Irrigation And Aspiration Device And Method

Patent No. US11318234 (titled "Irrigation And Aspiration Device And Method") was filed by Aardvark Medical Inc on Nov 16, 2020.

What is this patent about?

’234 is related to the field of medicine, specifically to devices and methods for nasal and sinus cavity irrigation and aspiration. Nasal congestion is a common problem, often caused by viral illnesses or allergies, leading to rhinitis, congestion, and sinus blockage. Current treatments include over-the-counter and prescription medications, but these can have drawbacks like side effects and variable results. Saline irrigation is an alternative, but existing systems are often inadequate, and manual aspirators lack sufficient airflow and evacuation time.

The underlying idea behind ’234 is to provide a portable, handheld device that can simultaneously irrigate and aspirate nasal and sinus cavities with improved efficiency and control. The device aims to overcome the limitations of existing methods by offering a combination of irrigation and suction in a single, easy-to-use device. A key aspect is the separation of irrigation and aspiration functions, allowing for controlled fluid delivery and removal, potentially incorporating diagnostic capabilities.

The claims of ’234 focus on a portable handheld device with a removable head containing separate irrigant and aspirant reservoirs. The device features a compliant surface for sealing against the nose , and distinct ports and channels for irrigation and aspiration. The claims emphasize the spatial arrangement of these components, particularly the offset and articulation of the irrigation and aspiration channels relative to the body of the device. The claims also cover the ability to fill the irrigant reservoir through a dedicated port.

In practice, the device works by delivering irrigant through one port while simultaneously aspirating fluids through another, using a pump to create suction. The removable head allows for easy refilling of the irrigant reservoir and disposal of aspirated fluids, minimizing the risk of contamination. The articulation of the ports and channels ensures a comfortable and effective seal against the nose, even during movement.

The invention differentiates itself from prior approaches by integrating irrigation and aspiration into a single, portable device with improved control and hygiene. Unlike manual aspirators, it provides consistent suction. Unlike separate irrigation and aspiration systems, it combines both functions for simultaneous use. The removable head and separate reservoirs further enhance hygiene and ease of use, while the potential for integrated diagnostics offers a significant advantage over existing solutions. The tapered shapes of the reservoirs are also a differentiating feature.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2000s when ’234 was filed, nasal and sinus congestion was typically addressed with over-the-counter and prescription medications, at a time when saline irrigation was gaining traction as an alternative. Manual aspirators were available, but hardware or software constraints made it non-trivial to achieve adequate airflow and evacuation time in a user-friendly device. Diagnostic testing of aspirated fluids commonly relied on external lab analysis rather than integrated, point-of-care solutions.

Novelty and Inventive Step

The examiner approved the application because the independent claims were either not found or not suggested in the existing prior art. Independent claim 27 was amended to include the subject matter of now-cancelled claim 28, which was indicated as allowable in the 10/7/2021 Detailed Action. Independent claim 31 has been amended to include the subject matter of now-cancelled claim 44, which was indicated as allowable in the 10/7/2021 Detailed Action. Independent claim 57 was indicated as allowable in the 10/7/2021 Detailed Action.

Claims

This patent contains 28 claims, with independent claims numbered 1, 4, and 24. The independent claims are directed to a portable handheld device for irrigating and aspirating, detailing specific structural and functional relationships between components like the irrigant and aspirant reservoirs, ports, and channels. The dependent claims generally add further detail, limitations, or specific embodiments to the features described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Aspirant port
(Claim 1, Claim 4, Claim 24)
“At least one nozzle may extend from the housing, the nozzle including an irrigant lumen and an aspirant lumen, the irrigant lumen adapted to provide fluid communication between the irrigant reservoir and an irrigant port, the aspirant lumen adapted to provide fluid communication between the aspirant reservoir and an aspirant port.”An opening through which aspirated fluid enters the device from the nasal cavity.
Aspirant reservoir
(Claim 1, Claim 4, Claim 24)
“One aspect of the invention provides a device for delivery and/or removal of a fluid. The device comprises a housing, an irrigant reservoir within the housing, the irrigant reservoir adapted to contain irrigation fluid, and an aspirant reservoir within the housing, the aspirant reservoir adapted to contain aspirated fluid.”A container within the device that collects aspirated fluid removed from the nasal cavity.
Compliant surface engageable with a nose
(Claim 1, Claim 4, Claim 24)
“The invention provides improved devices and methods for providing irrigation and/or aspiration of a body including an opening, an orifice, a cavity, a lumen, a vessel, or a fold.”A surface of the device that is shaped and configured to create a seal when placed against a user's nose.
First irrigant port
(Claim 1, Claim 4, Claim 24)
“At least one nozzle may extend from the housing, the nozzle including an irrigant lumen and an aspirant lumen, the irrigant lumen adapted to provide fluid communication between the irrigant reservoir and an irrigant port, the aspirant lumen adapted to provide fluid communication between the aspirant reservoir and an aspirant port.”An opening through which irrigation fluid exits the device and enters the nasal cavity.
Irrigant reservoir
(Claim 1, Claim 4, Claim 24)
“One aspect of the invention provides a device for delivery and/or removal of a fluid. The device comprises a housing, an irrigant reservoir within the housing, the irrigant reservoir adapted to contain irrigation fluid, and an aspirant reservoir within the housing, the aspirant reservoir adapted to contain aspirated fluid.”A container within the device that holds irrigation fluid to be expelled into the nasal cavity.

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US11318234

AARDVARK MEDICAL INC
Application Number
US17099482
Filing Date
Nov 16, 2020
Status
Granted
Expiry Date
Nov 6, 2027
External Links
Slate, USPTO, Google Patents