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US-20260124436-A1 - SYSTEMS AND METHODS FOR TREATING PULMONARY HYPERTENSION

US20260124436A1US 20260124436 A1US20260124436 A1US 20260124436A1US-20260124436-A1

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.

Inventors

  • Karl Vollmers
  • John Scandurra

Assignees

  • ARIA CV, INC.

Dates

Publication Date
20260507
Application Date
20260105

Claims (20)

  1. 1 . A system comprising: a balloon sized and shaped to be implanted in a blood vessel; a reservoir configured to hold a fluid; a conduit configured to fluidically couple the balloon and the reservoir such that the fluid flows from the reservoir towards the balloon via the conduit to expand the balloon and flows from the balloon towards the reservoir via the conduit to contract the balloon, the balloon configured to, when expanded, reduce volume for blood flow within the blood vessel; a getter positioned within the reservoir, the getter configured to extract portions of the fluid within the reservoir; and an anchor configured to be implanted in the blood vessel in an expanded deployed state to secure the balloon within the blood vessel.
  2. 2 . The system of claim 1 , wherein the balloon is sized and shaped to be implanted in a pulmonary artery, such that the balloon expands and contracts responsive to pressure changes in the pulmonary artery to treat pulmonary hypertension.
  3. 3 . The system of claim 1 , wherein the reservoir is configured to be implanted subcutaneously.
  4. 4 . The system of claim 1 , wherein the fluid comprises at least one of carbon dioxide, oxygen, nitrogen, or water.
  5. 5 . The system of claim 1 , wherein the fluid is configured to flow between the balloon and the reservoir via the conduit in a closed-loop manner responsive to pressure changes in the blood vessel.
  6. 6 . The system of claim 1 , wherein the fluid is selected to reduce diffusion through the balloon.
  7. 7 . The system of claim 1 , wherein a distal region of the conduit is configured to be removably coupled to the anchor.
  8. 8 . The system of claim 7 , wherein the distal region of the conduit is configured to disengage from the anchor in vivo.
  9. 9 . The system of claim 1 , wherein, when the fluid comprises a gas, the getter is configured to absorb liquid within the reservoir.
  10. 10 . The system of claim 1 , wherein the getter is configured to absorb moisture within the reservoir.
  11. 11 . The system of claim 1 , wherein the getter is configured to be removable from the reservoir.
  12. 12 . The system of claim 1 , wherein the anchor is formed from a shape memory material and configured to self-expand upon deployment within the blood vessel.
  13. 13 . The system of claim 1 , further comprising: a sensor configured to generate a signal indicative of a sensed parameter associated with the balloon; and an external monitoring component operatively coupled to the sensor, the external monitoring component configured to receive the signal to permit a user to monitor the sensed parameter.
  14. 14 . The system of claim 13 , wherein the external monitoring component is configured to: determine if the sensed parameter is above or below a predetermined threshold; and generate an alert if the sensed parameter is above or below the predetermined threshold.
  15. 15 . The system of claim 13 , wherein the sensed 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.
  16. 16 . The system of claim 13 , wherein the external monitoring component comprises a graphical user interface configured to display information indicative of the sensed parameter based on the signal.
  17. 17 . 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.
  18. 18 . A method comprising: advancing a balloon within a blood vessel, the balloon fluidically coupled to a conduit; implanting an anchor within the blood vessel in an expanded deployed state to secure the balloon within the blood vessel; fluidically coupling the balloon to a reservoir via the conduit, such that fluid within the reservoir flows from the reservoir towards the balloon via the conduit to expand the balloon and flows from the balloon towards the reservoir via the conduit to contract the balloon; and extracting portions of the fluid within the reservoir via a getter positioned within the reservoir, wherein the balloon, when expanded, reduces volume for blood flow within the blood vessel.
  19. 19 . The method of claim 18 , wherein advancing the balloon within the blood vessel comprises advancing the balloon within a pulmonary artery, such that the balloon expands and contracts responsive to pressure changes in the pulmonary artery to treat pulmonary hypertension.
  20. 20 . The method of claim 18 , wherein the fluid flows between the balloon and the reservoir via the conduit in a closed-loop manner responsive to pressure changes in the blood vessel.

