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Publication Number
US-11510564-B2
Publication Date
2022-11-29
Expiration Date
Abstract
A seeker device for facilitating access to a desired location within an ear, nose, throat or other location in a body may include a proximal shaft, an elastic distal portion, and an atraumatic distal tip. The elastic distal portion has a default shape with at least one curve to facilitate advancement of a distal end of the elastic distal portion through various anatomical passageways, toward the desired location. In some embodiments, the seeker device may be paired with a dilator device, to perform a dilation procedure on an anatomical structure in the ear, nose, throat or other part of the body. In other embodiments, the seeker device may be paired with a flexible endoscope, to facilitate visualization of an anatomical structure or area.
Core Innovation
The invention describes a medical otolaryngology seeker device that transitions between a constrained configuration for navigating tight anatomy and a default curved configuration for directing an atraumatic distal tip into a target. The seeker includes an elastic distal portion whose shape change facilitates advancement into a target while directing an atraumatic tip, and example targets include paranasal sinus ostia and the Eustachian tube. The medical system uses the seeker as a guiding structure for an over-the-seeker flexible dilation member.
The system pairs the seeker with a dilator device that includes a flexible distal portion comprising a balloon. The balloon is sufficiently flexible to assume the shape of the distal portion of the seeker device when the flexible distal portion is located over the distal portion of the seeker, and the balloon remains positioned without advancing or retracting over the seeker. The arrangement is described as simplifying one-physician dilation.
The invention further describes an inflation device and associated mechanical and safety features for balloon inflation management. The inflation device includes a syringe with pressure-related structures such as a plunger with an excess pressure indicator and a pressure release valve, and an automatic deflation spring coupled to the plunger to cause automatic deflation if the plunger is released from constraint. Mechanical excess-pressure indicators are described with embodiments using a rod and cap hole or pins and multiple apertures, and an inflation holder/kit is described for controlled saline fill, with optional components including a sheath and a flexible endoscope for visualization.
Claims Coverage
The partial content provides three independent claims for dilating a paranasal sinus ostium, with additional independent claim content directed to the same ostium dilation system. Across the independent claims, the inventive coverage centers on a curved seeker that guides advancement into a paranasal sinus ostium, an over-the-seeker flexible balloon dilator that assumes the seeker curvature, and a one-handed syringe-based inflation arrangement with an excess pressure indicator and automatic deflation features.
Curved seeker for paranasal sinus ostium advancement
A seeker device having a proximal shaft and a distal portion, wherein the distal portion has a shape with at least one curve configured to facilitate advancement of a distal end of the distal portion into the paranasal sinus ostium.
Over-the-seeker flexible balloon dilator conforming to seeker curvature
A dilator device comprising a proximal portion having an inner lumen configured for passage of the seeker, and a flexible distal portion comprising a balloon, wherein the inner lumen extends through the balloon, and wherein the flexible distal portion is sufficiently flexible to assume the shape of the distal portion of the seeker device when the flexible distal portion is located over the distal portion of the seeker device.
One-hand operation with syringe inflation advancing inflation substance with the same hand
An inflation device attached to the handle, wherein the inflation device comprises a syringe with a plunger, wherein the inflation device is configured to allow a user to hold the handle with one hand and advance the inflation substance out of the inflation device to inflate the balloon with the same hand.
Automatic deflation and holder to avoid unwanted deflation
A syringe with a plunger with an excess pressure indicator; and an automatic deflation spring coupled with the plunger to cause the dilation member to automatically deflate if the plunger is released from constraint; wherein a holder removably attached to the inflation device holds the plunger in a stable position relative to the barrel to avoid unwanted deflation of the dilation member.
Excess pressure indicator using cap hole, spring, and rod contacting a user's finger
A plunger comprising a shaft with an inner cavity, and an excess pressure indicator comprising a cap on a proximal end of the plunger and having a hole; a spring disposed within the inner cavity and contacting the cap; and a rod in the inner cavity, within the spring and extending into the hole in the cap, wherein when excess pressure builds up in the barrel of the syringe, the spring compresses and the rod extends through the hole in the cap to contact a user's thumb or other finger used to depress the plunger.
Excess pressure indicator using cap with multiple apertures, spring platform, and multiple pins contacting a user's finger
A plunger comprising a shaft with an inner cavity, and an excess pressure indicator comprising a cap on a proximal end of the plunger and having multiple apertures; a spring disposed within the inner cavity; a platform attached to a proximal end of the spring; and multiple pins attached to the platform and extending into the multiple apertures in the cap, wherein when excess pressure builds up in the barrel of the syringe, the spring compresses and the multiple pins extend through the multiple apertures in the cap to contact a user's thumb or other finger used to depress the plunger.
Across the independent claims, the covered inventive theme is a paranasal sinus ostium dilation system using a curved seeker to guide distal advancement, an over-the-seeker flexible balloon dilator whose inner lumen extends through the balloon so it assumes the seeker’s distal shape, and a one-handed syringe inflation approach. The claims further distinguish inflation safety and indication by requiring an excess pressure indicator with specific mechanical structures and, in one independent claim, an automatic deflation spring with a holder to avoid unwanted deflation.
Stated Advantages
Simplifies one-physician dilation.
Enables one-handed operation, where a user can hold the handle with one hand and advance the inflation substance to inflate the balloon with the same hand.
Avoids unwanted deflation of the dilation member by holding the plunger in a stable position relative to the syringe barrel.
Allows balloon inflation management with an excess pressure indicator and automatic deflation if the plunger is released from constraint.
Includes a pressure release valve to prevent over-inflation.
Documented Applications
Dilating a paranasal sinus ostium in a patient, including guidance into paranasal sinus ostia and dilation using the seeker-shaped over-the-seeker balloon.
Targeting an Eustachian tube using the seeker device shape change as an example target.
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