Insertion system for deploying a ventilation device
Inventors
Loushin, Michael K. H. • Leland, Keith J. • Goudreau, Paul M. • Smith, Andrew N.
Assignees
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Publication Number
US-10695224-B2
Publication Date
2020-06-30
Expiration Date
Abstract
An insertion system includes a handle assembly and a nose assembly removably attached to the handle assembly and including an insertion end. The handle assembly includes a main body, a nose interface and an actuating element. The nose assembly includes a nose, a positioning rod extending from the nose to a distal end, a cutting sheath surrounding a distal end of the positioning rod and including a cutting edge, an actuation member having a proximal end coupled to the actuating element when the nose assembly is attached to the handle assembly and a distal end attached to the cutting sheath, a ventilation tube positioned distal to the distal end of the positioning rod and proximal to the insertion end. The cutting sheath retracts from around the ventilation tube and along the positioning rod when the actuating element on the handle assembly is moved.
Core Innovation
The invention relates to an insertion system and an insertion method for maintaining an opening in a membrane of a body. The method obtains an insertion device with a handle assembly and a nose assembly, advances an insertion end so that a cutting sheath cutting edge pierces the membrane, and positions a ventilation element loaded in the cutting sheath across the membrane. The ventilation element is maintained across the membrane while the cutting sheath is retracted and then the insertion end is removed from the body.
A key aspect of the device is that the nose assembly is removably coupled to a nose interface of the handle assembly and the actuation member is removably coupled to a user operated actuating element. The entire nose assembly is rotatably adjusted relative to the nose interface to provide a user line of sight to the insertion end and, in lockable positions, user adjusted and lockable visualization to the insertion end before insertion. The nose assembly includes a positioning rod and a cutting sheath surrounding a distal end of the positioning rod, with the ventilation element loaded distal to the distal end of the positioning rod and proximal to the insertion end.
During use, the method retracts the cutting sheath from around the ventilation element by moving a user operated actuating element on the handle assembly from a first position to a second position. The cutting sheath retracts along the positioning rod to thereby leave the ventilation element across the membrane. In additional embodiments, a positioning rod includes a slot extending through a thickness of a wall of the positioning rod and a flexible actuation member extends inside the positioning rod through the slot, transitions from inside to outside the positioning rod, and pulls to retract the cutting sheath while leaving the ventilation element across the membrane.
The disclosed embodiments also include visualization features intended to provide placement assurance when positioning the ventilation element across the membrane. A visualization tab extends through a slot in the cutting sheath, and the visualization tab is configured to protrude from the ventilation element while the ventilation element is located across the membrane. The nose assembly can be set to multiple lockable positions by engaging a tab on the nose with one of a plurality of detents in a recessed area, enabling user line of sight prior to insertion.
Claims Coverage
The document provides three independent method claims. Across these independent claims, the inventive coverage centers on advancing a cutting sheath to pierce a membrane and position a ventilation element across the membrane, then retracting the cutting sheath to leave the ventilation element spanning the membrane, with additional structural and visualization features such as a rotatably adjustable lockable nose assembly and visualization tab/slot arrangements, plus a flexible actuation member mechanism in certain embodiments.
Rotatably adjustable removably coupled nose assembly for visualization
Obtaining an insertion device comprising a handle assembly having a nose interface and a user operated actuating element; a nose assembly having a nose, an insertion end and an actuation member, wherein the nose is removably coupled to the nose interface and the actuation member is removably coupled to the actuating element; and rotatably adjusting the entire nose assembly relative to the nose interface to provide a user line of sight to the insertion end.
Advance to pierce membrane and position ventilation element across membrane
Advancing the insertion end so that a cutting edge of a cutting sheath pierces the membrane and a ventilation element loaded in the cutting sheath is located across the membrane, the nose assembly including a positioning rod extending from the nose to the insertion end, the cutting sheath surrounding a distal end of the positioning rod, the actuation member extending from the nose to a distal end attached to the cutting sheath, and the ventilation element located distal to the distal end of the positioning rod and proximal to the insertion end.
Retract cutting sheath along positioning rod to leave ventilation element across membrane
Moving the actuating element on the handle assembly from a first position to a second position to retract the cutting sheath from around the ventilation element and along the positioning rod to thereby leave the ventilation element across the membrane; and removing the insertion end from the body.
Slot-through positioning rod with flexible actuation member for retraction
Providing an insertion end including a positioning rod having a distal portion with a slot extending entirely through a thickness of a wall of the positioning rod and for a length along the positioning rod; the cutting sheath surrounding the distal portion of the positioning rod and at least a portion of the slot; and a flexible actuation member extending inside the positioning rod, through the slot, and having a distal end attached to the cutting sheath so that when the flexible actuation member transitions from inside the positioning rod to outside the positioning rod the distal end of the flexible actuation member is located internal to the cutting sheath and the ventilation element is located distal to the distal portion of the positioning rod.
Pull flexible actuation member to retract cutting sheath and remove insertion end
Retracting the cutting sheath from around the ventilation element and thereby leaving the ventilation element across the membrane by pulling on the flexible actuation element that has the distal end attached to the cutting sheath; and removing the insertion end including the cutting sheath from the body.
Lockable visualization positions via tab and detents on nose
Obtaining an insertion device comprising a handle assembly having a nose interface; a nose assembly having an insertion end and being coupled to the nose interface and rotatably adjustable relative to the nose interface in a plurality of lockable positions so as to provide user adjusted and lockable visualization to the insertion end before insertion; wherein the plurality of lockable positions are obtained by engaging a tab on the nose with one of a plurality of detents in a recessed area.
Pierce membrane and locate ventilation element loaded inside cutting sheath across membrane
Advancing the insertion end into the body so that piercing the membrane with the cutting edge of the cutting sheath places a ventilation element that is loaded inside the cutting sheath and distal to the distal end of the positioning rod across the membrane.
Retract cutting sheath along positioning rod by actuating element movement
Retracting the cutting sheath from around the ventilation element and along the positioning rod by moving an actuating element located on the handle assembly and coupled to the actuation member from a first position to a second position.
Overall, the independent claims cover a method to pierce a body membrane with a cutting sheath, position a ventilation element across the membrane, and retract the cutting sheath to leave the ventilation element spanning the membrane. The claims further emphasize rotatably adjustable and lockable nose assembly visualization features, including detent-based positioning, and, in another independent embodiment, a positioning-rod slot with a flexible actuation member mechanism to retract the cutting sheath by pulling.
Stated Advantages
provides a user line of sight to the insertion end
provides user adjusted and lockable visualization to the insertion end before insertion
leaves the ventilation element across the membrane after retracting the cutting sheath
helps maintain the ventilation element across the membrane while the cutting sheath is retracted
Documented Applications
Maintaining an opening in a membrane of a body (including positioning a middle ear ventilation tube through a tympanic membrane, as described in the provided content).
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