Description

I. CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 18/668,835, filed May 20, 2024, now U.S. Pat. No. 12,515,023, which is a continuation of U.S. patent application Ser. No. 18/058,255, filed Nov. 22, 2022, now U.S. Pat. No. 11,992,636, which is a continuation of U.S. patent application Ser. No. 16/900,794, filed Jun. 12, 2020, now U.S. Pat. No. 11,511,089, which is a continuation of U.S. patent application Ser. No. 15/785,304, filed Oct. 16, 2017, now U.S. Pat. No. 10,682,448, which is a continuation of U.S. patent application Ser. No. 15/474,902, filed Mar. 30, 2017, now U.S. Pat. No. 9,801,989, which is a continuation of U.S. patent application Ser. No. 14/990,627, filed Jan. 7, 2016, now U.S. Pat. No. 9,610,391, which is a continuation of U.S. patent application Ser. No. 14/710,180, filed May 12, 2015, now U.S. Pat. No. 9,242,082, which is a continuation of U.S. patent application Ser. No. 14/531,846, filed Nov. 3, 2014, now U.S. Pat. No. 9,039,725, which is a continuation of U.S. patent application Ser. No. 14/309,758, filed Jun. 19, 2014, now U.S. Pat. No. 8,876,850, the entire contents of each of which are incorporated herein by reference. II. FIELD OF THE INVENTION This application generally relates to systems and methods for treating pulmonary hypertension, including implantable devices for reducing pulsatile load in the pulmonary artery and external devices for monitoring the implantable devices. III. BACKGROUND OF THE INVENTION Pulmonary hypertension (PH) is defined as a rise in mean pressure in the main pulmonary artery. PH may arise from many different causes, but, in all patients, has been shown to increase mortality rate. A deadly form of PH arises in the very small branches of the pulmonary arteries and is known as Pulmonary Arterial Hypertension (PAH). In PAH, the cells inside the small arteries multiply due to injury or disease, decreasing the area inside of the artery and thickening the arterial wall. As a result, these small pulmonary arteries narrow and stiffen, causing blood flow to become restricted and upstream pressures to rise. This increase in pressure in the main pulmonary artery is the common connection between all forms of PH regardless of underlying cause. PH causes the larger pulmonary arteries to stretch and stiffen. As a stroke volume of blood is delivered to the main pulmonary artery, the artery is already stretched and will not further expand. The lack of expansion causes a much larger rise in pressure with each heartbeat (called systolic or peak pressure) than would occur in a healthy, compliant vessel that could stretch to accommodate the stroke volume. In between heart beats, the arteries in a diseased patient do not contract as they normally would and diastolic pressure and flow through the lungs drops causing a reduction in cardiac output. The heart has to work harder to push the same stroke volume of blood into the stiff artery at a higher pressure. At the same time, the high pulse pressure travels down the pulmonary arteries to the small vessels and activates molecular signaling pathways causing the cells to multiply more rapidly, accelerating disease progression. As the pressure within the pulmonary artery increases, the right side of the heart enlarges and thickens to compensate, but eventually reaches the point where it cannot continue to pump enough blood through the lungs to satisfy the body's need for oxygenated blood. This progressive reduction of blood flow is first noticed as shortness of breath when exercising. Over time, the right ventricular remodeling worsens and patients lose the ability to maintain a normal daily level of activity and enter end stage heart failure where the right ventricle dilates and loses effectiveness reducing blood flow even further. At the end stage, the patient mortality rate is high. Current treatment protocols for PH and Primary PH include administration of pharmaceuticals. However, such pharmaceuticals are extremely expensive and not sufficiently effective. Previously known implantable systems having a balloon, conduit, and reservoir have been described. However, such systems suffer from a number of drawbacks for use in treating pulmonary hypertension including the inability to effectively and efficiently monitor operation of the system after implantation. It would therefore be desirable to provide systems and methods for treating heart disease, such as pulmonary hypertension and right heart failure, where the implantable components may be monitored externally. IV. SUMMARY OF THE INVENTION The present disclosure overcomes the drawbacks of previously-known systems by providing systems and methods for treating heart disease, e.g., pulmonary hypertension or right heart failure. The system includes an implantable component and external components for monitoring the implantable component. The implantable component may include a compliant member, e.g., balloon, coupled