Diffusion and infusion resistant implantable devices for reducing pulsatile pressure
Inventors
Vollmers, Karl • Zwiers, Lynn • Gainor, John • Scandurra, John
Assignees
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Publication Number
US-11141581-B2
Publication Date
2021-10-12
Expiration Date
Abstract
Diffusion and infusion resistant implantable devices and methods for reducing pulsatile pressure are provided. The implantable device includes a balloon implantable within a blood vessel of a patient, e.g., the pulmonary artery. The balloon is injected with a fluid mixture comprising a constituent fluid(s) and a diffusion-resistant gas to provide optimal balloon volume and limit fluid diffusion throughout multiple cardiac cycles. The fluid mixture may be pressurized such that the balloon is transitionable between an expanded state and a collapsed state responsive to pressure fluctuations in the blood vessel.
Core Innovation
The disclosed invention relates to implantable balloon systems for reducing pulsatile pressure in a blood vessel. The system includes a fluid mixture held pressurized inside an implanted balloon, where the balloon transitions between an expanded state and a collapsed state responsive to pressure fluctuations in the blood vessel.
The fluid mixture comprises one or more constituent fluids and a diffusion-resistant fluid configured to maintain the desired volume and pressure within the balloon throughout multiple cardiac cycles. The diffusion-resistant fluid resists diffusion of fluids across a balloon membrane, and the constituent fluids are pressurized within the balloon to match their respective partial pressure in the blood surrounding the balloon within the blood vessel to reduce permeation of fluids across the balloon.
The document further specifies that the diffusion-resistant fluid and the constituent fluids are pressurized such that the balloon is transitionable between expanded and collapsed states responsive to pressure fluctuations. Candidate diffusion-resistant fluids include sulfur hexafluoride and perfluorinated compounds, and the system architecture includes a balloon/compliant body, a conduit, and a reservoir for holding and transferring the fluid mixture, including configurations for accessing the reservoir and refill.
Claims Coverage
The partial content provides three independent claims. Across these claims, the coverage centers on an implantable blood-vessel balloon filled with a fluid mixture that includes a diffusion-resistant fluid, where constituent fluids are pressurized to match surrounding partial pressures to reduce permeation over multiple cardiac cycles while the balloon expands and collapses with blood-vessel pressure fluctuations.
Pressurized balloon fluid mixture for pulsatile pressure reduction
A balloon configured to be implanted in a blood vessel and to hold a fluid mixture pressurized such that the balloon transitions between an expanded state and a collapsed state responsive to pressure fluctuations in the blood vessel; the fluid mixture comprising one or more constituent fluids and a diffusion-resistant fluid configured to maintain a desired volume and pressure within the balloon throughout multiple cardiac cycles; wherein each constituent fluid is pressurized within the balloon to match its respective partial pressure in the blood surrounding the balloon within the blood vessel to reduce permeation of fluids across the balloon throughout multiple cardiac cycles.
Implanted balloon with sulfur hexafluoride diffusion-resistant fluid fraction
A balloon configured to be implanted within a blood vessel; a fluid mixture comprising one or more constituent fluids mixed with sulfur hexafluoride; wherein the sulfur hexafluoride makes up between 8-25% of the fluid mixture; wherein each constituent fluid is pressurized within the balloon to match its respective partial pressure in the blood surrounding the balloon within the blood vessel to reduce permeation of fluids across the balloon throughout multiple cardiac cycles.
Introducing diffusion-resistant fluid and constituent fluids to reach known partial-pressure state
A method for introducing fluids into an implantable system comprising implanting a balloon within a blood vessel of a patient; introducing a diffusion-resistant fluid into the balloon; introducing one or more constituent fluids into the balloon in an amount to reach a known state; and introducing an additional amount of the one or more constituent fluids into the balloon; wherein each constituent fluid is pressurized within the balloon to match its respective partial pressure in the blood surrounding the balloon within the blood vessel to reduce permeation of fluids across the balloon throughout multiple cardiac cycles; and wherein the diffusion-resistant fluid and the one or more constituent fluids within the balloon are pressurized such that the balloon is transitionable between an expanded state and a collapsed state responsive to pressure fluctuations in the blood vessel.
Across the independent claims, the inventive coverage is directed to an implantable balloon in a blood vessel containing a pressurized fluid mixture with a diffusion-resistant fluid, where constituent fluids are pressurized to match surrounding partial pressures to reduce permeation over multiple cardiac cycles, and where pressurization enables the balloon to transition between expanded and collapsed states responsive to pressure fluctuations. One independent claim additionally constrains the diffusion-resistant fluid as sulfur hexafluoride present at 8-25% of the mixture, and another independent claim covers a specific introducing sequence to reach a known state before introducing additional constituent-fluid amounts.
Stated Advantages
Reduces pulsatile pressure in a blood vessel.
Maintains a desired volume and pressure within the balloon throughout multiple cardiac cycles.
Reduces permeation of fluids across the balloon throughout multiple cardiac cycles by matching constituent-fluid partial pressures to partial pressures in surrounding blood.
Documented Applications
Reducing pulsatile pressure in a blood vessel, including systems discussed in the context of pulmonary hypertension.
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