# US 9,039,725 B1 · Systems and methods for treating pulmonary hypertension

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- Number: US 9,039,725 B1
- Document ID: US9039725B1
- Status: Granted
- Kind: B1
- Application number: 14/531,846
- Filed: 2014-11-03
- Granted: 2015-05-26
- Earliest claimed: 2014-06-19
- Assignees: Aria CV, Inc.
- Applicants: Aria Cv, Inc.
- Inventors: Karl Vollmers; John Scandurra
- Web page: https://patentgrep.com/patent/US9039725B1

## CPC

- A61M 25/104: {used for angioplasty}
- A61B 17/12036: {partial occlusion}
- A61B 17/1204: {temporary occlusion}
- A61B 17/12136: {Balloons}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61M 25/0662: {Guide tubes}
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61M 60/135: inside a blood vessel, e.g. using grafting
- A61M 60/295: Balloon pumps for circulatory assistance
- A61M 60/515: Regulation using real-time patient data
- A61M 60/523: using blood flow data, e.g. from blood flow transducers
- A61M 60/538: Regulation using real-time blood pump operational parameter data, e.g. motor current
- A61M 60/585: User interfaces
- A61M 60/869: Compliance chambers containing a gas or liquid other than blood to compensate volume variations of a blood chamber
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00212: {using remote controls}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2205/04: implanted
- A61M 2205/18: with alarm
- A61M 2205/3324: PH measuring means
- A61M 2205/3327: Measuring
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/3389: Continuous level detection (A61M2205/3393 takes precedence)
- A61M 2205/3515: using magnetic means
- A61M 2205/3523: using telemetric means
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2210/12: Blood circulatory system
- A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

## Claims

### Claim 1

A system for treating pulmonary hypertension, the system comprising:
an implantable component comprising a compliant member coupled to a reservoir via a conduit, the compliant member adapted to be implanted in a pulmonary artery and the reservoir adapted to be implanted subcutaneously, the implantable component further comprising a sensor disposed within the reservoir; and
an external monitoring component configured to wirelessly activate the sensor to cause the sensor to sense humidity within the implantable component,
wherein the sensor is configured to transmit a signal indicative of the sensed humidity to the external monitoring component.

### Claim 2 (depends on 1)

The system of claim 1, wherein the external monitoring component is configured to transmit the signal to a mobile device, the mobile device configured to display information indicative of humidity within the implantable component based on the signal.

### Claim 3 (depends on 2)

The system of claim 2, wherein the mobile device is configured to run a routine to generate an alert if the sensed humidity is above a first predetermined threshold or below a second predetermined threshold.

### Claim 4 (depends on 1)

The system of claim 1, wherein the external monitoring component comprises an inductive coil.

### Claim 5 (depends on 4)

The system of claim 4, wherein the inductive coil is configured to transmit power to the sensor.

### Claim 6 (depends on 1)

The system of claim 1, wherein the external monitoring component comprises a radio frequency (RF) transceiver.

### Claim 7 (depends on 6)

The system of claim 6, wherein the RF transceiver is configured to transmit power to the sensor.

### Claim 8 (depends on 1)

The system of claim 1, wherein the external monitoring component comprises a user interface.

### Claim 9 (depends on 8)

The system of claim 8, wherein the user interface is configured to display information indicative of humidity within the implantable component based on the signal.

### Claim 10 (depends on 1)

The system of claim 1, wherein the sensor is further configured to sense pressure within the reservoir, volume within the reservoir, temperature within the reservoir, fluid flow rate within the reservoir, fluid concentration within the reservoir, or pH within the reservoir, or any combination thereof.

### Claim 11 (depends on 1)

The system of claim 1, further comprising an additional sensor disposed within the reservoir, the additional sensor configured to sense pressure within the reservoir, volume within the reservoir, temperature within the reservoir, fluid flow rate within the reservoir, fluid concentration within the reservoir, or pH within the reservoir, or any combination thereof.

### Claim 12 (depends on 1)

The system of claim 1, wherein the compliant member has a tapered shape configured to reduce billowing of the compliant member.

### Claim 13 (depends on 1)

The system of claim 1, wherein the implantable component further comprises an anchor, the anchor configured to secure the compliant member within the pulmonary artery.

### Claim 14 (depends on 13)

The system of claim 13, wherein the anchor is coupled to the conduit distal to the compliant member and the anchor has a plurality of petals.

### Claim 15 (depends on 13)

The system of claim 13, wherein the compliant member is configured to be detachable from at least a portion of the anchor in vivo such that the compliant member is replaceable while at least the portion of the anchor remains implanted.

### Claim 16 (depends on 13)

The system of claim 13, wherein the anchor is configured to be delivered in a contracted state within a sheath and to expand to a deployed state when exposed from the sheath.

### Claim 17

A method for treating pulmonary hypertension, the method comprising:
providing an implantable component comprising a compliant member, a reservoir, and a conduit, the compliant member adapted to be disposed in a pulmonary artery, the reservoir adapted to be disposed subcutaneously, and the conduit adapted to be coupled between the compliant member and the reservoir;
providing an external monitoring component;
wirelessly activating a sensor disposed within the reservoir via the external monitoring component to cause the sensor to sense humidity within the implantable component; and
transmitting a signal indicative of the sensed humidity from the sensor to the external monitoring component.

### Claim 18 (depends on 17)

The method of claim 17, further comprising transmitting the signal from the external monitoring component to a mobile device, the mobile device configured to display information indicative of humidity within the implantable component based on the signal.

### Claim 19 (depends on 18)

The method of claim 18, further comprising generating an alert if the sensed humidity is above a first predetermined threshold or below a second predetermined threshold.

### Claim 20 (depends on 17)

The method of claim 17, further comprising displaying information indicative of the sensed humidity on a user interface of the external monitoring component.
