Methods and apparatus for renal neuromodulation

• US 10,245,429 B2
• Filed: 04/06/2018
• Issued: 04/02/2019
• Est. Priority Date: 04/08/2002
• Status: Expired due to Term

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Deem, Mark E., Gifford, III, Hanson, Zarins, Denise, Sutton, Douglas, Thai, Erik, Gelfand, Mark, Levin, Howard R.
• Primary Examiner(s): Bockelman, Mark W
• Application Number:
  US15/946,919
• Publication Number:
  US 20180229033A1
• Time in Patent Office: 361 Days
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/00071 Electrical conductivity
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61N 1/0412 : Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/18 : Applying electric currents by contact electrodes
• CPC Class Codes: A61N 1/205 : for promoting a biological process
• CPC Class Codes: A61N 1/326 : for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/327 : for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36057 : adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36103 : Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/36114 : Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 2007/0021 : Neural system treatment
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 5/00 : Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.

Claims

1. A method for catheter-based renal denervation of a hypertensive human patient, the method comprising:

intravascularly positioning a distal region of a catheter within a renal artery associated with a kidney of the patient; and

at least partially ablating target neural tissue innervating the kidney of the patient via ultrasound energy from the catheter, wherein the ultrasound energy is delivered via an ultrasound transducer carried by a shaft of the catheter,

wherein at least partially ablating the target neural tissue results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1, further comprising removing the catheter from the patient after at least partially ablating the target neural tissue via the ultrasound energy to conclude the procedure.

3. The method of claim 1 wherein at least partially ablating the target neural tissue innervating the kidney further results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

4. The method of claim 1 wherein the ultrasound energy is unfocused ultrasound energy.

5. The method of claim 1 wherein the ultrasound energy is high frequency ultrasound energy.

6. The method of claim 1 wherein intravascularly positioning a distal region of a catheter within a renal artery comprises intravascularly positioning the catheter over a guidewire.

7. The method of claim 1, further comprising monitoring a parameter of the catheter and/or tissue within the patient before and during delivery of ultrasound energy.

8. The method of claim 7, further comprising altering delivery of ultrasound energy in response to the monitored parameter.

9. The method of claim 1 wherein the distal region of the catheter further comprises an expandable centering element, and wherein the method further comprises transforming the centering element between a low-profile delivery configuration and an expanded configuration after intravascularly positioning the distal region of the catheter within the renal artery and before delivering the ultrasound energy via the ultrasound transducer.

10. The method of claim 9 wherein the expandable centering element comprises a balloon.

11. A method, comprising:

intravascularly advancing an energy delivery element carried by a catheter within renal vasculature of a human patient and proximate to renal nerves of the patient; and

delivering unfocused ultrasound energy via the energy delivery element, wherein the ultrasound energy inhibits neural traffic along the renal nerves to and/or from a kidney of the patient,

wherein inhibiting the neural traffic along the renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

12. The method of claim 11 wherein inhibiting neural traffic along the renal nerves via the ultrasound energy comprises blocking afferent and/or efferent renal nerve activity.

13. The method of claim 11 wherein a distal portion of the catheter further comprises an expandable positioning element, and wherein intravascularly advancing an energy delivery element within renal vasculature of the patient comprises positioning the catheter within a renal artery of the patient via the expandable positioning element before delivering the unfocused ultrasound energy via the energy delivery element.

14. The method of claim 13 wherein the expandable positioning element comprises an inflatable balloon.

15. The method of claim 11, further comprising intravascularly removing the catheter and energy delivery element from the patient after delivering the unfocused ultrasound energy to conclude the procedure.

16. The method of claim 11 wherein inhibiting neural traffic along the renal nerves via the ultrasound energy comprises reducing renal sympathetic nerve activity of the kidney of the patient.

17. The method of claim 11 wherein inhibiting neural traffic along the renal nerves via the ultrasound energy comprises denervating the kidney of the patient.