Systems and methods for treating pulmonary hypertension

• US 9,801,989 B2
• Filed: 03/30/2017
• Issued: 10/31/2017
• Est. Priority Date: 06/19/2014
• Status: Active Grant

• Current Assignee: Aria CV, Inc.
• Original Assignee: Aria CV, Inc.
• Inventors: Vollmers, Karl, Scandurra, John
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US15/474,902
• Publication Number:
  US 20170203020A1
• Time in Patent Office: 215 Days
• Field of Search: 606194, 606191, 606192, 604 66, 60428801
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3327 Measuring
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3515 using magnetic means
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 39/0208 : Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: A61M 60/135 : inside a blood vessel, e.g. using grafting
• CPC Class Codes: A61M 60/295 : Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/515 : Regulation using real-time patient data
• CPC Class Codes: A61M 60/523 : using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/538 : Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/585 : User interfaces
• CPC Class Codes: A61M 60/869 : Compliance chambers containing a gas or liquid other than blood to compensate volume variations of a blood chamber

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

1. A system for treating pulmonary hypertension, the system comprising:

a compliant member sized and shaped to be implanted in a pulmonary artery, the compliant member configured to expand and contract responsive to pressure changes in the pulmonary artery;

a reservoir in fluidic communication with the compliant member;

a conduit extending between and coupling the compliant member and the reservoir;

an external clinical controller comprising a fluidic connector configured to be coupled to the reservoir for introduction of fluid into the reservoir; and

a sensor associated with the external clinical controller, the sensor configured to generate a signal indicative of an amount of the fluid introduced from the external clinical controller.

2. The system of claim 1, wherein the external clinical controller further comprises a fluid source configured to hold the fluid to be introduced into the reservoir through the fluidic connector when the fluidic connector is in fluidic communication with the reservoir.

3. The system of claim 2, wherein the external clinical controller further comprises a fluid movement mechanism configured to move the fluid from the fluid source through the fluidic connector or to extract fluid from the reservoir through the fluidic connector or both.

4. The system of claim 3, wherein the fluid movement mechanism is a pump.

5. The system of claim 2, wherein the fluid in the fluid source is pressurized, wherein a lumen of the fluidic connector includes a valve, and wherein actuation of an actuator opens the valve such that fluid moves from the fluid source through the fluidic connector.

6. The system of claim 1, wherein the external clinical controller is configured to display information indicative of the amount of the fluid introduced from the external clinical controller based on the signal from the sensor.

7. The system of claim 1, wherein the fluidic connector comprises a needle adapted to be inserted transcutaneously into a septum of the reservoir to achieve fluidic communication with the reservoir.

8. The system of claim 1, wherein the sensor or another sensor of the external clinical controller is configured to generate a parameter signal indicative of a parameter, and wherein a non-transitory computer readable media is configured to cause a graphical user interface to display information indicative of the parameter based on the parameter signal.

9. The system of claim 8, wherein the parameter comprises pressure within the reservoir, temperature within the reservoir, humidity within the reservoir, fluid flow rate within the reservoir, amount of extracted fluid from the reservoir, gas concentration within the reservoir, liquid concentration within the reservoir, or pH within the reservoir, or any combination thereof.

10. The system of claim 1, wherein the compliant member is a balloon having a tapered shape configured to reduce billowing of the balloon.

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

12. The system of claim 11, wherein the implantable anchor is coupled to the conduit distal to the compliant member and the implantable anchor has a plurality of petals.

13. The system of claim 11, wherein the compliant member is configured to be detachable from at least a portion of the implantable anchor in vivo such that the compliant member is replaceable while at least the portion of the implantable anchor remains implanted.

14. The system of claim 1, wherein the fluid introduced by the external clinical controller comprises nitrogen or carbon dioxide.

15. The system of claim 1, further comprising a non-transitory computer readable media configured to run on a computer operatively coupled to the sensor, the non-transitory computer readable media configured to cause a graphical user interface to display information indicative of the amount of the fluid introduced from the external clinical controller based on the signal from the sensor.

16. The system of claim 1, further comprising an external monitoring component configured to wirelessly activate an implantable sensor associated with the compliant body or the reservoir or both.

17. A method for managing fluid introduction in a system for treating pulmonary hypertension, the method comprising:

coupling a fluidic connector of an external clinical controller to a reservoir coupled via a conduit to a compliant member sized and shaped to be implanted in a pulmonary artery, the compliant member configured to expand and contract responsive to pressure changes in the pulmonary artery;

introducing fluid from the external clinical controller via the fluidic connector to the reservoir; and

sensing an amount of the fluid introduced from the external clinical controller via a sensor of the external clinical controller.

18. The method of claim 17, further comprising displaying information indicative of the amount of the fluid introduced from the external clinical controller based on a signal from the sensor.

19. The method of claim 17, wherein coupling the fluidic connector of the external clinical controller to the reservoir comprises transcutaneously inserting the fluidic connector into a septum of the reservoir to achieve fluidic communication with the reservoir.

20. The method of claim 17, wherein introducing the fluid comprises injecting the fluid held in a fluid source of the external clinical controller.