Granted Patent B2

US 12,274,833 · App. 17/451,478 · Granted Apr 15, 2025

Inventor: Reinhard J. Warnking (East Setauket, NY)

Assignee: ReCor Medical, Inc.

A61M25/0082A61M25/1002A61N7/00A61N7/022A61B2017/003A61B2017/00323A61B2017/22021A61B2018/00023A61M25/0068A61M2025/1047A61M2025/1068A61M2025/1086A61M2025/1093A61N2007/0026A61N2007/0043

Abstract

Claims (58)

1. A system for inactivating renal nerve conduction in a mammalian subject having a renal artery, comprising:

a catheter comprising a distal portion configured to be inserted into the renal artery of the mammalian subject;

an ultrasound transducer positioned at the distal portion of the catheter, the ultrasound transducer configured to be inserted into the renal artery of the mammalian subject;

an actuator electrically connected to the ultrasound transducer, the actuator configured to cause the ultrasound transducer to emit a dose of unfocused ultrasound energy into an impact volume of at least 0.5 cm 3 ;

wherein the impact volume encompasses the renal artery so that the unfocused ultrasound energy is applied at a therapeutic level sufficient to inactivate conduction of renal nerves within the impact volume.

2. The system of claim 1 , wherein the ultrasound transducer has a length between 2 mm and 10 mm and wherein the acoustic power output of the transducer is 10 to 100 Watts.

3. The system of claim 1 , wherein:

the ultrasound transducer has a length of 6 mm,

the acoustic power output of the transducer is 10 to 100 Watts, and

the duration of acoustic power application of the transducer is 10 seconds to 20 seconds.

4. The system of claim 1 , wherein the ultrasound transducer is configured to emit the dose of unfocused ultrasound energy to inactivate conduction of the renal nerves along a length of 2 mm to 10 mm along an axis of the renal artery.

5. The system of claim 1 , wherein the impact volume encompasses nerves adjacent to the renal artery.

6. The system of claim 1 , wherein the ultrasound transducer is configured to emit the dose of unfocused ultrasound energy simultaneously in a 360° arc through an intima layer of the renal artery and into an adventitia layer of the renal artery.

7. The system of claim 1 , wherein an optimal actuation frequency of the ultrasound transducer is approximately 9 MHz.

8. The system of claim 1 , wherein:

a balloon is mounted to the catheter to surround the ultrasound transducer, and

the balloon is configured to engage a wall of the renal artery and, when inflated, to center the ultrasound transducer within the renal artery, the balloon further configured to receive a liquid delivered to the balloon to cool an intima layer of the renal artery.

9. The system of claim 1 , further comprising a machine-readable element affixed to the catheter, the machine-readable element encoding an optimum actuation frequency of ultrasonic energy to be emitted by the ultrasound transducer during use.

10. The system of claim 7 , wherein the ultrasound transducer is configured to emit the dose of unfocused ultrasound energy at a frequency sufficient to treat hypertension of the mammalian subject without causing stenosis of the renal artery.

11. The system of claim 1 , wherein the ultrasound transducer is configured to emit the dose of unfocused ultrasound energy at a frequency of 8.5 to 9.5 MHz.

12. A method for inactivating renal nerve conduction along renal nerves associated with a renal artery in a mammalian subject, the method comprising:

inserting an ultrasound transducer into a renal artery of the mammalian subject, wherein the ultrasound transducer is positioned along a distal portion of a catheter, the distal portion of the catheter comprising an expansible structure; and

actuating the ultrasound transducer, using an actuator electrically connected to the ultrasound transducer, to cause emission of a dose of unfocused ultrasound energy into an impact volume of at least 0.5 cm 3 ;

wherein the impact volume encompasses the renal artery so that the unfocused ultrasound energy is applied at a therapeutic level sufficient to inactivate conduction of renal nerves within the impact volume.

13. The method of claim 12 , wherein the actuating the ultrasound transducer to cause emission of the dose of unfocused ultrasound energy is performed so as to maintain a temperature of the inner wall of the renal artery below 65° C. while heating the renal nerves in the impact volume to above 42° C.

14. The method of claim 12 , further comprising:

actuating the ultrasound transducer to emit unfocused ultrasound energy at a measurement level;

receiving an echo signal representing reflected measurement ultrasound energy;

measuring a time delay between the actuation of the ultrasound transducer and a return of the echo signal; and

determining the dose using a lookup table showing a relationship between the time delay and the dose.

15. The method of claim 12 , further comprising:

actuating the ultrasound transducer to emit unfocused ultrasound energy at a measurement level;

receiving echo signals representing reflected measurement ultrasound energy;

measuring a time delay between the actuation of the ultrasound transducer and a return of the echo signals; and

determining the renal artery size based on the time delay.

16. The method of claim 12 , further comprising:

actuating the ultrasound transducer to emit unfocused ultrasound energy at a measurement level;

receiving echo signals representing reflected measurement ultrasound energy;

measuring a range of time delays between the actuation of the ultrasound transducer and

the return of the echo signals indicating variation in the shape of the renal artery or that the transducer is off-center from the wall of the renal artery; and

adjusting the power of energy delivery based on the range of time delays.

17. The method of claim 12 , further comprising:

actuating the ultrasound transducer to emit unfocused ultrasound energy at a measurement level toward the renal artery;

receiving echo signals representing reflected measurement ultrasound energy;

measuring a range of time delays between the actuation of the ultrasound transducer and the return of the echo signals indicating variation in the shape of the renal artery;

taking an average of the range of time delays to determine the average size of the renal artery; and

adjusting the power of energy delivery based on the average size of the renal artery.

18. The method of claim 12 , further comprising:

transitioning the expansible balloon structure from a compressed state to a radially expanded state, wherein the expansible structure is a balloon;

inflating the balloon such that the balloon engages an inner wall of the renal artery and the ultrasound transducer is centered within the renal artery; and

delivering liquid to the balloon to cool an intima layer of the renal artery, wherein the actuating of the ultrasound transducer to inactivate conduction of the renal nerves does not cause damage to the intima layer of the renal artery.

19. The method of claim 12 , wherein the ultrasound energy is transmitted at an acoustic power level of 10 to 100 Watts at a frequency of about 9 MHz for 10 seconds to 20 seconds, and wherein the dose of unfocused ultrasound energy is emitted in a pattern having a length of 2 mm to 10 mm along an axis of the renal artery.

20. The method of claim 12 , further comprising:

using a reader to read an optimum actuation frequency of the transducer encoded on a machine-readable element specific to the transducer;

conveying the optimum actuation frequency of the transducer to a control board; and

using the control board to set a frequency for exciting the transducer.

21. The system of claim 8 , wherein the balloon includes holes configured to permit the liquid to exit the balloon.

22. The system of claim 1 , wherein the ultrasound transducer is of a tubular shape and has an exterior emitting surface in the form of a cylindrical surface of revolution about a proximal-to-distal axis of the transducer.

Assignments (2)

Continuity (6)

References Cited (400)