Tray for a soft tissue cutting device and methods of use
Inventors
Barnes, Darryl E. • Keenan, Aaron • Smith, Jay • Arnal, Kevin • Schlick, Sara
Assignees
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Publication Number
US-12336732-B2
Publication Date
2025-06-24
Expiration Date
Abstract
Methods of using a soft tissue cutting device are disclosed. The methods include providing the soft tissue cutting device, positioning the soft tissue cutting device in a priming slot of a tray configured for receiving and holding the soft tissue cutting device, attaching a priming syringe to the soft tissue cutting device, priming a balloon disposed on a distal end of the soft tissue cutting device by equalizing a first pressure inside the balloon to a second pressure inside the priming syringe, removing the soft tissue cutting device from the priming slot, and positioning the distal end of the soft tissue cutting device on a safety slot included in the tray to determine whether the tissue cutting device has been properly primed.
Core Innovation
The disclosed invention is directed to a method for cutting a transverse carpal ligament in a patient using a soft tissue cutting device. The method includes advancing a distal end of a shaft into a carpal tunnel, depressing a balloon activation lever on a handle of the soft tissue cutting device to activate a bellows, and inflating two balloons on either side of the shaft.
After inflating the two balloons, the method activates a locking mechanism on the balloon activation lever to lock the two balloons in an inflated state. A blade is then deployed out of the shaft and placed between the two balloons to cut the transverse carpal ligament, followed by moving the blade back inside the shaft, unlocking the locking mechanism, deflating the two balloons, and removing the shaft from the patient.
The described system further includes a tray-based workflow for shipping, priming, and verifying the soft-tissue cutting device. The tray includes a housing slot for storage, a priming slot for priming using a priming syringe, and a safety slot used as a mechanical pass/fail check based on balloon inflation.
When properly primed, the distal end width is larger than the safety-slot width so the device rests above the slot with a distal top portion protruding, and when underinflated the device falls into the safety slot and does not protrude. The tray workflow is supported by device components that include a balloon activation lever having intermediate, depressed, and extended positions, balloon locking using a spring-biased button or pin engaging a groove, an inflation assembly with bellows and a spring-biased plunger, and blade deployment with a slider mechanism and a blade working end and slot on the shaft.
Claims Coverage
The independent claim covers a method sequence for cutting the transverse carpal ligament using balloon inflation, locking, blade deployment between balloons, blade retraction, unlocking, balloon deflation, and removing the shaft. The dependent claims refine the method with priming via a fill port and gas or fluid transfer to a bellows, placement verification relative to anatomical structures prior to balloon inflation, blade deployment by a slider button along a handle and through a guideway and slot, and locking mechanism behavior using a spring-biased button or pin and groove, including automatic activation and unlocking relationships.
Balloon-inflated placement for transverse carpal ligament cutting
Advancing a distal end of a shaft into a carpal tunnel; depressing a balloon activation lever to activate a bellows and inflate two balloons on either side of the shaft; locking the two balloons in an inflated state; deploying a blade out of the shaft between the two balloons to cut the transverse carpal ligament; moving the blade back inside the shaft; unlocking the locking mechanism; deflating the two balloons; and removing the shaft from the patient.
Priming via fill port and bellows transfer prior to advancement
Priming a soft tissue cutting device by filling two balloons with gas or fluid through a fill port and moving the balloon activation lever to an extended position to transfer the gas or fluid from the balloons into a bellows before advancing the distal end of the shaft.
Placement verification relative to anatomical structures before inflating balloons
Verifying the placement of the distal end of the shaft of a soft tissue cutting device relative to anatomical structures before inflating two balloons.
Blade deployment using a slider button and blade guideway within the shaft
Deploying a blade from within a shaft by moving a slider button coupled to the proximal end of the blade along a handle so the blade slides along a blade guideway within the shaft and the working end protrudes from a slot on the shaft.
Spring-biased pin/button locking using a groove on the handle
Activating a locking mechanism with a spring-biased button where a pin fitting engages a groove on the handle upon depressing a balloon activation lever, thereby locking the balloons in an inflated state.
Automatic unlocking relationship between depressing the balloon activation lever and blade unlocking
Depressing a balloon activation lever automatically activates a locking mechanism that unlocks a blade.
Across the independent method claim and its dependents, the inventive coverage centers on inflating and locking two balloons on either side of a shaft to position a blade between the balloons for cutting a transverse carpal ligament, with refinements including a fill-port priming and bellows transfer sequence, anatomical placement verification, specific blade deployment via a slider, guideway, and slot, and a spring-biased pin or button locking mechanism using a handle groove with defined actuation relationships.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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