IP Library Granted Patent US 12,011,212
Granted Patent B2
US 12,011,212 · App. 16/706,468 · Granted Jun 18, 2024

Modulation of targeted nerve fibers

Inventors: Bobak Robert Azamian (Newport Coast, CA); Jonathan Allen Coe (Menlo Park, CA); Scott Bradley Vafai (Boston, MA)
Assignee: Medtronic Ireland Manufacturing Unlimited Company
A61B18/1492A61N1/0551A61N1/3605A61B2018/00029A61B2018/00214A61B2018/00279A61B2018/00404A61B2018/00434A61B2018/00529A61B2018/00577A61B2018/1467A61B2090/064A61M25/0138A61M25/0141A61M25/0147A61M2025/1052
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Quick Facts
Patent No.
US 12,011,212
App. No.
16/706,468
Granted
Jun 18, 2024
Kind
B2
Abstract

According to various embodiments, systems, devices and methods for modulating targeted nerve fibers (e.g., hepatic neuromodulation) are provided. The systems may be configured to access tortuous anatomy of or adjacent hepatic vasculature. The systems may be configured to target nerves within a wall of (e.g., within adventitia surrounding a lumen of) an artery or other blood vessel, such as the common hepatic artery.

Claims (63)

1. A method for neuromodulation of nerves surrounding an artery, the method comprising:

inserting a radiofrequency (RF) ablation catheter into vasculature of a subject;

positioning an occlusive, expandable member of the RF ablation catheter within the artery while the occlusive, expandable member is in a non-expanded configuration,

wherein the occlusive, expandable member comprises a plurality of electrodes;

causing the occlusive, expandable member to expand into an expanded configuration such that at least one electrode of the plurality of electrodes is in contact with an inner wall of the artery and such that the occlusive, expandable member is occluding flow through the artery;

causing the at least one electrode to intravascularly deliver a therapeutically effective amount of RF energy to the inner wall of the artery sufficient to ablate sympathetic nerves surrounding the artery; and

actively cooling a surface of the at least one electrode by pumping coolant within the occlusive, expandable member through a lumen of the RF ablation catheter to increase lesion depth during ablation,

wherein a flow rate of the coolant is 100 mL/minute to 500 mL/minute,

wherein a range of drive pressures within the occlusive, expandable member to provide the flow rate is 25 psi to 150 psi, and

wherein the RF ablation catheter is configured to maintain continuous contact of the at least one electrode against the inner wall of the artery while the RF energy is being delivered and during movement of the artery caused by motion of a diaphragm during respiration.

2. The method of claim 1 , wherein:

each electrode of the plurality of electrodes is configured to function as a monopolar electrode;

each electrode of the plurality of electrodes has a surface area of 5 mm 2 to 20 mm 2 ;

the occlusive, expandable member is pneumatically expandable;

the RF energy is continuous; and

the therapeutically effective amount of RF energy has a power level of about 0.1 W to about 10 W.

3. The method of claim 1 , further comprising monitoring impedance to assess maintained contact of the at least one electrode against the inner wall of the artery.

4. The method of claim 3 , wherein the RF energy is pulsed based on the impedance.

5. The method of claim 1 , further comprising monitoring temperature at a distance of 2 mm to 10 mm from at least one electrode.

6. The method of claim 1 , further comprising monitoring temperature at a distance of 5 mm to 15 mm from the at least one electrode.

7. The method of claim 1 , further comprising monitoring temperature at a distance of 10 mm to 20 mm from the at least one electrode.

8. The method of claim 1 , wherein the RF energy is pulsed based on sensed temperature data.

9. The method of claim 1 , wherein the coolant is chilled fluid.

10. A method for neuromodulation of nerves surrounding an artery, the method comprising:

inserting a radiofrequency (RF) ablation catheter into vasculature of a subject;

positioning an occlusive, expandable member of the RF ablation catheter within the artery while the occlusive, expandable member is in a non-expanded configuration,

wherein the occlusive, expandable member comprises a plurality of electrodes;

causing the occlusive, expandable member to expand into an expanded configuration such that at least one electrode of the plurality of electrodes is in contact with an inner wall of the artery and such that the occlusive, expandable member is occluding flow through the artery;

causing the at least one electrode to intravascularly deliver a therapeutically effective amount of RF energy to the inner wall of the artery sufficient to ablate sympathetic nerves surrounding the artery; and

actively cooling a surface of the at least one electrode by pumping coolant within the occlusive, expandable member through a lumen of the RF ablation catheter to increase lesion depth during ablation,

wherein a flow rate of the coolant is 100 mL/minute to 500 mL/minute,

wherein a range of drive pressures within the occlusive, expandable member to provide the flow rate is 25 psi to 150 psi, and

wherein the RF ablation catheter is configured to maintain continuous contact of the at least one electrode against the inner wall of the artery while the RF energy is being delivered and during movement of the artery caused by motion of a diaphragm during respiration.

