Stabilization system and aspiration device with rapid diagnostics
Inventors
Loushin, Michael K. H. • Leland, Keith J.
Assignees
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Publication Number
US-8979868-B2
Publication Date
2015-03-17
Expiration Date
Abstract
A device performs a myringotomy and includes a main body oriented along a central axis. The main body includes an attachment hub for receiving components that provide suction. A hollow positioning member extends at least partially along the central axis, is coupled to the main body and includes a distal end. A cutting edge is located at the distal end of the hollow positioning member and is configured to pierce a tympanic membrane of a body. A sampling chamber is coupled to the main body for collecting at least a portion of the fluid located behind the tympanic membrane of the body using the components that provide suction at the attachment hub. A diagnostic indicator is housed in the sampling chamber and includes a visible indication of a test outcome when exposed to the fluid collected in the sampling chamber.
Core Innovation
The invention relates to an aspiration device and related stabilization systems for performing a myringotomy to access fluid located behind the tympanic membrane. A suction system is provided via an attachment hub that receives components providing suction to aspirate middle-ear fluid during the procedure. The device includes a hollow positioning member with a distal cutting edge that pierces the tympanic membrane while collecting a portion of the fluid behind the tympanic membrane into a sampling chamber using the suction.
Collected fluid is transported into the sampling chamber and exposed to a diagnostic element housed in the sampling chamber. The diagnostic element is indicative of a test outcome when exposed to the fluid collected in the sampling chamber, including visual indication, including visible color change and/or a diagnostic indicator with a visible outcome. Removable or separable sampling chambers are described for separating collected fluid for further diagnostic analysis.
The device further includes stabilization and positioning features intended to support controlled incision safety and aspiration. Penetration depth may be indicated using a visual indicator, and the device may include optional visualization aids. In some embodiments, the hollow positioning member and/or positioning structure may integrate a passageway for optional drug delivery to the ear canal and the tympanic membrane, and the device may include a rotatable nosepiece adjustable to orient the hollow positioning member in more than one direction relative to the central axis.
Claims Coverage
The partial content includes three independent claims: a device claim for a myringotomy with suction aspiration into a sampling chamber and a diagnostic element, a method claim for performing the myringotomy with aspiration and viewing the diagnostic element, and a further device claim that adds a rotatable adjustable nosepiece with a differently oriented hollow positioning member and a diagnostic element.
Suction-aspirated sampling chamber with diagnostic element for myringotomy
A device for performing a myringotomy with a main body having an attachment hub that provides suction; a hollow positioning member coupled to the main body extending at least partially along a central axis; a cutting edge at a distal end of the hollow positioning member configured to pierce a tympanic membrane; a sampling chamber coupled to the main body for collecting fluid located behind the tympanic membrane using the provided suction; and a diagnostic element housed in the sampling chamber indicative of a test outcome when exposed to the fluid collected in the sampling chamber.
Manually performed suction myringotomy with viewing diagnostic element
A method of performing a myringotomy comprising obtaining a device including a main body, a hollow positioning member and a cutting edge located at a distal end of the positioning member; manually inserting the hollow positioning member and the cutting edge into an ear canal of a patient and advancing them together to pierce a tympanic membrane; applying suction to aspirate fluid from behind the tympanic membrane and transporting the fluid through the hollow positioning member and an internal passageway in the main body into a sampling chamber coupled to the main body; manually extracting the hollow positioning member and the cutting edge from the ear canal using the handle; and viewing a diagnostic element housed in the sampling chamber indicative of a test outcome when exposed to the fluid collected in the sampling chamber.
Rotatable adjustable nosepiece oriented hollow positioning for suction diagnostic myringotomy
A device for performing a myringotomy with a main body providing suction via an attachment hub; a rotatable assembly coupled to a distal end of the main body including a rotatable nosepiece extending along the central axis; a hollow positioning member fixed to the nosepiece and extending at least partially along the axis and partially along an axis different from the central axis; a cutting edge at a distal end of the hollow positioning member configured to pierce a tympanic membrane; a sampling chamber coupled to the main body for collecting fluid located behind the tympanic membrane using suction; and a diagnostic element housed in the sampling chamber indicative of a test outcome when exposed to collected fluid; wherein the rotatable nosepiece is adjustable such that the hollow positioning member can be oriented in more than one direction relative to the central axis.
Across the independent claims, the core inventive coverage is directed to myringotomy devices and methods that aspirate fluid behind the tympanic membrane into a sampling chamber using suction and then expose a housed diagnostic element to generate and view a test outcome; one independent device claim further specifies a rotatable, adjustable nosepiece that orients the hollow positioning member relative to the central axis.
Stated Advantages
Documented Applications
Performing a myringotomy to access and aspirate fluid located behind a tympanic membrane.
Performing suction aspiration of middle-ear fluid followed by rapid in-situ diagnostics using a sampling chamber containing a diagnostic element indicative of a test outcome when exposed to collected fluid.
Using the diagnostic element housed in the sampling chamber to view a diagnostic test outcome exposed to the fluid collected in the sampling chamber.
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