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Publication Number
US-11406803-B2
Publication Date
2022-08-09
Expiration Date
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.
Core Innovation
A pulmonary-artery implantable pressure-reducing system is described that includes a remote reservoir with an injection port, a transvascular conduit, and a compliant body. The compliant body is gas- or fluid-filled such that it compresses during systole and expands during diastole, thereby increasing effective pulmonary vascular compliance while reducing peak pulmonary arterial pressure with minimal change in mean pressure.
The description explains fluid/gas coupling among the reservoir, the conduit, and the compliant body, including an optional use of compressible gas versus non-compressible fluid. Optional active pulsatile pump control is described, including sensors and a CPU for monitoring and controlling pressure/physiology-related signals, and passive operation with remote access is also described.
Implantation and structural embodiments are described, including deployment architectures with anchoring mechanisms, removable/replacement concepts via a persistent anchoring system/introducer, and multi-chamber or multi-lumen compliant body geometries. Anti-thrombogenic and MRI-compatible material concepts are described, including a flexible membrane and coatings and radio-opaque markers.
Claims Coverage
The provided independent claim recites a method for positioning implantable components for treating pulmonary hypertension. The claim has four inventive features spanning deployable anchoring in a pulmonary artery, a removable balloon-conduit assembly over an anchor wire, and a pressure-responsive balloon with fluid routing between the balloon and a reservoir.
Deployable pulmonary artery anchor via retractable sheath
Advancing a distal region of a sheath into a pulmonary artery of a patient, the sheath having an anchor disposed therein, the anchor comprising wire; retracting the sheath to transition the anchor from a contracted, delivery state to an expanded, deployed state such that the anchor contacts an inner wall of the pulmonary artery.
Balloon conduit anchored within pulmonary artery over anchor wire
Advancing a conduit over the wire of the anchor until a balloon coupled to a distal region of the conduit is within the pulmonary artery such that the anchor anchors the balloon within the pulmonary artery.
Pressure-responsive balloon with fluid exchange to and from reservoir
Pressurizing the balloon with a fluid such that the balloon transitions between an expanded state and a contracted state responsive to pressure change in the pulmonary artery, wherein the fluid moves towards a reservoir coupled to the conduit when the balloon transitions to the contracted state and the fluid moves towards the balloon to expand the balloon to the expanded state.
Removable conduit and balloon while anchor remains implanted
Wherein the conduit and the balloon are removable along the wire of the anchor while the anchor remains in the pulmonary artery.
Across the independent claim and its stated refinements, the coverage centers on deploying a wire-based anchor in the pulmonary artery using a retractable sheath, positioning a balloon on a conduit over the anchor wire such that the anchor anchors the balloon, driving balloon expansion and contraction in response to pulmonary artery pressure with fluid moving between the balloon and a reservoir, and enabling removal of the conduit and balloon while maintaining the anchor in place.
Stated Advantages
Reduces peak pulmonary arterial pressure with minimal change in mean pressure.
Increases effective pulmonary vascular compliance.
Documented Applications
Treating pulmonary hypertension via positioning implantable components in a pulmonary artery.
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