Intravascular membrane oxygenator catheter with oscillating hollow fiber membranes
Inventors
Straube, Tobias • Farling, Stewart • Klitzman, Bruce • Deshusses, Marc • Vesel, Travis • Cheifetz, Ira
Assignees
Publication Number
US-12329955-B2
Publication Date
2025-06-17
Expiration Date
2042-10-10
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Abstract
The present disclosure describes intravascular oxygenation systems and methods with one or more of improved oxygen diffusion flux, improved resistance to bubble formation on the surface of non-porous hollow fibers, and reduced size. The systems and methods include a pneumatic inlet coupled to a pneumatic source that provides a gas containing oxygen at a high pressure. A plurality of hollow fiber membranes (HFM) are in pneumatic communication with the pneumatic inlet to receive the gas containing oxygen and with an outlet to exhaust a partially deoxygenated gas. An electronic controller drives the motor to oscillate the plurality of HFMs to cause a diffusive flux of the gas containing oxygen from the plurality of HFMs into a region of interest of a subject. The electronic controller may drive the motor according to an oscillation pattern, which may include a macro-oscillation with superimposed micro-oscillations.
Core Innovation
The invention provides intravascular oxygenation systems and methods that use high-pressure oxygen-containing gas delivered to hollow fiber membranes (HFMs) inside a catheter, which is sized for intravascular use. A pneumatic inlet supplies the high-pressure gas to the HFMs, which are constructed as nonporous membranes permitting only diffusion, not convection, of oxygen into a region of interest of a subject.
A key aspect of the system is the oscillation of the HFMs, which is controlled by an electronic controller that drives a motor to cause oscillatory motion—either angular or rotational—of the HFMs inside the catheter. This oscillation increases diffusive oxygen flux from the HFM surfaces into the patient’s blood, enhancing oxygen transfer compared to static fibers. The oscillations can include a combination of macro-oscillations and superimposed micro-oscillations to further improve efficiency and reduce bubble formation at higher operating pressures.
The problem addressed is the need for effective, compact, and accessible alternatives to extracorporeal membrane oxygenation (ECMO), which requires complex and bulky devices with limited hospital availability and significant morbidity risks. Previous intravascular devices were unsuccessful due to size constraints and limited oxygen transfer. This invention overcomes these challenges by leveraging hyperbaric pressure and HFM oscillation to achieve high transfer efficiencies with reduced device size, making intravascular oxygenation feasible and more broadly deployable.
Claims Coverage
There are two primary independent inventive features claimed: an intravascular gas exchange system with integrated high-pressure HFM modules and active vacuum safety control, and a corresponding method for intravascular gas exchange with electronic detection and control.
Intravascular gas exchange system with high-pressure hollow fiber membranes and vacuum safety
The system includes: - A pneumatic inlet configured to couple to a pneumatic source that provides gas at or above 1.1 bar absolute pressure. - A plurality of hollow fiber membranes (HFMs) that receive the gas and provide a diffusive flux to a region of interest in a subject at an average intraluminal pressure at or above 1.1 bar absolute pressure. - A vacuum system pneumatically coupled to the HFMs. - An electronic controller coupled to the vacuum system, configured to control the vacuum system to de-pressurize the HFMs in response to detecting that a pressure change in the HFMs has exceeded a threshold.
Method for intravascular gas exchange using electronic detection and active pressure control
The method includes: 1. Receiving, by a pneumatic inlet coupled to a pneumatic source, gas at a pressure at or above 1.1 bar absolute pressure. 2. Delivering this gas, via a plurality of HFMs in pneumatic communication with the inlet, maintaining average intraluminal pressure at or above 1.1 bar absolute pressure. 3. Detecting, via an electronic controller, that a pressure change value in the HFMs has exceeded a threshold. 4. Controlling, by the electronic controller, a vacuum system to de-pressurize the HFMs in response to this detected threshold event.
These inventive features define an intravascular gas exchange system and method integrating high-pressure diffusive oxygenation with active safety control through an electronic monitoring and vacuum system.
Stated Advantages
Improved oxygen diffusion flux and transfer efficiency, enabling clinically significant intravascular oxygen delivery.
Enhanced resistance to bubble formation on nonporous hollow fibers, allowing safe operation at higher hyperbaric pressures.
Reduction in the required surface area and size of the gas diffusing membrane bundle, making the device more compact and suitable for intravascular use.
Enables precise titration and control of oxygen delivery based on continuous monitoring and clinician input.
Vacuum safety system prevents venous gas emboli by actively de-pressurizing fibers in the event of a detected leak or pressure drop.
The oscillation technique reduces the formation of blood boundary layers, increases convective mixing, and disrupts developing bubbles, further improving biocompatibility.
Documented Applications
Intravascular oxygenation for patients with acute or chronic lung disease, particularly those experiencing severe respiratory failure when mechanical ventilation is inadequate.
Use as an adjunct or alternative to mechanical ventilation and extracorporeal membrane oxygenation (ECMO), including in environments where ECMO is unavailable or impractical.
Insertion into central veins, such as the inferior vena cava or right atrium, for bedside intravascular deployment in both pediatric and adult patients.
Potential placement in arterial vessels (e.g., aorta) or non-vascular sites such as intrathecal, intraperitoneal, or subcutaneous locations.
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