Systems and methods for treating pulmonary hypertension

• US 9,242,082 B2
• Filed: 05/12/2015
• Issued: 01/26/2016
• 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): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/710,180
• Publication Number:
  US 20150367113A1
• Time in Patent Office: 259 Days
• Field of Search: 606/191, 606/192, 606/194
• US Class Current: 1/1
• 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 pulmonary artery anchor (PA anchor) adapted to be implanted within a pulmonary artery; and

an implantable component comprising a compliant member coupled to a reservoir via a conduit, the compliant member adapted to be implanted within the pulmonary artery and the reservoir adapted to be implanted subcutaneously, the implantable component further comprising an implantable component anchor,

wherein the PA anchor is adapted to be implanted prior to deployment of the implantable component anchor and the implantable component anchor is configured to be coupled to the PA anchor.

2. The system of claim 1, wherein the PA anchor comprises first and second protrusions and a groove between the first and second protrusions.

3. The system of claim 2, wherein the implantable component anchor is configured to be deployed within the groove such that the first and second protrusions maintain the implantable component anchor within the groove.

4. The system of claim 2, wherein the first and second protrusions have an annular shape.

5. The system of claim 1, wherein the PA anchor is configured to expand from a contracted state to an expanded state.

6. The system of claim 5, wherein the PA 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.

7. The system of claim 5, wherein the PA anchor is configured to expand to the expanded state responsive to expansion of the compliant member.

8. The system of claim 1, wherein the implantable component anchor comprises one or more arms coupled to the conduit and configured to expand to couple the implantable component to the PA anchor.

9. The system of claim 8, wherein the one or more arms are wire-like.

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

11. The system of claim 1, wherein the implantable component anchor is configured to be delivered in a contracted state within a sheath and configured to expand when exposed from the sheath to couple to the PA anchor.

12. The system of claim 8, wherein the one or more arms are configured to radially expand when the conduit is rotated in a first direction and to radially contract when the conduit is rotated in a second direction, opposite the first direction.

13. The system of claim 3, wherein the first and second protrusions and the implantable component anchor are radiopaque to permit visualization during delivery.

14. A method for implanting a system for treating pulmonary hypertension, the method comprising:

implanting a pulmonary artery anchor (PA anchor) within a pulmonary artery;

after implanting the PA anchor, delivering a compliant member and an implantable component anchor of an implantable component to the pulmonary artery, the implantable component further comprising a reservoir adapted to be coupled to the compliant member via a conduit;

coupling the implantable component anchor to the PA anchor such that the compliant member is disposed within the pulmonary artery; and

subcutaneously implanting the reservoir.

15. The method of claim 14, wherein the PA anchor comprises first and second protrusions and a groove between the first and second protrusions, and wherein coupling the implantable component anchor to the PA anchor comprises deploying the implantable component anchor within the groove such that the first and second protrusions maintain the implantable component anchor within the groove.

16. The method of claim 15, wherein the first and second protrusions and the implantable component anchor are radiopaque, and wherein coupling the implantable component anchor to the PA anchor further comprises visualizing the first and second protrusions and the implantable component anchor.

17. The method of claim 14, wherein implanting the PA anchor comprises delivering the PA anchor within a sheath in a contracted state and expanding the PA anchor to an expanded state when exposed from the sheath in the pulmonary artery.

18. The method of claim 14, wherein delivering the compliant member and the implantable component anchor comprises delivering the implantable component anchor in a contracted state within a sheath, and wherein coupling the implantable component anchor to the PA anchor comprises expanding the implantable component anchor to an expanded state when exposed from the sheath.

19. The method of claim 14, wherein coupling the implantable component anchor to the PA anchor comprises rotating the conduit in a first direction to radially expand the implantable component anchor within the PA anchor.

20. The method of claim 19, further comprising rotating the conduit in a second direction, opposite the first direction, to radially contract the implantable component anchor;

and

removing the compliant member and the conduit from the pulmonary artery.