Tray for a soft tissue cutting device and methods of use

Inventors

Barnes, Darryl E. • Keenan, Aaron • Smith, Jay • Arnal, Kevin • Schlick, Sara

Assignees

Mayo Clinic in Florida • Sonex Health Inc

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Publication Number

US-12064136-B2

Patent

Publication Date

2024-08-20

Expiration Date


Abstract

A soft tissue cutting device and methods of cutting soft tissue are disclosed. The soft tissue cutting device includes a blade having a blade working end. One or more balloons are disposed in proximity of the blade working end, and an inflation assembly configured inflate the one or more balloons is included. The inflation assembly includes a fill port in fluid communication with a bellows, and the one or more balloons.

Core Innovation

The invention relates to a tray system for shipping, storing, and priming a soft tissue cutting device used for transverse carpal ligament release. The tray system includes a tray body and a sterile removable cover and provides dedicated housing for the device and associated priming components. Dedicated slots in the tray are arranged to support a balloon activation lever in an extended position and to enable priming with a priming syringe via a fill port using an intermediate lever position.

A safety/priming verification structure is included in the tray system by a safety slot whose width is configured to determine whether the balloon-inflated distal end rests correctly or falls into the safety slot when underinflated. The tray includes receiving structures such as a priming slot and a safety slot to support proper priming verification.

The disclosed device includes balloons on the shaft and a bellows in fluid communication with the balloons in the handle. The bellows includes a body and a spring-biased plunger, and a balloon activation lever coupled with the handle and pivotably coupled with the spring-biased plunger is configured to move from an extended position to a depressed position to activate the bellows and inflate the one or more balloons. The lever is further configured to deflate the one or more balloons by moving from the depressed position back to the extended position and pulling gas or a fluid from the balloons into the bellows.

The invention also describes blade deployment behavior and optional features associated with the soft tissue cutting device. A blade deployment action is provided via a slider button that moves the blade through a distal slot toward an active position, and balloon inflation state is used to enable or condition blade movement as described. The disclosed device structure further includes optional echogenicity and an axial depth indicator, together with balloon locking of the lever in an inflated state and blade-related geometry such as a slot in a distal end.

Claims Coverage

The independent claim set defines a soft tissue cutting device having a balloon-inflatable system actuated by a pivoting activation lever that moves a spring-biased plunger to inflate and deflate one or more balloons. Additional independent refinements include conditional blade deployment, balloon activation lever locking, variable-elevation blade guideway geometry, and configuration sizing for transverse carpal ligament cutting.

Balloon inflation and deflation via pivoting activation lever

A balloon activation lever coupled with the handle and pivotably coupled with the spring-biased plunger of the bellows, wherein the balloon activation lever is configured to move from an extended position to a depressed position to move the spring-biased plunger toward a distal end of the shaft to activate the bellows and thus inflate the one or more balloons, and wherein the balloon activation lever is configured to deflate the one or more balloons by moving from the depressed position to the extended position and thus pulling a gas or a fluid from the one or more balloons into the bellows.

Slider-driven blade movement from inactive to active position

A handle slider coupled to the blade shaft that moves the blade from an inactive position inside the shaft to an active position at least partially outside the shaft.

Conditional blade actuation tied to balloon inflation

The slider moves the blade from the inactive position to the active position only when the one or more balloons are inflated.

Balloon activation lever locking in depressed position

A balloon lock on the handle that holds the balloon activation lever in a depressed position.

Variable-elevation blade guideway in the shaft

A blade guideway in the shaft with a variable-elevation track that raises and lowers the blade along the length of the shaft, including at least one incline and a plateau.

Transverse carpal ligament sized soft tissue cutting device

The soft tissue cutting device is configured in size and shape to function as a transverse carpal ligament cutting device.

Across the independent claim set, the inventive core is the balloon-inflatable system actuated by an activation lever that moves a spring-biased plunger to inflate and deflate balloons. Additional independent refinements emphasize controlled blade deployment via a slider, balloon inflation-conditioned movement, balloon activation lever locking, and specific blade guideway geometry, with the device configured for transverse carpal ligament cutting.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Shipping, storing, and priming a soft tissue cutting device used for transverse carpal ligament release.

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