# US 2019/0167481 A1 · Nitinol tympanostomy tube

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- Number: US 2019/0167481 A1
- Document ID: US20190167481A1
- Status: Published application
- Kind: A1
- Application number: 16/267,729
- Filed: 2019-02-05
- Published: 2019-06-06
- Earliest claimed: 2012-07-05
- Assignees: Ear Tech, LLC
- Applicants: Ear Tech, LLC
- Inventors: Michael H. Fritsch
- Web page: https://patentgrep.com/patent/US20190167481A1

## CPC

- A61F 11/202: {Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor}
- A61F 11/00: Methods or devices for treatment of the ears or hearing sense (implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00); Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand (headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A tympanostomy tube includes a nitinol body having a first configuration and a second configuration. In the first configuration, the nitinol body has a first cylindrical shape defining a first end, a central region, a second end, a longitudinal axis, and a lumen extending longitudinally through the nitinol body. In the second configuration, the nitinol body is expanded and has a second cylindrical shape different than the first cylindrical shape and defines the first end, the central region, the second end, the longitudinal axis, and the lumen. A diameter of the lumen at one of the first end, the central region, and the second end is larger in the second configuration than the diameter of the lumen at the corresponding first end, central region, or second end in the first configuration.

## Claims

### Claim 1

A tympanostomy tube, including:
a nitinol body having a first configuration and a second configuration;
wherein, in the first configuration, the nitinol body has a first cylindrical shape defining a first end, a central region, a second end, a longitudinal axis, and a lumen extending longitudinally through the nitinol body;
wherein, in the second configuration, the nitinol body has a second cylindrical shape different than the first cylindrical shape and defines the first end, the central region, the second end, the longitudinal axis, and the lumen;
wherein a diameter of the lumen at one of the first end, the central region, and the second end is larger in the second configuration than the diameter of the lumen at the corresponding first end, central region, or second end in the first configuration.

### Claim 2 (depends on 1)

The tympanostomy tube of claim 1, wherein, in the first configuration, the nitinol body is scrolled, and wherein, in the second configuration, the nitinol body is un-scrolled.

### Claim 3 (depends on 2)

The tympanostomy tube of claim 2, wherein, in the first configuration, the first end defines a beveled scroll.

### Claim 4 (depends on 1)

The tympanostomy tube of claim 1, wherein the first end includes a tapered tip having a first diameter in the first configuration and a second diameter, greater than the first diameter, in the second configuration.

### Claim 5 (depends on 1)

The tympanostomy tube of claim 1, further including incisions through the second end parallel to the longitudinal axis defining tabs extending radially in the second configuration.

### Claim 6 (depends on 1)

The tympanostomy tube of claim 1, wherein, in the first configuration, the nitinol body is flattened, and wherein, in the second configuration, the nitinol body is un-flattened.

### Claim 7 (depends on 1)

The tympanostomy tube of claim 1, wherein, in the first configuration, the nitinol body is folded, and wherein, in the second configuration, the nitinol body is un-folded.

### Claim 8 (depends on 1)

The tympanostomy tube of claim 1, wherein, in the first configuration, the nitinol body is plicated, and wherein, in the second configuration, the nitinol body is un-plicated.

### Claim 9 (depends on 1)

The tympanostomy tube of claim 1, wherein, in the first configuration, the nitinol body has an imbricated accordion-like configuration, and wherein, in the second configuration, the nitinol body has a circular configuration.

### Claim 10 (depends on 1)

The tympanostomy tube of claim 1, further including a heat target grasping tab extending radially from the nitinol body at the second end thereof, wherein the heat target grasping tab absorbs heat energy and conducts it into the nitinol body.

### Claim 11

A method for inserting a tympanostomy tube, wherein the tympanostomy tube has a nitinol body, the method comprising:
providing the tympanostomy tube in a first configuration, in which the nitinol body has a first cylindrical shape defining a first end, a central region, a second end, a longitudinal axis, and a lumen extending longitudinally through the nitinol body;
inserting the tympanostomy tube through a tympanic membrane; and
transforming the tympanostomy tube, after the inserting step, from the first configuration to a second configuration in which the nitinol body has a second cylindrical shape different than the first cylindrical shape and defines the first end, the second end, the central region, the second end, the longitudinal axis, and the lumen;
wherein a diameter of the lumen at one of the first end, the central region, and the second end is larger in the second configuration than the diameter of the lumen at the corresponding first end, central region, or second end in the first configuration.

### Claim 12 (depends on 11)

The method of claim 11, wherein the transforming step includes transforming the nitinol body from a scrolled configuration to an un-scrolled configuration.

### Claim 13 (depends on 11)

The method of claim 11, further including providing the tympanostomy tube in which the first configuration in which the first end defines a beveled scroll.

### Claim 14 (depends on 11)

The method of claim 11, wherein the first end includes a tapered tip having a first diameter in the first configuration and a second diameter, greater than the first diameter, in the second configuration.

### Claim 15 (depends on 11)

The method of claim 11, further including incisions through the second end parallel to the longitudinal axis defining tabs extending radially in the second configuration.

### Claim 16 (depends on 11)

The method of claim 11, wherein the transforming step includes transforming the nitinol body from a flattened configuration to an un-flattened configuration.

### Claim 17 (depends on 11)

The method of claim 11, wherein the transforming step includes transforming the nitinol body from a folded configuration to an un-folded configuration.

### Claim 18 (depends on 11)

The method of claim 11, where the transforming step includes transforming the nitinol body from a plicated configuration to an un-plicated configuration.

### Claim 19 (depends on 11)

The method of claim 11, wherein the transforming step includes transforming the nitinol body from an imbricated accordion-like configuration to a circular configuration.

### Claim 20 (depends on 11)

The method of claim 11, further including providing a heat target grasping tab extending radially from the nitinol body at the second end thereof, wherein the heat target grasping tab absorbs heat energy and conducts it into the nitinol body.
