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JP-2026514334-A - Local impedance indicators in cardiac tissue treatment

JP2026514334AJP 2026514334 AJP2026514334 AJP 2026514334AJP-2026514334-A

Abstract

The therapeutic catheter is part of a system that includes a local impedance indicator displayed on a screen. The local impedance indicator displays relative changes in impedance to the user to quickly convey information that helps the user better understand where the catheter is positioned within the cardiac chamber. [Selection Diagram] Figure 22

Inventors

  • シルキン‐ニコラウ，ジュディ
  • ラフナー，ジェイコブ アイ．
  • ハンター，デビッド ダブリュー．
  • アイスター，カート アール．
  • ブルシェット，クリストファー
  • コナー，ブライアン
  • メルスキー，ジェラルド

Assignees

  • カーディオフォーカス，インコーポレーテッド

Dates

Publication Date
20260511
Application Date
20240329
Priority Date
20230331

Claims (20)

  1. A system for delivering therapeutic energy during tissue repair procedures, At least one catheter, An energy delivery body comprising at least one catheter, A plurality of spline electrodes, each consisting of at least one catheter, An at least one impedance sensor comprising the at least one catheter, wherein each of the at least one impedance sensor is associated with at least one of the plurality of spline electrodes, A processor configured to process information associated with the at least one impedance sensor by executing instructions stored on a processor-readable medium, A display configured to provide information processed by the at least one processor, The aforementioned at least one processor further, Determining a reference impedance value, wherein the reference impedance value is based on the impedance detected by the at least one impedance sensor, Displaying an impedance indicator composed of multiple spokes on the display, wherein each spoke is associated with each electrode of the spline electrode, and each spoke is configured to represent the reference impedance value, and the display is as described above. Defining the threshold impedance value, The at least one impedance sensor detects a local impedance associated with at least one of the spline electrodes that navigate around an organ via the at least one catheter, The at least one processor determines the change in impedance from the reference impedance to the local impedance, The at least one processor modifies each of at least one spoke of the impedance indicator in response to the change in the impedance to generate a modified impedance indicator. The system is configured to display the modified impedance indicator on the display, The tissue modification device is a system that delivers the therapeutic energy via the energy delivery body.
  2. Each of the spokes is configured to have a single length representing the reference value, The system according to claim 1, further comprising the at least one processor, configured to modify each of the at least one spokes by extending the length of each of the at least one spokes.
  3. The aforementioned at least one processor further, Defining the threshold impedance value, Each of the spokes is composed of a color representing the reference value, The system according to claim 1, further comprising the configuration that the at least one processor modifies the at least one spoke by changing the color of each of the at least one spoke when the detected local impedance exceeds the threshold.
  4. The aforementioned at least one processor further, Defining multiple threshold impedance values, When the detected local impedance exceeds each of the plurality of thresholds, the at least one spoke is modified by changing the changed color of each of the at least one spokes. The system according to claim 3, configured to perform the following:
  5. The system according to claim 4, wherein the at least one processor is further configured to modify the changed color by changing at least one of the intensity, hue, color tone, saturation, and lightness of the changed color.
  6. The system according to claim 1, wherein the at least one catheter further includes a central electrode.
  7. The system according to claim 6, wherein the detected local impedance is based on the impedance detected by at least one impedance sensor associated with at least one of the plurality of spline electrodes and at least one impedance sensor associated with the central electrode.
  8. The system according to claim 1, wherein the at least one catheter includes a therapeutic catheter and a mapping catheter.
  9. The aforementioned at least one computing device further includes, The system according to claim 1, comprising determining contact stability by analyzing electrode measurements as a function of time.
  10. The system according to claim 1, wherein the impedance indicator represents the sum of all electrode inputs in vector form.
  11. The system further comprises a mapping component, and the at least one processor is further configured to transmit the vector to the mapping component. Furthermore, the system according to claim 10, wherein the mapping component displays the vector as a three-dimensional vector on the graphics of the moving catheter.
  12. The aforementioned processor further, The system according to claim 1, configured to determine the total impedance vector/direction by principal component analysis or statistical analysis using time-varying data.
  13. The processor further comprises a tactile sensation composed of at least one catheter, The system according to claim 1, configured to provide haptic-based feedback associated with the state of the impedance indicator.
  14. A method for delivering therapeutic energy during tissue repair procedures, Determining a reference impedance value by a tissue correction device including at least one catheter, an energy delivery body, at least one impedance sensor, at least one processor, and a display, wherein the at least one catheter includes a plurality of spline electrodes, Displaying an impedance indicator composed of multiple spokes on the display, wherein each spoke is associated with each electrode of the spline electrode, and each spoke is configured to represent the reference impedance value, and the display is as described above. The above-mentioned at least one processor defines a threshold impedance value, The at least one impedance sensor detects a local impedance associated with at least one of the spline electrodes that navigate around an organ via the at least one catheter, The at least one processor determines the change in impedance from the reference impedance to the local impedance, The at least one processor modifies each of at least one spoke of the impedance indicator in response to the change in the impedance to generate a modified impedance indicator. The modified impedance indicator is displayed on the aforementioned display, The aforementioned tissue modification device delivers therapeutic energy, The method, including the method described above.
  15. Each of the spokes is configured to have a length representing the reference value, Furthermore, the method according to claim 14, wherein modifying the at least one spoke includes extending the length of each of the at least one spokes.
  16. The above-mentioned at least one processor defines a threshold impedance value, Each of the spokes is composed of a color representing the reference value, Furthermore, the method according to claim 14, wherein changing the at least one spoke includes changing the color of the at least one spoke when the detected local impedance exceeds the threshold.
  17. The above-mentioned processor further includes defining a plurality of threshold impedance values, Furthermore, the system according to claim 3, wherein changing the at least one spoke includes changing the altered color of each of the at least one spoke when the detected local impedance exceeds each of the plurality of thresholds.
  18. Changing the aforementioned color means The method according to claim 17, comprising changing at least one of the intensity, hue, tone, saturation, and lightness of the changed color.
  19. The method according to claim 14, wherein the at least one catheter further includes a central electrode.
  20. The method according to claim 14, wherein the at least one catheter includes a therapeutic catheter and a mapping catheter.

