IP Library Granted Patent US 11,998,266
Granted Patent B2
US 11,998,266 · App. 17/486,826 · Granted Jun 4, 2024

Intravascular energy delivery

Inventor: Michael Gertner (Menlo Park, CA)
Assignee: Otsuka Medical Devices Co., Ltd
A61B18/1492A61B5/01A61B5/055A61B2018/00404A61B2018/00434A61B2018/00511A61B2018/00577A61B2018/048A61B90/50A61N2007/0021A61N2007/0078A61N7/02A61N7/022
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Quick Facts
Patent No.
US 11,998,266
App. No.
17/486,826
Granted
Jun 4, 2024
Kind
B2
Abstract

A method to apply a nerve inhibiting cloud surrounding a blood vessel includes creating a treatment plan, wherein the treatment plan prescribes application of the nerve inhibiting cloud towards at least a majority portion of a circumference of a blood vessel wall, and applying the nerve inhibiting cloud towards the majority portion of the circumference of the blood vessel wall for a time sufficient to inhibit a function of a nerve that surrounds the blood vessel wall.

Claims (81)

1. A method of facilitating thermally-induced neuromodulation in a subject, comprising:

inserting a neuromodulation catheter into a vasculature of the subject;

advancing a distal end of the neuromodulation catheter to at least one of a first blood vessel or a second blood vessel, the first blood vessel surrounded by one or more sympathetic nerves that innervate a liver of the subject and the second blood vessel surrounded by one or more nerves that innervate a pancreas of the subject; and

at least partially denervating at least one of the first blood vessel or the second blood vessel by delivering ablative energy to at least one of:

the first blood vessel to at least partially denervate the liver to modulate conversion of glycogen to glucose, or

the second blood vessel to at least partially denervate the pancreas to alter glucose tolerance of the subject.

2. The method of claim 1 , wherein the catheter comprises a stabilization mechanism for stabilizing a part of the neuromodulation catheter relative to at least one of the first blood vessel or the second blood vessel when the stabilization mechanism is in an expanded position and wherein denervating at least one of the first blood vessel or the second blood vessel by delivering ablative energy comprises energizing the at least one piezoelectric component to deliver unfocused ultrasound energy to create a cigar shaped lesion around at least one of the first blood vessel or the second blood vessel.

3. The method of claim 1 , wherein:

the catheter comprises at least one piezoelectric component,

advancing the distal end of the neuromodulation catheter comprises advancing the distal end of the neuromodulation catheter to the first blood vessel,

the first blood vessel comprises a hepatic artery,

denervating at least one of the first blood vessel or the second blood vessel by delivering ablative energy comprises energizing the at least one piezoelectric component to deliver unfocused ultrasound energy towards at least a majority portion of a circumference of the hepatic artery to thereby reach the one or more sympathetic nerves surrounding the hepatic artery, and

wherein the unfocused ultrasound energy is delivered to create a heated region at the one or more sympathetic nerves surrounding the hepatic artery.

4. The method of claim 1 , wherein:

the catheter comprises at least one piezoelectric component,

advancing the distal end of the neuromodulation catheter comprises advancing the distal end of the neuromodulation catheter to the second blood vessel,

the second blood vessel leading to the pancreas,

denervating at least one of the first blood vessel or the second blood vessel by delivering ablative energy comprises energizing the piezoelectric component to deliver unfocused ultrasound energy towards at least a majority portion of a circumference of the second blood vessel to thereby reach the one or more nerves innervating the pancreas, and

wherein the unfocused ultrasound energy is delivered to create a heated region at the one or more nerves surrounding the second blood vessels.

5. The method of claim 1 , wherein delivering ablative energy comprises delivering pulsed ultrasound energy.

6. The method of claim 1 , wherein delivering ablative energy comprises delivering an electric field.

7. The method of claim 1 , wherein delivering ablative energy comprises delivering radiofrequency energy to at least one of the first blood vessel or the second blood vessel.

8. The method of claim 1 , further comprising determining a norepinephrine level after delivering the energy to assess the effect of the energy delivery.

