Apparatus and method of providing high frequency variable pressure to a patient

Patent No. US6581596 (titled "Apparatus and method of providing high frequency variable pressure to a patient") on Sep 20, 2000. The application was issued on Jun 24, 2003.

What is this patent about?

’596 is related to the field of respiratory therapy and pulmonary hygiene, specifically focusing on devices that assist patients in clearing mucus and other secretions from their airways. Many patients with weakened respiratory systems lack the expiratory force required to cough effectively, leading to dangerous fluid buildup. While existing solutions like manual flutter valves or large mechanical blowers exist, they are often position-sensitive, bulky, or entirely dependent on the patient’s own breathing strength to function.

The underlying idea behind ’596 is to decouple the generation of airway pressure oscillations from the patient's physical effort by using an electromechanically actuated valve. By employing an independent power source and control circuit to drive a valve between open and restricted states, the device creates high-frequency pressure spikes that loosen secretions regardless of how weakly the patient breathes. This shift from a passive, flow-dependent mechanism to an active, motorized oscillation allows for consistent therapy across a wide range of patient capabilities and device orientations.

The claims of ’596 focus on a patient circuit defining a closed path between a gas source and the airway, featuring a valve assembly that transitions between a substantially unobstructed flow state and a flow-restricted state. Central to the claimed invention is an actuating system—such as a solenoid-style electromagnetic coil or a rotary motor—that drives these transitions at a predetermined frequency. The claims emphasize that this oscillation occurs independently of the patient's inspiratory or expiratory effort, ensuring the therapeutic pressure spikes are maintained at a controlled rate.

In practice, the invention can be implemented using a reciprocating sleeve valve driven by a voice coil and permanent magnet, or a rotary valve spun by a variable-speed motor. As the valve cycles, it rapidly interrupts the air stream, creating mechanical vibrations within the lungs that thin and mobilize mucus. The device further integrates a control interface allowing clinicians or users to tune the oscillation frequency, typically between 1 and 25 Hz, to find the specific resonance that best clears the patient's unique bronchial obstructions.

This approach differs from prior art by eliminating the requirement for high expiratory flow rates, which previously excluded the most vulnerable patients from using portable clearance aids. Unlike gravity-dependent ball-check valves, the active valve timing ensures the device works in any physical position, including for bedridden patients. Furthermore, by incorporating integrated flow sensors, the device differentiates itself by doubling as a diagnostic spirometer, allowing for the simultaneous monitoring of pulmonary function and the delivery of secretion clearance therapy in a single handheld unit.

How does this patent fit in bigger picture?

Technical Landscape

In the late 1990s when ’596 was filed, airway clearance therapy was typically implemented using mechanical flutter valves or large-scale pneumatic oscillation systems. At a time when portable secretion clearance commonly relied on gravity-dependent ball valves, the generation of pressure oscillations was often restricted by the patient's own expiratory force and the physical orientation of the device. When hardware constraints made the integration of diagnostic and therapeutic functions non-trivial, pulmonary monitoring and airway oscillation were generally treated as distinct clinical procedures requiring separate, specialized equipment. Consequently, existing portable solutions were often ineffective for patients with weakened respiratory muscles who could not maintain the threshold flow rates necessary to trigger mechanical valve oscillations.

Prosecution Position

The disclosed invention represents a technical advancement through the integration of an active, motorized valve assembly within a patient circuit that operates independently of the patient’s respiratory effort. By utilizing an actuating system to drive a valve between open and restricted positions at a predetermined frequency, the architecture overcomes the technical constraint of requiring a minimum expiratory flow to initiate pressure spikes. This structural shift enables high-frequency oscillation therapy for patients with severe respiratory weakness while eliminating the orientation sensitivity inherent in gravity-based systems. Furthermore, the integration of a flow sensor and a mode selection switch enables a dual-function capability, allowing the device to transition between a therapeutic secretion clearance mode and a diagnostic spirometry mode within a single pneumatic path.

Claims

The patent contains a total of 0 claims, with no independent claims identified to establish the scope of the invention. Consequently, there are no independent claims to define a specific technological focus, and no dependent claims exist to provide additional limitations or specific embodiments of the underlying disclosure.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Actuating system
(Claim 1)
An actuating system alternatively places the valve in the open position and the closed position at a predetermined oscillation rate and does so independent of patient effort. This allows the device to be used by patients with very weak respiratory systems who have very low expiratory flow rates.A mechanical or electronic mechanism that drives the movement of a valve between open and closed states at a set frequency without relying on the patient's breathing force.
High frequency pressure oscillation device
(Claim 1)
The device provides high frequency variable pressures to an airway of a patient in which a valve generates pressure oscillations independent of patient effort. Alternatively opening and closing the path between the patient's airway and the source of breathing gas while the patient inhales or exhales generates pressure spikes that facilitate loosening and removal of accumulated secretions.An apparatus designed to generate rapid pressure spikes or variations within a patient's airway to facilitate the loosening and removal of accumulated secretions, such as mucus.
Independent of patient effort
(Claim 1, Claim 11)
The valve generates the pressure oscillations in the delivery of gas to or from the patient independent of patient effort. This overcomes disadvantages of conventional flutter valves where the patient's own expiratory force is used to move the valve.A functional characteristic where the generation of pressure oscillations is controlled by the device's internal mechanism rather than the patient's own inhalation or exhalation strength.
Patient circuit
(Claim 1, Claim 11)
The patient circuit defines a closed path between a source of breathing gas and the airway of a patient. It includes a valve operable to control the flow of gas in the path.A conduit or assembly that establishes a closed fluid pathway for gas to travel between a source of breathing gas and the patient's respiratory system.
Predetermined oscillation rate
(Claim 1, Claim 11)
The actuating system alternatively places the valve in the open position and the closed position at a predetermined oscillation rate. This process repeats as the patient inhales or exhales to generate a series of pressure spikes.A specific, set frequency at which the valve cycles between obstructing and clearing the gas path to create pressure pulses.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
3:25-cv-01074Sep 12, 2025Hyper Ice, Inc. v. Namirsa, Inc.

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US6581596

Application Number
US09665280A
Filing Date
Sep 20, 2000
Publication Date
Jun 24, 2003
External Links
Slate, USPTO , Google Patents