Description

Cross-reference of related applications: This application claims priority and interest in U.S. Patent Application No. 63/493,713, filed on 31 March 2023, which is incorporated herein by reference in whole. Therapeutic energy can be applied to the heart and vascular system to treat a variety of conditions, including atherosclerosis (particularly in the prevention of restenosis after angioplasty) and atrial fibrillation. Atrial fibrillation is the most common persistent cardiac arrhythmia and significantly increases the risk of death in affected patients, especially by causing stroke. In this phenomenon, the heart deviates from normal sinus rhythm due to the generation of erroneous electrical impulses. Atrial fibrillation is thought to begin in the myocardial sleeve of the pulmonary veins (PV) due to the presence of automaticity in cells within the myocardial tissue of the PV. The pacemaker activity of these cells is thought to lead to the formation of ectopic contractions that cause atrial fibrillation. Furthermore, the PV is considered important for maintaining atrial fibrillation because its disordered structure and electrophysiological properties provide an environment in which atrial fibrillation can be sustained. Therefore, the goal is to destroy or remove these abnormal pacemaker cells within the myocardial sleeve of the PV, and atrial fibrillation is often treated by delivering therapeutic energy to the pulmonary veins. However, due to reports of PV stenosis, this technique has been conventionally modified to target the PV sinus to achieve conduction block between the PV and the left atrium. The PV sinus surrounds the ceiling and posterior wall of the left atrium, in addition to the pulmonary veins, and in the case of the right pulmonary sinus, it surrounds a portion of the atrial septum. In some cases, this technique offers a higher success rate and lower complication rate compared to pulmonary vein ostial isolation. Thermal ablation therapy, particularly radiofrequency (RF) ablation, is currently the "absolute standard" for treating atrial fibrillation symptoms caused by localized tissue necrosis. Typically, RF ablation is used to form a ring of ablation lesions around the outside of each of the four pulmonary veins. The RF current causes tissue drying by creating localized thermal areas, leading to individualized coagulation necrosis. The necrotic tissue acts as a conduction block, thereby electrically insulating the veins. Despite improvements in techniques for restoring sinus rhythm using available methods, both success rates and safety remain limited. RF ablation continues to present several limitations, some of which include: the long procedure time required to isolate pulmonary veins using RF local catheters; potential gaps in ablation patterns due to point-by-point ablation techniques using conventional RF catheters; difficulty in forming and confirming transmural ablation lesions; carbonization and/or gas formation at the catheter tip-tissue interface due to high temperatures (potentially leading to thrombosis or embolism during ablation); and thermal damage to collateral extracardial structures, including pulmonary vein stenosis, phrenic nerve injury, esophageal injury, atrial-esophageal fistula, periesophageal vagus nerve injury, perforation, thromboembolic events, vascular complications, and acute coronary artery occlusion. These limitations primarily stem from the ongoing debate faced by clinicians regarding balancing effective therapeutic doses with inadequate energy delivery to extracardiac tissues. Therefore, while maintaining this technology in clinical practice, safer and more versatile methods for removing abnormal tissue are being used, including irreversible electroporation (IRE), a non-thermal therapy based on irreversible permeabilization of cell membranes caused by specific short pulses of high-voltage energy. IRE is known to be tissue-specific, induces apoptosis rather than necrosis, and is safe for structures adjacent to the myocardium. However, the success of these IRE methodologies has been uneven to date. In some cases, the delivery of IRE energy resulted in incomplete blocking of the abnormal electrical rhythm. This can be attributed to various factors such as irregularities in the procedure around the pulmonary veins, insufficient transmural delivery of energy, or other deficiencies in energy delivery. In any case, atrial fibrillation is either not adequately treated or recurs later. Therefore, improvement in the treatment of atrial fibrillation is desired. Such treatment should be safe, effective, and result in reduced complications. At least some of these objectives are achieved by the systems, devices, and methods described herein. By Reference: All publications, patents, and patent applications described herein are referred to herein by reference to the same extent as each individual publication, patent, or patent application is explicitly and individually indicated