# US 10,369,333 B2 · Methods and apparatus to increase secretion of endogenous naturetic hormones

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- Number: US 10,369,333 B2
- Document ID: US10369333B2
- Status: Granted
- Kind: B2
- Application number: 15/613,344
- Filed: 2017-06-05
- Published: 2017-09-28
- Granted: 2019-08-06
- Earliest claimed: 2005-03-02
- Assignees: BackBeat Medical, Inc.
- Applicants: BackBeat Medical, Inc.
- Inventors: Howard Levin; Mark Gelfand
- Web page: https://patentgrep.com/patent/US10369333B2

## CPC

- A61M 25/10181: {Means for forcing inflation fluid into the balloon}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 25/1018: {Balloon inflating or inflation-control devices}
- A61M 25/10184: {Means for controlling or monitoring inflation or deflation}
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61N 1/36117: {for treating hypertension}
- A61N 1/3627: {for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy}
- A61N 1/368: comprising more than one electrode co-operating with different heart regions {(A61N1/3622, A61N1/3627 take precedence)}
- A61N 1/37235: {Aspects of the external programmer}
- A61M 2025/102: {driven by a solenoid-activated pump}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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 and apparatus for treatment of heart failure by increasing secretion of endogenous naturetic hormones ANP and BNP such as by stimulation of the heart atria. Heart pacing is done at an atrial contraction rate that is increased and can be higher than the ventricular contraction rate. Pacing may include mechanical distension of the right atrial appendage. An implantable device is used to periodically cyclically stretch the walls of the appendage with an implanted balloon.

## Claims

### Claim 1

A method for treating a patient comprising:
determining that the patient is suffering from a condition comprising one or more of hypertension, excessive fluid retention, or excessive sodium retention;
treating the condition by stressing a wall of at least one atrium of a heart of the patient beyond a natural stress condition of the wall, such that the stressed wall secretes a hormone at an elevated level above a natural secretion level occurring naturally when the wall of the at least one atrium is not stressed by the stressing,
wherein stressing the wall of the at least one atrium of the heart comprises stretching the at least one atrium; and
achieving a beneficial therapeutic effect in the patient by the hormone secreted at the elevated level, wherein the beneficial therapeutic effect includes a reduction in blood pressure,
wherein stretching the at least one atrium comprises expanding and contracting an expandable device implanted in an atrial appendage of the heart, and
wherein expanding and contracting the expandable device comprises using an implanted pump connected to the expandable device to bidirectionally shuttle fluid in a closed system between the expandable device and the implanted pump.

### Claim 2 (depends on 1)

The method of claim 1, wherein stretching the at least one atrium comprises expanding the expandable device implanted in the atrial appendage of the heart to temporarily stretch the wall of the at least one atrium.

### Claim 3 (depends on 1)

The method of claim 1, wherein the expandable device comprises an inflatable balloon.

### Claim 4 (depends on 1)

The method of claim 1, further comprising anchoring the expandable device to an apex of a right atrial appendage of the heart.

### Claim 5 (depends on 1)

The method of claim 1, wherein stressing the wall of the at least one atrium of the heart comprises stretching the wall and then restoring the wall to a substantially pre-stretched condition.

### Claim 6 (depends on 1)

The method of claim 1, wherein stressing the wall of the at least one atrium comprises mechanical distension of a right atrial appendage of the heart.

### Claim 7 (depends on 1)

The method of claim 1, wherein the beneficial therapeutic effect includes one or more of: limiting a degree of vasoconstriction, limiting a degree of sodium retention, increasing urine output, inhibiting a renin-angiotensin system, inhibiting endothelin secretion, inhibiting systemic and renal sympathetic activity, or counteracting effects of at least one of norepinephrine, endothelin, and angiotensin II.

### Claim 8 (depends on 1)

The method of claim 1, wherein stretching the at least one atrium comprises expanding a volume of the at least one atrium.

### Claim 9 (depends on 1)

The method of claim 1, wherein stretching the at least one atrium comprises a cycle of expanding a volume of the at least one atrium for a plurality of minutes followed by a plurality of minutes of rest.

### Claim 10 (depends on 9)

The method of claim 9, wherein stressing the wall of the at least one atrium of the heart further comprises repeating the cycle for a plurality of hours a plurality of times a day.

### Claim 11 (depends on 1)

The method of claim 1, wherein stressing the wall of the at least one atrium of the heart comprises cyclically stretching and contracting the at least one atrium.

### Claim 12 (depends on 1)

The method of claim 1, wherein stressing the wall of the at least one atrium of the heart comprises periodically stretching the at least one atrium.

### Claim 13 (depends on 12)

The method of claim 12, further comprising adjusting one or more parameters of the periodic stretching.

### Claim 14 (depends on 13)

The method of claim 13, wherein the one or more parameters comprise at least one of expansion volume, duty cycle of expansion, frequency of expansion, number of sessions, or time of sessions.

### Claim 15 (depends on 12)

The method of claim 12, wherein periodically stressing the wall of the at least one atrium of the heart comprises stretching the at least one atrium for one or more heartbeats followed by one or more heartbeats of rest.

### Claim 16 (depends on 13)

The method of claim 13, wherein adjusting the one or more parameters comprises remotely adjusting the one or more parameters.
