IP Library Granted Patent US 8,579,891
Granted Patent B2
US 8,579,891 · App. 13/789,509 · Granted Nov 12, 2013

Devices for thermally-induced hepatic neuromodulation

Inventors: Jonathan Allen Coe (Menlo Park, CA); Bobak Robert Azamian (Newport Coast, CA); Scott Bradley Vafai (Boston, MA)
Assignee: Metavention, Inc.
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Quick Facts
Patent No.
US 8,579,891
App. No.
13/789,509
Granted
Nov 12, 2013
Kind
B2
Abstract

According to some embodiments, a method of treating a subject having diabetes or symptoms associated with diabetes is provided. The method includes delivering a neuromodulation catheter within a vessel (e.g., hepatic artery) having surrounding nerves that innervate the liver (e.g., sympathetic nerves of the hepatic plexus). The method may also include modulating (e.g., disrupting, ablating, stimulating) the nerves by mechanical compression, energy delivery, or fluid delivery.

Claims (51)

1. A device for thermally-induced hepatic neuromodulation to decrease blood glucose levels within a subject, comprising:

a catheter body having a proximal end and a distal end and a lumen extending from the proximal end to the distal end,

wherein the catheter body is configured for percutaneous, intravascular placement within a hepatic artery branch; and

an articulatable portion at the distal end of the catheter body,

at least one articulation wire extending from the proximal end of the body and being coupled to the articulatable portion,

wherein the at least one articulation wire is configured to bend the articulatable portion at the distal end of the catheter body,

wherein the articulatable portion comprises at least one radiofrequency (RF) electrode,

wherein the at least one RF electrode is configured to be activated to deliver RF energy sufficient to achieve denervation of the hepatic artery branch, thereby decreasing blood glucose levels within the subject,

wherein the distal portion of the catheter body comprises a deflectable bend segment having a preformed bend shape such that the distal end of the catheter body bends off-axis relative to a longitudinal axis of the proximal portion of the catheter body,

wherein the articulatable portion and the deflectable bend segment facilitate treatment within variable and tortuous anatomy of the hepatic artery branch,

wherein the articulatable portion is configured to apply and maintain contact pressure between the at least one RF electrode and an inner arterial wall of the hepatic artery branch, thereby facilitating continuous contact as the hepatic artery branch moves in response to diaphragm motion,

wherein the contact pressure is between about 5 g/mm 2 and about 100 g/mm 2 , and

wherein the RF energy configured to be delivered to achieve denervation of the hepatic artery branch is between about 100 J and about 1 kJ.

2. The device of claim 1 , wherein the catheter body has a length sufficient to extend from a femoral artery to the hepatic artery branch.

3. The device of claim 1 , wherein the distal end of the catheter body has an outside diameter sized to fit within the hepatic artery branch.

4. The device of claim 1 , further comprising an outer sheath, and wherein the catheter body is configured to be delivered within a lumen of the outer sheath and is translatable relative to the outer sheath.

5. The device of claim 4 , wherein the deflectable bend segment of the catheter body is configured to transition to the preformed bend shape upon retraction of the outer sheath or upon advancement of the distal end of the catheter body out of the outer sheath.

6. The device of claim 1 , further comprising two radiopaque markers positioned along the distal end of the catheter body configured to be used to adjust the contact pressure.

7. The device of claim 1 , wherein the articulatable portion comprises a plurality of independently controllable bending segments.

8. The device of claim 1 , wherein the preformed bend shape of the deflectable bend segment is configured to correspond to a bend between a celiac artery and a common hepatic artery.

9. A device for thermally-induced hepatic neuromodulation to decrease blood glucose levels within a subject, comprising:

a catheter body having a proximal end and a distal end and a lumen extending from the proximal end to the distal end,

wherein the catheter body is configured for percutaneous, intravascular placement within a hepatic artery branch; and

an articulatable portion at the distal end of the catheter body,

wherein the articulatable portion comprises two independently controllable bending segments,

wherein the two independently controllable bending segments are configured to be individually articulated by two articulation wires extending from the proximal end of the catheter body to the two independently controllable bending segments,

wherein the two independently controllable bending segments together comprise two or more radiofrequency (RF) electrodes,

wherein at least one of the two or more RF electrodes is configured to be activated to deliver RF energy sufficient to achieve denervation of the hepatic artery branch, thereby decreasing blood glucose levels within the subject,

wherein the articulatable portion is configured to apply and maintain contact pressure between the at least one RF electrode and an inner arterial wall of the hepatic artery branch, thereby facilitating continuous contact as the hepatic artery branch moves in response to diaphragm motion and thereby facilitating treatment within variable and tortuous anatomy of the hepatic artery branch,

wherein the contact pressure is between about 5 g/mm 2 and about 100 g/mm 2 , and

wherein the RF energy configured to be delivered to achieve denervation of the hepatic artery branch is between about 100 J and about 1 kJ.

