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US-20260124474-A1 - DEVICES AND METHODS FOR RENAL DENERVATION AND ASSESSMENT THEREOF

US20260124474A1US 20260124474 A1US20260124474 A1US 20260124474A1US-20260124474-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, comprising: analyzing at least one of echo signals reflected by a blood vessel wall and data acquired by at least one measurement device positioned within a blood vessel; and assessing an effectiveness of a target tissue treatment based on the analysis of the at least one of echo signals reflected by the blood vessel wall and data acquired by the at least one measurement device positioned within the blood vessel.
  3. 3 . The method of claim 2 , wherein the analysis of the at least one of echo signals reflected by the blood vessel wall and data acquired by the at least one measurement device positioned within the blood vessel comprises determining at least one of one or more physical characteristics of the blood vessel and one or more hemodynamic properties of blood flowing in the blood vessel.
  4. 4 . The method of claim 3 , wherein the one or more physical characteristics comprise blood vessel wall stiffness and the one or more hemodynamic properties comprise blood flow rate.
  5. 5 . The method of claim 3 , wherein the at least one measurement device is a temperature sensor and the analysis comprises estimating, using the temperature sensor, a change in one or both of the one or more physical characteristics and the one or more hemodynamic properties.
  6. 6 . The method of claim 2 , wherein the blood vessel is a renal artery.
  7. 7 . The method of claim 2 , wherein the at least one measurement device is a temperature sensor and the method further comprises: estimating a cross-section area of the blood vessel based on the analysis of the echo signals reflected by the blood vessel wall; estimating a blood flow velocity based on one or more temperature changes measured by the temperature sensor; and determining a blood flow rate based on the cross-section area of the blood vessel estimated and the blood flow velocity estimated.
  8. 8 . The method of claim 2 , further comprises: emitting energy from one or more transceivers within the blood vessel; measuring a temperature of the one or more transceivers; and estimating a velocity of blood flow through the blood vessel according to a heat dissipation rate of the one or more transceivers and the temperature of the one or more transceivers.
  9. 9 . The method of claim 2 , further comprises: emitting energy to the blood vessel to apply the target tissue treatment to one or more nerves extending along the blood vessel, wherein assessing the effectiveness of the target tissue treatment based on the analysis of the at least one of echo signals reflected by the blood vessel wall and data acquired by the at least one measurement device positioned within the blood vessel comprises determining a behavioral change of wall tissue of the blood vessel following application of the target tissue treatment.
  10. 10 . The method of claim 2 , wherein assessing the effectiveness of the target tissue treatment occurs in real time.
  11. 11 . The method of claim 2 , further comprising: applying the target tissue treatment to one or more nerves extending along the blood vessel; and adjusting the target tissue treatment in response to assessing the effectiveness of the target tissue treatment.
  12. 12 . A catheter system comprising: a shaft for insertion into a blood vessel; one or more transceivers located along the shaft, the one or more transceivers output ultrasound energy for treating target tissue and receive echo signals from the blood vessel; and a console configured to analyze at least one of the echo signals received by the one or more transceivers and data acquired by at least one measurement device positioned along the shaft to assess an effectiveness of a target tissue treatment.
  13. 13 . The catheter system of claim 12 , wherein the console is configured to determine at least one of one or more physical characteristics of the blood vessel and one or more hemodynamic properties of blood flowing in the blood vessel.
  14. 14 . The catheter system of claim 12 , further comprising: a temperature sensor located along the shaft, wherein the at least one measurement device comprises the temperature sensor, wherein the console is configured to estimate a change in one or both of one or more physical characteristics of the blood vessel and hemodynamic properties of blood flowing in the blood vessel based on a temperature sensed by the temperature sensor.
  15. 15 . The catheter system of claim 12 , further comprising: one or more radiopaque markers along the shaft.
  16. 16 . The catheter system of claim 15 , wherein the one or more radiopaque markers comprise a radiopaque ring.
  17. 17 . The catheter system of claim 12 , further comprising: one or more expandable members along the shaft, the one or more expandable members are configured to adjust between a first configuration and a second configuration, wherein the one or more expandable members have a bend at a bend location when in the second configuration; and a radiopaque marker located at the bend location.
  18. 18 . The catheter system of claim 17 , wherein the one or more expandable members comprise one or more leaflets configured to adjust between the first configuration and the second configuration, wherein a leaflet of the one or more leaflets comprises the bend at the bend location when in the second configuration.
  19. 19 . A catheter system comprising: a shaft for insertion into a blood vessel; one or more transceivers located along the shaft, the one or more transceivers output ultrasound energy for treating target tissue and receive echo signals from the blood vessel; one or more expandable members extending along the shaft and configured to adjust between a first configuration and a second configuration; a radiopaque marker located along the shaft; and a console configured to analyze the echo signals received by the one or more transceivers to assess an effectiveness of a target tissue treatment.
  20. 20 . The catheter system of claim 19 , wherein the console is configured to determine at least one of one or more physical characteristics of the blood vessel based on the echo signals received by the one or more transceivers to assess the effectiveness of the target tissue treatment.

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