# US 11,992,636 B2 · Systems and methods for treating pulmonary hypertension

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- Number: US 11,992,636 B2
- Document ID: US11992636B2
- Status: Granted
- Kind: B2
- Application number: 18/058,255
- Filed: 2022-11-22
- Published: 2023-03-23
- Granted: 2024-05-28
- Earliest claimed: 2014-06-19
- Assignees: Aria CV, Inc.
- Applicants: Aria CV, Inc.
- Inventors: Karl Vollmers; John Scandurra
- Web page: https://patentgrep.com/patent/US11992636B2

## 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:
a balloon sized and shaped to be implanted in a pulmonary artery, the balloon configured to expand and contract responsive to pressure changes in the pulmonary artery;
a reservoir in fluidic communication with the balloon;
a conduit fluidicly coupling the balloon and the reservoir; and
an implantable anchor configured to transition between a contracted state and an expanded deployed state for securing the balloon within the pulmonary artery, the implantable anchor formed from a shape memory material and configured to self-expand upon deployment within the pulmonary artery, the implantable anchor configured to removably engage a distal region of the conduit to thereby secure the conduit to the implantable anchor,
wherein the conduit is configured to disengage from the implantable anchor in vivo upon a rotational movement at the distal region of the conduit.

### Claim 2 (depends on 1)

The system of claim 1, wherein the reservoir is adapted to be implanted subcutaneously.

### Claim 3 (depends on 1)

The system of claim 1, wherein the implantable anchor is configured to remain implanted upon removal of the conduit and the balloon.

### Claim 4 (depends on 1)

The system of claim 1, wherein the implantable anchor is coupled to the conduit distal to the balloon.

### Claim 5 (depends on 1)

The system of claim 1, wherein the shape memory material is nitinol.

### Claim 6 (depends on 1)

The system of claim 1, further comprising an external clinical controller comprising a fluidic connector configured to be coupled to the reservoir for introduction of fluid into the reservoir.

### Claim 7 (depends on 1)

The system of claim 1, wherein the implantable anchor comprises a groove sized and shaped to removably engage the distal region of the conduit to thereby secure the conduit to the implantable anchor.

### Claim 8 (depends on 7)

The system of claim 7, wherein the implantable anchor comprises one or more protrusions configured to secure the distal region of the conduit within the groove of the implantable anchor.

### Claim 9 (depends on 7)

The system of claim 7, wherein the distal region of the conduit comprises an implantable component anchor configured to transition between a contracted delivery state and an expanded deployed state within the groove of the implantable anchor to thereby secure the conduit to the implantable anchor.

### Claim 10 (depends on 9)

The system of claim 9, wherein the distal region of the conduit is configured to be rotated in a first direction to transition the implantable component anchor from the contracted delivery state to the expanded deployed state, and in a second direction opposite to the first direction to transition the implantable component anchor from the expanded deployed state to the contracted delivery state to thereby disengage the conduit from the implantable anchor.

### Claim 11 (depends on 1)

The system of claim 1, wherein an outer surface of the implantable anchor is configured to contact an inner wall of the pulmonary artery in the expanded deployed state.

### Claim 12 (depends on 6)

The system of claim 6, wherein the fluid introduced by the external clinical controller is selected to reduce diffusion through the balloon.

### Claim 13 (depends on 1)

The system of claim 1, further comprising an external clinical controller comprising a sensor configured to generate a parameter signal indicative of a parameter of the system.

### Claim 14 (depends on 13)

The system of claim 13, wherein the parameter comprises pressure within the reservoir, temperature within the reservoir, humidity within the reservoir, fluid flow rate within the reservoir, fluid diffusion rate, amount of extracted fluid from the reservoir, fluid concentration within the reservoir, or pH within the reservoir, or any combination thereof.

### Claim 15 (depends on 13)

The system of claim 13, further comprising software configured to run on a computer operatively coupled to the sensor, the software configured to cause a graphical user interface to display information indicative of the parameter based on the parameter signal.

### Claim 16

A method for implanting a system for treating pulmonary hypertension, the method comprising:
delivering an implantable anchor to a pulmonary artery, the implantable anchor configured to removably engage a distal region of a conduit, the conduit fluidicly coupling a balloon sized and shaped to be implanted in the pulmonary artery and a reservoir; and
deploying the implantable anchor within the pulmonary artery such that the implantable anchor self-expands from a contracted state to an expanded deployed state wherein an outer surface of the implantable anchor contacts an inner wall of the pulmonary artery for securing the balloon within the pulmonary artery, the balloon configured to expand and contract responsive to pressure changes in the pulmonary artery to treat pulmonary hypertension,
wherein the conduit is configured to disengage from the implantable anchor in vivo upon a rotational movement at the distal region of the conduit.

### Claim 17 (depends on 16)

The method of claim 16, wherein the implantable anchor is coupled to the conduit distal to the balloon.

### Claim 18 (depends on 16)

The method of claim 16, further comprising applying the rotational movement at the distal region of the conduit to disengage the conduit from the implantable anchor in vivo.

### Claim 19 (depends on 18)

The method of claim 18, further comprising removing the conduit and the balloon from the pulmonary artery while the implantable anchor remains implanted.

### Claim 20 (depends on 6)

The method of claim 6, wherein the implantable anchor comprises:
a groove sized and shaped to removably engage the distal region of the conduit; and
one or more protrusions configured to secure the distal region of the conduit within the groove of the implantable anchor.
