System and method for reducing pulsatile pressure

• US 10,350,397 B2
• Filed: 12/01/2015
• Issued: 07/16/2019
• Est. Priority Date: 11/22/2010
• Status: Active Grant

• Current Assignee: Aria CV, Inc.
• Original Assignee: Aria CV, Inc.
• Inventors: Scandurra, John, Vollmers, Karl
• Primary Examiner(s): Erezo, Darwin P
• Assistant Examiner(s): Herbermann, Erich
• Application Number:
  US14/956,127
• Publication Number:
  US 20160082170A1
• Time in Patent Office: 1,323 Days
• Field of Search: 606192-195, 606200, 604509, 604 9601, 600 17
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 60/122 Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
• CPC Class Codes: A61M 60/135 inside a blood vessel, e.g. using grafting
• CPC Class Codes: A61M 60/17 inside a ventricle, e.g. intraventricular balloon pumps
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/40 Details relating to driving
• CPC Class Codes: A61M 60/405 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/50 Details relating to control
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/562 for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• 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 device for reducing pressure within a lumen includes a reservoir structured for holding a fluid therein, an injection port in fluid communication with the reservoir, a compliant body structured to expand and contract upon changes in pressure, and a conduit extending between and fluidly coupling the reservoir and the compliant body. The fluid may be a compressible or a noncompressible fluid.

Claims

1. An apparatus for improving compliance of a pulmonary artery, the apparatus comprising:

a subcutaneously implantable reservoir configured to hold a fluid;

a conduit having first and second implantable ends, the first implantable end configured to be coupled to the subcutaneously implantable reservoir to provide fluidic communication between the subcutaneously implantable reservoir and the conduit;

a compliant body configured to be fully implantable, the compliant body coupled to the second implantable end of the conduit to provide fluidic communication between the compliant body and the conduit, the compliant body sized and shaped to be implanted in the pulmonary artery;

a fluid disposed in the subcutaneously implantable reservoir, conduit, and compliant body, the fluid pressurized so that the compliant body transitions between an expanded state, caused by diastolic pressure in the pulmonary artery, and a contracted state, caused by systolic pressure in the pulmonary artery; and

a fully implantable anchoring system configured to anchor the compliant body within the pulmonary artery, the anchoring system comprising wire that engages an inner wall of the pulmonary artery and remains anchored, allowing the complaint body to be periodically removed and replaced.

2. The apparatus of claim 1, further comprising an injection port coupled to the subcutaneously implantable reservoir, the injection port configured to permit fluid filling and pressure adjustments.

3. The apparatus of claim 2, wherein the injection port is mounted directly on the subcutaneously implantable reservoir.

4. The apparatus of claim 1, wherein the anchoring system is configured to be anchored in the pulmonary artery distal to bifurcation of the pulmonary artery.

5. The apparatus of claim 1, wherein the wire is removably coupled to the compliant body.

6. The apparatus of claim 1, wherein the wire is configured to be inserted through a lumen in the conduit.

7. The apparatus of claim 1, wherein the wire comprises at least two members at a distal end of the wire configured to expand outwardly when passed out of a lumen of the conduit distal to the distal end of the compliant body.

8. The apparatus of claim 1, wherein the conduit is configured to be pulled proximally to remove the compliant body from the pulmonary artery.

9. The apparatus of claim 1, further comprising a sheath having a sheath lumen therethrough, the compliant body and the conduit configured to be introduced through the sheath lumen.

10. The apparatus of claim 9, wherein the sheath is configured to be anchored and implanted.

11. The apparatus of claim 10, wherein the compliant body and the conduit are configured to be removable and replaceable through the sheath lumen.

12. The apparatus of claim 1, wherein the conduit is configured to be anchored in a right ventricle, proximate a pulmonary valve, in a valve annulus, or in a wall of the pulmonary artery.

13. The apparatus of claim 1, wherein the conduit comprises two lumens extending between the compliant body and the subcutaneously implantable reservoir, further comprising a one-way valve disposed in one of the two lumens, the one-way valve configured to permit the fluid to flow to the compliant body through one lumen and return from the compliant body through another lumen.

14. The apparatus of claim 1, wherein the fluid is compressible.

15. The apparatus of claim 1, wherein the fluid comprises a gas.

16. The apparatus of claim 1, further comprising a sensor configured to monitor at least one of fluid pressure or volume.

17. The apparatus of claim 16, wherein the sensor is disposed within the subcutaneously implantable reservoir.

18. The apparatus of claim 1, wherein the compliant body comprises a material configured to reduce diffusion of the fluid from the compliant body.