System and method for reducing pulsatile pressure

• US 9,333,328 B2
• Filed: 04/15/2014
• Issued: 05/10/2016
• 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): Manahan, Todd E
• Assistant Examiner(s): HERBERMANN, ERICH G.
• Application Number:
  US14/253,127
• Publication Number:
  US 20140228878A1
• Time in Patent Office: 756 Days
• Field of Search: 606192-195, 606/200, 604/509, 604/96.01
• US Class Current: 1/1
• 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. Apparatus for improving compliance of a pulmonary artery for treatment of pulmonary hypertension, the apparatus consisting essentially of:

an inelastic, subcutaneous reservoir having a hollow body;

a conduit having a distal end and a proximal end coupled to the subcutaneous reservoir, the conduit configured to extend through the subclavian vein such that the distal end is implanted distal to a pulmonary valve;

a compliant body coupled to the distal end of the conduit, the compliant body configured for placement in the pulmonary artery distal to the pulmonary valve; and

a compressible fluid disposed in the subcutaneous reservoir, the conduit, and the compliant body, the compressible fluid having a pressure selected such that the compliant body expands during diastole and contracts during systole,

wherein the compliant body further is configured to contract during systole to move the compressible fluid towards the subcutaneous reservoir and to expand during diastole, the expansion and contraction configured to decrease peak pressure in the pulmonary artery and improve compliance of the pulmonary artery, thereby reducing remodeling of the pulmonary artery.

2. The apparatus of claim 1, further comprising an anchoring member coupled to the compliant body, the anchoring member configured to anchor the compliant body in the pulmonary artery.

3. The apparatus of claim 2, wherein the anchoring member is configured to be anchored in the pulmonary artery distal to bifurcation of the pulmonary artery.

4. The apparatus of claim 1, further comprising an injection port attached to the subcutaneous reservoir, the injection port configured to permit fluid filling and pressure adjustments.

5. The apparatus of claim 1, wherein the compliant body comprises a guidewire lumen configured to receive a guidewire therethrough.

6. The apparatus of claim 5, wherein the compliant body is removably coupled to the guidewire.

7. The apparatus of claim 6, wherein the guidewire comprises at least two members at a distal end of the guidewire configured to expand outwardly when passed out of the guidewire lumen and to be pulled proximally to remove the compliant body from the pulmonary artery.

8. 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 and removed through the sheath lumen.

9. The apparatus of claim 8, further comprising an anchoring member coupled to the sheath, the anchoring member configured to anchor the sheath in the pulmonary artery.

10. The apparatus of claim 1, wherein the conduit comprises two lumens extending between the compliant body and the subcutaneous reservoir.

11. The apparatus of claim 10, further comprising a one-way valve disposed in one of the two lumens, the one-way valve configured to permit the compressible fluid to flow to the compliant body through one lumen and return from the compliant body through another lumen.

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

13. The apparatus of claim 1, further comprising a sensor disposed within the subcutaneous reservoir, the sensor configured to monitor at least one of fluid pressure and volume within the subcutaneous reservoir.

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

15. A method for improving compliance of a pulmonary artery for treatment of pulmonary hypertension, the method comprising:

implanting a compliant body in the pulmonary artery distal to a pulmonary valve, a reservoir subcutaneously, and a conduit coupled to the compliant body and the reservoir such that the conduit extends through the subclavian vein;

contracting the compliant body during systole to move a compressible fluid from the compliant body towards the reservoir through the conduit without expanding the reservoir; and

expanding the compliant body during diastole to move the compressible fluid from the reservoir towards the compliant body through the conduit,

wherein the contracting and the expanding are configured to decrease peak pressure in the pulmonary artery and improve compliance of the pulmonary artery, thereby reducing remodeling of the pulmonary artery.

18. The method of claim 15, further comprising filling the reservoir with the compressible fluid and making pressure adjustments via an injection port attached to the reservoir.

19. The method of claim 15, further comprising implanting a sheath, wherein implanting the compliant body and the conduit comprises implanting the compliant body and the conduit through the sheath.

20. The method of claim 19, further comprising removing the compliant body through the sheath using a guidewire comprising at least two members at a distal end of the guidewire, wherein the members are configured to expand outwardly when passed out of a guidewire lumen in the compliant body and to be pulled proximally to remove the compliant body from the pulmonary artery.

16. A method for improving compliance of a pulmonary artery for treatment of pulmonary hypertension, the method comprising:

implanting a compliant body in the pulmonary artery distal to a pulmonary valve, an inelastic reservoir subcutaneously, and a conduit coupled to the compliant body and the reservoir such that the conduit extends through the subclavian vein;

contracting the compliant body during systole to move a compressible fluid from the compliant body towards the reservoir through the conduit without expanding the reservoir; and

expanding the compliant body during diastole to move the compressible fluid from the reservoir towards the compliant body through the conduit, wherein the compressible fluid has a pressure selected such that the compliant body expands during diastole and contracts during systole, wherein the contracting and the expanding are configured to decrease peak pressure in the pulmonary artery and improve compliance of the pulmonary artery, thereby reducing remodeling of the pulmonary artery.

17. The method of claim 16, wherein implanting the compliant body and the conduit comprises implanting the compliant body and the conduit through a sheath, and wherein the anchoring member is configured to expand when passed out of the sheath.