FIELD OF THE DISCLOSURE

The present disclosure relates generally to medical devices that are used in the human body. In particular, in many embodiments, the present disclosure relates to electroporation systems and methods of energizing a catheter for delivering electroporation.

BACKGROUND

It is generally known that ablation therapy may be used to treat various conditions afflicting the human anatomy. One such condition in which ablation therapy finds a particular application in, for example, is the treatment of atrial arrhythmias. When tissue is ablated, or at least subjected to ablative energy generated by an ablation generator and delivered by an ablation catheter, lesions form in the tissue. Electrodes mounted on or in ablation catheters are used to create tissue necrosis in cardiac tissue to correct conditions such as atrial arrhythmia (including, but not limited to, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter). Arrhythmia (i.e., irregular heart rhythm) can create a variety of dangerous conditions including loss of synchronous atrioventricular contractions and stasis of blood flow that can lead to a variety of ailments and even death. It is believed that the primary cause of atrial arrhythmia is stray electrical signals within the left or right atrium of the heart. The ablation catheter imparts ablative energy (e.g., radio frequency energy, cryoablation, lasers, chemicals, high-intensity focused ultrasound, etc.) to cardiac tissue to create a lesion in the cardiac tissue. This lesion disrupts undesirable electrical pathways and thereby limits or prevents stray electrical signals that lead to arrhythmias.

One candidate for use in therapy of cardiac arrhythmias is electroporation. Electroporation therapy involves electric field induced pore formation on the cell membrane. The electric field may be induced by applying a direct current (DC) signal delivered as a relatively short duration pulse that may last, for instance, from a nanosecond to several milliseconds. Such a pulse may be repeated to form a pulse train. When such an electric field is applied to tissue in an in vivo setting, the cells in the tissue are subjected to trans-membrane potential, which opens the pores on the cell wall, hence the term electroporation. Electroporation may be reversible (i.e., the temporally-opened pores will reseal) or irreversible (i.e., the pores will remain open). For example, in the field of gene therapy, reversible electroporation (i.e., temporarily open pores) is used to transfect high molecular weight therapeutic vectors into the cells. In other therapeutic applications, a suitably configured pulse train alone may be used to cause cell destruction, for instance by causing irreversible electroporation.

BRIEF SUMMARY OF THE DISCLOSURE

The present disclosure generally relates to electroporation systems and methods of energizing a catheter for delivering electroporation. In many embodiments, the electroporation system includes a catheter connected to a direct current (DC) energy source. The catheter and DC energy source are further connected to a computing system that, in certain embodiments, enables three-dimensional or two-dimensional visualization of the catheter within a vein of a body. The catheter includes an electrode assembly having a structure about which a plurality of electrodes is distributed. The structure may include, for example, a hoop catheter, a basket catheter, or a balloon catheter. The electrodes may include, for example, flexible circuits, printed electrodes, or ring electrodes. In many embodiments, the computing system determines positioning of the catheter in the vein and controls the DC energy source to energize selected electrodes of the plurality. The selection of the electrodes, in certain embodiments, is automatic. In other embodiments, the selection of electrodes is made by a clinician or physician based on a visualization. The selected electrodes to be energized form a ring of electrodes that is concentric with a central axis of the vein in which the catheter is positioned. Other embodiments and descriptions of the present disclosure are set forth below.

In one embodiment, the present disclosure provides a catheter for delivering electroporation. The catheter includes a distal section and an electrode assembly. The distal section is configured to be positioned in a vein within a body. The vein defines a central axis. The electrode assembly is coupled to the distal section and includes a structure and a plurality of electrodes distributed thereabout. The structure is configured to at least partially contact the vein. Each of the electrodes is configured to be selectively energized to form a circumferential ring of energized electrodes that is concentric with the central axis of the vein.

In another embodiment, the present disclosure is directed to an electroporation system, including a catheter, a DC energy source, and a computing system. The catheter includes an electrode assembly configured to be positioned in a vein of a body. The vein defines a central axis. The electrode assembly includes a structure configured to at least partially contact the vein, and a plurality of electrodes distributed about the structure. Each electrode of the plurality of electrodes is configured to be individually energized. The DC energy source is coupled to the catheter and is configured to selectively energize a subset of electrodes of the plurality of electrodes. The computing system is coupled to the catheter and the DC energy source. The computing system configured to detect respective positions of the plurality of electrodes within the vein, and select the subset of electrodes to form a circumferential ring of energized electrodes that is concentric with the central axis of the vein.

In another embodiment, the present disclosure is directed to a method of energizing a catheter. The method includes positioning a distal section of the catheter relative to a central axis in space. The distal section includes a plurality of electrodes distributed about a structure, and the structure at least partially surrounds the central axis. The method includes determining respective locations of the plurality of electrodes relative to the central axis. The method includes selecting a subset of electrodes from among the plurality of electrodes based on the respective locations thereof to form a circumferential ring of electrodes that is concentric with the central axis. The method includes energizing the subset of electrodes.

The foregoing and other aspects, features, details, utilities and advantages of the present disclosure will be apparent from reading the following description and claims, and from reviewing the accompanying drawings.

