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US-20260124475-A1 - DEVICES AND METHODS FOR RENAL DENERVATION AND ASSESSMENT THEREOF

US20260124475A1US 20260124475 A1US20260124475 A1US 20260124475A1US-20260124475-A1

Abstract

The present invention, in some embodiments thereof, relates to a devices and methods for intravascular denervation and assessment thereof and, more particularly, but not exclusively, to devices and methods for renal denervation. Some embodiments of the invention relate to an intravascular catheter configured for ultrasonic ablation of the tissue, comprising a plurality of piezoelectric transceivers. In some embodiments, an intravascular distancing device is provided, the device adapted for obtaining at least a minimal distance between an ultrasound emitting element and a tissue, such as the blood vessel wall. Some embodiments of the invention relate to assessment of renal sympathetic denervation (RSD) treatment effectiveness. Some embodiments of the invention relate to processing echo of signals, such as processing of signals to characterize physical and/or mechanical properties of the blood vessel.

Inventors

  • Ariel Sverdlik
  • Or Shabtay
  • Ronen Neeman
  • Giora BEIT-YAAKOV
  • Lilah MARZIANO
  • Avital Schauder
  • Marina DUBINSKY
  • Yehuda Zadok
  • Jonathan YALOM

Assignees

  • SONIVIE LTD.

Dates

Publication Date
20260507
Application Date
20251231

Claims (20)

  1. 1 . (canceled)
  2. 2 . A method for treating one or more nerves, the method comprising: inserting one or more ultrasonic transceivers into a blood vessel; emitting ultrasound energy towards a wall of the blood vessel; recording echo signals reflected from the wall of the blood vessel; analyzing the echo signals recorded to determine a source of the echo signals; and determining a distance of the wall of the blood vessel from the one or more ultrasonic transceivers.
  3. 3 . The method of claim 2 , wherein analyzing the echo signals recorded to determine a source of the echo signals recorded comprises analyzing the echo signals recorded according to an interference pattern of each of the echo signals.
  4. 4 . The method of claim 2 , further comprising determining a diameter of the blood vessel based on the distance of the blood vessel from the one or more ultrasonic transceivers.
  5. 5 . The method of claim 2 , wherein inserting one or more ultrasonic transceivers into the blood vessel includes inserting one or more ultrasonic transceivers into a renal artery.
  6. 6 . The method of claim 2 , further comprising emitting ablating energy from the one or more ultrasonic transceivers.
  7. 7 . The method of claim 6 , further comprising stimulating a nerve disposed adjacent to the blood vessel prior to emitting ablating energy from the one or more ultrasonic transceivers.
  8. 8 . The method of claim 7 , further comprising stimulating the nerve disposed adjacent to the blood vessel after emitting ablating energy from the one or more ultrasonic transceivers.
  9. 9 . The method of claim 8 , wherein emitting ablating energy from the one or more ultrasonic transceivers results in a treatment, and further comprising comparing a first physiological response to stimulating the nerve prior to emitting ablating energy with a second physiological response to stimulating the nerve after emitting ablating energy in order to determine an effectiveness of the treatment.
  10. 10 . The method of claim 2 , wherein determining a threshold distance of the wall of the blood vessel from the one or more ultrasonic transceivers includes applying a threshold to determine whether the distance is suitable for an ablation treatment.
  11. 11 . The method of claim 10 , wherein the threshold distance is at least 1 millimeter.
  12. 12 . A method for ablating nerves, the method comprising: advancing a catheter through a blood vessel to a position adjacent to one or more target nerves, wherein the catheter includes an ultrasonic transceiver; emitting ultrasound energy from the ultrasonic transceiver towards a wall of the blood vessel; recording echo signals reflected from the wall of the blood vessel with the ultrasonic transceiver; analyzing the echo signals recorded to determine a source of the echo signals; determining a distance of the wall of the blood vessel from the ultrasonic transceiver; and if the distance is at or above a pre-determined threshold distance, emitting ablating energy from the ultrasonic transceiver to ablate one or more nerves disposed adjacent to the wall of the blood vessel.
  13. 13 . The method of claim 12 , wherein analyzing the echo signals recorded to determine a source of the echo signals recorded comprises analyzing the echo signals recorded according to an interference pattern of each of the echo signals.
  14. 14 . The method of claim 12 , further comprising determining a diameter of the blood vessel based on the distance of the blood vessel from the ultrasonic transceiver.
  15. 15 . The method of claim 12 , wherein inserting the ultrasonic transceiver into the blood vessel includes inserting the ultrasonic transceiver into a renal artery.
  16. 16 . The method of claim 12 , wherein the pre-determined threshold distance is at least 1 millimeter.
  17. 17 . A system for ablating nerves adjacent to a wall of a blood vessel, the system comprising: a catheter having one or more ultrasonic transceivers disposed thereon; and a control unit coupled to the catheter, the control unit being configured to: emit ultrasound energy towards the wall of the blood vessel, record echo signals reflected from the wall of the blood vessel, analyze the echo signals recorded to determine a source of the echo signals, and determine a distance of the wall of the blood vessel from the one or more ultrasonic transceivers.
  18. 18 . The system of claim 17 , wherein the catheter includes at least three ultrasonic transceivers.
  19. 19 . The system of claim 17 , wherein the catheter includes at least three facets each having one of the one or more ultrasonic transceivers disposed thereon.
  20. 20 . The system of claim 17 , wherein the control unit is configured to analyze the echo signals recorded to determine a source of the echo signals recorded comprises analyzing the echo signals recorded according to an interference pattern of each of the echo signals.

