Systems comprising an implantable component for treating pulmonary hypertension

• US 9,610,391 B2
• Filed: 01/07/2016
• Issued: 04/04/2017
• 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): Moran, Edward
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/990,627
• Publication Number:
  US 20160114091A1
• Time in Patent Office: 453 Days
• Field of Search: 606191, 606192, 606194, 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:

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 an anchor configured to secure the compliant member within the pulmonary artery;

a sensor configured to generate a signal indicative of a sensed parameter associated with the implantable component, the signal indicative of the sensed parameter configured to be wirelessly transmitted to a wireless device; and

a non-transitory computer readable media having instructions stored thereon, wherein the instructions, when executed by a processor of the wireless device operatively coupled to the sensor, cause a graphical user interface to display information indicative of the sensed parameter associated with the implantable component based on the signal from the sensor.

2. The system of claim 1, further comprising an external clinical controller component configured to be operatively coupled to the implantable component, the external clinical controller component comprising the sensor.

3. The system of claim 1, further comprising an external monitoring component configured to wirelessly activate the sensor to cause the sensor to sense the sensed parameter,

wherein the sensor is configured to transmit the signal indicative of the sensed parameter to the external monitoring component.

4. The system of claim 3, wherein the external monitoring component is configured to transmit the signal to the wireless device.

5. The system of claim 1, wherein the wireless device is configured to run a routine to generate an alert if the sensed parameter is above a first predetermined threshold or below a second predetermined threshold.

6. The system of claim 2, wherein the external clinical controller is configured to display information indicative of the sensed parameter associated with the implantable component based on the signal from the sensor.

7. The system of claim 1, wherein the sensed parameter comprises pressure within the implantable component, temperature within the implantable component, humidity within the implantable component, fluid flow rate within the implantable component, volume of injected fluid from the external clinical controller, volume of extracted fluid from the implantable component, gas concentration within the implantable component, liquid concentration within the implantable component, or pH within the implantable component, or any combination thereof.

8. The system of claim 1, wherein the anchor is coupled to the conduit distal to the compliant member and the anchor has a plurality of petals.

9. The system of claim 1, wherein the graphical user interface is configured to display a waveform showing pressure versus time based on the signal from the sensor.

10. The system of claim 1, wherein the instructions stored on the non-transitory computer readable media are configured to cause the processor to run a routine to calculate pulmonary arterial compliance and to cause the graphical user interface to display the calculated pulmonary arterial compliance.

16. The system of claim 1, wherein the compliant member is configured to be detachable from the anchor in vivo such that the compliant member is configured to be removed while the anchor remains implanted.

17. The system of claim 16, further comprising a replacement compliant member configured to be implanted after the compliant member is removed.

18. The system of claim 16, wherein the conduit is configured to be removed while the anchor remains implanted.

19. The system of claim 18, further comprising a replacement conduit configured to be implanted after the conduit is removed.

20. The system of claim 16, wherein the implantable component further comprises another anchor, wherein the implantable component is configured to be coupled to the anchor by coupling the other anchor to the anchor.

21. The system of claim 20, wherein the anchor comprises first and second protrusions and a groove between the first and second protrusions, and

wherein the other anchor is configured to be deployed within the groove such that the first and second protrusions maintain the other anchor within the groove.

22. The system of claim 16, wherein the anchor is configured to be compressed within a sheath in the contracted state and to expand to the expanded state when exposed from the sheath.

11. 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;

a sensor operatively associated with the implantable component; and

an external monitoring component configured to wirelessly activate the sensor to cause the sensor to sense a parameter associated with the implantable component,

wherein the sensor is configured to transmit a signal indicative of the sensed parameter to the external monitoring component and the external monitoring component is configured to transmit the signal to a wireless device to permit the wireless device to display information indicative of the sensed parameter based on the signal.

12. The system of claim 11, wherein the wireless device is configured to run a routine to generate an alert if the sensed parameter is above a first predetermined threshold or below a second predetermined threshold.

13. The system of claim 11, wherein the external monitoring component comprises a user interface configured to display information indicative of the sensed parameter associated with the implantable component based on the signal from the sensor.

14. The system of claim 11, wherein the implantable component further comprises an anchor configured to secure the compliant member within the pulmonary artery.

15. The system of claim 11, wherein the sensed parameter comprises pressure within the reservoir, humidity 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.