10. The device of claim 9 , wherein the catheter body has a length sufficient to extend from a femoral artery to the hepatic artery branch.

11. The device of claim 9 , wherein the distal end of the catheter body has an outside diameter sized to fit within the hepatic artery branch.

12. The device of claim 9 , further comprising an outer sheath, and wherein the catheter body is configured to be delivered within a lumen of the outer sheath and is translatable relative to the outer sheath.

13. The device of claim 9 , further comprising two radiopaque markers positioned along the distal end of the catheter body configured to be used to adjust the contact pressure.

14. The device of claim 9 , wherein articulation of a first bending segment of the two independently controllable bending segments is controlled by a first articulation wire and wherein articulation of a second bending segment of the two independently controllable bending segments is controlled by a second articulation wire.

15. The device of claim 14 , wherein the first bending segment is configured to articulate to conform to a first arterial bend, and wherein the second bending segment is configured to conform to a second arterial bend.

16. The device of claim 9 , wherein said denervation of the hepatic artery branch comprises permanently disabling neural communication of sympathetic nerves of the hepatic plexus.

17. The device of claim 9 , wherein said denervation of the hepatic artery branch comprises temporarily inhibiting or reducing neural communication of sympathetic nerves of the hepatic plexus.

18. A device for thermally-induced hepatic neuromodulation to decrease blood glucose levels within a subject, comprising:

a catheter body having a proximal end and a distal end and a lumen extending from the proximal end to the distal end,

wherein the catheter body is configured for percutaneous, intravascular placement within a hepatic artery branch,

wherein the catheter body has a length sufficient to extend from a femoral artery to the hepatic artery branch,

wherein the distal end of the catheter body has an outside diameter sized to fit within the hepatic artery branch;

a deflectable bend segment having a preformed bend shape such that the distal end of the catheter body bends off-axis relative to a longitudinal axis of the proximal portion of the catheter body,

wherein the deflectable bend segment comprises at least one radiofrequency (RF) electrode, wherein the at least one RF electrode is configured to be activated to deliver RF energy sufficient to achieve denervation of the hepatic artery branch, thereby decreasing blood glucose levels within the subject,

wherein the deflectable bend segment is configured to apply and maintain contact pressure between the at least one RF electrode and an inner arterial wall of the hepatic artery branch, thereby facilitating continuous contact as the hepatic artery branch moves in response to diaphragm motion and thereby facilitating treatment within variable and tortuous anatomy of the hepatic artery branch,

wherein the contact pressure is between about 5 g/mm 2 and about 100 g/mm 2 , and

wherein the RF energy configured to be delivered to achieve denervation of the hepatic artery branch is between about 100 J and about 1 kJ.

19. The device of claim 18 , further comprising an outer sheath, and wherein the catheter body is configured to be delivered within a lumen of the outer sheath and is translatable relative to the outer sheath.

20. The device of claim 18 , wherein the deflectable bend segment of the catheter body is configured to transition to the preformed bend shape upon retraction of the outer sheath or upon advancement of the distal end of the catheter body out of the outer sheath.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2023
From: METAVENTION, INC.
To: MEDTRONIC IRELAND MANUFACTURING UNLIMITED COMPANY
Reel/Frame 064987/0161 →
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 Jun 29, 2022
From: METAVENTION, INC.
To: RVLHC II, LLC, AS COLLATERAL AGENT
Reel/Frame 060358/0417 →
SECURITY INTEREST Recorded Dec 20, 2021
From: METAVENTION, INC.
To: SIGNATURE BANK
Reel/Frame 058433/0587 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 11, 2013
From: AZAMIAN, BOBAK ROBERT; COE, JONATHAN ALLEN; VAFAI, SCOTT BRADLEY
To: METAVENTION, INC.
Reel/Frame 031578/0683 →
Continuity (3)
Continuation PCTUS2012068630 · Dec 7, 2012
Provisional Application 61568843 · Dec 9, 2011
Related Publication 20130190748A1 · Jul 25, 2013