indifferent electrode.
Moreover, it is noted that the distributed electrode 60 can deliver RF energy while the spine mounted electrodes can deliver IRE energy. This can be reversed in that the distributed electrode 60 can deliver IRE energy while the spine mounted electrodes 50 can deliver RF energy.
The spine mounted electrodes 50 have the ability to deliver energy independently to a small subset of electrodes 50, sequentially or simultaneously whereas the distributed electrode 60 can only deliver ablation energy simultaneously to the entire structure. In one exemplary method, an operator can transport the end effector 40 or 40′ into the target organ, map the organ to determine a targeted site for ablation, deliver RF energy (or IRE energy) to the distributed electrode 60, map the resulting tissues via the spine mounted electrodes 50 to determine if ablated site has been electrically isolated and depending the size of the area needing further ablation, some of the spine mounted electrode can be used to deliver IRE energy (or RF energy) from a small subset of spine mounted electrodes to ensure a complete isolation of the targeted site. Techniques for application of the pulse fields are provided in U.S. patent application Ser. No. 16/842,648 on Apr. 7, 2020 (Attorney Docket No. BIO6265USNP1) published as US20210307815 and incorporated and provided in an Appendix to this application. Although the embodiments described herein mainly address cardiac applications, the methods and systems described herein can also be used in other catheter-based applications, such as in performing ablation inside other organs, e.g., inside a bladder or in the renal artery outside of the kidney.
It will thus be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art. Documents incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated documents in a manner that conflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.
