# US 11,998,266 B2 · Intravascular energy delivery

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- Number: US 11,998,266 B2
- Document ID: US11998266B2
- Status: Granted
- Kind: B2
- Application number: 17/486,826
- Filed: 2021-09-27
- Published: 2022-06-30
- Granted: 2024-06-04
- Earliest claimed: 2009-10-12
- Assignees: Otsuka Medical Devices Co., Ltd.
- Applicants: Otsuka Medical Devices Co., Ltd.
- Inventors: Michael Gertner
- Web page: https://patentgrep.com/patent/US11998266B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 5/4035: {Evaluating the autonomic nervous system}
- A61B 5/4041: {Evaluating nerves condition}
- A61B 5/4047: {afferent nerves, i.e. nerves that relay impulses to the central nervous system}
- A61B 5/412: {Detecting or monitoring sepsis}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/489: {Blood vessels}
- A61B 5/4893: {Nerves}
- A61B 8/00: Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B 8/06: Measuring blood flow
- A61B 8/08: Clinical applications (A61B8/02, A61B8/04, A61B8/06 take precedence)
- A61B 8/0808: {for diagnosis of the brain}
- A61B 8/0833: {involving detecting or locating foreign bodies or organic structures}
- A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules}
- A61B 8/0858: {involving measuring tissue layers, e.g. skin, interfaces}
- A61B 8/483: {involving the acquisition of a 3D volume of data}
- A61B 17/320068: {using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745)}
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61N 5/0601: {Apparatus for use inside the body}
- A61N 5/0622: {Optical stimulation for exciting neural tissue}
- 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})
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/0225: the pressure being controlled by electric signals, e.g. derived from Korotkoff sounds
- A61B 5/055: involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
- A61B 5/4052: {efferent nerves, i.e. nerves that relay impulses from the central nervous system}
- A61B 5/4528: {Joints (A61B5/4533, A61B5/4538 take precedence)}
- A61B 6/03: Computed tomography [CT]
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 6/037: {Emission tomography}
- A61B 6/504: {for diagnosis of blood vessels, e.g. by angiography}
- A61B 6/506: {for diagnosis of nerves}
- A61B 8/0891: {for diagnosis of blood vessels}
- A61B 8/10: Eye inspection
- A61B 8/4245: {involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient}
- A61B 8/485: {involving measuring strain or elastic properties}
- A61B 8/488: {involving Doppler signals}
- A61B 90/50: Supports for surgical instruments, e.g. articulated arms
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00511: {Kidney}
- A61B 2018/00529: {Liver}
- A61B 2018/00577: {Ablation}
- A61B 2018/048: {in gaseous form}
- A61B 2090/374: {NMR or MRI}
- A61B 2090/3762: {using computed tomography systems [CT]}
- A61B 2090/378: {using ultrasound}
- A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent}
- A61N 7/02: Localised ultrasound hyperthermia
- A61N 7/022: {intracavitary}
- A61N 2005/0602: {for treatment of blood vessels}
- A61N 2005/063: {comprising light transmitting means, e.g. optical fibres}
- A61N 2005/0651: {Diodes}
- A61N 2007/0021: {Neural system treatment}
- A61N 2007/0026: {Stimulation of nerve tissue}
- A61N 2007/003: {Destruction of nerve tissue}
- A61N 2007/0078: {with multiple treatment transducers}
- A61N 2007/025: {interstitial}
- A61N 2007/027: {with multiple foci created simultaneously}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 1)

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.

### Claim 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.

### Claim 13 (depends on 12)

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.

### Claim 14 (depends on 13)

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

### Claim 15 (depends on 13)

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

### Claim 16 (depends on 13)

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

### Claim 17 (depends on 13)

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.

### Claim 18 (depends on 13)

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.

### Claim 19 (depends on 12)

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.

### Claim 20 (depends on 13)

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.

### Claim 21 (depends on 13)

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.

### Claim 22 (depends on 13)

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.

### Claim 23 (depends on 13)

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.

### Claim 24 (depends on 13)

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

### Claim 25 (depends on 24)

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.

### Claim 26 (depends on 13)

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.

### Claim 27 (depends on 12)

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

### Claim 28 (depends on 13)

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.

### Claim 29 (depends on 12)

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.

### Claim 30 (depends on 29)

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

### Claim 31 (depends on 29)

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

### Claim 32 (depends on 29)

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

### Claim 33 (depends on 12)

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.

### Claim 34 (depends on 12)

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.

### Claim 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.

### Claim 36 (depends on 35)

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.

### Claim 37 (depends on 35)

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.

### Claim 38 (depends on 37)

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.

### Claim 39 (depends on 37)

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.

### Claim 40 (depends on 35)

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