# US 12,004,884 B2 · Tray for a soft tissue cutting device and methods of use

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- Number: US 12,004,884 B2
- Document ID: US12004884B2
- Status: Granted
- Kind: B2
- Application number: 18/226,138
- Filed: 2023-07-25
- Published: 2023-11-16
- Granted: 2024-06-11
- Earliest claimed: 2017-10-13
- Assignees: Sonex Health, Inc.; Mayo Foundation for Medical Education and Research
- Applicants: Sonex Health, Inc.; Mayo Foundation for Medical Education and Research
- Inventors: Darryl E. Barnes; Aaron Keenan; Jay Smith; Kevin Arnal; Sara Schlick
- Web page: https://patentgrep.com/patent/US12004884B2

## CPC

- A61B 17/3209: Incision instruments
- A61B 17/320036: {adapted for use within the carpal tunnel}
- A61B 50/20: Holders specially adapted for surgical or diagnostic appliances or instruments (drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02)
- A61B 50/33: Trays
- A61M 25/10182: {Injector syringes}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2017/320048: {Balloon dissectors}
- A61B 2017/320052: {Guides for cutting instruments}
- A61B 2050/005: {with a lid or cover}
- A61B 2050/006: {perpendicular to the lid plane, e.g. by a downward movement}
- A61B 2050/3008: {having multiple compartments}
- A61B 2090/062: {penetration depth}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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.

## Claims

### Claim 1

A method for cutting a transverse carpal ligament in a hand of a patient, the method comprising:
advancing a distal end of a shaft of a device into the patient's hand below the transverse carpal ligament;
verifying a position of the distal end with an ultrasound device positioned outside the hand;
depressing a balloon activation lever on a handle of the device to activate a bellows in the handle to inflate at least one balloon coupled at or near the distal end of the shaft, wherein depressing the balloon activation lever causes a locking mechanism on the balloon activation lever to lock the balloon activation lever to the handle in a depressed position and thus lock the at least one balloon in an inflated state;
moving a blade of the device proximally along the shaft to cut the transverse carpal ligament;
positioning the blade at least partially within the shaft;
releasing the locking mechanism to release the balloon activation lever and thus allow the at least one balloon to deflate; and
removing the shaft from the hand.

### Claim 2 (depends on 1)

The method of claim 1, wherein depressing the balloon activation lever causes a spring-biased button with a pin on the balloon activation lever to move toward a groove in the handle until the pin rests within the groove to lock the balloon activation lever to the handle.

### Claim 3 (depends on 1)

The method of claim 1, wherein releasing the balloon activation lever causes gas or fluid to move from the at least one balloon into the bellows, thus deflating the at least one balloon.

### Claim 4 (depends on 2)

The method of claim 2, further comprising, before advancing the distal end of the shaft, priming the device by:
filling the at least one balloon with gas or fluid via a fill port on the handle of the device; and
releasing the balloon activation lever to cause the gas or the fluid to move from the at least one balloon into the bellows.

### Claim 5 (depends on 1)

The method of claim 1, wherein the at least one balloon comprises two balloons that expand radially outwardly from the shaft.

### Claim 6 (depends on 1)

The method of claim 1, wherein moving the blade proximally along the shaft comprises sliding a slider of the device proximally toward the handle to cause a cutting edge of the blade to extend out of an opening along a longitudinal length of the shaft.

### Claim 7 (depends on 2)

The method of claim 2, wherein releasing the locking mechanism comprises releasing the spring biased button with a thumb or other finger.