# US 2014/0194891 A1 · System and method for the simultaneous automated bilateral delivery of pressure equalization tubes

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- Number: US 2014/0194891 A1
- Document ID: US20140194891A1
- Status: Published application
- Kind: A1
- Application number: 14/221,470
- Filed: 2014-03-21
- Published: 2014-07-10
- Earliest claimed: 2007-04-19
- Assignees: Acclarent, Inc.
- Applicants: Acclarent, Inc.
- Inventors: Erik J. Shahoian
- Web page: https://patentgrep.com/patent/US20140194891A1

## CPC

- A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008})
- A61B 1/00082: {Balloons}
- A61B 1/227: for ears, i.e. otoscopes
- A61B 5/0077: {Devices for viewing the surface of the body, e.g. camera, magnifying lens}
- A61F 11/202: {Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor}
- A61N 1/30: Apparatus for iontophoresis, {i.e. transfer of media in ionic state by an electromotoric force into the body}, or cataphoresis
- A61N 1/306: {Arrangements where at least part of the apparatus is introduced into the body}
- A61B 2017/00787: {Surgery of the ear}
- A61F 2230/0039: H-shaped
- A61F 2230/0052: T-shaped
- A61F 2250/0039: differing in diameter
- A61F 2250/0082: specially designed for children, e.g. having means for adjusting to their growth
- A61M 2210/0662: Ears
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Systems and methods for treating a patient having a head with a first ear and a second ear, function by aligning a first device with a tympanic membrane of the first ear; inputting a command to an input device operatively coupled to the first device to generate a signal; and actuating the first device in response to the signal so as to drive a penetrator of the device through the tympanic membrane.

## Claims

### Claim 1

A method for treating a patient, the patient having a head with a first ear and a second ear, the method comprising:
aligning a first device with a tympanic membrane of the first ear;
inputting a command to an input device operatively coupled to the first device to generate a signal; and
actuating the first device in response to the signal so as to drive a penetrator of the device through the tympanic membrane.

### Claim 2 (depends on 1)

The method of claim 1, wherein the input device is movably coupled to the first device so as to isolate a command movement and inhibit deviation from the alignment.

### Claim 3 (depends on 1)

The method of claim 1, further comprising:
aligning a second device with a tympanic membrane of the second ear; and
actuating the second device in response to the signal so as to drive a penetrator of the device through the tympanic membrane of the second ear, penetration of the tympanic membranes being synchronized by circuitry coupling the input device to the devices.

### Claim 4 (depends on 1)

The method of claim 1, further comprising deploying a tympanostomy tube with the device, the tympanostomy tube advancing with the penetrator and the penetrator retracting back into the ear canal after releasing the tympanostomy tube.

### Claim 5 (depends on 4)

The method of claim 4, wherein the signal comprises an electrical signal, the device comprising an electromechanical mechanism effecting axial movement of the penetrator.

### Claim 6 (depends on 5)

The method of claim 5, wherein the device comprises a first spring urging the penetrator distally through the tympanic membrane and a second spring urging the tympanostomy tube free of the penetrator and the penetrator proximally of the tympanic membrane, wherein the first and second springs are restrained prior to the signal and wherein the signal effects sequential release of the first spring and the second spring.

### Claim 7 (depends on 6)

The method of claim 6, further comprising damping the axial movement of the penetrator.

### Claim 8 (depends on 6)

The method of claim 6, wherein the first and second springs are restrained by associated first and second electrically fusable members, and wherein the fusable members are coupled to the input device with a flex circuit bent around the axis.

### Claim 9 (depends on 5)

The method of claim 5, wherein the first device comprises a shape memory alloy actuator coupled to an electrical driving circuit.

### Claim 10 (depends on 1)

The method of claim 1, wherein the first device comprises a hydraulic actuator, an electromagnetic actuator, and/or a permanent magnet actuator.

### Claim 11 (depends on 4)

The method of claim 4, wherein the tympanostomy tube is radially constrained within a receptacle of the penetrator, and wherein the tympanostomy tube expands radially when released so as to inhibit expulsion.

### Claim 12 (depends on 6)

The method of claim 6, wherein the first device is contained within a housing having an axial length of less that 15 mm and a maximum transverse dimension of less than 5 mm.

### Claim 13 (depends on 1)

The method of claim 1, wherein the actuation of the penetrator has a stroke, and further comprising measuring an axial distance between the tympanic membrane and the penetrator so that the stroke penetrates the tympanic membrane by a desired amount.

### Claim 14 (depends on 1)

The method of claim 1, wherein the patient is sitting upright.

### Claim 15

A system for treating a patient, the patient having a head with a first ear and a second ear, each ear having a tympanic membrane, the system comprising:
an input device configured to generate a signal in response to entry of a command; and
a penetrator having a proximal end, a distal end, and an axis therebetween, the distal end sharpened for penetration through a tympanic membrane; and
an actuation mechanism movably supporting the penetrator and coupled with the input device, the actuation mechanism changing from a ready state to a pierce state in response to the signal so as to penetrate the tympanic membrane when aligned therewith.

### Claim 16 (depends on 15)

The system of claim 15, further comprising a support system configured for maintaining alignment between the actuation mechanism and the head of the patient, wherein the input device is movably coupled to the first device so as to isolate a command movement and inhibit deviation from the alignment.

### Claim 17 (depends on 16)

The system of claim 16, further comprising:
another penetrator alignable with a tympanic membrane of the second ear;
another actuation mechanism supporting the other penetrator, the other actuation mechanism effecting axial movement of the other penetrator in response to the signal so as to drive the other penetrator through the tympanic membrane of the second ear; and
circuitry coupling the input device to the actuation mechanisms such that penetration of the tympanic membranes is synchronized.

### Claim 18 (depends on 15)

The system of claim 15, further comprising a tympanostomy tube supported by the actuation mechansim, the tympanostomy tube advancing with the penetrator and the penetrator retracting back into the ear canal after releasing the tympanostomy tube.

### Claim 19 (depends on 18)

The system of claim 18, wherein the signal comprises an electrical signal, the actuation mechanism comprising an electromechanical mechanism configured for effecting axial movement of the penetrator.

### Claim 20 (depends on 19)

The system of claim 19, wherein the device comprises a first spring for urging the penetrator distally through the tympanic membrane and a second spring urging the tympanostomy tube free of the penetrator and the penetrator proximally, wherein the first and second springs are restrained prior to the signal and wherein the signal effects sequential release of the first spring and the second spring.