9. The method of claim 1 , wherein the energy is delivered to ablate the nerves while cooling the at least one of the first blood vessel or the second blood vessel.

10. The method of claim 1 , wherein the first blood vessel comprises one or more hepatic arteries and the second blood vessel comprises a blood vessel leading to the pancreas of the subject, the method further comprising delivering cooling to protect a wall of at least one of the hepatic arteries or the blood vessel leading to the pancreas during energy delivery.

11. The method of claim 1 , further comprising:

advancing the distal end of the neuromodulation catheter to one or more branch renal arteries of the subject; and

denervating one or more sympathetic nerves of the one or more branch renal arteries by delivering radiofrequency energy to the one or more sympathetic nerves.

12. A method comprising:

inserting a first neuromodulation catheter into a vasculature of a patient;

advancing a distal end of the first neuromodulation catheter to one or more hepatic arteries of the patient; and

at least partially denervating a liver of the patient by delivering ablative energy to the sympathetic nerves surrounding the one or more hepatic arteries, wherein the denervation inhibits conversion of glycogen to glucose by the liver.

13. The method of claim 12 , further comprising:

advancing the distal end of a second neuromodulation catheter to one or more renal arteries of the patient; and

at least partially denervating one or more renal sympathetic nerves by delivering energy to the one or more renal sympathetic nerves of the one or more renal arteries.

14. The method of claim 13 , wherein the first and second neuromodulation catheters are the same catheter.

15. The method of claim 13 , wherein at least one of the first or second neuromodulation catheters is configured to deliver radiofrequency energy.

16. The method of claim 13 , wherein the energy is delivered at a bifurcation point along the one or more renal arteries.

17. The method of claim 13 , wherein delivering energy to one or more renal sympathetic nerves of the one or more renal arteries comprises delivering energy to the one or more renal sympathetic nerves at the aorta-renal artery ostium.

18. The method of claim 13 , wherein the delivery of energy to the one or more renal sympathetic nerves of the one or more renal arteries creates one or more spiral shaped lesions along the length of the one or more renal arteries.

19. The method of claim 12 , wherein the energy delivery creates one or more annular shaped lesions along the length of the one or more hepatic arteries.

20. The method of claim 13 , wherein the energy delivery creates a plurality of annular shaped lesions along the length of at least one of the one or more renal arteries and one annular shaped lesion at a bifurcation point along the one or more renal arteries to treat a patient's hypertension.

21. The method of claim 13 , wherein the energy delivery creates three annular shaped lesions along the length of at least one of the one or more renal arteries and one annular shaped lesion at a bifurcation point along the one or more renal arteries to treat a patient's hypertension.

22. The method of claim 13 , wherein the energy delivery at least partially blocks renal nerve function while resulting in no damage to the renal artery.

23. The method of claim 13 , further comprising:

applying a test dose of energy to at least one of the one or more renal arteries; and

determining whether the test dose energy had an effect on sympathetic nerve activity of the patient.

24. The method of claim 13 , further comprising determining an approximate temperature rise of the one or more renal arteries during or after energy delivery.

25. The method of claim 24 , wherein determining an approximate temperature rise comprises using ultrasound imaging to determine the approximate temperature rise of the one or more renal arteries by measuring the relative speed of the ultrasound transmission from the one or more renal arteries.

26. The method of claim 13 , further comprising determining changes in the elastic properties of the one or more renal arteries to assess the effect of the energy delivery.

27. The method of claim 12 , further comprising monitoring changes in tissue characteristics and properties in order to monitor the delivery of energy.

28. The method of claim 13 , further comprising determining whether the energy delivery successfully denervated the renal nerves by:

stimulating the patient's baroreceptors using a compression balloon before and after the delivery of energy;

determining the patient's blood pressure before and after the delivery of energy while the patient's baroreceptors are being stimulated; and

determining that the treatment was successful when stimulating the baroreceptors before the energy delivery results in a lower blood pressure than stimulating the baroreceptors after the energy delivery.