Description

RELATED APPLICATION/S This application is continuation of and claims the benefit of the earlier filing date of U.S. patent application Ser. No. 17/187,813, filed Feb. 28, 2021, which is a continuation of U.S. patent application Ser. No. 14/889,890 filed on Nov. 9, 2015, now U.S. Pat. No. 10,933,259, which is a National Phase of PCT Patent Application No. PCT/IL2014/050457 having International Filing Date of May 22, 2014, which claims the benefit of priority under 35 USC § 119 (e) of U.S. Provisional Application Nos. 61/931,890 filed on Jan. 27, 2014, 61/931,838 filed on Jan. 27, 2014, 61/924,848 filed on Jan. 8, 2014, 61/924,778 filed on Jan. 8, 2014 and 61/826,583 filed on May 23, 2013. The contents of the above applications are all incorporated by reference as if fully set forth herein in their entirely. FIELD AND BACKGROUND OF THE INVENTION EP publication number EP2455133 A1 to Dekker et al. discloses “A catheter (700, 800, 1206) comprising: a shaft with distal (808, 906, 1004, 1208) and proximal ends (1006), wherein the distal end comprises at least one array of capacitive micromachined ultrasound transducers (308, 402, 404, 500, 512, 600, 604, 802, 1008) with an adjustable focus for controllably heating a target zone (806, 1014, 1210); and a connector (1012) at the proximal end for supplying the at least one array of capacitive micromachined ultrasound transducers with electrical power and for controlling the adjustable focus.” U.S. Pat. No. 5,938,582 to Ciamacco et al. discloses “An apparatus for centering a radiation delivery device at a selected location in a body vessel such as a coronary artery. An elongated catheter is insertable into the body vessel until the catheter head is in the desired position. The catheter has a guidewire lumen, inflation lumen and treatment lumen running lengthwise. The catheter head includes an expandable mechanism for engaging the vessel internal wall with the treatment lumen centered in the vessel. At least one channel is provided extending past the expandable mechanism so that a fluid, such as blood, can perfuse past the catheter head. A radiation delivery device, such as a wire having a radiation source at the distal end can be inserted into the treatment lumen to uniformly irradiate the vessel wall at the selected location.” Modulation and inhibition of renal sympathetic afferent and/or efferent nerve activity has been proven to contribute to the treatment of hypertension and related disorders. Renal denervation treatment has been shown, for example, to reduce sympathetic activation of the kidney, reduce renin release, and/or change vasodilatation properties of the renal artery, thereby modulating the patient's blood pressure. The denervation treatment may affect one or more physiological parameters, assessment of which may indicate an effectiveness of the treatment. U.S. patent application Ser. No. 13/327,161 to Stahmann et al. discloses “A catheter includes a flexible shaft having a length sufficient to access a patient's renal artery relative to a percutaneous access location. A treatment arrangement is provided at a distal end of the shaft and configured for deployment in the renal artery. The treatment arrangement includes an ablation arrangement configured to deliver renal denervation therapy. An occlusion arrangement is configured for deployment in the renal artery and for altering blood flow through the renal artery during or subsequent to renal denervation therapy delivery. A monitoring unit is configured for monitoring for a change in one or more physiologic parameters influenced by the renal denervation therapy. The monitoring unit is configured to produce data useful in assessing effectiveness of the renal denervation therapy based on the physiologic parameter monitoring”. PCT Publication No. 2012/033974 A2 to Smith discloses “A transducer arrangement causes target tissue of the body to vibrate and senses resulting vibration of the target tissue. Changes in one or more mechanical properties of the target tissue are measured based on the sensed vibration. Changes in one or more electromechanical properties of the target tissue can also be measured based on the sensed vibration and various electrical parameters. An output indicative of the measured changes in the one or more mechanical and/or electromechanical properties of the target tissue is generated. Changes in elasticity of the target tissue, for example, can be measured based on the sensed vibration, such as changes resulting from ablation of the target tissue”. PCT Patent Publication No. WO1994023652 to Talhami et al. titled “Tissue characterization using intravascular echoscopy” discloses: An intravascular transducer (10) at a location within an artery (15) is used to obtain frames of ultrasound during at least one cardiac cycle of a subject. The ultrasound data obtained is processed to produce an indication of the elasticity of the artery wall (12), namely the average fractional deformation of e