11. The method of claim 10 , wherein:

each electrode of the plurality of electrodes is configured to function as a monopolar electrode;

each electrode of the plurality of electrodes has a surface area of 5 mm 2 to 20 mm 2 ;

the occlusive, expandable member is pneumatically expandable;

the RF energy is continuous; and

the therapeutically effective amount of RF energy has a power level of about 0.1 W to about 10 W.

12. The method of claim 10 , further comprising monitoring impedance to assess maintained contact of the at least one electrode against the inner wall of the artery.

13. The method of claim 12 , wherein the RF energy is pulsed based on the impedance.

14. The method of claim 10 , further comprising monitoring temperature at a distance of 5 mm to 15 mm from the at least one electrode.

15. The method of claim 10 , wherein the RF energy is pulsed based on sensed temperature data.

16. The method of claim 10 , wherein the coolant is chilled fluid.

17. A method for neuromodulation of nerves surrounding an artery, the method comprising:

inserting a radiofrequency (RF) ablation catheter into vasculature of a subject,

wherein the RF ablation catheter is configured to form a first bend to conform to a first anatomical bend of a first artery portion and is configured to form a second bend to conform to a second anatomical bend of a second artery portion;

positioning an occlusive, expandable member of the RF ablation catheter within the artery while the occlusive, expandable member is in a non-expanded configuration,

wherein the occlusive, expandable member comprises a plurality of electrodes;

causing the occlusive, expandable member to expand into an expanded configuration such that at least one electrode of the plurality of electrodes is in contact with an inner wall of the artery and such that the occlusive, expandable member is occluding flow through the artery;

causing the at least one electrode to intravascularly deliver a therapeutically effective amount of RF energy to the inner wall of the artery sufficient to ablate sympathetic nerves surrounding the artery; and

actively cooling a surface of the at least one electrode to increase lesion depth during ablation by pumping coolant within the occlusive, expandable member through a lumen of the RF ablation catheter,

wherein the RF ablation catheter is configured to maintain continuous contact of the at least one electrode against the inner wall of the artery while the RF energy is being delivered and during movement of the artery caused by motion of a diaphragm during respiration,

wherein a flow rate of the coolant is 100 mL/minute to 500 mL/minute,

wherein a range of drive pressures within the occlusive, expandable member to provide the flow rate is 25 to 150 psi; and

monitoring impedance to assess maintained contact of the at least one electrode against the inner wall of the artery,

wherein the RF energy is pulsed based on the monitored impedance.

18. The method of claim 17 , wherein:

the artery is a hepatic artery;

each electrode of the plurality of electrodes is configured to function as a monopolar electrode; and

the occlusive, expandable member is pneumatically expandable.

19. The method of claim 18 , wherein the artery is a common hepatic artery.

20. The method of claim 17 , wherein the artery is selected from the group consisting of: a superior mesenteric artery, an inferior mesenteric artery, a splenic artery, a gastric artery, a left hepatic artery, a right hepatic artery, a renal artery, and a gastroduodenal artery.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 11, 2023
From: METAVENTION, INC.
To: MEDTRONIC IRELAND MANUFACTURING UNLIMITED COMPANY
Reel/Frame 064864/0730 →
RELEASE OF SECURITY INTEREST Recorded Aug 22, 2023
From: CUSTOMERS BANK (SUCCESSOR IN INTEREST TO SIGNATURE BANK)
To: METAVENTION, INC.
Reel/Frame 064670/0039 →
SECURITY INTEREST Recorded Jan 11, 2023
From: METAVENTION, INC.
To: RVLHC II, LLC, AS COLLATERAL AGENT
Reel/Frame 062349/0859 →
SECURITY INTEREST Recorded Oct 31, 2022
From: METAVENTION, INC.
To: RVLHC II, LLC, AS COLLATERAL AGENT
Reel/Frame 061602/0249 →
SECURITY INTEREST Recorded Oct 7, 2022
From: METAVENTION, INC.
To: SIGNATURE BANK
Reel/Frame 061341/0724 →
SECURITY INTEREST Recorded Jun 29, 2022
From: METAVENTION, INC.
To: RVLHC II, LLC, AS COLLATERAL AGENT
Reel/Frame 060358/0417 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 1, 2022
From: AZAMIAN, BOBAK ROBERT; COE, JONATHAN ALLEN; VAFAI, SCOTT BRADLEY; HANSEN, JAMES G; HYKES, KEVIN ROBERT; MCCRYSTLE, KELLY JUSTIN; MOTTA, ROSSANA; PERRY, MICHAEL DAVID; REULAND, ERIC ROBERT; SUN, VICTOR KELVIN; WEBSTER, MARK WILSON IAN; VRBA, ANTHONY CIRO; SMITH, SCOTT RAYMOND
To: METAVENTION, INC.
Reel/Frame 059137/0291 →
Continuity (4)
Continuation 14896063
Provisional Application 61906830 · Nov 20, 2013
Provisional Application 61831507 · Jun 5, 2013
Related Publication 20200197086A1 · Jun 25, 2020
Cited By (1)
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