# US 11,439,749 B2 · Apparatus and method for trans-round window membrane drug delivery

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- Number: US 11,439,749 B2
- Document ID: US11439749B2
- Status: Granted
- Kind: B2
- Application number: 16/169,498
- Filed: 2018-10-24
- Published: 2019-04-25
- Granted: 2022-09-13
- Earliest claimed: 2017-10-25
- Assignees: The Charles Stark Draper Laboratory, Inc.
- Applicants: The Charles Stark Draper Laboratory, Inc.
- Inventors: Marcello Peppi; Vishal Tandon
- Web page: https://patentgrep.com/patent/US11439749B2

## CPC

- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- 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)
- A61M 1/85: {with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208)}
- A61M 5/14276: {specially adapted for implantation}
- A61M 5/145: using pressurised reservoirs, e.g. by means of pistons
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- 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)}
- 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

The present solution provides trans-round window membrane (RWM) drug delivery. As an overview, the system can include a micropump that is connected to a flexible cannula. The cannula can include a stiffened and sharpened tip to facilitate insertion through the RWM. The cannula can be inserted through the RWM to improve the distribution of the delivered drug throughout the inner ear. The present solution can function as a small implantable or wearable device that can be used for both chronic and acute trans-RWM drug delivery. With this configuration, the micropump can constantly or intermittently deliver, over a period of days to months, small volumes of drugs from an internal reservoir.

## Claims

### Claim 1

A system to deliver a fluid to the inner ear, comprising:
a micropump configured for implantation in a patient, the micropump comprising:
at least one first layer comprising a drug reservoir configured to store a compound, a fluid storage capacitor, and a plurality of channels between the drug reservoir and the fluid storage capacitor;
at least one second layer comprising a pump coupled with a reservoir inlet of the drug reservoir to pump the compound from the drug reservoir through a reservoir outlet of the drug reservoir through an outlet of the micropump; and
a membrane separating the at least one first layer from the at least one second layer; and
a cannula comprising:
a first end coupled with the outlet of the micropump; and
a second end comprising a stopper configured to seat into a round window and enable a tip of the cannula to be inserted through a round window membrane and into a cochlea of the patient a predetermined distance.

### Claim 2 (depends on 1)

The system of claim 1, wherein the pump is configured to inject a predetermined volume of the compound into the cochlea.

### Claim 3 (depends on 2)

System of claim 2, wherein the pump is configured to withdraw at least a portion of the predetermined volume of a fluid from the cochlea after injecting the predetermined volume of the compound into the cochlea.

### Claim 4 (depends on 1)

The system of claim 1, wherein the pump is configured to store the at least a portion of the predetermined volume of the fluid from the cochlea in the fluid storage capacitor.

### Claim 5 (depends on 1)

The system of claim 1, wherein the tip of the cannula comprises a beveled tip configured to pierce the round window membrane.

### Claim 6 (depends on 1)

The system of claim 1, further comprising a silicone-based glue to secure the cannula.

### Claim 7 (depends on 1)

The system of claim 1, wherein the cannula comprises a first portion comprising polyetheretherketone and a second portion comprising polytetrafluoroethylene.

### Claim 8 (depends on 7)

The system of claim 7, wherein the second portion comprises the tip of the cannula.

### Claim 9 (depends on 7)

The system of claim 7, wherein the second portion is between about 2 cm and about 5 cm long.

### Claim 10 (depends on 7)

The system of claim 7, wherein a stiffness of the second portion is greater than a stiffness of the first portion.

### Claim 11 (depends on 1)

The system of claim 1, wherein the cannula has an inner diameter of between about 15 μm and about 150 μm.

### Claim 12 (depends on 1)

The system of claim 1, wherein the cannula tip comprises a bevel between about 10 degrees and about 45 degrees.

### Claim 13 (depends on 1)

The system of claim 1, wherein the drug reservoir is etched into the at least one first layer, and the fluid storage capacitor is a cylinder formed in the at least one first layer.

### Claim 14 (depends on 1)

The system of claim 1, comprising a plurality of fluid storage capacitors in line with the plurality of channels and the drug reservoir, wherein the plurality of fluid storage capacitors comprises the fluid storage capacitor.