29. The method of claim 12 , further comprising:

advancing the distal end of a second neuromodulation catheters to an artery of a pancreas; and

at least partially denervating the pancreas by delivering ablative energy to nerves Pill surrounding the artery of the pancreas, wherein the denervation improves the patient's glucose tolerance.

30. The method of claim 29 , wherein the first and second neuromodulation catheters are the same.

31. The method of claim 29 , wherein at least one of the first and second neuromodulation catheters is configured to deliver radiofrequency energy.

32. The method of claim 29 , wherein at least one of the first and second neuromodulation catheters is configured to deliver unfocused ultrasound energy.

33. The method of claim 12 , further comprising:

advancing the distal end of a second neuromodulation catheter to one or more branch renal arteries of the patient; and

denervating one or more sympathetic nerves of the one or more branch renal arteries by delivering radiofrequency energy to the one or more sympathetic nerves.

34. The method of claim 12 , further comprising:

advancing the distal end of a second neuromodulation catheter to one or more blood vessels leading to the heart of the patient; and

delivering energy to the one or more blood vessels leading to the heart.

35. A method of affecting one or more nerves surrounding one or more blood vessels in a patient comprising:

placing a part of an intravascular catheter inside at least one of a hepatic artery or a blood vessel leading to a pancreas of the patient, the

catheter comprising a piezoelectric component; and

energizing the piezoelectric component to deliver unfocused ultrasound energy towards at least a majority portion of a circumference of at least one of the hepatic artery or the blood vessel leading to the pancreas to thereby reach the one or more sympathetic nerves surrounding at least one of the hepatic artery or the nerves surrounding the blood vessel leading to the pancreas,

wherein the unfocused ultrasound energy is delivered to create a heated region at at least one of:

the one or more sympathetic nerves surrounding the hepatic artery to inhibit conversion of glycogen to glucose by the liver, or

the one or more nerves surrounding the blood vessel leading to the pancreas to improve glucose tolerance of the patient.

36. The method of claim 35 , wherein the energy delivery creates one or more annular shaped lesions along the length of at least one of the hepatic artery or the blood vessel leading to the pancreas.

37. The method of claim 35 , further comprising:

advancing a distal end of the neuromodulation catheter to one or more renal arteries of the patient; and

delivering unfocused ultrasound energy to one or more renal sympathetic nerves of the one or more renal arteries to denervate the one or more renal sympathetic nerves.

38. The method of claim 37 , wherein the unfocused ultrasound energy is delivered with a certain intensity to affect the renal sympathetic nerves to reduce hypertension.

39. The method of claim 37 , wherein the energy delivered to the renal artery at least partially blocks renal nerve function to treat hypertension while resulting in no damage to the renal artery.

40. The method of claim 35 , further comprising delivering testing energy to the patient to determine whether there is a reaction resulting therefrom.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2021
From: GERTNER, MICHAEL
To: KONA MEDICAL, INC.
Reel/Frame 057615/0899 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2021
From: KONA MEDICAL, INC.
To: OTSUKA MEDICAL DEVICES CO., LTD.
Reel/Frame 057615/0942 →
Continuity (16)
Continuation 16412379 · May 14, 2019
Continuation 15662179 · Jul 27, 2017
Continuation 14939670 · Nov 12, 2015
Continuation 13896247 · May 16, 2013
Continuation 13048842 · Mar 15, 2011
Continuation In Part 12902133 · Oct 11, 2010
Continuation In Part 12725450 · Mar 16, 2010
Continuation In Part 12685655 · Jan 11, 2010
Provisional Application 61377908 · Aug 27, 2010
Provisional Application 61347375 · May 21, 2010
Provisional Application 61303307 · Feb 10, 2010
Provisional Application 61291359 · Dec 30, 2009
Provisional Application 61261741 · Nov 16, 2009
Provisional Application 61256983 · Oct 31, 2009
Provisional Application 61250857 · Oct 12, 2009
Related Publication 20220202483A1 · Jun 30, 2022