# US 9,750,568 B2 · Ovarian neuromodulation and associated systems and methods

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- Number: US 9,750,568 B2
- Document ID: US9750568B2
- Status: Granted
- Kind: B2
- Application number: 14/379,890
- Filed: 2013-03-07
- Published: 2015-02-19
- Granted: 2017-09-05
- Earliest claimed: 2012-03-08
- Assignees: Medtronic Ardian Luxembourg S.a.r.l.
- Applicants: Medtronic Ardian Luxembourg S.A.R.L.; Paul Sobotka
- Inventors: Paul Sobotka
- Web page: https://patentgrep.com/patent/US9750568B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18)
- A61B 18/1482: {having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy}
- A61N 1/36057: {adapted for stimulating afferent nerves}
- A61N 1/36117: {for treating hypertension}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00559: {Female reproductive organs}
- A61B 2018/00577: {Ablation}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- 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

Methods for treating polycystic ovary syndrome with therapeutic ovarian neuromodulation and associated systems and methods are disclosed herein. Polycystic ovary syndrome can be associated, for example, with a condition including at least one of oligo/amenorrhea, infertility, hirsutism, obesity, metabolic syndrome, insulin resistance, and increased cardiovascular risk profile. One aspect of the present technology is directed to methods that at least partially inhibit sympathetic neural activity in nerves proximate an ovarian artery of an ovary of a patient. Sympathetic drive in the patient can thereby be reduced in a manner that treats the patient for the polycystic ovary syndrome. Ovarian sympathetic nerve activity can be modulated along afferent and/or efferent pathways. The modulation can be achieved, for example, using an intravascularly positioned catheter carrying a therapeutic assembly, e.g., a therapeutic assembly configured to use electrically-induced, thermally-induced, and/or chemically-induced approaches to modulate the ovarian nerve.

## Claims

### Claim 1

A method of treating a human patient diagnosed with polycystic ovary syndrome, the method comprising:
intravascularly positioning a neuromodulation assembly within an ovarian blood vessel of the human patient and adjacent to an ovarian nerve of the human patient; and
reducing ovarian sympathetic neural activity in the human patient by delivering energy to the ovarian nerve via the neuromodulation assembly to modulate the ovarian nerve,
wherein reducing the ovarian sympathetic neural activity reduces expansion of, maintains the size of, or reduces the size of an ovarian cyst in the human patient diagnosed with polycystic ovary syndrome.

### Claim 2 (depends on 1)

The method of claim 1 wherein reducing the ovarian sympathetic neural activity in the human patient reduces the size of an ovarian cyst in the human patient at least by about 5% within about three months to about 12 months after reducing the ovarian sympathetic neural activity in the human patient by delivering energy to the ovarian nerve.

### Claim 3 (depends on 1)

The method of claim 1 wherein reducing the sympathetic neural activity in the human patient further reduces a number of ovarian cysts in the human patient at least by about 5% within about three months to about 12 months after reducing the ovarian sympathetic neural activity in the human patient by delivering energy to the ovarian nerve.

### Claim 4 (depends on 1)

The method of claim 1 wherein reducing the ovarian sympathetic neural activity in the human patient further reduces muscle sympathetic nerve activity in the human patient.

### Claim 5 (depends on 1)

The method of claim 1 wherein reducing the ovarian sympathetic neural activity in the human patient further reduces whole body norepinephrine spillover in the human patient.

### Claim 6 (depends on 1)

The method of claim 1 wherein reducing the ovarian sympathetic neural activity in the human patient further reduces ovarian norepinephrine spillover to plasma in the human patient.

### Claim 7 (depends on 1)

The method of claim 1 wherein the polycystic ovary syndrome is associated with a condition including oligo/amenorrhea, and wherein reducing the ovarian sympathetic neural activity in the human patient further causes resumption of menses in the human patient within about three months to about 12 months after reducing the ovarian sympathetic neural activity in the human patient by delivering energy to the ovarian nerve.

### Claim 8 (depends on 1)

The method of claim 1 wherein reducing the ovarian sympathetic neural activity in the human patient by delivering energy to the ovarian nerve comprises at least partially inhibiting afferent neural activity.

### Claim 9 (depends on 1)

The method of claim 1 wherein reducing the ovarian sympathetic neural activity in the human patient by delivering energy to the ovarian nerve comprises at least partially inhibiting efferent neural activity.

### Claim 10 (depends on 1)

The method of claim 1 wherein reducing the ovarian sympathetic neural activity in the human patient by delivering energy to the ovarian nerve comprises modulating the ovarian nerve of the human patient via an intravascularly positioned catheter carrying a neuromodulation assembly positioned at least proximate to the ovarian nerve.

### Claim 11 (depends on 10)

The method of claim 10 wherein modulating the ovarian nerve includes thermally modulating the ovarian nerve from within the ovarian blood vessel of the human patient.

### Claim 12 (depends on 11)

The method of claim 11 wherein thermally modulating the ovarian nerve includes cryotherapeutically cooling the ovarian nerve.

### Claim 13 (depends on 11)

The method of claim 11 wherein thermally modulating the ovarian nerve includes delivering an energy field to the ovarian nerve.

### Claim 14

A method, comprising:
percutaneously introducing a neuromodulation assembly at a distal portion of a treatment device within an ovarian artery proximate to neural fibers innervating an ovary of a human patient diagnosed with polycystic ovary syndrome;
at least partially disrupting function of the neural fibers innervating the ovary by applying thermal energy to the neural fibers innervating the ovary via the neuromodulation assembly; and
removing the neuromodulation assembly from the human patient after treatment,
wherein at least partial disruption of the function of the neural fibers innervating the ovary reduces a number of ovarian cysts in the human patient.

### Claim 15 (depends on 14)

The method of claim 14 wherein at least partial disruption of the function of the neural fibers innervating the ovary further provides an improvement in one or more endocrine hormone levels in the human patient diagnosed with polycystic ovary syndrome.

### Claim 16 (depends on 14)

The method of claim 14 wherein at least partial disruption of the function of the neural fibers innervating the ovary further reduces at least one of lipid levels, blood pressure, acne and hirsutism.

### Claim 17 (depends on 14)

The method of claim 14 wherein the human patient is further diagnosed with infertility, and wherein at least partial disruption of the function of the neural fibers innervating the ovary reverses infertility in the human patient.

### Claim 18 (depends on 15)

The method of claim 15 wherein the improvement in one or more endocrine hormone levels in the human patient includes a reduction in an androgen level in the human patient.

### Claim 19

A method for treating polycystic ovary syndrome in a human patient, the method comprising:
positioning an energy delivery element of an ovarian denervation catheter within an ovarian blood vessel of the human patient and adjacent to post-ganglionic neural fibers that innervate an ovary of the human patient; and
at least partially ablating the post-ganglionic neural fibers innervating the ovary of the human patient via the energy delivery element,
wherein at least partially ablating the post-ganglionic neural fibers innervating the ovary results in a therapeutically beneficial reduction in the expansion of or the size of one or more ovarian cysts in the human patient having polycystic ovary syndrome.

### Claim 20 (depends on 19)

The method of claim 19, further comprising administering one or more pharmaceutical drugs to the human patient, wherein the pharmaceutical drugs are selected from the group consisting of antihypertensive drugs, hormone therapy drugs and anti-diabetic drugs.

### Claim 21 (depends on 19)

The method of claim 19 wherein at least partially ablating the post-ganglionic neural fibers innervating the ovary further reduces a number of ovarian cysts in the human patient.

### Claim 22 (depends on 19)

The method of claim 19 wherein the ovarian denervation catheter is a 3 French or 4 French catheter.
