# US 11,896,763 B2 · Percutaneous dilation tracheostomy device and method of using

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- Number: US 11,896,763 B2
- Document ID: US11896763B2
- Status: Granted
- Kind: B2
- Application number: 18/055,586
- Filed: 2022-11-15
- Published: 2023-08-10
- Granted: 2024-02-13
- Earliest claimed: 2017-12-20
- Assignees: University of Maryland, Baltimore; University of Maryland, College Park
- Applicants: University of Maryland, Baltimore; University of Maryland, College Park
- Inventors: Joseph Rabin; Conor Bloomer; Paige Chan; Scott Kivitz; Peter Chen; Torrance Wang
- Web page: https://patentgrep.com/patent/US11896763B2

## CPC

- A61M 16/0472: {Devices for performing a tracheostomy}
- A61M 16/0465: {Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters}
- A61M 16/0816: {Joints or connectors}
- A61M 16/085: {Gas sampling}
- A61M 2016/0413: {with detectors of CO2 in exhaled gases}
- 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

The present invention provides an improved percutaneous dilation tracheostomy device. The device is configured to include all of the required components to perform a percutaneous tracheotomy. The device includes a retractable needle and an extendable j-wire rather than having separate components as in typical percutaneous tracheostomy devices. The device includes a dilator section to expand the diameter of a patient's stoma. The device is further configured to allow an operator to perform a bubble test to alert the user that the tube is in the trachea. In addition, the device is generally more compact than typical emergency tracheostomy devices.

## Claims

### Claim 1

A percutaneous dilation tracheostomy device comprising:
a hollow casing having an elongate cylindrical proximal section and a curved tubular distal section;
a plunger mechanism housed within the casing;
a rotatable cam positioned within the proximal section of the casing distal to the plunger mechanism;
a dilating mechanism positioned in the curved tubular distal section, mechanically coupled to the plunger mechanism;
a flexible needle coupled to the plunger mechanism and extendable out of the hollow casing; and
a lumen running from a proximal end of the proximal section to a distal tip of the distal section.

### Claim 2 (depends on 1)

The device of claim 1, the rotatable cam further comprising a j-wire catch.

### Claim 3 (depends on 2)

The device of claim 2, further comprising a flexible j-wire connected to the j-wire catch at a proximal end and extendable out of the distal tip.

### Claim 4 (depends on 1)

The device of claim 1, the rotatable cam further comprising a needle catch.

### Claim 5 (depends on 4)

The device of claim 4, wherein the flexible needle is connected to the needle catch at a proximal end and extendable out of the distal tip.

### Claim 6 (depends on 1)

The device of claim 1, wherein the plunger mechanism comprises a depressible cylindrical plunger having a proximal end and a distal end positioned within the proximal section of the casing, the plunger comprising a portion of the lumen.

### Claim 7 (depends on 1)

The device of claim 1, wherein the distal tip comprises a tapered outlet.

### Claim 8 (depends on 1)

The device of claim 1, the dilating mechanism comprising a plurality of wall members positioned on an exterior surface of the curved tubular distal section.

### Claim 9 (depends on 8)

The device of claim 8, the plurality of wall members configured to be expandable between a retracted configuration that positions each of the plurality of wall members flush against the exterior surface of the curved tubular distal section and an extended configuration that positions each of the plurality of wall members at an adjustable distance radially outward from the exterior surface of the curved tubular distal section.

### Claim 10 (depends on 9)

The device of claim 9, wherein each of the plurality of wall members is radially equidistant from the lumen in the extended configuration.

### Claim 11 (depends on 9)

The device of claim 9, the dilating mechanism further comprising a dilator column hingedly connected to a plurality of struts, each of the plurality of wall members being hingedly connected to two struts of the plurality of struts.

### Claim 12 (depends on 11)

The device of claim 11, the plunger mechanism comprising a plunger depressible to advance the dilator column in a distal direction to move the plurality of wall members from the retracted configuration to the extended configuration.

### Claim 13 (depends on 1)

The device of claim 1, further comprising an elongate flexible plunger connector positioned within the proximal section of the casing distal to the cam, extending into the distal section of the casing.

### Claim 14 (depends on 13)

The device of claim 13, wherein the elongate flexible plunger connector comprises a portion of the lumen.

### Claim 15 (depends on 1)

The device of claim 1, wherein the plunger mechanism comprises a plunger configured to rotate the cam.

### Claim 16 (depends on 1)

The device of claim 1, further comprising a side port positioned in the proximal section of the casing, the side port fluidly connected to an outlet of the distal tip.

### Claim 17 (depends on 1)

The device of claim 1, wherein the distal section of the casing has an outer diameter between 5 mm and 25 mm.

### Claim 18 (depends on 1)

The device of claim 1, wherein the dilating mechanism is configured to dilate a diameter of the curved tubular distal section by between 3 mm and 15 mm.

### Claim 19 (depends on 1)

The device of claim 1, wherein the dilating mechanism is configured to support an applied pressure of at least 15 MPa when expanded.

### Claim 20 (depends on 1)

The device of claim 1, wherein a first rotation step of the rotatable cam is configured to extend a j-wire catch and a j-wire, and to retract a needle catch and the needle.
